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OBG Management is a leading publication in the ObGyn specialty addressing patient care and practice management under one cover.
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
fuckers
fuckes
fuckface
fuckfaceed
fuckfaceer
fuckfacees
fuckfaceing
fuckfacely
fuckfaces
fuckin
fuckined
fuckiner
fuckines
fucking
fuckinged
fuckinger
fuckinges
fuckinging
fuckingly
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texarkana
Vaginal hysterectomy with basic instrumentation
In the United States, gynecologic surgeons remove approximately one uterus every minute of the year.1 That rate translates to more than 525,000 hysterectomies annually in this country alone. Yet, despite the widespread availability of information on the benefits of a vaginal approach to hysterectomy, the great majority of these operations—close to 50%—are still performed via an open abdominal approach.2
As I pointed out last month in my “Update on Vaginal Hysterectomy,” the vaginal approach not only is more cosmetically pleasing than laparoscopic and robot-assisted hysterectomy (not to mention open abdominal surgery) but also has a lower complication rate.3
As I also noted, one reason for the low rate of vaginal hysterectomy may be the assumption, on the part of many gynecologic surgeons, that the techniques and tools they learned to use during training are still the only options available today. That assumption is wrong.
In this article, I describe the technique for vaginal hysterectomy using basic instru mentation. This article is based on a master class in vaginal hysterectomy produced by the AAGL and co-sponsored by the Am erican College of Obstetricians and Gynecologists and the Society of Gynecologic Surgeons. This master class offers continuing medical education credits and is avail able at http://www.aagl.org/vaghystwebinar.
For a look at innovative tools for this procedure, see my “Update on Vaginal Hysterectomy” in the September 2015 issue of this journal at obgmanagement.com.
Vaginal hysterectomy has few contraindications
Many commonly cited contraindications to the vaginal approach are not, in fact, absolute contraindications. An open or laparoscopic approach is preferred when the patient has a known cancer, of course, and when deep infiltrating endometriosis is present at the rectovaginal septum. However, previous pelvic surgery, nulliparity, an enlarged uterus, or lack of a prior vaginal delivery need not exclude the vaginal approach. Nor does a narrow introitus necessarily mandate a laparoscopic or open abdominal approach. In fact, in this article, I describe my basic technique in a patient (a cadaver) with a very narrow pubic arch, and I offer strategies for gaining some needed mobility and avoiding complications (TABLES 1 and 2).
Next month, in the November issue of OBG Management, John B. Gebhart, MD, will describe his vaginal technique for right salpingectomy with ovarian preservation, as well as his technique for right salpingo-oophorectomy.
Proper patient positioning is key
You can simplify the operation by positioning the patient so that her buttocks are over the edge of the table fairly far—at least 1 inch beyond the edge of the table for optimal exposure and greater access. If the patient is thin, it then becomes important to pad the sacrum because, when she is positioned that far off the table, all her weight comes to rest on the sacrum. In overweight patients, this is not an issue, but for thin patients, I place a bit of egg crate or gel beneath the sacrum.
For the procedure, I prefer to place my instruments on a tray that is kept on my lap. This arrangement frees the scrub technician from having to hand tools over my shoulder—and it saves time. I use a narrow, covered Mayo stand, and I place a stepstool beneath my feet to keep my knees at right angles so that things don’t slip during the operation.
Surgical technique
Choose an appropriate retractor
In a woman with a narrow introitus, I find that a posterior weighted speculum takes up too much space. Once I place a clamp on the cervix with that speculum in place, I don’t have much room to work. However, if I substitute a small Deaver retractor, which is narrower, I gain more workspace.
Inject the uterosacral ligaments
Grasp the cervix using a Jacobs vulsellum tenaculum. Use of a single tenaculum allows for much more movement than the use of instruments placed anteriorly and posteriorly. The Jacobs tenaculum obtains a better purchase on the tissue than a single tooth and is considerably less likely to tear through the tissue.
Before beginning the hysterectomy, locate the uterosacral ligaments and inject each one at its junction with the cervix, aspirating slightly before infiltrating the ligament with 0.25% to 0.50% bupivacaine with epinephrine, with dilute vasopressin mixed in. (I place 1 unit in 20 mL of the local solution.) Injection of this solution achieves 2 goals:
- improved intraoperative hemostasis
- postoperative pain relief.
Use a short needle with a needle extender attached to a control syringe rather than a spinal needle for greater control.
Enter the posterior peritoneal cavity
Before entering the peritoneal cavity, create a right angle with the Jacobs tenaculum and Deaver retractor in relation to the surgical field (FIGURE 1). This right angle is difficult to achieve when you are using a weighted speculum in a tight vagina. Once you have a right angle, tent the vaginal tissue in the midline (FIGURE 2).
In a nulliparous patient or a woman with a tight pelvis, you may discover that the peritoneum is pulled up between the uterosacral ligaments. One common pitfall arises when the surgeon, having dissected the vaginal epithelium, continues cutting into the vaginal epithelium instead of reaching into the peritoneal cavity. Palpate the tissue to ensure that there is no bowel in the way and stay at right angles while confidently grasping the peritoneum with a toothed forceps.
I like to use a bit of electrosurgery to incise the vaginal wall. I don’t begin at the cervix but incise more distally into the vaginal epithelium approximately 2 cm from the cervicovaginal junction. This strategy prevents dissection into the cervix and/or rectovaginal septum rather than the posterior
cul-de-sac (FIGURE 3).
Once the incision is made, it is possible to feel the posterior peritoneum. And as you tent the peritoneum, you can then very confidently extend the incision and enter the cavity posteriorly.
In a patient with significant adhesions such as this one, I feel around posteriorly to determine exactly where I am. One tactic I use is to release the tenaculum and regrasp the cervix with it. This allows for improved visualization and movement of the cervix as the procedure progresses. Depending on the case, it may be necessary to insert a sponge to hold bowel out of the way.
Avoid the bladder
Move the Deaver retractor to the anterior position, switch the Jacobs clamp to the anterior cervix, and pull straight down. Now that you have incised the vaginal epithelium posteriorly, the length of the cervix should be apparent to you, and you can easily determine the location of the bladder reflection.
Keep in mind that, in a postmenopausal patient, there will be fewer vaginal rugae to guide you. Place the Jacobs tenaculum as close to the midline as possible so that you can confidently grab the tissue without fear of grabbing the bladder. If you tilt the Jacobs clamp, you can feel the edge of the bladder reflection. Remember that postmenopausal patients with prolapse (or, occasionally, obese patients with cervical elongation but little actual descensus) may have altered anatomy.
You can create a bit more space in which to dissect by injecting the bupivacaine/ epinephrine solution into the vaginal epithelium. This technique also ensures that the vaginal epithelial incisions won’t bleed.
Now, tilt the Jacobs tenaculum downward and push the junction of the cervix with the bladder reflection toward you so that you have a good sense of how deeply to incise.
Once you’ve made the incision, reclamp the Jacobs tenaculum so that it holds all of that tissue, and repeat the maneuver, tilting the clamp downward and pushing the junction toward you. In this way, you create traction and countertraction, sweeping the tissue out of your way.
Always use sharp dissection. When adhesions are present, surgeons often get into trouble using blunt dissection and may inadvertently enter the bladder if they use a sponge-covered digit for dissection, because adhesions can be much denser than normal tissue. In such cases, the bladder tears open rather than the adhesions being swept away.
Consider this: You don’t need to enter the peritoneal cavity anteriorly in order to continue working on the procedure. You can safely protect the bladder throughout the case, until the very end, if necessary, in patients who have undergone multiple previous surgeries or cesarean deliveries.
Rather than enter the anterior peritoneum, I dissect as much of the vaginal epithelium as possible and place a second Deaver retractor posteriorly.
I massage the uterosacral ligament for about 10 seconds to lengthen it and create more descensus, then place a Ballantine Heaney clamp on the ligament.
Next, I cut the pedicle and suture it, maintaining a clamp on the uterosacral ligament suture so that I can use it later for repair of the vaginal cuff.
I recommend a vessel-sealing device to secure the major blood supply, but I do suture the uterosacral and round ligaments for attachment to the apex at the conclusion of the hysterectomy. I suggest that you place straight clamps to hold the uterosacral ligament sutures and curved clamps on the round ligament ties to help you keep track of what you’re doing.
I generally prefer to use a smaller vessel-sealing device, such as the LigaSure Max (Covidien), because it allows me to take very small bites of tissue. It is also less expensive because it uses a disposable electrode within a reusable Heaney-type clamp.
Many people have argued that we need to teach surgeons to suture vaginally and, for that reason, should avoid vessel sealing. My response: Why wouldn’t we want to use the very best technology available? Randomized trials have demonstrated a 50% reduction in pain relief postoperatively when we use vessel sealing.4 Less foreign material is left in the pelvis, lowering the risk of infection. And it really doesn’t matter which vessel-sealing technology you use, as long as you’re familiar with the specifics of the system you choose. Another advantage: There is no need to pass needles back and forth.
Take small bites of tissue
Because this patient has a very small uterus, a small bite of tissue will get you close to where you want to be. When you take a bite with the vessel sealer, try to protect the vaginal epithelium and vulva from the steam that is emitted. The clamp itself does not heat up, but the steam that is released from the tissue is 100° C, so place a finger between the clamp and the sidewall for protection. It is preferable to burn your own finger than to burn the patient.
Because you haven’t entered the peritoneal cavity anteriorly, it is important to ensure that you don’t take too big of a bite with the vessel sealer. Rather, stay where you know you’ve done your dissection, where things are safe.
One cardinal principle of surgery is that you shouldn’t operate where you can’t feel or see. One of the common errors in vaginal surgery is that surgeons start dissecting higher than they can see. It’s easy to get into trouble when you start pushing tissue or dissecting tissue that you can’t visualize.
At this point, the anterior Deaver retractor is not essential, so I remove it. If you don’t need it, don’t use it. I try to avoid metal when I can.
If I were using suture rather than vessel sealing, I would place a Heaney clamp on the uterosacral ligament and cut. Using a clamp-cut-tie technique, I would pull on the pedicle and cut just beyond the tip of the clamp to ensure that the suture will be secure (FIGURE 4). This approach would not be appropriate during use of a vessel sealer. In that case, you would want to cut to but not beyond the tip of the clamp.
One of the skills helpful in suturing is learning to move your elbow and wrist to achieve the proper angle. Determine where you want the suture to exit the tissue, and then angle your elbow and wrist so that the suture comes out where you want it. It’s easy to lose track of the needle tip, especially when you’re working in a limited space under the pubic symphysis, so use your shoulder, elbow, and wrist to control
suture placement.
Protect the anterior epithelium
Because you have not yet entered the peritoneal cavity anteriorly, it is important to protect the anterior epithelium and bladder. Reinsert a narrow Deaver retractor anteriorly, remove the Jacobs clamp, and replace the clamp laterally so that the cervix can be pulled off to the side (FIGURE 5).
One nice thing about some vessel sealers is that the surgeon can twist them in any direction. It isn’t necessary to move your hand; you simply move the device itself.
Once you have taken at least the descending branch of the uterine artery, remove the posterior retractor and pull downward on the Jacobs tenaculum. You should have reached just about to the level of the uterine fundus, with the anatomy well visualized (FIGURE 6). Next, open the anterior peritoneum.
Pay attention to the surgical field
Now that you have entered the peritoneum anteriorly as well as posteriorly, identify the broad ligament, keeping in mind that the ureter is retroperitoneal, not intraperitoneal. If you were to place a clamp from the posterior leaf of the broad ligament across to the anterior leaf of the broad ligament, you would be grasping all the vessels but not the ureter. In fact, the anterior Deaver retractor is lifting both ureters up and out of the way. If you pull the cervix off to the opposite side, you create an additional couple of centimeters—a safe space for the vessel sealer
(FIGURE 7).
In placing the vessel sealer, there is no need to move out laterally, as there is no need for space to place suture. Instead, hug the uterus. At this point, the main concern is the risk of damaging any small bowel behind the uterine fundus that might be coming down into the surgical field, obscured from vision. And because there may be steam emitted at the tip of the vessel-sealing clamp, keep a finger back there to protect anything that might be in the field.
Last steps
Before taking the last bite of tissue on the right-hand side, place the round ligament in a Heaney clamp. Now that the round and utero-ovarian ligaments have been skeletonized, you can grasp the pedicle in a clamp. If the pedicle is especially thick, it may be beneficial to close the clamp, leave it on for a few seconds, and then reapply it. In that way, you obtain a better purchase.
Next, free the rest of the tissue with a vessel sealer, or cut it. I prefer to use a vessel sealer, and I again protect the adjacent tissue with my fingers anteriorly and posteriorly.
With the clamp remaining on the round ligament and utero-ovarian ligament
(FIGURE 8), which will be sutured, push the uterine tissue out of the way, back into the pelvis, to make room for suturing.
Because a postmenopausal vulva may be cut by the suture, it’s important to take pains not to abrade that tissue. Once you have finished suturing the round/utero-ovarian pedicle, leave the needle on the suture so that you can reconnect the round ligament to the anterior pubocervical ring to reconstruct the vaginal apex. For safekeeping, clamp the needle out of the way and tuck it beneath the drape.
Switching to the other side, use a Lahey clamp to flip the uterus, then clamp the pedicle and use the vessel sealer to separate it, again protecting the tissue beneath and ahead of the clamp. Sometimes, with an especially thick pedicle, the vessel sealer will signal that the tissue hasn’t been completely sealed. In that case, get another purchase of the pedicle, protect the adjacent tissue, and seal again.
Once the uterus has been removed completely, suture the utero-ovarian and round ligament on this side.
One tip to aid in the placement of suture is to move your clamped tissue in such a way as to prevent inadvertent suturing of other tissue (FIGURE 9).
An additional strategy for pain relief at this point is to infiltrate the round ligaments with local anesthetic. We know that we’re working with higher-level fibers—T10 to T12—through the round ligaments. By infiltrating them with anesthetic, you achieve denser pain relief for post- operative management.
Uterine reduction strategies facilitate vaginal removal of tissue
When the uterus is too large to remove intact through the vagina, there are a number of techniques for coring, wedging, and morcellating the tissue. As always, a complete knowledge of anatomy is essential, as well as an understanding that fibroids can frequently distort the uterus, twisting it to the left or right. It is important to anticipate such distortion to avoid the inadvertent destruction of anatomic landmarks or damage to the adnexae.
One straight-forward strategy is to debulk the uterus using a knife to core it, removing the central portion. In cases in which you need to keep the entire endometrial cavity intact, you can core the central portion of the uterus while grasping the cervix so that you can remove the endometrium intact for the pathologist (FIGURE).
For this strategy it is important to protect the vaginal sidewalls with metal. You can use another retractor to do that, pulling down on the cervix and beginning the morcellation. I generally prefer to use a short knife handle only because I want to be sure I’m not tempted to cut any higher than I can see.
For more on coring and wedging techniques, see the introductory video for the ACOG/SGS/AAGL master class on vaginal hysterectomy at http://www.aagl.org/vaghystwebinar.
Close the vaginal cuff
The reconstruction of the vaginal cuff is a critical component of any hysterectomy. My approach is to reattach the uterosacral ligaments to the posterior cuff and the round ligaments to the anterior cuff, thereby re- creating an intact pubocervical ring. It is not necessary to include the peritoneum in the cuff closure. In fact, kinking of the ureters is more likely when the peritoneum is closed.
Attach one uterosacral ligament, then place a running, full-thickness stitch across the posterior cuff, and attach the uterosacral ligament on the opposite side. Use the needle you left attached to the round ligament to bring the right pedicle to the anterior cuff at 10 o’clock (be sure you grasp the full thickness of the vaginal epithelium without compromising the bladder). Attach the left round-ligament pedicle at the 2 o’clock position. Then close the cuff side to side down to the uterosacral ligaments. This completely reconstructs the pubocervical ring and provides excellent support at the apex.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Brigham and Women’s Hospital. Minimally Invasive Gynecologic Surgery: Hysterectomy Options. http://www .brighamandwomens.org/Departments_and_Services/obgyn /services/mininvgynsurg/mininvoptions/hysterectomy.aspx. Published October 3, 2014. Accessed September 2, 2015.
- American Congress of Obstetricians and Gynecologists. 2011 Women’s Health Stats & Facts. Washington, DC: ACOG; 2011. http://www.acog.org/~/media/NewsRoom/MediaKit.pdf. Accessed August 6, 2015.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 444: Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009; 114(5):1156–1158.
- Silva-Filho AL, Rodrigues AM, Vale de Castro Monteiro M, et al. Randomized study of bipolar vessel sealing system versus conventional suture ligature for vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2009;146(2):200–203.
In the United States, gynecologic surgeons remove approximately one uterus every minute of the year.1 That rate translates to more than 525,000 hysterectomies annually in this country alone. Yet, despite the widespread availability of information on the benefits of a vaginal approach to hysterectomy, the great majority of these operations—close to 50%—are still performed via an open abdominal approach.2
As I pointed out last month in my “Update on Vaginal Hysterectomy,” the vaginal approach not only is more cosmetically pleasing than laparoscopic and robot-assisted hysterectomy (not to mention open abdominal surgery) but also has a lower complication rate.3
As I also noted, one reason for the low rate of vaginal hysterectomy may be the assumption, on the part of many gynecologic surgeons, that the techniques and tools they learned to use during training are still the only options available today. That assumption is wrong.
In this article, I describe the technique for vaginal hysterectomy using basic instru mentation. This article is based on a master class in vaginal hysterectomy produced by the AAGL and co-sponsored by the Am erican College of Obstetricians and Gynecologists and the Society of Gynecologic Surgeons. This master class offers continuing medical education credits and is avail able at http://www.aagl.org/vaghystwebinar.
For a look at innovative tools for this procedure, see my “Update on Vaginal Hysterectomy” in the September 2015 issue of this journal at obgmanagement.com.
Vaginal hysterectomy has few contraindications
Many commonly cited contraindications to the vaginal approach are not, in fact, absolute contraindications. An open or laparoscopic approach is preferred when the patient has a known cancer, of course, and when deep infiltrating endometriosis is present at the rectovaginal septum. However, previous pelvic surgery, nulliparity, an enlarged uterus, or lack of a prior vaginal delivery need not exclude the vaginal approach. Nor does a narrow introitus necessarily mandate a laparoscopic or open abdominal approach. In fact, in this article, I describe my basic technique in a patient (a cadaver) with a very narrow pubic arch, and I offer strategies for gaining some needed mobility and avoiding complications (TABLES 1 and 2).
Next month, in the November issue of OBG Management, John B. Gebhart, MD, will describe his vaginal technique for right salpingectomy with ovarian preservation, as well as his technique for right salpingo-oophorectomy.
Proper patient positioning is key
You can simplify the operation by positioning the patient so that her buttocks are over the edge of the table fairly far—at least 1 inch beyond the edge of the table for optimal exposure and greater access. If the patient is thin, it then becomes important to pad the sacrum because, when she is positioned that far off the table, all her weight comes to rest on the sacrum. In overweight patients, this is not an issue, but for thin patients, I place a bit of egg crate or gel beneath the sacrum.
For the procedure, I prefer to place my instruments on a tray that is kept on my lap. This arrangement frees the scrub technician from having to hand tools over my shoulder—and it saves time. I use a narrow, covered Mayo stand, and I place a stepstool beneath my feet to keep my knees at right angles so that things don’t slip during the operation.
Surgical technique
Choose an appropriate retractor
In a woman with a narrow introitus, I find that a posterior weighted speculum takes up too much space. Once I place a clamp on the cervix with that speculum in place, I don’t have much room to work. However, if I substitute a small Deaver retractor, which is narrower, I gain more workspace.
Inject the uterosacral ligaments
Grasp the cervix using a Jacobs vulsellum tenaculum. Use of a single tenaculum allows for much more movement than the use of instruments placed anteriorly and posteriorly. The Jacobs tenaculum obtains a better purchase on the tissue than a single tooth and is considerably less likely to tear through the tissue.
Before beginning the hysterectomy, locate the uterosacral ligaments and inject each one at its junction with the cervix, aspirating slightly before infiltrating the ligament with 0.25% to 0.50% bupivacaine with epinephrine, with dilute vasopressin mixed in. (I place 1 unit in 20 mL of the local solution.) Injection of this solution achieves 2 goals:
- improved intraoperative hemostasis
- postoperative pain relief.
Use a short needle with a needle extender attached to a control syringe rather than a spinal needle for greater control.
Enter the posterior peritoneal cavity
Before entering the peritoneal cavity, create a right angle with the Jacobs tenaculum and Deaver retractor in relation to the surgical field (FIGURE 1). This right angle is difficult to achieve when you are using a weighted speculum in a tight vagina. Once you have a right angle, tent the vaginal tissue in the midline (FIGURE 2).
In a nulliparous patient or a woman with a tight pelvis, you may discover that the peritoneum is pulled up between the uterosacral ligaments. One common pitfall arises when the surgeon, having dissected the vaginal epithelium, continues cutting into the vaginal epithelium instead of reaching into the peritoneal cavity. Palpate the tissue to ensure that there is no bowel in the way and stay at right angles while confidently grasping the peritoneum with a toothed forceps.
I like to use a bit of electrosurgery to incise the vaginal wall. I don’t begin at the cervix but incise more distally into the vaginal epithelium approximately 2 cm from the cervicovaginal junction. This strategy prevents dissection into the cervix and/or rectovaginal septum rather than the posterior
cul-de-sac (FIGURE 3).
Once the incision is made, it is possible to feel the posterior peritoneum. And as you tent the peritoneum, you can then very confidently extend the incision and enter the cavity posteriorly.
In a patient with significant adhesions such as this one, I feel around posteriorly to determine exactly where I am. One tactic I use is to release the tenaculum and regrasp the cervix with it. This allows for improved visualization and movement of the cervix as the procedure progresses. Depending on the case, it may be necessary to insert a sponge to hold bowel out of the way.
Avoid the bladder
Move the Deaver retractor to the anterior position, switch the Jacobs clamp to the anterior cervix, and pull straight down. Now that you have incised the vaginal epithelium posteriorly, the length of the cervix should be apparent to you, and you can easily determine the location of the bladder reflection.
Keep in mind that, in a postmenopausal patient, there will be fewer vaginal rugae to guide you. Place the Jacobs tenaculum as close to the midline as possible so that you can confidently grab the tissue without fear of grabbing the bladder. If you tilt the Jacobs clamp, you can feel the edge of the bladder reflection. Remember that postmenopausal patients with prolapse (or, occasionally, obese patients with cervical elongation but little actual descensus) may have altered anatomy.
You can create a bit more space in which to dissect by injecting the bupivacaine/ epinephrine solution into the vaginal epithelium. This technique also ensures that the vaginal epithelial incisions won’t bleed.
Now, tilt the Jacobs tenaculum downward and push the junction of the cervix with the bladder reflection toward you so that you have a good sense of how deeply to incise.
Once you’ve made the incision, reclamp the Jacobs tenaculum so that it holds all of that tissue, and repeat the maneuver, tilting the clamp downward and pushing the junction toward you. In this way, you create traction and countertraction, sweeping the tissue out of your way.
Always use sharp dissection. When adhesions are present, surgeons often get into trouble using blunt dissection and may inadvertently enter the bladder if they use a sponge-covered digit for dissection, because adhesions can be much denser than normal tissue. In such cases, the bladder tears open rather than the adhesions being swept away.
Consider this: You don’t need to enter the peritoneal cavity anteriorly in order to continue working on the procedure. You can safely protect the bladder throughout the case, until the very end, if necessary, in patients who have undergone multiple previous surgeries or cesarean deliveries.
Rather than enter the anterior peritoneum, I dissect as much of the vaginal epithelium as possible and place a second Deaver retractor posteriorly.
I massage the uterosacral ligament for about 10 seconds to lengthen it and create more descensus, then place a Ballantine Heaney clamp on the ligament.
Next, I cut the pedicle and suture it, maintaining a clamp on the uterosacral ligament suture so that I can use it later for repair of the vaginal cuff.
I recommend a vessel-sealing device to secure the major blood supply, but I do suture the uterosacral and round ligaments for attachment to the apex at the conclusion of the hysterectomy. I suggest that you place straight clamps to hold the uterosacral ligament sutures and curved clamps on the round ligament ties to help you keep track of what you’re doing.
I generally prefer to use a smaller vessel-sealing device, such as the LigaSure Max (Covidien), because it allows me to take very small bites of tissue. It is also less expensive because it uses a disposable electrode within a reusable Heaney-type clamp.
Many people have argued that we need to teach surgeons to suture vaginally and, for that reason, should avoid vessel sealing. My response: Why wouldn’t we want to use the very best technology available? Randomized trials have demonstrated a 50% reduction in pain relief postoperatively when we use vessel sealing.4 Less foreign material is left in the pelvis, lowering the risk of infection. And it really doesn’t matter which vessel-sealing technology you use, as long as you’re familiar with the specifics of the system you choose. Another advantage: There is no need to pass needles back and forth.
Take small bites of tissue
Because this patient has a very small uterus, a small bite of tissue will get you close to where you want to be. When you take a bite with the vessel sealer, try to protect the vaginal epithelium and vulva from the steam that is emitted. The clamp itself does not heat up, but the steam that is released from the tissue is 100° C, so place a finger between the clamp and the sidewall for protection. It is preferable to burn your own finger than to burn the patient.
Because you haven’t entered the peritoneal cavity anteriorly, it is important to ensure that you don’t take too big of a bite with the vessel sealer. Rather, stay where you know you’ve done your dissection, where things are safe.
One cardinal principle of surgery is that you shouldn’t operate where you can’t feel or see. One of the common errors in vaginal surgery is that surgeons start dissecting higher than they can see. It’s easy to get into trouble when you start pushing tissue or dissecting tissue that you can’t visualize.
At this point, the anterior Deaver retractor is not essential, so I remove it. If you don’t need it, don’t use it. I try to avoid metal when I can.
If I were using suture rather than vessel sealing, I would place a Heaney clamp on the uterosacral ligament and cut. Using a clamp-cut-tie technique, I would pull on the pedicle and cut just beyond the tip of the clamp to ensure that the suture will be secure (FIGURE 4). This approach would not be appropriate during use of a vessel sealer. In that case, you would want to cut to but not beyond the tip of the clamp.
One of the skills helpful in suturing is learning to move your elbow and wrist to achieve the proper angle. Determine where you want the suture to exit the tissue, and then angle your elbow and wrist so that the suture comes out where you want it. It’s easy to lose track of the needle tip, especially when you’re working in a limited space under the pubic symphysis, so use your shoulder, elbow, and wrist to control
suture placement.
Protect the anterior epithelium
Because you have not yet entered the peritoneal cavity anteriorly, it is important to protect the anterior epithelium and bladder. Reinsert a narrow Deaver retractor anteriorly, remove the Jacobs clamp, and replace the clamp laterally so that the cervix can be pulled off to the side (FIGURE 5).
One nice thing about some vessel sealers is that the surgeon can twist them in any direction. It isn’t necessary to move your hand; you simply move the device itself.
Once you have taken at least the descending branch of the uterine artery, remove the posterior retractor and pull downward on the Jacobs tenaculum. You should have reached just about to the level of the uterine fundus, with the anatomy well visualized (FIGURE 6). Next, open the anterior peritoneum.
Pay attention to the surgical field
Now that you have entered the peritoneum anteriorly as well as posteriorly, identify the broad ligament, keeping in mind that the ureter is retroperitoneal, not intraperitoneal. If you were to place a clamp from the posterior leaf of the broad ligament across to the anterior leaf of the broad ligament, you would be grasping all the vessels but not the ureter. In fact, the anterior Deaver retractor is lifting both ureters up and out of the way. If you pull the cervix off to the opposite side, you create an additional couple of centimeters—a safe space for the vessel sealer
(FIGURE 7).
In placing the vessel sealer, there is no need to move out laterally, as there is no need for space to place suture. Instead, hug the uterus. At this point, the main concern is the risk of damaging any small bowel behind the uterine fundus that might be coming down into the surgical field, obscured from vision. And because there may be steam emitted at the tip of the vessel-sealing clamp, keep a finger back there to protect anything that might be in the field.
Last steps
Before taking the last bite of tissue on the right-hand side, place the round ligament in a Heaney clamp. Now that the round and utero-ovarian ligaments have been skeletonized, you can grasp the pedicle in a clamp. If the pedicle is especially thick, it may be beneficial to close the clamp, leave it on for a few seconds, and then reapply it. In that way, you obtain a better purchase.
Next, free the rest of the tissue with a vessel sealer, or cut it. I prefer to use a vessel sealer, and I again protect the adjacent tissue with my fingers anteriorly and posteriorly.
With the clamp remaining on the round ligament and utero-ovarian ligament
(FIGURE 8), which will be sutured, push the uterine tissue out of the way, back into the pelvis, to make room for suturing.
Because a postmenopausal vulva may be cut by the suture, it’s important to take pains not to abrade that tissue. Once you have finished suturing the round/utero-ovarian pedicle, leave the needle on the suture so that you can reconnect the round ligament to the anterior pubocervical ring to reconstruct the vaginal apex. For safekeeping, clamp the needle out of the way and tuck it beneath the drape.
Switching to the other side, use a Lahey clamp to flip the uterus, then clamp the pedicle and use the vessel sealer to separate it, again protecting the tissue beneath and ahead of the clamp. Sometimes, with an especially thick pedicle, the vessel sealer will signal that the tissue hasn’t been completely sealed. In that case, get another purchase of the pedicle, protect the adjacent tissue, and seal again.
Once the uterus has been removed completely, suture the utero-ovarian and round ligament on this side.
One tip to aid in the placement of suture is to move your clamped tissue in such a way as to prevent inadvertent suturing of other tissue (FIGURE 9).
An additional strategy for pain relief at this point is to infiltrate the round ligaments with local anesthetic. We know that we’re working with higher-level fibers—T10 to T12—through the round ligaments. By infiltrating them with anesthetic, you achieve denser pain relief for post- operative management.
Uterine reduction strategies facilitate vaginal removal of tissue
When the uterus is too large to remove intact through the vagina, there are a number of techniques for coring, wedging, and morcellating the tissue. As always, a complete knowledge of anatomy is essential, as well as an understanding that fibroids can frequently distort the uterus, twisting it to the left or right. It is important to anticipate such distortion to avoid the inadvertent destruction of anatomic landmarks or damage to the adnexae.
One straight-forward strategy is to debulk the uterus using a knife to core it, removing the central portion. In cases in which you need to keep the entire endometrial cavity intact, you can core the central portion of the uterus while grasping the cervix so that you can remove the endometrium intact for the pathologist (FIGURE).
For this strategy it is important to protect the vaginal sidewalls with metal. You can use another retractor to do that, pulling down on the cervix and beginning the morcellation. I generally prefer to use a short knife handle only because I want to be sure I’m not tempted to cut any higher than I can see.
For more on coring and wedging techniques, see the introductory video for the ACOG/SGS/AAGL master class on vaginal hysterectomy at http://www.aagl.org/vaghystwebinar.
Close the vaginal cuff
The reconstruction of the vaginal cuff is a critical component of any hysterectomy. My approach is to reattach the uterosacral ligaments to the posterior cuff and the round ligaments to the anterior cuff, thereby re- creating an intact pubocervical ring. It is not necessary to include the peritoneum in the cuff closure. In fact, kinking of the ureters is more likely when the peritoneum is closed.
Attach one uterosacral ligament, then place a running, full-thickness stitch across the posterior cuff, and attach the uterosacral ligament on the opposite side. Use the needle you left attached to the round ligament to bring the right pedicle to the anterior cuff at 10 o’clock (be sure you grasp the full thickness of the vaginal epithelium without compromising the bladder). Attach the left round-ligament pedicle at the 2 o’clock position. Then close the cuff side to side down to the uterosacral ligaments. This completely reconstructs the pubocervical ring and provides excellent support at the apex.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
In the United States, gynecologic surgeons remove approximately one uterus every minute of the year.1 That rate translates to more than 525,000 hysterectomies annually in this country alone. Yet, despite the widespread availability of information on the benefits of a vaginal approach to hysterectomy, the great majority of these operations—close to 50%—are still performed via an open abdominal approach.2
As I pointed out last month in my “Update on Vaginal Hysterectomy,” the vaginal approach not only is more cosmetically pleasing than laparoscopic and robot-assisted hysterectomy (not to mention open abdominal surgery) but also has a lower complication rate.3
As I also noted, one reason for the low rate of vaginal hysterectomy may be the assumption, on the part of many gynecologic surgeons, that the techniques and tools they learned to use during training are still the only options available today. That assumption is wrong.
In this article, I describe the technique for vaginal hysterectomy using basic instru mentation. This article is based on a master class in vaginal hysterectomy produced by the AAGL and co-sponsored by the Am erican College of Obstetricians and Gynecologists and the Society of Gynecologic Surgeons. This master class offers continuing medical education credits and is avail able at http://www.aagl.org/vaghystwebinar.
For a look at innovative tools for this procedure, see my “Update on Vaginal Hysterectomy” in the September 2015 issue of this journal at obgmanagement.com.
Vaginal hysterectomy has few contraindications
Many commonly cited contraindications to the vaginal approach are not, in fact, absolute contraindications. An open or laparoscopic approach is preferred when the patient has a known cancer, of course, and when deep infiltrating endometriosis is present at the rectovaginal septum. However, previous pelvic surgery, nulliparity, an enlarged uterus, or lack of a prior vaginal delivery need not exclude the vaginal approach. Nor does a narrow introitus necessarily mandate a laparoscopic or open abdominal approach. In fact, in this article, I describe my basic technique in a patient (a cadaver) with a very narrow pubic arch, and I offer strategies for gaining some needed mobility and avoiding complications (TABLES 1 and 2).
Next month, in the November issue of OBG Management, John B. Gebhart, MD, will describe his vaginal technique for right salpingectomy with ovarian preservation, as well as his technique for right salpingo-oophorectomy.
Proper patient positioning is key
You can simplify the operation by positioning the patient so that her buttocks are over the edge of the table fairly far—at least 1 inch beyond the edge of the table for optimal exposure and greater access. If the patient is thin, it then becomes important to pad the sacrum because, when she is positioned that far off the table, all her weight comes to rest on the sacrum. In overweight patients, this is not an issue, but for thin patients, I place a bit of egg crate or gel beneath the sacrum.
For the procedure, I prefer to place my instruments on a tray that is kept on my lap. This arrangement frees the scrub technician from having to hand tools over my shoulder—and it saves time. I use a narrow, covered Mayo stand, and I place a stepstool beneath my feet to keep my knees at right angles so that things don’t slip during the operation.
Surgical technique
Choose an appropriate retractor
In a woman with a narrow introitus, I find that a posterior weighted speculum takes up too much space. Once I place a clamp on the cervix with that speculum in place, I don’t have much room to work. However, if I substitute a small Deaver retractor, which is narrower, I gain more workspace.
Inject the uterosacral ligaments
Grasp the cervix using a Jacobs vulsellum tenaculum. Use of a single tenaculum allows for much more movement than the use of instruments placed anteriorly and posteriorly. The Jacobs tenaculum obtains a better purchase on the tissue than a single tooth and is considerably less likely to tear through the tissue.
Before beginning the hysterectomy, locate the uterosacral ligaments and inject each one at its junction with the cervix, aspirating slightly before infiltrating the ligament with 0.25% to 0.50% bupivacaine with epinephrine, with dilute vasopressin mixed in. (I place 1 unit in 20 mL of the local solution.) Injection of this solution achieves 2 goals:
- improved intraoperative hemostasis
- postoperative pain relief.
Use a short needle with a needle extender attached to a control syringe rather than a spinal needle for greater control.
Enter the posterior peritoneal cavity
Before entering the peritoneal cavity, create a right angle with the Jacobs tenaculum and Deaver retractor in relation to the surgical field (FIGURE 1). This right angle is difficult to achieve when you are using a weighted speculum in a tight vagina. Once you have a right angle, tent the vaginal tissue in the midline (FIGURE 2).
In a nulliparous patient or a woman with a tight pelvis, you may discover that the peritoneum is pulled up between the uterosacral ligaments. One common pitfall arises when the surgeon, having dissected the vaginal epithelium, continues cutting into the vaginal epithelium instead of reaching into the peritoneal cavity. Palpate the tissue to ensure that there is no bowel in the way and stay at right angles while confidently grasping the peritoneum with a toothed forceps.
I like to use a bit of electrosurgery to incise the vaginal wall. I don’t begin at the cervix but incise more distally into the vaginal epithelium approximately 2 cm from the cervicovaginal junction. This strategy prevents dissection into the cervix and/or rectovaginal septum rather than the posterior
cul-de-sac (FIGURE 3).
Once the incision is made, it is possible to feel the posterior peritoneum. And as you tent the peritoneum, you can then very confidently extend the incision and enter the cavity posteriorly.
In a patient with significant adhesions such as this one, I feel around posteriorly to determine exactly where I am. One tactic I use is to release the tenaculum and regrasp the cervix with it. This allows for improved visualization and movement of the cervix as the procedure progresses. Depending on the case, it may be necessary to insert a sponge to hold bowel out of the way.
Avoid the bladder
Move the Deaver retractor to the anterior position, switch the Jacobs clamp to the anterior cervix, and pull straight down. Now that you have incised the vaginal epithelium posteriorly, the length of the cervix should be apparent to you, and you can easily determine the location of the bladder reflection.
Keep in mind that, in a postmenopausal patient, there will be fewer vaginal rugae to guide you. Place the Jacobs tenaculum as close to the midline as possible so that you can confidently grab the tissue without fear of grabbing the bladder. If you tilt the Jacobs clamp, you can feel the edge of the bladder reflection. Remember that postmenopausal patients with prolapse (or, occasionally, obese patients with cervical elongation but little actual descensus) may have altered anatomy.
You can create a bit more space in which to dissect by injecting the bupivacaine/ epinephrine solution into the vaginal epithelium. This technique also ensures that the vaginal epithelial incisions won’t bleed.
Now, tilt the Jacobs tenaculum downward and push the junction of the cervix with the bladder reflection toward you so that you have a good sense of how deeply to incise.
Once you’ve made the incision, reclamp the Jacobs tenaculum so that it holds all of that tissue, and repeat the maneuver, tilting the clamp downward and pushing the junction toward you. In this way, you create traction and countertraction, sweeping the tissue out of your way.
Always use sharp dissection. When adhesions are present, surgeons often get into trouble using blunt dissection and may inadvertently enter the bladder if they use a sponge-covered digit for dissection, because adhesions can be much denser than normal tissue. In such cases, the bladder tears open rather than the adhesions being swept away.
Consider this: You don’t need to enter the peritoneal cavity anteriorly in order to continue working on the procedure. You can safely protect the bladder throughout the case, until the very end, if necessary, in patients who have undergone multiple previous surgeries or cesarean deliveries.
Rather than enter the anterior peritoneum, I dissect as much of the vaginal epithelium as possible and place a second Deaver retractor posteriorly.
I massage the uterosacral ligament for about 10 seconds to lengthen it and create more descensus, then place a Ballantine Heaney clamp on the ligament.
Next, I cut the pedicle and suture it, maintaining a clamp on the uterosacral ligament suture so that I can use it later for repair of the vaginal cuff.
I recommend a vessel-sealing device to secure the major blood supply, but I do suture the uterosacral and round ligaments for attachment to the apex at the conclusion of the hysterectomy. I suggest that you place straight clamps to hold the uterosacral ligament sutures and curved clamps on the round ligament ties to help you keep track of what you’re doing.
I generally prefer to use a smaller vessel-sealing device, such as the LigaSure Max (Covidien), because it allows me to take very small bites of tissue. It is also less expensive because it uses a disposable electrode within a reusable Heaney-type clamp.
Many people have argued that we need to teach surgeons to suture vaginally and, for that reason, should avoid vessel sealing. My response: Why wouldn’t we want to use the very best technology available? Randomized trials have demonstrated a 50% reduction in pain relief postoperatively when we use vessel sealing.4 Less foreign material is left in the pelvis, lowering the risk of infection. And it really doesn’t matter which vessel-sealing technology you use, as long as you’re familiar with the specifics of the system you choose. Another advantage: There is no need to pass needles back and forth.
Take small bites of tissue
Because this patient has a very small uterus, a small bite of tissue will get you close to where you want to be. When you take a bite with the vessel sealer, try to protect the vaginal epithelium and vulva from the steam that is emitted. The clamp itself does not heat up, but the steam that is released from the tissue is 100° C, so place a finger between the clamp and the sidewall for protection. It is preferable to burn your own finger than to burn the patient.
Because you haven’t entered the peritoneal cavity anteriorly, it is important to ensure that you don’t take too big of a bite with the vessel sealer. Rather, stay where you know you’ve done your dissection, where things are safe.
One cardinal principle of surgery is that you shouldn’t operate where you can’t feel or see. One of the common errors in vaginal surgery is that surgeons start dissecting higher than they can see. It’s easy to get into trouble when you start pushing tissue or dissecting tissue that you can’t visualize.
At this point, the anterior Deaver retractor is not essential, so I remove it. If you don’t need it, don’t use it. I try to avoid metal when I can.
If I were using suture rather than vessel sealing, I would place a Heaney clamp on the uterosacral ligament and cut. Using a clamp-cut-tie technique, I would pull on the pedicle and cut just beyond the tip of the clamp to ensure that the suture will be secure (FIGURE 4). This approach would not be appropriate during use of a vessel sealer. In that case, you would want to cut to but not beyond the tip of the clamp.
One of the skills helpful in suturing is learning to move your elbow and wrist to achieve the proper angle. Determine where you want the suture to exit the tissue, and then angle your elbow and wrist so that the suture comes out where you want it. It’s easy to lose track of the needle tip, especially when you’re working in a limited space under the pubic symphysis, so use your shoulder, elbow, and wrist to control
suture placement.
Protect the anterior epithelium
Because you have not yet entered the peritoneal cavity anteriorly, it is important to protect the anterior epithelium and bladder. Reinsert a narrow Deaver retractor anteriorly, remove the Jacobs clamp, and replace the clamp laterally so that the cervix can be pulled off to the side (FIGURE 5).
One nice thing about some vessel sealers is that the surgeon can twist them in any direction. It isn’t necessary to move your hand; you simply move the device itself.
Once you have taken at least the descending branch of the uterine artery, remove the posterior retractor and pull downward on the Jacobs tenaculum. You should have reached just about to the level of the uterine fundus, with the anatomy well visualized (FIGURE 6). Next, open the anterior peritoneum.
Pay attention to the surgical field
Now that you have entered the peritoneum anteriorly as well as posteriorly, identify the broad ligament, keeping in mind that the ureter is retroperitoneal, not intraperitoneal. If you were to place a clamp from the posterior leaf of the broad ligament across to the anterior leaf of the broad ligament, you would be grasping all the vessels but not the ureter. In fact, the anterior Deaver retractor is lifting both ureters up and out of the way. If you pull the cervix off to the opposite side, you create an additional couple of centimeters—a safe space for the vessel sealer
(FIGURE 7).
In placing the vessel sealer, there is no need to move out laterally, as there is no need for space to place suture. Instead, hug the uterus. At this point, the main concern is the risk of damaging any small bowel behind the uterine fundus that might be coming down into the surgical field, obscured from vision. And because there may be steam emitted at the tip of the vessel-sealing clamp, keep a finger back there to protect anything that might be in the field.
Last steps
Before taking the last bite of tissue on the right-hand side, place the round ligament in a Heaney clamp. Now that the round and utero-ovarian ligaments have been skeletonized, you can grasp the pedicle in a clamp. If the pedicle is especially thick, it may be beneficial to close the clamp, leave it on for a few seconds, and then reapply it. In that way, you obtain a better purchase.
Next, free the rest of the tissue with a vessel sealer, or cut it. I prefer to use a vessel sealer, and I again protect the adjacent tissue with my fingers anteriorly and posteriorly.
With the clamp remaining on the round ligament and utero-ovarian ligament
(FIGURE 8), which will be sutured, push the uterine tissue out of the way, back into the pelvis, to make room for suturing.
Because a postmenopausal vulva may be cut by the suture, it’s important to take pains not to abrade that tissue. Once you have finished suturing the round/utero-ovarian pedicle, leave the needle on the suture so that you can reconnect the round ligament to the anterior pubocervical ring to reconstruct the vaginal apex. For safekeeping, clamp the needle out of the way and tuck it beneath the drape.
Switching to the other side, use a Lahey clamp to flip the uterus, then clamp the pedicle and use the vessel sealer to separate it, again protecting the tissue beneath and ahead of the clamp. Sometimes, with an especially thick pedicle, the vessel sealer will signal that the tissue hasn’t been completely sealed. In that case, get another purchase of the pedicle, protect the adjacent tissue, and seal again.
Once the uterus has been removed completely, suture the utero-ovarian and round ligament on this side.
One tip to aid in the placement of suture is to move your clamped tissue in such a way as to prevent inadvertent suturing of other tissue (FIGURE 9).
An additional strategy for pain relief at this point is to infiltrate the round ligaments with local anesthetic. We know that we’re working with higher-level fibers—T10 to T12—through the round ligaments. By infiltrating them with anesthetic, you achieve denser pain relief for post- operative management.
Uterine reduction strategies facilitate vaginal removal of tissue
When the uterus is too large to remove intact through the vagina, there are a number of techniques for coring, wedging, and morcellating the tissue. As always, a complete knowledge of anatomy is essential, as well as an understanding that fibroids can frequently distort the uterus, twisting it to the left or right. It is important to anticipate such distortion to avoid the inadvertent destruction of anatomic landmarks or damage to the adnexae.
One straight-forward strategy is to debulk the uterus using a knife to core it, removing the central portion. In cases in which you need to keep the entire endometrial cavity intact, you can core the central portion of the uterus while grasping the cervix so that you can remove the endometrium intact for the pathologist (FIGURE).
For this strategy it is important to protect the vaginal sidewalls with metal. You can use another retractor to do that, pulling down on the cervix and beginning the morcellation. I generally prefer to use a short knife handle only because I want to be sure I’m not tempted to cut any higher than I can see.
For more on coring and wedging techniques, see the introductory video for the ACOG/SGS/AAGL master class on vaginal hysterectomy at http://www.aagl.org/vaghystwebinar.
Close the vaginal cuff
The reconstruction of the vaginal cuff is a critical component of any hysterectomy. My approach is to reattach the uterosacral ligaments to the posterior cuff and the round ligaments to the anterior cuff, thereby re- creating an intact pubocervical ring. It is not necessary to include the peritoneum in the cuff closure. In fact, kinking of the ureters is more likely when the peritoneum is closed.
Attach one uterosacral ligament, then place a running, full-thickness stitch across the posterior cuff, and attach the uterosacral ligament on the opposite side. Use the needle you left attached to the round ligament to bring the right pedicle to the anterior cuff at 10 o’clock (be sure you grasp the full thickness of the vaginal epithelium without compromising the bladder). Attach the left round-ligament pedicle at the 2 o’clock position. Then close the cuff side to side down to the uterosacral ligaments. This completely reconstructs the pubocervical ring and provides excellent support at the apex.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Brigham and Women’s Hospital. Minimally Invasive Gynecologic Surgery: Hysterectomy Options. http://www .brighamandwomens.org/Departments_and_Services/obgyn /services/mininvgynsurg/mininvoptions/hysterectomy.aspx. Published October 3, 2014. Accessed September 2, 2015.
- American Congress of Obstetricians and Gynecologists. 2011 Women’s Health Stats & Facts. Washington, DC: ACOG; 2011. http://www.acog.org/~/media/NewsRoom/MediaKit.pdf. Accessed August 6, 2015.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 444: Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009; 114(5):1156–1158.
- Silva-Filho AL, Rodrigues AM, Vale de Castro Monteiro M, et al. Randomized study of bipolar vessel sealing system versus conventional suture ligature for vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2009;146(2):200–203.
- Brigham and Women’s Hospital. Minimally Invasive Gynecologic Surgery: Hysterectomy Options. http://www .brighamandwomens.org/Departments_and_Services/obgyn /services/mininvgynsurg/mininvoptions/hysterectomy.aspx. Published October 3, 2014. Accessed September 2, 2015.
- American Congress of Obstetricians and Gynecologists. 2011 Women’s Health Stats & Facts. Washington, DC: ACOG; 2011. http://www.acog.org/~/media/NewsRoom/MediaKit.pdf. Accessed August 6, 2015.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 444: Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009; 114(5):1156–1158.
- Silva-Filho AL, Rodrigues AM, Vale de Castro Monteiro M, et al. Randomized study of bipolar vessel sealing system versus conventional suture ligature for vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2009;146(2):200–203.
In this Article
- 5 solutions to difficult vaginal access
- The need to take small bites of tissue
- Uterine reduction strategies
Does hormone therapy reduce mortality in recently menopausal women?
Clinicians work to maximize the quality of life and longevity of every patient. For women with moderate to severe menopausal symptoms, oral estrogen therapy can improve quality of life, but at the cost of significant adverse effects. The Women’s Health Initiative (WHI) reported that for postmenopausal women with a uterus, conjugated estrogen plus medroxyprogesterone acetate (CEE+MPA) hormone therapy (HT) versus placebo significantly increased the risk of cardiovascular events (relative risk [RR], 1.13), breast cancer (RR, 1.24), stroke (RR, 1.37), deep vein thrombosis (RR, 1.87), and pulmonary embolism (RR, 1.98).1 In postmeno pausal women without a uterus, CEE HT did not increase the risk of breast cancer (RR, 0.79), compared with placebo, but it did significantly in crease the risk of cardiovascular events (RR, 1.11), stroke (RR, 1.35), deep vein thrombosis (RR, 1.48), and pulmonary embolism (RR, 1.35).1
Clinicians prescribing estrogen must individualize therapy according to its benefits and risks. An important issue that has received insufficient at tention is, “What is the effect of HT on mortality in recently menopausal women?” Here, I examine this issue.
HT reduces mortality in recently menopausal women
Pooling the results of the WHI CEE+MPA and CEE-only trials reveals that there were 70 deaths in the HT-treated groups and 98 deaths in the placebo groups among women aged 50 to 59 years.1 With 4,706 and 4,259 women alive at the conclusion of the study in the HT and placebo groups, respectively, the women in the placebo group had significantly more deaths than the women in the HT-treated groups (Fisher exact test, P = .0194, χ2 test with Yates correction, P = .0226).
Using pooled data from the WHI, the RR of death in the HT versus placebo group was estimated at 0.70 (95% confidence interval [CI], 0.51−0.96), representing approximately 5 fewer deaths per 1,000 women per 5 years of therapy.2 In women aged 60 to 69 years and 70 to 79 years there were no significant differences in death rates between the HT- and placebo-treated women.
My interpretation of these results is that HT likely is associated with a reduced risk of death in recently menopausal women, but not in women distant from menopause onset.
Cochrane review of HT and mortality
Consistent with the WHI findings, authors of a recent Cochrane meta-analysis of 19 randomized trials including 40,410 menopausal women reported that HT significantly increased the risk of stroke (RR, 1.24; 95% CI, 1.10−1.41), venous thromboembolism (RR, 1.92; 95% CI, 1.36−2.69), and pulmonary emboli (RR, 1.81; 95% CI, 1.32−2.48).3 However, among women treated with oral HT within 10 years after the start of menopause, there was a reduced risk of coronary heart disease (RR, 0.52; 95% CI, 0.29−0.96). Using data from 5 clinical trials, the Cochrane meta-analysis researchers reported that, compared with placebo, HT reduced mortality (RR, 0.70; 95% CI, 0.52−0.95).3
Results of the Cochrane meta-analysis are consistent with those of a previous meta-analysis of 19 randomized trials involving 16,000 women. In this analysis, investigators found a reduced risk of death in recently menopausal women treated with hormone therapy (RR, 0.73; 95% CI, 0.52−0.96).4
Early menopause, HT, and mortality
Authors of multiple large epidemiologic studies have reported that early menopause is associated with an increased risk of death if HT is not initiated.5−7 For example, results of a study of women in Olmsted County, Minnesota, conducted from 1950 to 1987, indicated that, for women younger than age 45 years who underwent bilateral oophorectomy, the risk of death was increased among those who did not initiate HT, compared with women who did not undergo oophorectomy (hazard ratio [HR], 1.84; 95% CI, 1.27−2.68; P = .001).7
By contrast, women younger than 45 years who underwent bilateral oophorectomy and initiated estrogen therapy did not have an increased risk of death compared with women who did not undergo oophorectomy (HR, 0.65; 95% CI, 0.30−1.41; P = .28).7 An excess number of cardiovascular events appeared to account for the increased mortality among women with early surgical menopause who did not initiate HT.
The “timing hypothesis” proposes that the initiation of HT soon after the onset of menopause is associated with beneficial cardiovascular effects, but initiation more than 10 years after the onset of menopause is not associated with beneficial cardiovascular effects. The timing hypothesis is supported by the finding that, in recently menopausal women, HT is associated with reduced carotid intima-media thickness (CIMT), compared with placebo.8 Greater CIMT thickness is associated with an increased risk of cardiovascular events.
In my experience, few primary care clinicians are aware of these data. Often, these clinicians over-emphasize the risks and withhold HT in this vulnerable group of women.
HT: Minimizing the risks of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer
Results of multiple studies have shown that certain HT regimens increase the risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer. Is it possible to prescribe HT in a way that reduces these risks?
Results of observational studies indicate that, compared with oral estrogen therapy, transdermal HT is associated with a lower risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer (TABLE).9−15
Reducing the risk of stroke caused by HT is an important goal. In a study of 15,710 women who had stroke and 59,958 control women aged 50 to 79 years, transdermal estradiol at a dose of 50 µg or less daily was not associated with an increased risk of stroke, compared with HT nonuse (rate ratio, 0.81; 95% CI, 0.62−1.05).9 Compared with HT nonuse, the use of oral estrogen (rate ratio, 1.28; 95% CI, 1.15−1.42) or transdermal estradiol 50 µg or greater daily (rate ratio, 1.89; 95% CI, 1.15−3.11) was associated with an increased risk of stroke.9
Reducing the risks of deep venous thromboembolism (VTE) and pulmonary embolism caused by HT is an important goal. In a meta-analysis of the risk of VTE with HT, compared with nonusers, oral estrogen therapy was associated with a significantly increased risk of VTE (odds ratio [OR], 2.5; 95% CI, 1.9−3.4). Compared with nonuse, transdermal estrogen therapy was not associated with an increased risk of VTE (OR, 1.2; 95% CI, 0.9−1.7).11 In a study comparing oral versus transdermal estradiol, transdermal estradiol was associated with a reduced risk of pulmonary embolism (0.46 [95% CI, 0.22−0.97]).13
Reducing the risk of breast cancer caused by HT is an important goal. Results of one study showed that the combination of oral estrogen plus synthetic progestin was associated with an increased risk of breast cancer, compared with nonuse (RR, 1.5; 95% CI, 1.1−1.9). By contrast, the combination of transdermal estradiol plus micronized progesterone was not associated with an increased risk of breast cancer, compared with nonuse (RR, 0.9; 95% CI, 0.7−1.2).15
The bottom line
In recently menopausal women with moderate to severe hot flashes, HT improves quality of life and appears to decrease mortality. However, HT with oral estrogen plus synthetic progestin is associated with an increased risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer. Compared with oral estrogen, transdermal estradiol treatment is associated with a lower risk of stroke, deep vein thrombosis, and pulmonary embolism. Compared with oral estrogen plus a synthetic progestin, transdermal estradiol plus micronized progesterone is associated with a lower risk of breast cancer. The benefits of HT are likely maximized by initiating therapy in the perimenopause transition or early in the postmenopause, and the risks are minimized by using transdermal estradiol.16−18
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended post-stopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353−1368.
- Santen RJ, Allred DC, Ardoin SP, et al. J Clin Endocrinol Metab. 2010;95(suppl 1):S1−S66.
- Boardman HM, Hartley L, Eisinga A, et al. Hormone therapy for preventing cardiovascular disease in postmenopausal women. Cochrane Database Syst Rev. 2015;3:CD002229.
- Salpeter SR, Cheng J, Thabane L, Buckley NS, Salpeter EE. Bayesian meta-analysis of hormone therapy and mortality in younger post-menopausal women. Am J Med. 2009;122(11):1016−1022.
- Gordon T, Kannel WB, Hjortland MC, McNamara PM. Menopause and coronary heart disease: The Framingham Study. Ann Intern Med. 1978;89(2):157−161.
- Stampfer MJ, Colditz GA, Willet WC, et al. Postmenopausal estrogen therapy and cardiovascular disease. Ten-year follow-up from the Nurses Health Study. N Engl J Med. 1991;325(11):756−762.
- Rivera CM, Grossardt BR, Rhodes DJ, et al. Increased cardiovascular mortality after early bilateral oophorectomy. Menopause. 2009;16(1):15−23.
- Hodis HN, Mack WJ, Shoupe D, et al. Testing the menopausal hormone therapy timing hypothesis: the early versus late intervention trial with estradiol [abstract 13283]. American Heart Association Meeting 2014. Circulation. 2014;130:A13283.
- Renoux C, Dell’Aniello S, Garbe E, Suissa S. Transdermal and oral hormone replacement therapy and the risk of stroke: a nested case-control study. BMJ. 2010;340:c2519
- Renoux C, Dell’Aniello S, Suissa S. Hormone replacement therapy and the risk of venous thromboembolism: a population-based study. J Thromb Haemost. 2010;8(5):979−986.
- Canonico M, Plu-Bureau G, Lowe GD, Scarabin PY. Hormone replacement therapy and risk of venous thromboembolism in postmenopausal women: systematic review and meta-analysis. BMJ. 2008;336(7655):1227−1231.
- Canonico M, Fournier A, Carcaillon L, et al. Postmenopausal hormone therapy and risk of idiopathic venous thromboembolism: results from the E3N cohort study. Arterioscler Thromb Vasc Biol. 2010;30(2):340−345.
- Laliberte F, Dea K, Duh MS, Kahler KH, Rolli M, Lefebvre P. Does the route of administration for estrogen hormone therapy impact the risk of venous thromboembolism? Estradiol transdermal system versus oral estrogen-only hormone therapy. Menopause. 2011;18(10):1052−1059.
- Sweetland S, Beral V, Balkwill A, et al. Venous thromboembolism risk in relation to different types of postmenopausal hormone therapy in a large prospective study. J Thromb Haemost. 2012;10(11):2277−2286.
- Fournier A, Berrino F, Riboli E, Avenel V, Clavel-Chapelon F. Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort. Int J Cancer. 2005;114(3):448−454.
- L’Hermite M. HRT optimization, using transdermal estradiol plus micronized progesterone, a safer HRT. Climacteric. 2013;16(suppl 1):44−53.
- Simon JA. What’s new in hormone replacement therapy: focus on transdermal estradiol and micronized progesterone. Climacteric. 2012;15(suppl 1):3−10.
- Mueck AO. Postmenopausal hormone replacement therapy and cardiovascular disease: the value of transdermal estradiol and micronized progesterone. Climacteric. 2012;15(suppl 1): 11−17.
Clinicians work to maximize the quality of life and longevity of every patient. For women with moderate to severe menopausal symptoms, oral estrogen therapy can improve quality of life, but at the cost of significant adverse effects. The Women’s Health Initiative (WHI) reported that for postmenopausal women with a uterus, conjugated estrogen plus medroxyprogesterone acetate (CEE+MPA) hormone therapy (HT) versus placebo significantly increased the risk of cardiovascular events (relative risk [RR], 1.13), breast cancer (RR, 1.24), stroke (RR, 1.37), deep vein thrombosis (RR, 1.87), and pulmonary embolism (RR, 1.98).1 In postmeno pausal women without a uterus, CEE HT did not increase the risk of breast cancer (RR, 0.79), compared with placebo, but it did significantly in crease the risk of cardiovascular events (RR, 1.11), stroke (RR, 1.35), deep vein thrombosis (RR, 1.48), and pulmonary embolism (RR, 1.35).1
Clinicians prescribing estrogen must individualize therapy according to its benefits and risks. An important issue that has received insufficient at tention is, “What is the effect of HT on mortality in recently menopausal women?” Here, I examine this issue.
HT reduces mortality in recently menopausal women
Pooling the results of the WHI CEE+MPA and CEE-only trials reveals that there were 70 deaths in the HT-treated groups and 98 deaths in the placebo groups among women aged 50 to 59 years.1 With 4,706 and 4,259 women alive at the conclusion of the study in the HT and placebo groups, respectively, the women in the placebo group had significantly more deaths than the women in the HT-treated groups (Fisher exact test, P = .0194, χ2 test with Yates correction, P = .0226).
Using pooled data from the WHI, the RR of death in the HT versus placebo group was estimated at 0.70 (95% confidence interval [CI], 0.51−0.96), representing approximately 5 fewer deaths per 1,000 women per 5 years of therapy.2 In women aged 60 to 69 years and 70 to 79 years there were no significant differences in death rates between the HT- and placebo-treated women.
My interpretation of these results is that HT likely is associated with a reduced risk of death in recently menopausal women, but not in women distant from menopause onset.
Cochrane review of HT and mortality
Consistent with the WHI findings, authors of a recent Cochrane meta-analysis of 19 randomized trials including 40,410 menopausal women reported that HT significantly increased the risk of stroke (RR, 1.24; 95% CI, 1.10−1.41), venous thromboembolism (RR, 1.92; 95% CI, 1.36−2.69), and pulmonary emboli (RR, 1.81; 95% CI, 1.32−2.48).3 However, among women treated with oral HT within 10 years after the start of menopause, there was a reduced risk of coronary heart disease (RR, 0.52; 95% CI, 0.29−0.96). Using data from 5 clinical trials, the Cochrane meta-analysis researchers reported that, compared with placebo, HT reduced mortality (RR, 0.70; 95% CI, 0.52−0.95).3
Results of the Cochrane meta-analysis are consistent with those of a previous meta-analysis of 19 randomized trials involving 16,000 women. In this analysis, investigators found a reduced risk of death in recently menopausal women treated with hormone therapy (RR, 0.73; 95% CI, 0.52−0.96).4
Early menopause, HT, and mortality
Authors of multiple large epidemiologic studies have reported that early menopause is associated with an increased risk of death if HT is not initiated.5−7 For example, results of a study of women in Olmsted County, Minnesota, conducted from 1950 to 1987, indicated that, for women younger than age 45 years who underwent bilateral oophorectomy, the risk of death was increased among those who did not initiate HT, compared with women who did not undergo oophorectomy (hazard ratio [HR], 1.84; 95% CI, 1.27−2.68; P = .001).7
By contrast, women younger than 45 years who underwent bilateral oophorectomy and initiated estrogen therapy did not have an increased risk of death compared with women who did not undergo oophorectomy (HR, 0.65; 95% CI, 0.30−1.41; P = .28).7 An excess number of cardiovascular events appeared to account for the increased mortality among women with early surgical menopause who did not initiate HT.
The “timing hypothesis” proposes that the initiation of HT soon after the onset of menopause is associated with beneficial cardiovascular effects, but initiation more than 10 years after the onset of menopause is not associated with beneficial cardiovascular effects. The timing hypothesis is supported by the finding that, in recently menopausal women, HT is associated with reduced carotid intima-media thickness (CIMT), compared with placebo.8 Greater CIMT thickness is associated with an increased risk of cardiovascular events.
In my experience, few primary care clinicians are aware of these data. Often, these clinicians over-emphasize the risks and withhold HT in this vulnerable group of women.
HT: Minimizing the risks of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer
Results of multiple studies have shown that certain HT regimens increase the risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer. Is it possible to prescribe HT in a way that reduces these risks?
Results of observational studies indicate that, compared with oral estrogen therapy, transdermal HT is associated with a lower risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer (TABLE).9−15
Reducing the risk of stroke caused by HT is an important goal. In a study of 15,710 women who had stroke and 59,958 control women aged 50 to 79 years, transdermal estradiol at a dose of 50 µg or less daily was not associated with an increased risk of stroke, compared with HT nonuse (rate ratio, 0.81; 95% CI, 0.62−1.05).9 Compared with HT nonuse, the use of oral estrogen (rate ratio, 1.28; 95% CI, 1.15−1.42) or transdermal estradiol 50 µg or greater daily (rate ratio, 1.89; 95% CI, 1.15−3.11) was associated with an increased risk of stroke.9
Reducing the risks of deep venous thromboembolism (VTE) and pulmonary embolism caused by HT is an important goal. In a meta-analysis of the risk of VTE with HT, compared with nonusers, oral estrogen therapy was associated with a significantly increased risk of VTE (odds ratio [OR], 2.5; 95% CI, 1.9−3.4). Compared with nonuse, transdermal estrogen therapy was not associated with an increased risk of VTE (OR, 1.2; 95% CI, 0.9−1.7).11 In a study comparing oral versus transdermal estradiol, transdermal estradiol was associated with a reduced risk of pulmonary embolism (0.46 [95% CI, 0.22−0.97]).13
Reducing the risk of breast cancer caused by HT is an important goal. Results of one study showed that the combination of oral estrogen plus synthetic progestin was associated with an increased risk of breast cancer, compared with nonuse (RR, 1.5; 95% CI, 1.1−1.9). By contrast, the combination of transdermal estradiol plus micronized progesterone was not associated with an increased risk of breast cancer, compared with nonuse (RR, 0.9; 95% CI, 0.7−1.2).15
The bottom line
In recently menopausal women with moderate to severe hot flashes, HT improves quality of life and appears to decrease mortality. However, HT with oral estrogen plus synthetic progestin is associated with an increased risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer. Compared with oral estrogen, transdermal estradiol treatment is associated with a lower risk of stroke, deep vein thrombosis, and pulmonary embolism. Compared with oral estrogen plus a synthetic progestin, transdermal estradiol plus micronized progesterone is associated with a lower risk of breast cancer. The benefits of HT are likely maximized by initiating therapy in the perimenopause transition or early in the postmenopause, and the risks are minimized by using transdermal estradiol.16−18
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Clinicians work to maximize the quality of life and longevity of every patient. For women with moderate to severe menopausal symptoms, oral estrogen therapy can improve quality of life, but at the cost of significant adverse effects. The Women’s Health Initiative (WHI) reported that for postmenopausal women with a uterus, conjugated estrogen plus medroxyprogesterone acetate (CEE+MPA) hormone therapy (HT) versus placebo significantly increased the risk of cardiovascular events (relative risk [RR], 1.13), breast cancer (RR, 1.24), stroke (RR, 1.37), deep vein thrombosis (RR, 1.87), and pulmonary embolism (RR, 1.98).1 In postmeno pausal women without a uterus, CEE HT did not increase the risk of breast cancer (RR, 0.79), compared with placebo, but it did significantly in crease the risk of cardiovascular events (RR, 1.11), stroke (RR, 1.35), deep vein thrombosis (RR, 1.48), and pulmonary embolism (RR, 1.35).1
Clinicians prescribing estrogen must individualize therapy according to its benefits and risks. An important issue that has received insufficient at tention is, “What is the effect of HT on mortality in recently menopausal women?” Here, I examine this issue.
HT reduces mortality in recently menopausal women
Pooling the results of the WHI CEE+MPA and CEE-only trials reveals that there were 70 deaths in the HT-treated groups and 98 deaths in the placebo groups among women aged 50 to 59 years.1 With 4,706 and 4,259 women alive at the conclusion of the study in the HT and placebo groups, respectively, the women in the placebo group had significantly more deaths than the women in the HT-treated groups (Fisher exact test, P = .0194, χ2 test with Yates correction, P = .0226).
Using pooled data from the WHI, the RR of death in the HT versus placebo group was estimated at 0.70 (95% confidence interval [CI], 0.51−0.96), representing approximately 5 fewer deaths per 1,000 women per 5 years of therapy.2 In women aged 60 to 69 years and 70 to 79 years there were no significant differences in death rates between the HT- and placebo-treated women.
My interpretation of these results is that HT likely is associated with a reduced risk of death in recently menopausal women, but not in women distant from menopause onset.
Cochrane review of HT and mortality
Consistent with the WHI findings, authors of a recent Cochrane meta-analysis of 19 randomized trials including 40,410 menopausal women reported that HT significantly increased the risk of stroke (RR, 1.24; 95% CI, 1.10−1.41), venous thromboembolism (RR, 1.92; 95% CI, 1.36−2.69), and pulmonary emboli (RR, 1.81; 95% CI, 1.32−2.48).3 However, among women treated with oral HT within 10 years after the start of menopause, there was a reduced risk of coronary heart disease (RR, 0.52; 95% CI, 0.29−0.96). Using data from 5 clinical trials, the Cochrane meta-analysis researchers reported that, compared with placebo, HT reduced mortality (RR, 0.70; 95% CI, 0.52−0.95).3
Results of the Cochrane meta-analysis are consistent with those of a previous meta-analysis of 19 randomized trials involving 16,000 women. In this analysis, investigators found a reduced risk of death in recently menopausal women treated with hormone therapy (RR, 0.73; 95% CI, 0.52−0.96).4
Early menopause, HT, and mortality
Authors of multiple large epidemiologic studies have reported that early menopause is associated with an increased risk of death if HT is not initiated.5−7 For example, results of a study of women in Olmsted County, Minnesota, conducted from 1950 to 1987, indicated that, for women younger than age 45 years who underwent bilateral oophorectomy, the risk of death was increased among those who did not initiate HT, compared with women who did not undergo oophorectomy (hazard ratio [HR], 1.84; 95% CI, 1.27−2.68; P = .001).7
By contrast, women younger than 45 years who underwent bilateral oophorectomy and initiated estrogen therapy did not have an increased risk of death compared with women who did not undergo oophorectomy (HR, 0.65; 95% CI, 0.30−1.41; P = .28).7 An excess number of cardiovascular events appeared to account for the increased mortality among women with early surgical menopause who did not initiate HT.
The “timing hypothesis” proposes that the initiation of HT soon after the onset of menopause is associated with beneficial cardiovascular effects, but initiation more than 10 years after the onset of menopause is not associated with beneficial cardiovascular effects. The timing hypothesis is supported by the finding that, in recently menopausal women, HT is associated with reduced carotid intima-media thickness (CIMT), compared with placebo.8 Greater CIMT thickness is associated with an increased risk of cardiovascular events.
In my experience, few primary care clinicians are aware of these data. Often, these clinicians over-emphasize the risks and withhold HT in this vulnerable group of women.
HT: Minimizing the risks of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer
Results of multiple studies have shown that certain HT regimens increase the risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer. Is it possible to prescribe HT in a way that reduces these risks?
Results of observational studies indicate that, compared with oral estrogen therapy, transdermal HT is associated with a lower risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer (TABLE).9−15
Reducing the risk of stroke caused by HT is an important goal. In a study of 15,710 women who had stroke and 59,958 control women aged 50 to 79 years, transdermal estradiol at a dose of 50 µg or less daily was not associated with an increased risk of stroke, compared with HT nonuse (rate ratio, 0.81; 95% CI, 0.62−1.05).9 Compared with HT nonuse, the use of oral estrogen (rate ratio, 1.28; 95% CI, 1.15−1.42) or transdermal estradiol 50 µg or greater daily (rate ratio, 1.89; 95% CI, 1.15−3.11) was associated with an increased risk of stroke.9
Reducing the risks of deep venous thromboembolism (VTE) and pulmonary embolism caused by HT is an important goal. In a meta-analysis of the risk of VTE with HT, compared with nonusers, oral estrogen therapy was associated with a significantly increased risk of VTE (odds ratio [OR], 2.5; 95% CI, 1.9−3.4). Compared with nonuse, transdermal estrogen therapy was not associated with an increased risk of VTE (OR, 1.2; 95% CI, 0.9−1.7).11 In a study comparing oral versus transdermal estradiol, transdermal estradiol was associated with a reduced risk of pulmonary embolism (0.46 [95% CI, 0.22−0.97]).13
Reducing the risk of breast cancer caused by HT is an important goal. Results of one study showed that the combination of oral estrogen plus synthetic progestin was associated with an increased risk of breast cancer, compared with nonuse (RR, 1.5; 95% CI, 1.1−1.9). By contrast, the combination of transdermal estradiol plus micronized progesterone was not associated with an increased risk of breast cancer, compared with nonuse (RR, 0.9; 95% CI, 0.7−1.2).15
The bottom line
In recently menopausal women with moderate to severe hot flashes, HT improves quality of life and appears to decrease mortality. However, HT with oral estrogen plus synthetic progestin is associated with an increased risk of stroke, deep vein thrombosis, pulmonary embolism, and breast cancer. Compared with oral estrogen, transdermal estradiol treatment is associated with a lower risk of stroke, deep vein thrombosis, and pulmonary embolism. Compared with oral estrogen plus a synthetic progestin, transdermal estradiol plus micronized progesterone is associated with a lower risk of breast cancer. The benefits of HT are likely maximized by initiating therapy in the perimenopause transition or early in the postmenopause, and the risks are minimized by using transdermal estradiol.16−18
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended post-stopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353−1368.
- Santen RJ, Allred DC, Ardoin SP, et al. J Clin Endocrinol Metab. 2010;95(suppl 1):S1−S66.
- Boardman HM, Hartley L, Eisinga A, et al. Hormone therapy for preventing cardiovascular disease in postmenopausal women. Cochrane Database Syst Rev. 2015;3:CD002229.
- Salpeter SR, Cheng J, Thabane L, Buckley NS, Salpeter EE. Bayesian meta-analysis of hormone therapy and mortality in younger post-menopausal women. Am J Med. 2009;122(11):1016−1022.
- Gordon T, Kannel WB, Hjortland MC, McNamara PM. Menopause and coronary heart disease: The Framingham Study. Ann Intern Med. 1978;89(2):157−161.
- Stampfer MJ, Colditz GA, Willet WC, et al. Postmenopausal estrogen therapy and cardiovascular disease. Ten-year follow-up from the Nurses Health Study. N Engl J Med. 1991;325(11):756−762.
- Rivera CM, Grossardt BR, Rhodes DJ, et al. Increased cardiovascular mortality after early bilateral oophorectomy. Menopause. 2009;16(1):15−23.
- Hodis HN, Mack WJ, Shoupe D, et al. Testing the menopausal hormone therapy timing hypothesis: the early versus late intervention trial with estradiol [abstract 13283]. American Heart Association Meeting 2014. Circulation. 2014;130:A13283.
- Renoux C, Dell’Aniello S, Garbe E, Suissa S. Transdermal and oral hormone replacement therapy and the risk of stroke: a nested case-control study. BMJ. 2010;340:c2519
- Renoux C, Dell’Aniello S, Suissa S. Hormone replacement therapy and the risk of venous thromboembolism: a population-based study. J Thromb Haemost. 2010;8(5):979−986.
- Canonico M, Plu-Bureau G, Lowe GD, Scarabin PY. Hormone replacement therapy and risk of venous thromboembolism in postmenopausal women: systematic review and meta-analysis. BMJ. 2008;336(7655):1227−1231.
- Canonico M, Fournier A, Carcaillon L, et al. Postmenopausal hormone therapy and risk of idiopathic venous thromboembolism: results from the E3N cohort study. Arterioscler Thromb Vasc Biol. 2010;30(2):340−345.
- Laliberte F, Dea K, Duh MS, Kahler KH, Rolli M, Lefebvre P. Does the route of administration for estrogen hormone therapy impact the risk of venous thromboembolism? Estradiol transdermal system versus oral estrogen-only hormone therapy. Menopause. 2011;18(10):1052−1059.
- Sweetland S, Beral V, Balkwill A, et al. Venous thromboembolism risk in relation to different types of postmenopausal hormone therapy in a large prospective study. J Thromb Haemost. 2012;10(11):2277−2286.
- Fournier A, Berrino F, Riboli E, Avenel V, Clavel-Chapelon F. Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort. Int J Cancer. 2005;114(3):448−454.
- L’Hermite M. HRT optimization, using transdermal estradiol plus micronized progesterone, a safer HRT. Climacteric. 2013;16(suppl 1):44−53.
- Simon JA. What’s new in hormone replacement therapy: focus on transdermal estradiol and micronized progesterone. Climacteric. 2012;15(suppl 1):3−10.
- Mueck AO. Postmenopausal hormone replacement therapy and cardiovascular disease: the value of transdermal estradiol and micronized progesterone. Climacteric. 2012;15(suppl 1): 11−17.
- Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended post-stopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013;310(13):1353−1368.
- Santen RJ, Allred DC, Ardoin SP, et al. J Clin Endocrinol Metab. 2010;95(suppl 1):S1−S66.
- Boardman HM, Hartley L, Eisinga A, et al. Hormone therapy for preventing cardiovascular disease in postmenopausal women. Cochrane Database Syst Rev. 2015;3:CD002229.
- Salpeter SR, Cheng J, Thabane L, Buckley NS, Salpeter EE. Bayesian meta-analysis of hormone therapy and mortality in younger post-menopausal women. Am J Med. 2009;122(11):1016−1022.
- Gordon T, Kannel WB, Hjortland MC, McNamara PM. Menopause and coronary heart disease: The Framingham Study. Ann Intern Med. 1978;89(2):157−161.
- Stampfer MJ, Colditz GA, Willet WC, et al. Postmenopausal estrogen therapy and cardiovascular disease. Ten-year follow-up from the Nurses Health Study. N Engl J Med. 1991;325(11):756−762.
- Rivera CM, Grossardt BR, Rhodes DJ, et al. Increased cardiovascular mortality after early bilateral oophorectomy. Menopause. 2009;16(1):15−23.
- Hodis HN, Mack WJ, Shoupe D, et al. Testing the menopausal hormone therapy timing hypothesis: the early versus late intervention trial with estradiol [abstract 13283]. American Heart Association Meeting 2014. Circulation. 2014;130:A13283.
- Renoux C, Dell’Aniello S, Garbe E, Suissa S. Transdermal and oral hormone replacement therapy and the risk of stroke: a nested case-control study. BMJ. 2010;340:c2519
- Renoux C, Dell’Aniello S, Suissa S. Hormone replacement therapy and the risk of venous thromboembolism: a population-based study. J Thromb Haemost. 2010;8(5):979−986.
- Canonico M, Plu-Bureau G, Lowe GD, Scarabin PY. Hormone replacement therapy and risk of venous thromboembolism in postmenopausal women: systematic review and meta-analysis. BMJ. 2008;336(7655):1227−1231.
- Canonico M, Fournier A, Carcaillon L, et al. Postmenopausal hormone therapy and risk of idiopathic venous thromboembolism: results from the E3N cohort study. Arterioscler Thromb Vasc Biol. 2010;30(2):340−345.
- Laliberte F, Dea K, Duh MS, Kahler KH, Rolli M, Lefebvre P. Does the route of administration for estrogen hormone therapy impact the risk of venous thromboembolism? Estradiol transdermal system versus oral estrogen-only hormone therapy. Menopause. 2011;18(10):1052−1059.
- Sweetland S, Beral V, Balkwill A, et al. Venous thromboembolism risk in relation to different types of postmenopausal hormone therapy in a large prospective study. J Thromb Haemost. 2012;10(11):2277−2286.
- Fournier A, Berrino F, Riboli E, Avenel V, Clavel-Chapelon F. Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort. Int J Cancer. 2005;114(3):448−454.
- L’Hermite M. HRT optimization, using transdermal estradiol plus micronized progesterone, a safer HRT. Climacteric. 2013;16(suppl 1):44−53.
- Simon JA. What’s new in hormone replacement therapy: focus on transdermal estradiol and micronized progesterone. Climacteric. 2012;15(suppl 1):3−10.
- Mueck AO. Postmenopausal hormone replacement therapy and cardiovascular disease: the value of transdermal estradiol and micronized progesterone. Climacteric. 2012;15(suppl 1): 11−17.
Innovations in patient safety for women's health: Minimally invasive gynecologic surgery
Click here to download the PDF.
Every surgeon knows that, if you operate, complications will follow. Surgeons are perfectionists and strive to reduce complications through years of diligent personal training and continuous quality improvement. Surgeons hate complications, especially those that might be preventable (such as retained foreign bodies, wrong site surgery, and medication errors).
In this special issue of OBG Management, world-renowned experts focus on topical issues in safety in minimally invasive gynecologic surgery (MIGS). In a roundtable, Drs. Neal Lonky, John Gebhart, Rosanne Kho, and Malcolm Munro discuss important issues in MIGS, including the need to prioritize the vaginal and laparoscopic routes of hysterectomy and the role of single-port surgery. In a concise yet detailed discussion of safety issues related to radiofrequency and ultrasound energy devices, Dr. Munro alerts us to the dangers of heat injury and direct and capacitative coupling. Drs. Andrew Sokol and Katelyn Smithling provide guidance on preventing apical prolapse of the vagina following hysterectomy. And Dr. Antonio Gargiulo explores the rapidly expanding role of simulation training with computer-assisted (robotic) surgical simulators and predicts that, instead of learning surgery on patients, future trainees will gain skills in a simulation environment.
We thank the master surgeons who participated in this special issue for providing guidance and helping us to reduce complications. Our patients are the beneficiaries of the wisdom provided herein.
>>Robert L. Barbieri, MD
Editor in Chief, OBG Management
To view the video, "McCall" culdoplasty technique by Mickey Karram, MD, that accompanies the article by Sokol et al in this supplement, click here.
Click here to download the PDF.
Every surgeon knows that, if you operate, complications will follow. Surgeons are perfectionists and strive to reduce complications through years of diligent personal training and continuous quality improvement. Surgeons hate complications, especially those that might be preventable (such as retained foreign bodies, wrong site surgery, and medication errors).
In this special issue of OBG Management, world-renowned experts focus on topical issues in safety in minimally invasive gynecologic surgery (MIGS). In a roundtable, Drs. Neal Lonky, John Gebhart, Rosanne Kho, and Malcolm Munro discuss important issues in MIGS, including the need to prioritize the vaginal and laparoscopic routes of hysterectomy and the role of single-port surgery. In a concise yet detailed discussion of safety issues related to radiofrequency and ultrasound energy devices, Dr. Munro alerts us to the dangers of heat injury and direct and capacitative coupling. Drs. Andrew Sokol and Katelyn Smithling provide guidance on preventing apical prolapse of the vagina following hysterectomy. And Dr. Antonio Gargiulo explores the rapidly expanding role of simulation training with computer-assisted (robotic) surgical simulators and predicts that, instead of learning surgery on patients, future trainees will gain skills in a simulation environment.
We thank the master surgeons who participated in this special issue for providing guidance and helping us to reduce complications. Our patients are the beneficiaries of the wisdom provided herein.
>>Robert L. Barbieri, MD
Editor in Chief, OBG Management
To view the video, "McCall" culdoplasty technique by Mickey Karram, MD, that accompanies the article by Sokol et al in this supplement, click here.
Click here to download the PDF.
Every surgeon knows that, if you operate, complications will follow. Surgeons are perfectionists and strive to reduce complications through years of diligent personal training and continuous quality improvement. Surgeons hate complications, especially those that might be preventable (such as retained foreign bodies, wrong site surgery, and medication errors).
In this special issue of OBG Management, world-renowned experts focus on topical issues in safety in minimally invasive gynecologic surgery (MIGS). In a roundtable, Drs. Neal Lonky, John Gebhart, Rosanne Kho, and Malcolm Munro discuss important issues in MIGS, including the need to prioritize the vaginal and laparoscopic routes of hysterectomy and the role of single-port surgery. In a concise yet detailed discussion of safety issues related to radiofrequency and ultrasound energy devices, Dr. Munro alerts us to the dangers of heat injury and direct and capacitative coupling. Drs. Andrew Sokol and Katelyn Smithling provide guidance on preventing apical prolapse of the vagina following hysterectomy. And Dr. Antonio Gargiulo explores the rapidly expanding role of simulation training with computer-assisted (robotic) surgical simulators and predicts that, instead of learning surgery on patients, future trainees will gain skills in a simulation environment.
We thank the master surgeons who participated in this special issue for providing guidance and helping us to reduce complications. Our patients are the beneficiaries of the wisdom provided herein.
>>Robert L. Barbieri, MD
Editor in Chief, OBG Management
To view the video, "McCall" culdoplasty technique by Mickey Karram, MD, that accompanies the article by Sokol et al in this supplement, click here.
My go-to Web resources for quick ICD-10 coding questions
An OBG Management reader recently requested assistance finding an app or Web site that would be helpful for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10) coding, particularly for practicing ObGyns. It is not surprising that I have received this question, as we already are seeing a ton of smartphone apps that promise to search through the code descriptions quickly. None of these apps are ObGyn-specific but, given the vast amount, deciding which one is the best option to purchase and download can be a challenge.
Purchase considerations
Before you buy, decide what features you are looking for and make sure the app you have chosen can deliver what you need. Pay special attention to any reviews to learn the app’s pros and the cons. For instance, some apps offer code conversion from ICD-9 to ICD-10. Keep in mind, however, that not all conversions are accurate, and your search may just lead you to another unspecified code. Some apps will offer a decision tree, which is ideal. What you would like to avoid is an app that generates a list of 200 codes from a single search term.
A useful resource that I have found is this Buyers Guide to Mobile ICD-10 Apps from mHealthNews.1 This guide compares and contrasts the available apps (as of March 2014) for Android and Apple products. Some, you will note, are free; others are not. Try out a few before choosing. While several companies have developed products geared for ICD-10, many are not geared for mobile use and may have a substantial purchase price. Many of them also seem to be geared toward coders, not toward physician users.
My picks
ICD-10 Search was developed by e-MDs.2 It appears that this search program is part of a more extensive product that e-MDs sells, but for the time being, is free. This app deserves a look, especially because the decision tree format quickly gets you to the most specific code.
ICD-10 Code Lookup is the official offering from the Centers for Medicare & Medicaid Services (CMS).3 After you type in the term you are looking for, you get the search results in code order. The more specific your search terms, the closer you will get to the needed code. One caveat: the search mode is not set up to accept all clinical terms. For instance, I typed in "menorrhagia" and got 0 results; I typed in “menstruation, frequent” and I received 2 codes.
I hope this information is helpful, and I wish you an easy transition from ICD-9 to ICD-10.
WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com
1. Schwartz E. Buyers guide to mobile ICD-10 apps. mHealthNews. http://www.mhealthnews.com/news/buyers-guide-mobile-icd-10-apps-smartphone-Apple-Android?page=0. Published March 24, 2014. Accessed September 16, 2015.
2. ICD-10 Search. e-MDs, Inc. http://app.icd10survivalkit.com/#tabDiagnosis. Accessed September 16, 2015.
3. Centers for Medicare & Medicaid Services. ICD-10 Code Lookup. https://www.cms.gov/medicare-coverage-database/staticpages/icd-10-code-lookup.aspx?KeyWord=follicular%20cyst&bc=AAAAAAAAAAACAA%3d%3d&. Accessed September 16, 2015.
An OBG Management reader recently requested assistance finding an app or Web site that would be helpful for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10) coding, particularly for practicing ObGyns. It is not surprising that I have received this question, as we already are seeing a ton of smartphone apps that promise to search through the code descriptions quickly. None of these apps are ObGyn-specific but, given the vast amount, deciding which one is the best option to purchase and download can be a challenge.
Purchase considerations
Before you buy, decide what features you are looking for and make sure the app you have chosen can deliver what you need. Pay special attention to any reviews to learn the app’s pros and the cons. For instance, some apps offer code conversion from ICD-9 to ICD-10. Keep in mind, however, that not all conversions are accurate, and your search may just lead you to another unspecified code. Some apps will offer a decision tree, which is ideal. What you would like to avoid is an app that generates a list of 200 codes from a single search term.
A useful resource that I have found is this Buyers Guide to Mobile ICD-10 Apps from mHealthNews.1 This guide compares and contrasts the available apps (as of March 2014) for Android and Apple products. Some, you will note, are free; others are not. Try out a few before choosing. While several companies have developed products geared for ICD-10, many are not geared for mobile use and may have a substantial purchase price. Many of them also seem to be geared toward coders, not toward physician users.
My picks
ICD-10 Search was developed by e-MDs.2 It appears that this search program is part of a more extensive product that e-MDs sells, but for the time being, is free. This app deserves a look, especially because the decision tree format quickly gets you to the most specific code.
ICD-10 Code Lookup is the official offering from the Centers for Medicare & Medicaid Services (CMS).3 After you type in the term you are looking for, you get the search results in code order. The more specific your search terms, the closer you will get to the needed code. One caveat: the search mode is not set up to accept all clinical terms. For instance, I typed in "menorrhagia" and got 0 results; I typed in “menstruation, frequent” and I received 2 codes.
I hope this information is helpful, and I wish you an easy transition from ICD-9 to ICD-10.
WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com
An OBG Management reader recently requested assistance finding an app or Web site that would be helpful for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10) coding, particularly for practicing ObGyns. It is not surprising that I have received this question, as we already are seeing a ton of smartphone apps that promise to search through the code descriptions quickly. None of these apps are ObGyn-specific but, given the vast amount, deciding which one is the best option to purchase and download can be a challenge.
Purchase considerations
Before you buy, decide what features you are looking for and make sure the app you have chosen can deliver what you need. Pay special attention to any reviews to learn the app’s pros and the cons. For instance, some apps offer code conversion from ICD-9 to ICD-10. Keep in mind, however, that not all conversions are accurate, and your search may just lead you to another unspecified code. Some apps will offer a decision tree, which is ideal. What you would like to avoid is an app that generates a list of 200 codes from a single search term.
A useful resource that I have found is this Buyers Guide to Mobile ICD-10 Apps from mHealthNews.1 This guide compares and contrasts the available apps (as of March 2014) for Android and Apple products. Some, you will note, are free; others are not. Try out a few before choosing. While several companies have developed products geared for ICD-10, many are not geared for mobile use and may have a substantial purchase price. Many of them also seem to be geared toward coders, not toward physician users.
My picks
ICD-10 Search was developed by e-MDs.2 It appears that this search program is part of a more extensive product that e-MDs sells, but for the time being, is free. This app deserves a look, especially because the decision tree format quickly gets you to the most specific code.
ICD-10 Code Lookup is the official offering from the Centers for Medicare & Medicaid Services (CMS).3 After you type in the term you are looking for, you get the search results in code order. The more specific your search terms, the closer you will get to the needed code. One caveat: the search mode is not set up to accept all clinical terms. For instance, I typed in "menorrhagia" and got 0 results; I typed in “menstruation, frequent” and I received 2 codes.
I hope this information is helpful, and I wish you an easy transition from ICD-9 to ICD-10.
WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com
1. Schwartz E. Buyers guide to mobile ICD-10 apps. mHealthNews. http://www.mhealthnews.com/news/buyers-guide-mobile-icd-10-apps-smartphone-Apple-Android?page=0. Published March 24, 2014. Accessed September 16, 2015.
2. ICD-10 Search. e-MDs, Inc. http://app.icd10survivalkit.com/#tabDiagnosis. Accessed September 16, 2015.
3. Centers for Medicare & Medicaid Services. ICD-10 Code Lookup. https://www.cms.gov/medicare-coverage-database/staticpages/icd-10-code-lookup.aspx?KeyWord=follicular%20cyst&bc=AAAAAAAAAAACAA%3d%3d&. Accessed September 16, 2015.
1. Schwartz E. Buyers guide to mobile ICD-10 apps. mHealthNews. http://www.mhealthnews.com/news/buyers-guide-mobile-icd-10-apps-smartphone-Apple-Android?page=0. Published March 24, 2014. Accessed September 16, 2015.
2. ICD-10 Search. e-MDs, Inc. http://app.icd10survivalkit.com/#tabDiagnosis. Accessed September 16, 2015.
3. Centers for Medicare & Medicaid Services. ICD-10 Code Lookup. https://www.cms.gov/medicare-coverage-database/staticpages/icd-10-code-lookup.aspx?KeyWord=follicular%20cyst&bc=AAAAAAAAAAACAA%3d%3d&. Accessed September 16, 2015.
Postpartum preeclampsia, mother dies: $6.9M settlement
Postpartum preeclampsia, mother dies: $6.9M settlement
Four days after delivery of a healthy child, a 31-year-old mother went to the emergency department (ED) reporting tightness in her chest, difficulty breathing, and swelling in her lower extremities. Pulmonary embolism was ruled out and she was discharged. When she returned 3 days later, her legs were more swollen than before and her systolic blood pressure was 160 mm Hg. She was sent home again. Four days later, she suffered a seizure at home, in the ambulance during transport, and at the hospital. She was transferred to another facility a few days later where she died a week after transfer.
Estate’s Claim The ED physicians and hospital staff were negligent in not diagnosing and treating postpartum preeclampsia. This led to seizures, brain damage, and death. Antihypertensive and antiseizure medications would have prevented her death.
Defendant’s defense The actions taken were reasonable because she had no symptoms of preeclampsia during pregnancy or delivery.
Verdict A $6.9 million Illinois settlement was reached.
Ovary not removed; cyst develops
A 38-year-old woman underwent what was planned as total hysterectomy with bilateral salpingo-oophorectomy. The procedure was prophylactic: she had been treated for stage 3 breast cancer and her family history put her at high risk for developing ovarian cancer. Two days after surgery, the pathology report noted only 1 ovary.
Two months later, the patient went to the ED with right lower quadrant pain. It was determined that she had an ovarian cyst. She underwent additional surgery to remove the right ovary.
Patient’s claim The gynecologist was negligent in failing to remove the patient’s right ovary.
Physician’s defense Failure to remove the ovary was due to the patient’s abnormal anatomy.
Verdict A $250,000 Missouri verdict was returned.
Microcephaly not detected before birth
At 19 weeks’ gestation, an ultrasonographic anatomy scan showed that both hands of the fetus were clenched tightly. Amniocentesis results were reported as normal. No further fetal testing was ordered.
At birth, the baby was found to have Dandy Walker Variant, a severe brain malformation. The child has difficulty moving, is cognitively impaired, and requires a feeding tube and 24-hour care.
Parents’ claim Seen on ultrasonography, the fetus’ clenched fists were a sign of possible fetal abnormality. The maternal-fetal medicine (MFM) specialist who evaluated the ultrasound and amniocentesis and the ObGyn should have recommended fetal magnetic resonance imaging, which would have shown the microcephaly. If the parents had known of the abnormality, they would have terminated the pregnancy.
Defendant’s defense The case was settled during trial.
Verdict A $6 million New Jersey settlement was reached, including $5 million from the MFM and $1 million from the ObGyn.
Injury during hydrothermal ablation
When a 41-year-old woman underwent hydrothermal ablation to treat menorrhagia, her uterus was perforated and hot saline solution injured her intestines. During repair surgery, 21 inches of bowel were resected and a colostomy was created, which was reversed 8 months later.
Patient’s claim The gynecologist was negligent in performing the ablation. The manufacturer produced a poorly designed device.
Defendant’s defense The rupture was spontaneous. The procedure was properly performed. The device is safe.
Verdict A $2 million Kansas verdict was returned. The gynecologist was found 60% at fault and the manufacturer was 40% at fault. The patient’s net recovery was $322,300 due to the state cap.
Postpartum preeclampsia, mother dies: $6.9M settlement
Four days after delivery of a healthy child, a 31-year-old mother went to the emergency department (ED) reporting tightness in her chest, difficulty breathing, and swelling in her lower extremities. Pulmonary embolism was ruled out and she was discharged. When she returned 3 days later, her legs were more swollen than before and her systolic blood pressure was 160 mm Hg. She was sent home again. Four days later, she suffered a seizure at home, in the ambulance during transport, and at the hospital. She was transferred to another facility a few days later where she died a week after transfer.
Estate’s Claim The ED physicians and hospital staff were negligent in not diagnosing and treating postpartum preeclampsia. This led to seizures, brain damage, and death. Antihypertensive and antiseizure medications would have prevented her death.
Defendant’s defense The actions taken were reasonable because she had no symptoms of preeclampsia during pregnancy or delivery.
Verdict A $6.9 million Illinois settlement was reached.
Ovary not removed; cyst develops
A 38-year-old woman underwent what was planned as total hysterectomy with bilateral salpingo-oophorectomy. The procedure was prophylactic: she had been treated for stage 3 breast cancer and her family history put her at high risk for developing ovarian cancer. Two days after surgery, the pathology report noted only 1 ovary.
Two months later, the patient went to the ED with right lower quadrant pain. It was determined that she had an ovarian cyst. She underwent additional surgery to remove the right ovary.
Patient’s claim The gynecologist was negligent in failing to remove the patient’s right ovary.
Physician’s defense Failure to remove the ovary was due to the patient’s abnormal anatomy.
Verdict A $250,000 Missouri verdict was returned.
Microcephaly not detected before birth
At 19 weeks’ gestation, an ultrasonographic anatomy scan showed that both hands of the fetus were clenched tightly. Amniocentesis results were reported as normal. No further fetal testing was ordered.
At birth, the baby was found to have Dandy Walker Variant, a severe brain malformation. The child has difficulty moving, is cognitively impaired, and requires a feeding tube and 24-hour care.
Parents’ claim Seen on ultrasonography, the fetus’ clenched fists were a sign of possible fetal abnormality. The maternal-fetal medicine (MFM) specialist who evaluated the ultrasound and amniocentesis and the ObGyn should have recommended fetal magnetic resonance imaging, which would have shown the microcephaly. If the parents had known of the abnormality, they would have terminated the pregnancy.
Defendant’s defense The case was settled during trial.
Verdict A $6 million New Jersey settlement was reached, including $5 million from the MFM and $1 million from the ObGyn.
Injury during hydrothermal ablation
When a 41-year-old woman underwent hydrothermal ablation to treat menorrhagia, her uterus was perforated and hot saline solution injured her intestines. During repair surgery, 21 inches of bowel were resected and a colostomy was created, which was reversed 8 months later.
Patient’s claim The gynecologist was negligent in performing the ablation. The manufacturer produced a poorly designed device.
Defendant’s defense The rupture was spontaneous. The procedure was properly performed. The device is safe.
Verdict A $2 million Kansas verdict was returned. The gynecologist was found 60% at fault and the manufacturer was 40% at fault. The patient’s net recovery was $322,300 due to the state cap.
Postpartum preeclampsia, mother dies: $6.9M settlement
Four days after delivery of a healthy child, a 31-year-old mother went to the emergency department (ED) reporting tightness in her chest, difficulty breathing, and swelling in her lower extremities. Pulmonary embolism was ruled out and she was discharged. When she returned 3 days later, her legs were more swollen than before and her systolic blood pressure was 160 mm Hg. She was sent home again. Four days later, she suffered a seizure at home, in the ambulance during transport, and at the hospital. She was transferred to another facility a few days later where she died a week after transfer.
Estate’s Claim The ED physicians and hospital staff were negligent in not diagnosing and treating postpartum preeclampsia. This led to seizures, brain damage, and death. Antihypertensive and antiseizure medications would have prevented her death.
Defendant’s defense The actions taken were reasonable because she had no symptoms of preeclampsia during pregnancy or delivery.
Verdict A $6.9 million Illinois settlement was reached.
Ovary not removed; cyst develops
A 38-year-old woman underwent what was planned as total hysterectomy with bilateral salpingo-oophorectomy. The procedure was prophylactic: she had been treated for stage 3 breast cancer and her family history put her at high risk for developing ovarian cancer. Two days after surgery, the pathology report noted only 1 ovary.
Two months later, the patient went to the ED with right lower quadrant pain. It was determined that she had an ovarian cyst. She underwent additional surgery to remove the right ovary.
Patient’s claim The gynecologist was negligent in failing to remove the patient’s right ovary.
Physician’s defense Failure to remove the ovary was due to the patient’s abnormal anatomy.
Verdict A $250,000 Missouri verdict was returned.
Microcephaly not detected before birth
At 19 weeks’ gestation, an ultrasonographic anatomy scan showed that both hands of the fetus were clenched tightly. Amniocentesis results were reported as normal. No further fetal testing was ordered.
At birth, the baby was found to have Dandy Walker Variant, a severe brain malformation. The child has difficulty moving, is cognitively impaired, and requires a feeding tube and 24-hour care.
Parents’ claim Seen on ultrasonography, the fetus’ clenched fists were a sign of possible fetal abnormality. The maternal-fetal medicine (MFM) specialist who evaluated the ultrasound and amniocentesis and the ObGyn should have recommended fetal magnetic resonance imaging, which would have shown the microcephaly. If the parents had known of the abnormality, they would have terminated the pregnancy.
Defendant’s defense The case was settled during trial.
Verdict A $6 million New Jersey settlement was reached, including $5 million from the MFM and $1 million from the ObGyn.
Injury during hydrothermal ablation
When a 41-year-old woman underwent hydrothermal ablation to treat menorrhagia, her uterus was perforated and hot saline solution injured her intestines. During repair surgery, 21 inches of bowel were resected and a colostomy was created, which was reversed 8 months later.
Patient’s claim The gynecologist was negligent in performing the ablation. The manufacturer produced a poorly designed device.
Defendant’s defense The rupture was spontaneous. The procedure was properly performed. The device is safe.
Verdict A $2 million Kansas verdict was returned. The gynecologist was found 60% at fault and the manufacturer was 40% at fault. The patient’s net recovery was $322,300 due to the state cap.
In This Article
- Ovary not removed; cyst develops
- Microcephaly not detected before birth
- Injury during hydrothermal ablation
Individualizing treatment of menopausal symptoms
Menopause experts Andrew M. Kaunitz, MD, and JoAnn E. Manson, MD, DrPH, provide a comprehensive review of various treatments for menopausal symptoms in an article recently published ahead of print in Obstetrics and Gynecology.1 They discuss hormonal and nonhormonal options to treat vasomotor symptoms, genitourinary syndrome of menopause (GSM), and considerations for the use of hormone therapy in special populations: women with early menopause, women with a history of breast cancer and those who carry the BRCA gene mutation, and women with a history of venous thrombosis.1
The authors write that, “given the lower rates of adverse events on HT among women close to menopause onset and at lower baseline risk of cardiovascular disease, risk stratification and personalized risk assessment appear to represent a sound strategy for optimizing the benefit–risk profile and safety of HT.”1 They suggest that instead of stopping systemic HT at age 65 years, the length of treatment be individualized based on a woman’s risk profile and preferences. The authors encourage gynecologists and other clinicians to use benefit–risk profile tools for both hormonal and nonhormonal options to help women make sound decisions on treating menopausal symptoms.1
Readthe full Clinical Expert Series here.
Reference
- Kaunitz AM, Manson JE. Management of menopausal symptoms [published online ahead of print September 3, 2015]. Obstet Gynecol. doi: 10.1097/AOG.0000000000001058. Accessed September 18, 2015.
Menopause experts Andrew M. Kaunitz, MD, and JoAnn E. Manson, MD, DrPH, provide a comprehensive review of various treatments for menopausal symptoms in an article recently published ahead of print in Obstetrics and Gynecology.1 They discuss hormonal and nonhormonal options to treat vasomotor symptoms, genitourinary syndrome of menopause (GSM), and considerations for the use of hormone therapy in special populations: women with early menopause, women with a history of breast cancer and those who carry the BRCA gene mutation, and women with a history of venous thrombosis.1
The authors write that, “given the lower rates of adverse events on HT among women close to menopause onset and at lower baseline risk of cardiovascular disease, risk stratification and personalized risk assessment appear to represent a sound strategy for optimizing the benefit–risk profile and safety of HT.”1 They suggest that instead of stopping systemic HT at age 65 years, the length of treatment be individualized based on a woman’s risk profile and preferences. The authors encourage gynecologists and other clinicians to use benefit–risk profile tools for both hormonal and nonhormonal options to help women make sound decisions on treating menopausal symptoms.1
Readthe full Clinical Expert Series here.
Menopause experts Andrew M. Kaunitz, MD, and JoAnn E. Manson, MD, DrPH, provide a comprehensive review of various treatments for menopausal symptoms in an article recently published ahead of print in Obstetrics and Gynecology.1 They discuss hormonal and nonhormonal options to treat vasomotor symptoms, genitourinary syndrome of menopause (GSM), and considerations for the use of hormone therapy in special populations: women with early menopause, women with a history of breast cancer and those who carry the BRCA gene mutation, and women with a history of venous thrombosis.1
The authors write that, “given the lower rates of adverse events on HT among women close to menopause onset and at lower baseline risk of cardiovascular disease, risk stratification and personalized risk assessment appear to represent a sound strategy for optimizing the benefit–risk profile and safety of HT.”1 They suggest that instead of stopping systemic HT at age 65 years, the length of treatment be individualized based on a woman’s risk profile and preferences. The authors encourage gynecologists and other clinicians to use benefit–risk profile tools for both hormonal and nonhormonal options to help women make sound decisions on treating menopausal symptoms.1
Readthe full Clinical Expert Series here.
Reference
- Kaunitz AM, Manson JE. Management of menopausal symptoms [published online ahead of print September 3, 2015]. Obstet Gynecol. doi: 10.1097/AOG.0000000000001058. Accessed September 18, 2015.
Reference
- Kaunitz AM, Manson JE. Management of menopausal symptoms [published online ahead of print September 3, 2015]. Obstet Gynecol. doi: 10.1097/AOG.0000000000001058. Accessed September 18, 2015.
Which is the more effective treatment for uncomplicated skin infections—clindamycin or trimethoprim-sulfamethoxazole?
Miller and colleagues conducted their study in adults as well as children. Patients were included if they had either a discrete skin abscess or cellulitis, or both. They were excluded if they had one of the following:
- impetigo
- perirectal, genital, or hand infection
- a human or animal bite at the site of infection
- temperature of 38.5° C or higher
- immunocompromise
- morbid obesity
- prosthetic device at the site of infection.
The remaining patients then were stratified into one of 2 groups:
- those with a larger abscess (>5 cm in maximum diameter in adults, proportionally smaller in children) and/or cellulitis
- those who had a smaller abscess.
This study by Miller and colleagues focuses only on the patients in the former group.
Details of the trial
All discrete abscesses were incised and drained, and patients were randomly assigned to either:
- clindamycin, 300 mg 3 times daily for 10 days
- trimethoprim-sulfamethoxazole, 2 single-strength tablets orally twice daily for 10 days.
The primary endpoint was clinical cure at 7 to 10 days after completion of antibiotic therapy.
The study enrolled 524 patients—264 in the clindamycin group and 260 in the trimethoprim-sulfamethoxazole group. Approximately 30% of the patients were children. One hundred sixty patients (30.5%) had a discrete abscess, 280 (53.4%) had cellulitis, and 82 (15.6%) had both an abscess and cellulitis. An incision and drainage procedure was performed in 44.5% of patients. Slightly more than 50% of patients had a microbiological culture.
The most common organism isolated was S aureus (217 of 524 patients, or 41.4%), of which 167 (77%) were methicillin-resistant S aureus (MRSA). Of the 217 isolates identified as S aureus, 27 (12.4%) were resistant to clindamycin, and only one (0.5%) was resistant to trimethoprim-sulfamethoxazole.
Of the 466 patients who were fully evaluable, the rate of cure was 89.5% in the clindamycin group (95% confidence interval [CI], 85.2–93.7) and 88.2% in the trimethoprim-sulfamethoxazole group (95% CI, 83.7–92.7). The difference in the observed rate of clinical cure was not statistically significant.
Eleven of 15 patients in the clindamycin group who had clindamycin-resistant isolates were cured, compared with 77 of 84 patients with susceptible isolates (73.3% vs 91.7%; P = .06). At 1 month after treatment, cure rates remained similar. The overall rates of adverse effects in the 2 groups were similar, at 19%. No patient developed Clostridium difficile-associated diarrhea.
Skin infections can be life-threatening
Skin and skin-structure infections are common—and can influence the decision of when to perform a cesarean delivery, how to prepare the skin before surgery, and where to place the surgical incision. In some patients, these infections can be quite debilitating, even life-threatening. When a discrete abscess (furuncle, carbuncle) is present, the most likely organism is S aureus, and the majority of strains are MRSA. When cellulitis is present, S aureus is less likely, and the dominant organisms are usually streptococci, particularly Streptococcus pyogenes.
Abscesses of any size need incision and drainage and, in most cases, systemic antibiotic therapy. When cellulitis without a discrete abscess is present, the key to treatment is antibiotic therapy.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
For uncomplicated skin and skin-structure infections in immunocompetent women, oral clindamycin and oral trimethoprim-sulfamethoxazole are equally effective; both achieve cures in approximately 90% of patients.
Given that more strains of S aureus were resistant to clindamycin, trimethoprim-sulfamethoxazole may be the preferred agent. It also is less expensive and, in theory at least, less likely to cause drug-induced diarrhea.
Affected patients need to be followed closely because recurrences are common and, in isolated instances, serious complications such as sepsis can develop.
—Patrick Duff, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Miller and colleagues conducted their study in adults as well as children. Patients were included if they had either a discrete skin abscess or cellulitis, or both. They were excluded if they had one of the following:
- impetigo
- perirectal, genital, or hand infection
- a human or animal bite at the site of infection
- temperature of 38.5° C or higher
- immunocompromise
- morbid obesity
- prosthetic device at the site of infection.
The remaining patients then were stratified into one of 2 groups:
- those with a larger abscess (>5 cm in maximum diameter in adults, proportionally smaller in children) and/or cellulitis
- those who had a smaller abscess.
This study by Miller and colleagues focuses only on the patients in the former group.
Details of the trial
All discrete abscesses were incised and drained, and patients were randomly assigned to either:
- clindamycin, 300 mg 3 times daily for 10 days
- trimethoprim-sulfamethoxazole, 2 single-strength tablets orally twice daily for 10 days.
The primary endpoint was clinical cure at 7 to 10 days after completion of antibiotic therapy.
The study enrolled 524 patients—264 in the clindamycin group and 260 in the trimethoprim-sulfamethoxazole group. Approximately 30% of the patients were children. One hundred sixty patients (30.5%) had a discrete abscess, 280 (53.4%) had cellulitis, and 82 (15.6%) had both an abscess and cellulitis. An incision and drainage procedure was performed in 44.5% of patients. Slightly more than 50% of patients had a microbiological culture.
The most common organism isolated was S aureus (217 of 524 patients, or 41.4%), of which 167 (77%) were methicillin-resistant S aureus (MRSA). Of the 217 isolates identified as S aureus, 27 (12.4%) were resistant to clindamycin, and only one (0.5%) was resistant to trimethoprim-sulfamethoxazole.
Of the 466 patients who were fully evaluable, the rate of cure was 89.5% in the clindamycin group (95% confidence interval [CI], 85.2–93.7) and 88.2% in the trimethoprim-sulfamethoxazole group (95% CI, 83.7–92.7). The difference in the observed rate of clinical cure was not statistically significant.
Eleven of 15 patients in the clindamycin group who had clindamycin-resistant isolates were cured, compared with 77 of 84 patients with susceptible isolates (73.3% vs 91.7%; P = .06). At 1 month after treatment, cure rates remained similar. The overall rates of adverse effects in the 2 groups were similar, at 19%. No patient developed Clostridium difficile-associated diarrhea.
Skin infections can be life-threatening
Skin and skin-structure infections are common—and can influence the decision of when to perform a cesarean delivery, how to prepare the skin before surgery, and where to place the surgical incision. In some patients, these infections can be quite debilitating, even life-threatening. When a discrete abscess (furuncle, carbuncle) is present, the most likely organism is S aureus, and the majority of strains are MRSA. When cellulitis is present, S aureus is less likely, and the dominant organisms are usually streptococci, particularly Streptococcus pyogenes.
Abscesses of any size need incision and drainage and, in most cases, systemic antibiotic therapy. When cellulitis without a discrete abscess is present, the key to treatment is antibiotic therapy.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
For uncomplicated skin and skin-structure infections in immunocompetent women, oral clindamycin and oral trimethoprim-sulfamethoxazole are equally effective; both achieve cures in approximately 90% of patients.
Given that more strains of S aureus were resistant to clindamycin, trimethoprim-sulfamethoxazole may be the preferred agent. It also is less expensive and, in theory at least, less likely to cause drug-induced diarrhea.
Affected patients need to be followed closely because recurrences are common and, in isolated instances, serious complications such as sepsis can develop.
—Patrick Duff, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Miller and colleagues conducted their study in adults as well as children. Patients were included if they had either a discrete skin abscess or cellulitis, or both. They were excluded if they had one of the following:
- impetigo
- perirectal, genital, or hand infection
- a human or animal bite at the site of infection
- temperature of 38.5° C or higher
- immunocompromise
- morbid obesity
- prosthetic device at the site of infection.
The remaining patients then were stratified into one of 2 groups:
- those with a larger abscess (>5 cm in maximum diameter in adults, proportionally smaller in children) and/or cellulitis
- those who had a smaller abscess.
This study by Miller and colleagues focuses only on the patients in the former group.
Details of the trial
All discrete abscesses were incised and drained, and patients were randomly assigned to either:
- clindamycin, 300 mg 3 times daily for 10 days
- trimethoprim-sulfamethoxazole, 2 single-strength tablets orally twice daily for 10 days.
The primary endpoint was clinical cure at 7 to 10 days after completion of antibiotic therapy.
The study enrolled 524 patients—264 in the clindamycin group and 260 in the trimethoprim-sulfamethoxazole group. Approximately 30% of the patients were children. One hundred sixty patients (30.5%) had a discrete abscess, 280 (53.4%) had cellulitis, and 82 (15.6%) had both an abscess and cellulitis. An incision and drainage procedure was performed in 44.5% of patients. Slightly more than 50% of patients had a microbiological culture.
The most common organism isolated was S aureus (217 of 524 patients, or 41.4%), of which 167 (77%) were methicillin-resistant S aureus (MRSA). Of the 217 isolates identified as S aureus, 27 (12.4%) were resistant to clindamycin, and only one (0.5%) was resistant to trimethoprim-sulfamethoxazole.
Of the 466 patients who were fully evaluable, the rate of cure was 89.5% in the clindamycin group (95% confidence interval [CI], 85.2–93.7) and 88.2% in the trimethoprim-sulfamethoxazole group (95% CI, 83.7–92.7). The difference in the observed rate of clinical cure was not statistically significant.
Eleven of 15 patients in the clindamycin group who had clindamycin-resistant isolates were cured, compared with 77 of 84 patients with susceptible isolates (73.3% vs 91.7%; P = .06). At 1 month after treatment, cure rates remained similar. The overall rates of adverse effects in the 2 groups were similar, at 19%. No patient developed Clostridium difficile-associated diarrhea.
Skin infections can be life-threatening
Skin and skin-structure infections are common—and can influence the decision of when to perform a cesarean delivery, how to prepare the skin before surgery, and where to place the surgical incision. In some patients, these infections can be quite debilitating, even life-threatening. When a discrete abscess (furuncle, carbuncle) is present, the most likely organism is S aureus, and the majority of strains are MRSA. When cellulitis is present, S aureus is less likely, and the dominant organisms are usually streptococci, particularly Streptococcus pyogenes.
Abscesses of any size need incision and drainage and, in most cases, systemic antibiotic therapy. When cellulitis without a discrete abscess is present, the key to treatment is antibiotic therapy.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
For uncomplicated skin and skin-structure infections in immunocompetent women, oral clindamycin and oral trimethoprim-sulfamethoxazole are equally effective; both achieve cures in approximately 90% of patients.
Given that more strains of S aureus were resistant to clindamycin, trimethoprim-sulfamethoxazole may be the preferred agent. It also is less expensive and, in theory at least, less likely to cause drug-induced diarrhea.
Affected patients need to be followed closely because recurrences are common and, in isolated instances, serious complications such as sepsis can develop.
—Patrick Duff, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
2015 Update on vaginal hysterectomy
We’ve come a long way since Conrad Langebeck performed the first vaginal hysterectomy in 1813. For the inaugural surgery, Langebeck used no anesthesia, gloves, or other sterilization strategies, and he held the suture in his teeth at one point during the operation! (The patient survived.)1
Despite our dramatic progress since then, too many of us still perform benign hysterectomy by an approach other than vaginal. And too many of us still perform vaginal hysterectomy the way it was taught in the 1950s—frequently a backbreaking, frustrating undertaking.
That approach is unnecessary. In recent years, the technological world has developed many useful tools for minimally invasive gynecologic surgery, some of which greatly facilitate vaginal hysterectomy. In this Update, I focus on 3 of them:
- vessel-sealing devices
- a unique visualization system
- a lighted suction irrigator.
It is my hope that you will incorporate these tools into your vaginal hysterectomy cases and gain some of the significant benefits they have to offer. The revival of vaginal hysterectomy and vaginal surgery in general is all about using the best tools that we have available and using them well, cost- effectively, and thoughtfully to improve the experience of both surgeon and patient.
Why you should default to vaginal hysterectomy
Not only is vaginal hysterectomy more cosmetically pleasing but it also has a lower complication rate than laparoscopic, robot-assisted, or laparotomic hysterectomy, requiring no incisions through the abdominal wall. The original natural orifice translumenal endoscopic surgery (NOTES) procedure also is less expensive than laparoscopic or robot-assisted hysterectomy. Vaginal hysterectomy has so much to recommend it, in fact, that the biggest barrier to widespread use may simply be the lack of industry support.
According to the latest committee opinion from the American College of Obstetricians and Gynecologists (ACOG), “When choosing the route and method of hysterectomy, the physician should take into consideration how the procedure may be performed most safely and cost-effectively to fulfill the medical needs of the patient. Most literature supports the opinion that, when feasible, vaginal hysterectomy is the safest and most cost-effective route by which to remove the uterus.”2
A 2009 Cochrane review of surgical approaches to hysterectomy found that vaginal hysterectomy should be performed in preference to abdominal hysterectomy whenever possible.3 Yet data from 2008 indicate that almost 50% of all hysterectomies were still being performed using an open abdominal approach, and laparoscopic hysterectomy made up almost another 25%.4
To address the disparity between the evidence and practice, ACOG has joined forces with the AAGL and the Society for Gynecologic Surgeons (SGS) to present an online master course on vaginal hysterectomy, available at http://www.aagl.org/vaghystwebinar. This course features videos and live demonstrations on cadaveric models and is free to physicians, with continuing medical education (CME) credits available.
Vessel sealing offers real benefits over suturing
In any surgery, the need to achieve reliable hemostasis is critical. In vaginal hysterectomy, this goal traditionally has been attained by clamping and suturing of the vessels. In many respects, vaginal surgeons seem to have gotten trapped in the mindset that we need to suture during vaginal surgery—and train residents to suture, too. When it comes to laparoscopic surgery, however, the reverse is true. In that setting, vessel-sealing devices are used to seal blood vessels with “supraphysiologic burst pressure equal to that of previously used surgical clips or ligatures.”5
Why is vessel sealing necessarily better than suturing?
It’s safer, for one thing, eliminating the need to pass needles back and forth. It also frees the scrub technician to become the surgical assistant because there are no needles to load and unload. In order for suture to hold around a pedicle, it is necessary to have tissue adjacent to it. The surgeon ties and cuts but must have something beyond the suture or the suture won’t hold. That something is dead, devascularized tissue. Before healing can occur, all this tissue must be absorbed by the body. That is not the case with vessel sealing, which fuses the walls of the blood vessels, leaving less foreign material and dead tissue behind.
What the data show
The literature offers several randomized comparisons of bipolar vessel sealing and suturing during vaginal hysterectomy, and all of them find increased benefits for the vessel-sealing approach.
For example, in 2003, I published a randomized comparison looking specifically at blood loss and operative time.6 Sixty women in a single surgical practice were randomly allocated to vessel sealing or sutures for hemostasis during vaginal hysterectomy. In the vessel-sealing group, the mean operative time was 39.1 minutes (range, 22–93), compared with 53.6 minutes in the suturing group (range, 37–160; P = .003). Mean estimated blood loss also was significantly lower with vessel sealing, at 68.9 mL (range, 20–200) versus 126.7 mL for suturing (range, 25–600; P = .005). Complication rates and length of stay were similar between groups.6
In another randomized trial of vessel sealing versus suturing involving 68 women undergoing vaginal hysterectomy, pain was markedly reduced in the vessel-sealing group (median score, 4 vs 6; P<.0001). Operative time again was shorter with vessel sealing than with suturing (median of 32 vs 40 minutes; P = .003), but there were no differences in blood loss and hospitalization.7
Silva-Filho and colleagues randomly allocated 90 women to bipolar vessel sealing or suturing during vaginal hysterectomy.8 Vessel sealing provided reduced postoperative pain (pain score [SD] of 1.6 [0.4] vs 3.6 [0.4]; P<.001), shorter operative time (mean of 29.2 [2.1] vs 75.2 [5] minutes; P<.001), less blood loss (mean of 84 [5.9] vs 136.4 [89.1] mL; P = .001), and a shorter hospital stay (mean of 25.6 [0.9] vs 33.2 [1.7] hours; P<.001).8
A systematic review and meta-analysis by Kroft and Selk found that vessel sealing reduced: operative time by a mean of 17.2 minutes (95% confidence interval [CI], 7.5–27.0); blood loss by a mean of 47.7 mL (95% CI, 15.5–79.9); and hospital stay by a mean of 0.25 days (95% CI, 0.13–0.37) during vaginal hysterectomy.9
And in a randomized controlled trial from the Netherlands, women undergoing vaginal hysterectomy reported significantly less pain the evening after surgery in the vessel-sealing group, compared with the suturing group (pain score of 4.5 vs 5.7 on a scale of 1 to 10; P = .03).10 They also had a shorter operative time than women in the suturing group (60 vs 71 minutes; P = .05). Blood loss and hospital stays did not differ between groups, and there were no major differences in cost.
A reduction in pain is an especially important indicator of surgical success. In an interesting twist, Candiani and colleagues compared laparoscopic and vaginal hysterectomy for a number of variables, including pain, for benign pathology.11 They found less postoperative pain the day of surgery and a reduced number of days of analgesic request in the laparoscopic group, compared with vaginal hysterectomy. One reason: Hemostasis was achieved via vessel sealing in the laparoscopic group, compared with clamping and suturing in the vaginal group.11
Lighted suction irrigator facilitates visualization “around corners”
Many years ago, I conducted some informal studies for industry that showed—as one might guess intuitively—that the ability to see well during surgery cuts operative time. We all know that light is good. One useful lighting aid I’ve adopted of late is the Vital Vue (Covidien/Medtronic) suction irrigator. It has a disposable tip like all suction devices, but it includes 3 channels: one for a fiber optic cord, another for fluid, and the third for suction (FIGURE 1). It plugs into a regular suction machine, with a reusable box that provides the fiber optic light.
Because the suction tip is curved, the device makes it possible to illuminate the surgical field “around corners” if need be. Any bleeding can be irrigated to clear the field.
How to choose a vessel sealer
When selecting a vessel-sealing device for vaginal hysterectomy, keep in mind a number of factors:
- size of the vessels that will need to be controlled. Most devices on the market today control vessels 7 mm in size or smaller.
- amount of steam it releases, which can damage adjacent tissue
- overall size of the device
- size of the pedicles that will need to be controlled
- overall space required for use
- cost of the device.
In other words, to choose an appropriate device, you will need to think in advance about the specifics of the case you are planning, as not all hysterectomies are alike. The type of vessel sealer best for the surgery will vary with these details.
Both bipolar electrosurgical and ultrasonic devices now provide consistent hemostasis, increased functionality, and greater efficiency. What’s more, they cause minimal to no damage to surrounding tissue.
External scope offers visualization of vaginal procedures to entire OR
Designed for open surgeries, the VITOM system (Karl Storz) is an innovative tool for displaying procedures in which surgical access is limited. It’s an external telescope, or “exoscope,” with a 90° lens. It clips onto the table, providing visualization for the entire operative team (FIGURE 2).
As we all know, the advent of the camera made an enormous difference in laparoscopic procedures and in teaching because it enabled the assistant to see what the surgeon was doing and anticipate his or her needs. This device offers the same advantages for vaginal hysterectomy. In my opinion, it’s a game changer.
The VITOM system provides outstanding image quality and depth of view. It is placed at a distance of 25 cm to 75 cm from the surgical field and thus does not impinge on the surgeon’s workspace. Because it is compact, it facilitates the use of long instruments, if necessary. In addition, because it can be sterilized, the VITOM system can be manipulated directly by the surgeon or assistant.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Brigham and Women’s Hospital. Minimally Invasive Gynecologic Surgery: Hysterectomy Options. http://www.brighamandwomens.org/Departments_and_Services/obgyn/ser vices/mininvgynsurg/mininvoptions/hysterectomy.aspx. Updated October 3, 2014. Accessed August 6, 2015.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 444: Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114(5):1156–1158.
- Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677.
- American Congress of Obstetricians and Gynecologists. 2011 Women’s Health Stats & Facts. Washington, DC: ACOG; 2011. http://www.acog.org/~/media/NewsRoom/MediaKit.pdf. Accessed August 6, 2015.
- Nezhat C, Lewis M, King LP. Laparoscopic vessel sealing devices. Society of Laparoendoscopic Surgeons. http://laparoscopy.blogs.com/prevention_management_3/2010/10/laparoscopic-vessel-sealing-devices.html. Published 2010. Accessed August 6, 2015.
- Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol. 2003;102(1):147–151.
- Cronjé HS, de Coning EC. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet. 2005;91(3):243–245.
- Silva-Filho AL, Rodrigues AM, Vale de Castro Monteiro M, et al. Randomized study of bipolar vessel sealing system versus conventional suture ligature for vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2009;146(2):200–203.
- Kroft J, Selk A. Energy-based vessel sealing in vaginal hysterectomy: a systematic review and meta-analysis. Obstet Gynecol. 2011;118(5):1127–1136.
- Lakeman MM, The S, Schellart RP, et al. Electrosurgical bipolar vessel sealing versus conventional clamping and suturing for vaginal hysterectomy: a randomised controlled trial. BJOG. 2012;119(12):1473–1482.
- Candiani M, Izzo S, Bulfoni A, Riparini J, Ronzoni S, Marconi A. Laparoscopic vs vaginal hysterectomy for benign pathology. Am J Obstet Gynecol. 2009;200(4):368.e1–e7.
We’ve come a long way since Conrad Langebeck performed the first vaginal hysterectomy in 1813. For the inaugural surgery, Langebeck used no anesthesia, gloves, or other sterilization strategies, and he held the suture in his teeth at one point during the operation! (The patient survived.)1
Despite our dramatic progress since then, too many of us still perform benign hysterectomy by an approach other than vaginal. And too many of us still perform vaginal hysterectomy the way it was taught in the 1950s—frequently a backbreaking, frustrating undertaking.
That approach is unnecessary. In recent years, the technological world has developed many useful tools for minimally invasive gynecologic surgery, some of which greatly facilitate vaginal hysterectomy. In this Update, I focus on 3 of them:
- vessel-sealing devices
- a unique visualization system
- a lighted suction irrigator.
It is my hope that you will incorporate these tools into your vaginal hysterectomy cases and gain some of the significant benefits they have to offer. The revival of vaginal hysterectomy and vaginal surgery in general is all about using the best tools that we have available and using them well, cost- effectively, and thoughtfully to improve the experience of both surgeon and patient.
Why you should default to vaginal hysterectomy
Not only is vaginal hysterectomy more cosmetically pleasing but it also has a lower complication rate than laparoscopic, robot-assisted, or laparotomic hysterectomy, requiring no incisions through the abdominal wall. The original natural orifice translumenal endoscopic surgery (NOTES) procedure also is less expensive than laparoscopic or robot-assisted hysterectomy. Vaginal hysterectomy has so much to recommend it, in fact, that the biggest barrier to widespread use may simply be the lack of industry support.
According to the latest committee opinion from the American College of Obstetricians and Gynecologists (ACOG), “When choosing the route and method of hysterectomy, the physician should take into consideration how the procedure may be performed most safely and cost-effectively to fulfill the medical needs of the patient. Most literature supports the opinion that, when feasible, vaginal hysterectomy is the safest and most cost-effective route by which to remove the uterus.”2
A 2009 Cochrane review of surgical approaches to hysterectomy found that vaginal hysterectomy should be performed in preference to abdominal hysterectomy whenever possible.3 Yet data from 2008 indicate that almost 50% of all hysterectomies were still being performed using an open abdominal approach, and laparoscopic hysterectomy made up almost another 25%.4
To address the disparity between the evidence and practice, ACOG has joined forces with the AAGL and the Society for Gynecologic Surgeons (SGS) to present an online master course on vaginal hysterectomy, available at http://www.aagl.org/vaghystwebinar. This course features videos and live demonstrations on cadaveric models and is free to physicians, with continuing medical education (CME) credits available.
Vessel sealing offers real benefits over suturing
In any surgery, the need to achieve reliable hemostasis is critical. In vaginal hysterectomy, this goal traditionally has been attained by clamping and suturing of the vessels. In many respects, vaginal surgeons seem to have gotten trapped in the mindset that we need to suture during vaginal surgery—and train residents to suture, too. When it comes to laparoscopic surgery, however, the reverse is true. In that setting, vessel-sealing devices are used to seal blood vessels with “supraphysiologic burst pressure equal to that of previously used surgical clips or ligatures.”5
Why is vessel sealing necessarily better than suturing?
It’s safer, for one thing, eliminating the need to pass needles back and forth. It also frees the scrub technician to become the surgical assistant because there are no needles to load and unload. In order for suture to hold around a pedicle, it is necessary to have tissue adjacent to it. The surgeon ties and cuts but must have something beyond the suture or the suture won’t hold. That something is dead, devascularized tissue. Before healing can occur, all this tissue must be absorbed by the body. That is not the case with vessel sealing, which fuses the walls of the blood vessels, leaving less foreign material and dead tissue behind.
What the data show
The literature offers several randomized comparisons of bipolar vessel sealing and suturing during vaginal hysterectomy, and all of them find increased benefits for the vessel-sealing approach.
For example, in 2003, I published a randomized comparison looking specifically at blood loss and operative time.6 Sixty women in a single surgical practice were randomly allocated to vessel sealing or sutures for hemostasis during vaginal hysterectomy. In the vessel-sealing group, the mean operative time was 39.1 minutes (range, 22–93), compared with 53.6 minutes in the suturing group (range, 37–160; P = .003). Mean estimated blood loss also was significantly lower with vessel sealing, at 68.9 mL (range, 20–200) versus 126.7 mL for suturing (range, 25–600; P = .005). Complication rates and length of stay were similar between groups.6
In another randomized trial of vessel sealing versus suturing involving 68 women undergoing vaginal hysterectomy, pain was markedly reduced in the vessel-sealing group (median score, 4 vs 6; P<.0001). Operative time again was shorter with vessel sealing than with suturing (median of 32 vs 40 minutes; P = .003), but there were no differences in blood loss and hospitalization.7
Silva-Filho and colleagues randomly allocated 90 women to bipolar vessel sealing or suturing during vaginal hysterectomy.8 Vessel sealing provided reduced postoperative pain (pain score [SD] of 1.6 [0.4] vs 3.6 [0.4]; P<.001), shorter operative time (mean of 29.2 [2.1] vs 75.2 [5] minutes; P<.001), less blood loss (mean of 84 [5.9] vs 136.4 [89.1] mL; P = .001), and a shorter hospital stay (mean of 25.6 [0.9] vs 33.2 [1.7] hours; P<.001).8
A systematic review and meta-analysis by Kroft and Selk found that vessel sealing reduced: operative time by a mean of 17.2 minutes (95% confidence interval [CI], 7.5–27.0); blood loss by a mean of 47.7 mL (95% CI, 15.5–79.9); and hospital stay by a mean of 0.25 days (95% CI, 0.13–0.37) during vaginal hysterectomy.9
And in a randomized controlled trial from the Netherlands, women undergoing vaginal hysterectomy reported significantly less pain the evening after surgery in the vessel-sealing group, compared with the suturing group (pain score of 4.5 vs 5.7 on a scale of 1 to 10; P = .03).10 They also had a shorter operative time than women in the suturing group (60 vs 71 minutes; P = .05). Blood loss and hospital stays did not differ between groups, and there were no major differences in cost.
A reduction in pain is an especially important indicator of surgical success. In an interesting twist, Candiani and colleagues compared laparoscopic and vaginal hysterectomy for a number of variables, including pain, for benign pathology.11 They found less postoperative pain the day of surgery and a reduced number of days of analgesic request in the laparoscopic group, compared with vaginal hysterectomy. One reason: Hemostasis was achieved via vessel sealing in the laparoscopic group, compared with clamping and suturing in the vaginal group.11
Lighted suction irrigator facilitates visualization “around corners”
Many years ago, I conducted some informal studies for industry that showed—as one might guess intuitively—that the ability to see well during surgery cuts operative time. We all know that light is good. One useful lighting aid I’ve adopted of late is the Vital Vue (Covidien/Medtronic) suction irrigator. It has a disposable tip like all suction devices, but it includes 3 channels: one for a fiber optic cord, another for fluid, and the third for suction (FIGURE 1). It plugs into a regular suction machine, with a reusable box that provides the fiber optic light.
Because the suction tip is curved, the device makes it possible to illuminate the surgical field “around corners” if need be. Any bleeding can be irrigated to clear the field.
How to choose a vessel sealer
When selecting a vessel-sealing device for vaginal hysterectomy, keep in mind a number of factors:
- size of the vessels that will need to be controlled. Most devices on the market today control vessels 7 mm in size or smaller.
- amount of steam it releases, which can damage adjacent tissue
- overall size of the device
- size of the pedicles that will need to be controlled
- overall space required for use
- cost of the device.
In other words, to choose an appropriate device, you will need to think in advance about the specifics of the case you are planning, as not all hysterectomies are alike. The type of vessel sealer best for the surgery will vary with these details.
Both bipolar electrosurgical and ultrasonic devices now provide consistent hemostasis, increased functionality, and greater efficiency. What’s more, they cause minimal to no damage to surrounding tissue.
External scope offers visualization of vaginal procedures to entire OR
Designed for open surgeries, the VITOM system (Karl Storz) is an innovative tool for displaying procedures in which surgical access is limited. It’s an external telescope, or “exoscope,” with a 90° lens. It clips onto the table, providing visualization for the entire operative team (FIGURE 2).
As we all know, the advent of the camera made an enormous difference in laparoscopic procedures and in teaching because it enabled the assistant to see what the surgeon was doing and anticipate his or her needs. This device offers the same advantages for vaginal hysterectomy. In my opinion, it’s a game changer.
The VITOM system provides outstanding image quality and depth of view. It is placed at a distance of 25 cm to 75 cm from the surgical field and thus does not impinge on the surgeon’s workspace. Because it is compact, it facilitates the use of long instruments, if necessary. In addition, because it can be sterilized, the VITOM system can be manipulated directly by the surgeon or assistant.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
We’ve come a long way since Conrad Langebeck performed the first vaginal hysterectomy in 1813. For the inaugural surgery, Langebeck used no anesthesia, gloves, or other sterilization strategies, and he held the suture in his teeth at one point during the operation! (The patient survived.)1
Despite our dramatic progress since then, too many of us still perform benign hysterectomy by an approach other than vaginal. And too many of us still perform vaginal hysterectomy the way it was taught in the 1950s—frequently a backbreaking, frustrating undertaking.
That approach is unnecessary. In recent years, the technological world has developed many useful tools for minimally invasive gynecologic surgery, some of which greatly facilitate vaginal hysterectomy. In this Update, I focus on 3 of them:
- vessel-sealing devices
- a unique visualization system
- a lighted suction irrigator.
It is my hope that you will incorporate these tools into your vaginal hysterectomy cases and gain some of the significant benefits they have to offer. The revival of vaginal hysterectomy and vaginal surgery in general is all about using the best tools that we have available and using them well, cost- effectively, and thoughtfully to improve the experience of both surgeon and patient.
Why you should default to vaginal hysterectomy
Not only is vaginal hysterectomy more cosmetically pleasing but it also has a lower complication rate than laparoscopic, robot-assisted, or laparotomic hysterectomy, requiring no incisions through the abdominal wall. The original natural orifice translumenal endoscopic surgery (NOTES) procedure also is less expensive than laparoscopic or robot-assisted hysterectomy. Vaginal hysterectomy has so much to recommend it, in fact, that the biggest barrier to widespread use may simply be the lack of industry support.
According to the latest committee opinion from the American College of Obstetricians and Gynecologists (ACOG), “When choosing the route and method of hysterectomy, the physician should take into consideration how the procedure may be performed most safely and cost-effectively to fulfill the medical needs of the patient. Most literature supports the opinion that, when feasible, vaginal hysterectomy is the safest and most cost-effective route by which to remove the uterus.”2
A 2009 Cochrane review of surgical approaches to hysterectomy found that vaginal hysterectomy should be performed in preference to abdominal hysterectomy whenever possible.3 Yet data from 2008 indicate that almost 50% of all hysterectomies were still being performed using an open abdominal approach, and laparoscopic hysterectomy made up almost another 25%.4
To address the disparity between the evidence and practice, ACOG has joined forces with the AAGL and the Society for Gynecologic Surgeons (SGS) to present an online master course on vaginal hysterectomy, available at http://www.aagl.org/vaghystwebinar. This course features videos and live demonstrations on cadaveric models and is free to physicians, with continuing medical education (CME) credits available.
Vessel sealing offers real benefits over suturing
In any surgery, the need to achieve reliable hemostasis is critical. In vaginal hysterectomy, this goal traditionally has been attained by clamping and suturing of the vessels. In many respects, vaginal surgeons seem to have gotten trapped in the mindset that we need to suture during vaginal surgery—and train residents to suture, too. When it comes to laparoscopic surgery, however, the reverse is true. In that setting, vessel-sealing devices are used to seal blood vessels with “supraphysiologic burst pressure equal to that of previously used surgical clips or ligatures.”5
Why is vessel sealing necessarily better than suturing?
It’s safer, for one thing, eliminating the need to pass needles back and forth. It also frees the scrub technician to become the surgical assistant because there are no needles to load and unload. In order for suture to hold around a pedicle, it is necessary to have tissue adjacent to it. The surgeon ties and cuts but must have something beyond the suture or the suture won’t hold. That something is dead, devascularized tissue. Before healing can occur, all this tissue must be absorbed by the body. That is not the case with vessel sealing, which fuses the walls of the blood vessels, leaving less foreign material and dead tissue behind.
What the data show
The literature offers several randomized comparisons of bipolar vessel sealing and suturing during vaginal hysterectomy, and all of them find increased benefits for the vessel-sealing approach.
For example, in 2003, I published a randomized comparison looking specifically at blood loss and operative time.6 Sixty women in a single surgical practice were randomly allocated to vessel sealing or sutures for hemostasis during vaginal hysterectomy. In the vessel-sealing group, the mean operative time was 39.1 minutes (range, 22–93), compared with 53.6 minutes in the suturing group (range, 37–160; P = .003). Mean estimated blood loss also was significantly lower with vessel sealing, at 68.9 mL (range, 20–200) versus 126.7 mL for suturing (range, 25–600; P = .005). Complication rates and length of stay were similar between groups.6
In another randomized trial of vessel sealing versus suturing involving 68 women undergoing vaginal hysterectomy, pain was markedly reduced in the vessel-sealing group (median score, 4 vs 6; P<.0001). Operative time again was shorter with vessel sealing than with suturing (median of 32 vs 40 minutes; P = .003), but there were no differences in blood loss and hospitalization.7
Silva-Filho and colleagues randomly allocated 90 women to bipolar vessel sealing or suturing during vaginal hysterectomy.8 Vessel sealing provided reduced postoperative pain (pain score [SD] of 1.6 [0.4] vs 3.6 [0.4]; P<.001), shorter operative time (mean of 29.2 [2.1] vs 75.2 [5] minutes; P<.001), less blood loss (mean of 84 [5.9] vs 136.4 [89.1] mL; P = .001), and a shorter hospital stay (mean of 25.6 [0.9] vs 33.2 [1.7] hours; P<.001).8
A systematic review and meta-analysis by Kroft and Selk found that vessel sealing reduced: operative time by a mean of 17.2 minutes (95% confidence interval [CI], 7.5–27.0); blood loss by a mean of 47.7 mL (95% CI, 15.5–79.9); and hospital stay by a mean of 0.25 days (95% CI, 0.13–0.37) during vaginal hysterectomy.9
And in a randomized controlled trial from the Netherlands, women undergoing vaginal hysterectomy reported significantly less pain the evening after surgery in the vessel-sealing group, compared with the suturing group (pain score of 4.5 vs 5.7 on a scale of 1 to 10; P = .03).10 They also had a shorter operative time than women in the suturing group (60 vs 71 minutes; P = .05). Blood loss and hospital stays did not differ between groups, and there were no major differences in cost.
A reduction in pain is an especially important indicator of surgical success. In an interesting twist, Candiani and colleagues compared laparoscopic and vaginal hysterectomy for a number of variables, including pain, for benign pathology.11 They found less postoperative pain the day of surgery and a reduced number of days of analgesic request in the laparoscopic group, compared with vaginal hysterectomy. One reason: Hemostasis was achieved via vessel sealing in the laparoscopic group, compared with clamping and suturing in the vaginal group.11
Lighted suction irrigator facilitates visualization “around corners”
Many years ago, I conducted some informal studies for industry that showed—as one might guess intuitively—that the ability to see well during surgery cuts operative time. We all know that light is good. One useful lighting aid I’ve adopted of late is the Vital Vue (Covidien/Medtronic) suction irrigator. It has a disposable tip like all suction devices, but it includes 3 channels: one for a fiber optic cord, another for fluid, and the third for suction (FIGURE 1). It plugs into a regular suction machine, with a reusable box that provides the fiber optic light.
Because the suction tip is curved, the device makes it possible to illuminate the surgical field “around corners” if need be. Any bleeding can be irrigated to clear the field.
How to choose a vessel sealer
When selecting a vessel-sealing device for vaginal hysterectomy, keep in mind a number of factors:
- size of the vessels that will need to be controlled. Most devices on the market today control vessels 7 mm in size or smaller.
- amount of steam it releases, which can damage adjacent tissue
- overall size of the device
- size of the pedicles that will need to be controlled
- overall space required for use
- cost of the device.
In other words, to choose an appropriate device, you will need to think in advance about the specifics of the case you are planning, as not all hysterectomies are alike. The type of vessel sealer best for the surgery will vary with these details.
Both bipolar electrosurgical and ultrasonic devices now provide consistent hemostasis, increased functionality, and greater efficiency. What’s more, they cause minimal to no damage to surrounding tissue.
External scope offers visualization of vaginal procedures to entire OR
Designed for open surgeries, the VITOM system (Karl Storz) is an innovative tool for displaying procedures in which surgical access is limited. It’s an external telescope, or “exoscope,” with a 90° lens. It clips onto the table, providing visualization for the entire operative team (FIGURE 2).
As we all know, the advent of the camera made an enormous difference in laparoscopic procedures and in teaching because it enabled the assistant to see what the surgeon was doing and anticipate his or her needs. This device offers the same advantages for vaginal hysterectomy. In my opinion, it’s a game changer.
The VITOM system provides outstanding image quality and depth of view. It is placed at a distance of 25 cm to 75 cm from the surgical field and thus does not impinge on the surgeon’s workspace. Because it is compact, it facilitates the use of long instruments, if necessary. In addition, because it can be sterilized, the VITOM system can be manipulated directly by the surgeon or assistant.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Brigham and Women’s Hospital. Minimally Invasive Gynecologic Surgery: Hysterectomy Options. http://www.brighamandwomens.org/Departments_and_Services/obgyn/ser vices/mininvgynsurg/mininvoptions/hysterectomy.aspx. Updated October 3, 2014. Accessed August 6, 2015.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 444: Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114(5):1156–1158.
- Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677.
- American Congress of Obstetricians and Gynecologists. 2011 Women’s Health Stats & Facts. Washington, DC: ACOG; 2011. http://www.acog.org/~/media/NewsRoom/MediaKit.pdf. Accessed August 6, 2015.
- Nezhat C, Lewis M, King LP. Laparoscopic vessel sealing devices. Society of Laparoendoscopic Surgeons. http://laparoscopy.blogs.com/prevention_management_3/2010/10/laparoscopic-vessel-sealing-devices.html. Published 2010. Accessed August 6, 2015.
- Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol. 2003;102(1):147–151.
- Cronjé HS, de Coning EC. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet. 2005;91(3):243–245.
- Silva-Filho AL, Rodrigues AM, Vale de Castro Monteiro M, et al. Randomized study of bipolar vessel sealing system versus conventional suture ligature for vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2009;146(2):200–203.
- Kroft J, Selk A. Energy-based vessel sealing in vaginal hysterectomy: a systematic review and meta-analysis. Obstet Gynecol. 2011;118(5):1127–1136.
- Lakeman MM, The S, Schellart RP, et al. Electrosurgical bipolar vessel sealing versus conventional clamping and suturing for vaginal hysterectomy: a randomised controlled trial. BJOG. 2012;119(12):1473–1482.
- Candiani M, Izzo S, Bulfoni A, Riparini J, Ronzoni S, Marconi A. Laparoscopic vs vaginal hysterectomy for benign pathology. Am J Obstet Gynecol. 2009;200(4):368.e1–e7.
- Brigham and Women’s Hospital. Minimally Invasive Gynecologic Surgery: Hysterectomy Options. http://www.brighamandwomens.org/Departments_and_Services/obgyn/ser vices/mininvgynsurg/mininvoptions/hysterectomy.aspx. Updated October 3, 2014. Accessed August 6, 2015.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 444: Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114(5):1156–1158.
- Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677.
- American Congress of Obstetricians and Gynecologists. 2011 Women’s Health Stats & Facts. Washington, DC: ACOG; 2011. http://www.acog.org/~/media/NewsRoom/MediaKit.pdf. Accessed August 6, 2015.
- Nezhat C, Lewis M, King LP. Laparoscopic vessel sealing devices. Society of Laparoendoscopic Surgeons. http://laparoscopy.blogs.com/prevention_management_3/2010/10/laparoscopic-vessel-sealing-devices.html. Published 2010. Accessed August 6, 2015.
- Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol. 2003;102(1):147–151.
- Cronjé HS, de Coning EC. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet. 2005;91(3):243–245.
- Silva-Filho AL, Rodrigues AM, Vale de Castro Monteiro M, et al. Randomized study of bipolar vessel sealing system versus conventional suture ligature for vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2009;146(2):200–203.
- Kroft J, Selk A. Energy-based vessel sealing in vaginal hysterectomy: a systematic review and meta-analysis. Obstet Gynecol. 2011;118(5):1127–1136.
- Lakeman MM, The S, Schellart RP, et al. Electrosurgical bipolar vessel sealing versus conventional clamping and suturing for vaginal hysterectomy: a randomised controlled trial. BJOG. 2012;119(12):1473–1482.
- Candiani M, Izzo S, Bulfoni A, Riparini J, Ronzoni S, Marconi A. Laparoscopic vs vaginal hysterectomy for benign pathology. Am J Obstet Gynecol. 2009;200(4):368.e1–e7.
In this Article
- Benefits of vessel sealing over suturing
- Lighted suction irrigator: visualization “around corners”
- External scope offers optimal visualization to the entire team
Your teenage patient and contraception: Think “long-acting” first
CASE: Teen patient asks to switch contraceptive methods
A 17-year-old nulliparous woman comes to your clinic for an annual examination. She has no significant health problems, and her examination is normal. She notes that she was started on oral contraceptives (OCs) the year before because of heavy menstrual flow and a desire for birth control but has trouble remembering to take them—though she does usually use condoms. She asks your advice about switching to a different method but indicates that she has lost her health insurance coverage.
What can you offer her as an effective, low-cost contraceptive?
Long-acting reversible contraception (LARC) methods are especially suited for adolescent and young adult women, for whom daily compliance with a shorter-acting contraceptive may be problematic. Five LARC methods are available in the United States, including a new levonorgestrel-releasing intrauterine system (LNG-IUS; Liletta), which received approval from the US Food and Drug Administration (FDA) this year. Like Mirena, Liletta contains 52 mg of levonorgestrel that is released over time. Liletta was introduced by the nonprofit organization Medicines360 and its commercial partner Actavis Pharma in response to evidence that poor women continue to lack access to LARC because of cost or problems with insurance coverage.1
For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs. For health care practices, the reduced price of Liletta may make it feasible for them to offer LARC to more patients. The reduced pricing also makes Liletta an attractive option for women who choose to pay for the device directly rather than use insurance, such as the patient described above.
Patient experience with Liletta also is key. Not surprisingly, Liletta’s clinical trial found patient satisfaction to be similar to that of Mirena users.2 The failure rate is less than 1%, again comparable to Mirena. The rate of pelvic infection with Liletta use was 0.5%, also comparable to previously published data.3
One difference between Liletta and Mirena is that Liletta carries FDA approval for 3 years of contraceptive efficacy, compared with 5 years for Mirena. In order to make Liletta available to US patients now, Medicines360 decided to apply for 3-year contraceptive labeling while 5- and 7-year efficacy data are being collected. Like Mirena, Liletta is expected to provide excellent contraception for at least 5 years.
How to insert Liletta
- While still pinching the insertion tube, slide the tube through the cervical canal until the upper edge of the flange is approximately 1.5 to 2 cm from the cervix. Do not force the inserter. If necessary, dilate the cervical canal. Release your hold on the tenaculum.
- Hold the insertion tube with the fingers of one hand (Hand A) and the rod with the fingers of the other hand (Hand B).
- Holding the rod in place (Hand B), relax your pinch on the tube and pull the insertion tube back with Hand A to the edge of the second indent of the rod. This will allow the IUS arms to unfold in the lower uterine segment (FIGURE). Wait 10 to 15 seconds for the arms of the IUS to open fully.
- Apply gentle traction with the tenaculum before advancing the IUS. With Hand A still holding the proximal end of the tube, advance both the insertion tube and rod simultaneously up to the uterine fundus. You will feel slight resistance when the IUS is at the fundus. Make sure the flange is touching the cervix when the IUS reaches the uterine fundus. Fundal positioning is important to prevent expulsion.
- Hold the rod still (Hand B) while pulling the insertion tube back with Hand A to the ring of the rod. While holding the inserter tube with Hand A, withdraw the rod from the insertion tube all of the way out to prevent the rod from catching on the knot at the lower end of the IUS. Completely remove the insertion tube.
- Using blunt-tipped sharp scissors, cut the IUS threads perpendicular to the thread length, leaving about 3 cm outside of the cervix. Do not apply tension or pull on the threads when cutting to prevent displacing the IUS. Insertion is now complete.
Source: Liletta [package insert]. Actavis Pharma, Parsippany, NJ; 2015.
Skyla is another LARC option for womenseeking an LNG-IUS for contraception. It provides highly effective contraception for at least 3 years through the release of 13.5 mg of levonorgestrel over time. Skyla’s reduced levonorgestrel content, as compared with Mirena and Liletta, means that fewer users will experience amenorrhea (13% vs 25%).
Paragard is a nonhormonal IUD that uses copper for contraceptive efficacy. The device contains a total of 380 mm of copper. Possible mechanisms of action include interference with sperm migration in the uterus and damage to or destruction of ova. It is FDA-approved for at least 10 years of use. The lack of any hormone in Paragard IUDs may make them attractive to women who do not wish to experience amenorrhea.
Nexplanon is a subdermal implant containing 68 mg of etonogestrel; it is approved for at least 3 years of use. It is the only LARC method that does not require a pelvic examination. Providers are required to complete a training course offered by the manufacturer to ensure proper placement and removal technique.
LARC should be a first-line birth control option
The primary indication for LARC is preg-nancy prevention. Because LARC methods are the most effective reversible means to prevent pregnancy—apart from complete abstinence from sexual intercourse—they should be offered as first-line birth control options to patients who do not wish to conceive. The ability to discontinue LARC methods is an attractive option for women who may want to become pregnant in the future, such as the patient in the opening vignette.
Efficacy rates are high
Because LARC methods do not require users to take action daily or prior to intercourse, they carry a risk of pregnancy of less than 1% (TABLE 1)4-7—equal to or better than rates seen with tubal sterilization. In comparison, the OC pill has a typical use contraceptive failure rate of about 8%.
LARC still has a low utilization rate
It is unfortunate that barriers to LARC methods remain in the United States (see, for example, “National organization identifies barriers to LARC,” above). As recently as 2011 to 2013, only 7.2% of US women aged 15 to 44 years used a LARC method.8 Provider inexperience and patient fears surrounding LARC use remain major barriers. In the past, nulliparity and young age were thought to be contraindications to IUD use. Research and experience have demonstrated, however, that IUDs and contraceptive implants are safe for use in young women and those who have not had children.
Cost barriers also have significantly limited the use of LARC methods. Over time, however, these contraceptives have become less costly to patients, and most insurance providers routinely cover LARC devices and insertion fees. The contraceptive mandate of the Affordable Care Act ensures coverage of contraception, including LARC, for interested women. These trends suggest continued improvement in women’s access to LARC.
National organization identifies barriers to LARC
In 2014, the National Committee for Quality Assurance (NCQA), with support from Bayer Healthcare, organized a meeting of key opinion leaders to discuss ways to eliminate barriers to the most effective contraceptive methods, better known as long-acting reversible contraception (LARC). The resultant issue brief, Women’s Health: Approaches to improving unintended pregnancy rates in the United States, identified a number of key barriers:
- Financial and logistical obstacles. The consensus attendees agreed that LARC methods should be offered to all women not planning a pregnancy in the next 2 years, but acknowledged that operational or administrative process issues sometimes interfere with this goal. One of the most prominent of these issues was the lack of opportunity for same-day insertion of LARC. Other issues included the cost to stock LARC methods, a lack of understanding of billing and reimbursement for LARC, reimbursement policies that prohibit billing for the visit and placement on the same day, and an overabundance of paperwork.
- Timing of the contraceptive counseling session. Many women fail to return for the 6-week postpartum visit—the visit typically set aside for counseling about contraception.
- Lack of a quality measure that would “motivate change in clinical practice.”1 One option: Treat family planning as a “vital sign” that needs to be addressed during the annual visit. “This would lead to stronger evidence for effecting change,” the report notes.1
- Lack of adequate communication skills by the provider. According to the NCQA report, “There are strong positive relationships between a health care team member’s communication skills and a patient’s willingness to follow through with medical recommendations.”1 The establishment of a “current counseling approach” that emphasizes the efficiency and effectiveness of LARC methods as well as the tremendous impact an unintended pregnancy would have on a woman’s whole life course would help improve provider-patient communication and increase the likelihood of LARC methods being utilized.1
- Lack of receptivity among some patients. For some women, the person delivering the message is as important as the message itself, depending on social and cultural norms. Sensitivity of health care providers to these nuances of communication can help enhance patient receptivity to the key message. As the NCQA report notes, “Physicians and the health care system are not always the most trusted source of information, and understanding disparities in contraception care will be important in changing patient behavior.”1
- Basic issues such as cost and access to care.1 Not all women are covered by insurance, particularly in states that opted against expanding access to Medicaid. For these women, the cost of LARC methods and insertion may be prohibitive.
Reference
Noncontraceptive benefits include reduced bleeding
The 3 LNG-IUS methods and the subdermal implant offer several benefits beyond contraception. Because of their progestin content, these methods reduce or even eliminate menses. This benefit can be very helpful for women who experience heavy menstrual periods and the consequent risk of anemia. Because of reduced menstrual flow, users of hormonal LARC methods also commonly experience less cramping associated with menses.
Women with endometriosis often benefit from hormonal LARC methods, as the disease is suppressed by the progestin component. Users of IUDs also have a reduced risk of endometrial cancer.
Contraindications to LARC
There are few contraindications to LARC methods, making them an appropriate choice for most women. The US Medical Eligibility Criteria for Contraceptive Use, 2010, published by the Centers for Disease Control and Prevention (CDC), contain guidelines that are based on the best available evidence.9 Contraceptive methods that are labeled as Category 1 or 2 are not contraindicated for most women. Methods that fall into Category 3 (theoretical or proven risks outweigh the advantages) or Category 4 (unacceptable health risk) are contraindicated (TABLE 2).9
IUDs once were thought to expose women to an increased risk of pelvic inflammatory disease, but this fear has long been disproven. Screening for chlamydia can be performed at the time of placement, as recommended annually for women younger than 25 years. Unless there is concern for active cervical or uterine infection, there is no need to delay insertion of an IUD while awaiting test results. In most cases, women found to have positive cultures after insertion can be treated successfully without IUD removal.
Main adverse effect is altered bleeding patterns
Adverse effects vary depending on the method being used. All LARC methods may affect menstrual patterns. For example, clinical trials involving the copper IUD indicate that abnormal heavy bleeding may lead to discontinuation in up to 10% of users.5,10 Amenorrhea or oligomenorrhea is uncommon with this method and rarely leads to discontinuation. For example, in one trial involving more than 900 women using a copper IUD for up to 5 years, there were no discontinuations due to amenorrhea. Dysmenorrhea may arise, but data from clinical trials indicate that its frequency decreases over time. In one trial, the frequency of any menstrual pain decreased from about 9% of users to 5% after 8 months or more of use.
The LNG-IUS also can be associated with abnormal uterine bleeding. In contrast to the copper IUD, LNG devices tend to reduce menstrual bleeding and can be unpredictable. Clinical trials involving the 5-year 52-mg LNG-IUS indicate that bleeding decreases over time, with as many as 70% of users developing amenorrhea or oligomenorrhea.5,11 However, some women using an LNG-IUS experience heavy bleeding— although the frequency of such bleeding tends to be substantially less than that experienced by copper IUD users.7
A lack of comparative trials makes it unclear whether the newer 3-year LNG-IUS devices are associated with a significantly altered bleeding pattern. Noncomparative data from the package insert for Skyla suggest that women using it may have a higher frequency of heavy menstrual bleeding and less amenorrhea than users of the 5-year device.6
Data from a 3-year clinical trial of the newest 52-mg LNG-IUS (Liletta) indicate that bleeding and dysmenorrhea led to discontinuation 1% to 2% of the time.2
Although the concentration of progestincirculating systemically is low with the various LNG-IUS devices, some women may experience symptoms such as mood swings, headaches, acne, and breast tenderness.
Expulsions during the first year of use of the copper IUD and the 3 LNG-IUS devices range from 2% to 10%, with the higher rates associated with immediate postpartum insertion.5
Uterine perforation has been reported in about 1 of every 1,000 insertions. Other adverse events are uncommon.
Clinical trials indicate that about 11% of implant users will discontinue the method due to bleeding abnormalities.12 About 25% to 30% of users will experience heavy or prolonged bleeding, while up to 33% will experience infrequent bleeding or amenorrhea. About 50% of implant users will experience improved bleeding patterns over time.
Other reasons for discontinuation of implant use in a very small percentage of users include emotional lability, weight gain, acne, and headaches.4 Complications due to insertion and removal are rare and include pain, bleeding, and hematoma formation.
Public health impact of LARC methods
An important question in regard to LARC use is: How do we best provide safe and effective contraception for teens and young adult women? There is increasing evidence that, with appropriate counseling and the removal of cost barriers, LARC methods can have a significant public health impact in this population.
The Contraceptive CHOICE Project, a cohort study in a teenage population of women in the St. Louis, Missouri, area, achieved increased utilization of LARC methods and significantly lower rates of pregnancy, birth, and abortion.13 Investigators proactively counseled young women about the advantages of LARC methods and offered them free of charge. As a result, 72% of women in the study chose an IUD or implant as their method of contraception. Pregnancy, birth, and abortion rates among participants were 34.0, 19.4, and 9.7 per 1,000 teens, respectively. By comparison, national statistics during the same time frame for pregnancy, birth, and abortion were 158.5, 94.0, and 41.5 per 1,000 US teens, respectively.13
A similar project in Colorado received $23.6 million in 2009 from an outside donor to make LARC methods more affordable to patients in family planning clinics in the state.14 Between 2009 and 2014, 30,000 contraceptive implants or IUDs were made available at low or no cost to low-income women attending 68 family planning clinics statewide. The use of these methods at participating clinics quadrupled. Further, the teen birth rate declined by 40% between 2009 and 2013—from 37 to 22 births per 1,000 teens.14 Seventy-five percent of this decline was attributable to increased use of these methods. The teen abortion rate declined by 35% in the same time frame.
In 2014, the Colorado governor’s office indicated that the state had saved $42.5 million in health care expenditures associated with teen births. It was estimated that, for every dollar spent on contraceptives, the state saved $5.68 in Medicaid costs. However, a bipartisan bill to continue funding the project has failed so far in 2015 due to concerns among some legislators that these methods—particularly the IUDs—are abortifacients. The reduced cost of the 3-year LNG-IUS (Liletta) and recent guidance from the US Department of Health and Human Services mandating that at least 1 form of contraception in each of the FDA-approved categories must be covered by insurers may help to overcome this barrier.
CASE: Resolved
You counsel the patient about the value of each LARC method, letting her know that they are all highly effective in the prevention of pregnancy. You also let her know how each method would affect her menstrual cycle and acknowledge that she may have a preference for whether the contraceptive is placed in her uterus or under the skin of her arm. She chooses the contraceptive implant, which you insert during the same visit. At a follow-up visit 6 weeks later, she reports satisfaction with the method.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
1. Dehlendorf C, Rodriguez MI, Levy K, Borrero S, Steinauer J.Disparities in family planning. Am J Obstet Gynecol. 2010;202(3):214–220.
2. Eisenberg DL, Schreiber CA, Turok DK, et al. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015;92(1):10–16.
3. Sufrin C, Postlethwaite D, Armstrong MA, et al. Neisseria gonorrhea and Chlamydia trachomatis screening at intrauterine device insertion and pelvic inflammatory disease. Obstet Gynecol. 2012;120(6):1314–1321.
4. Espey E, Ogburn T. Long-acting reversible contraceptives—intrauterine devices and the contraceptive implant. Obstet Gynecol. 2011;117(3):705–719.
5. American College of Obstetricians and Gynecologists. Practice Bulletin No. 121: Long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2011;118(1):184–196.
6. Skyla [package insert]. Bayer Healthcare, Wayne, NJ; 2013.
7. Liletta [package insert]. Actavis Pharma, Parsippany, NJ; 2015.
8. Branum AM, Jones J. Centers for Disease Control and Prevention: NCHS Data Brief No. 188: Trends in Long-Acting Reversible Contraception Use Among US Women Aged 15–44. http://www.cdc.gov/nchs/data/databriefs/db188.htm. Published February 2015. Accessed August 14, 2015.
9. Centers for Disease Control and Prevention. US medical eligibility criteria for contraceptive use, 2010. MMWR Recomm Rep. 2010;59(RR4):1–86.
10. Andersson K, Odlind VL, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use; a randomized comparative trial. Contraception. 1994;49(1):56–72.
11. Sivin I, Stern J, Diaz J, et al. Two years of intrauterine contraception with levonorgestrel and copper: a randomized comparison of the TCu 380Ag and levonorgestrel 20 mcg/day devices. Contraception. 1987;35(3):245–255.
12. Mansour F, Korver T, Marintcheva-Petrova M, Fraser IS. The effects of Implanon on menstrual bleeding patterns. Eur J Contracept Reprod Health Care. 2008;13(suppl 1):13–28.
13. Secura GM, Madden T, McNicholas C, et al. Provision of no-cost, long-acting contraception and teenage pregnancy. N Engl J Med. 2014;371:1316–1323.
14. Tavernise S. Colorado’s effort against teenage pregnancies is a startling success. New York Times. http://www.nytimes.com/2015/07/06/science/colorados-push-against-teenage-pregnancies-is-a-startling-success.html. Published July 6, 2015. Accessed August 17, 2015.
CASE: Teen patient asks to switch contraceptive methods
A 17-year-old nulliparous woman comes to your clinic for an annual examination. She has no significant health problems, and her examination is normal. She notes that she was started on oral contraceptives (OCs) the year before because of heavy menstrual flow and a desire for birth control but has trouble remembering to take them—though she does usually use condoms. She asks your advice about switching to a different method but indicates that she has lost her health insurance coverage.
What can you offer her as an effective, low-cost contraceptive?
Long-acting reversible contraception (LARC) methods are especially suited for adolescent and young adult women, for whom daily compliance with a shorter-acting contraceptive may be problematic. Five LARC methods are available in the United States, including a new levonorgestrel-releasing intrauterine system (LNG-IUS; Liletta), which received approval from the US Food and Drug Administration (FDA) this year. Like Mirena, Liletta contains 52 mg of levonorgestrel that is released over time. Liletta was introduced by the nonprofit organization Medicines360 and its commercial partner Actavis Pharma in response to evidence that poor women continue to lack access to LARC because of cost or problems with insurance coverage.1
For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs. For health care practices, the reduced price of Liletta may make it feasible for them to offer LARC to more patients. The reduced pricing also makes Liletta an attractive option for women who choose to pay for the device directly rather than use insurance, such as the patient described above.
Patient experience with Liletta also is key. Not surprisingly, Liletta’s clinical trial found patient satisfaction to be similar to that of Mirena users.2 The failure rate is less than 1%, again comparable to Mirena. The rate of pelvic infection with Liletta use was 0.5%, also comparable to previously published data.3
One difference between Liletta and Mirena is that Liletta carries FDA approval for 3 years of contraceptive efficacy, compared with 5 years for Mirena. In order to make Liletta available to US patients now, Medicines360 decided to apply for 3-year contraceptive labeling while 5- and 7-year efficacy data are being collected. Like Mirena, Liletta is expected to provide excellent contraception for at least 5 years.
How to insert Liletta
- While still pinching the insertion tube, slide the tube through the cervical canal until the upper edge of the flange is approximately 1.5 to 2 cm from the cervix. Do not force the inserter. If necessary, dilate the cervical canal. Release your hold on the tenaculum.
- Hold the insertion tube with the fingers of one hand (Hand A) and the rod with the fingers of the other hand (Hand B).
- Holding the rod in place (Hand B), relax your pinch on the tube and pull the insertion tube back with Hand A to the edge of the second indent of the rod. This will allow the IUS arms to unfold in the lower uterine segment (FIGURE). Wait 10 to 15 seconds for the arms of the IUS to open fully.
- Apply gentle traction with the tenaculum before advancing the IUS. With Hand A still holding the proximal end of the tube, advance both the insertion tube and rod simultaneously up to the uterine fundus. You will feel slight resistance when the IUS is at the fundus. Make sure the flange is touching the cervix when the IUS reaches the uterine fundus. Fundal positioning is important to prevent expulsion.
- Hold the rod still (Hand B) while pulling the insertion tube back with Hand A to the ring of the rod. While holding the inserter tube with Hand A, withdraw the rod from the insertion tube all of the way out to prevent the rod from catching on the knot at the lower end of the IUS. Completely remove the insertion tube.
- Using blunt-tipped sharp scissors, cut the IUS threads perpendicular to the thread length, leaving about 3 cm outside of the cervix. Do not apply tension or pull on the threads when cutting to prevent displacing the IUS. Insertion is now complete.
Source: Liletta [package insert]. Actavis Pharma, Parsippany, NJ; 2015.
Skyla is another LARC option for womenseeking an LNG-IUS for contraception. It provides highly effective contraception for at least 3 years through the release of 13.5 mg of levonorgestrel over time. Skyla’s reduced levonorgestrel content, as compared with Mirena and Liletta, means that fewer users will experience amenorrhea (13% vs 25%).
Paragard is a nonhormonal IUD that uses copper for contraceptive efficacy. The device contains a total of 380 mm of copper. Possible mechanisms of action include interference with sperm migration in the uterus and damage to or destruction of ova. It is FDA-approved for at least 10 years of use. The lack of any hormone in Paragard IUDs may make them attractive to women who do not wish to experience amenorrhea.
Nexplanon is a subdermal implant containing 68 mg of etonogestrel; it is approved for at least 3 years of use. It is the only LARC method that does not require a pelvic examination. Providers are required to complete a training course offered by the manufacturer to ensure proper placement and removal technique.
LARC should be a first-line birth control option
The primary indication for LARC is preg-nancy prevention. Because LARC methods are the most effective reversible means to prevent pregnancy—apart from complete abstinence from sexual intercourse—they should be offered as first-line birth control options to patients who do not wish to conceive. The ability to discontinue LARC methods is an attractive option for women who may want to become pregnant in the future, such as the patient in the opening vignette.
Efficacy rates are high
Because LARC methods do not require users to take action daily or prior to intercourse, they carry a risk of pregnancy of less than 1% (TABLE 1)4-7—equal to or better than rates seen with tubal sterilization. In comparison, the OC pill has a typical use contraceptive failure rate of about 8%.
LARC still has a low utilization rate
It is unfortunate that barriers to LARC methods remain in the United States (see, for example, “National organization identifies barriers to LARC,” above). As recently as 2011 to 2013, only 7.2% of US women aged 15 to 44 years used a LARC method.8 Provider inexperience and patient fears surrounding LARC use remain major barriers. In the past, nulliparity and young age were thought to be contraindications to IUD use. Research and experience have demonstrated, however, that IUDs and contraceptive implants are safe for use in young women and those who have not had children.
Cost barriers also have significantly limited the use of LARC methods. Over time, however, these contraceptives have become less costly to patients, and most insurance providers routinely cover LARC devices and insertion fees. The contraceptive mandate of the Affordable Care Act ensures coverage of contraception, including LARC, for interested women. These trends suggest continued improvement in women’s access to LARC.
National organization identifies barriers to LARC
In 2014, the National Committee for Quality Assurance (NCQA), with support from Bayer Healthcare, organized a meeting of key opinion leaders to discuss ways to eliminate barriers to the most effective contraceptive methods, better known as long-acting reversible contraception (LARC). The resultant issue brief, Women’s Health: Approaches to improving unintended pregnancy rates in the United States, identified a number of key barriers:
- Financial and logistical obstacles. The consensus attendees agreed that LARC methods should be offered to all women not planning a pregnancy in the next 2 years, but acknowledged that operational or administrative process issues sometimes interfere with this goal. One of the most prominent of these issues was the lack of opportunity for same-day insertion of LARC. Other issues included the cost to stock LARC methods, a lack of understanding of billing and reimbursement for LARC, reimbursement policies that prohibit billing for the visit and placement on the same day, and an overabundance of paperwork.
- Timing of the contraceptive counseling session. Many women fail to return for the 6-week postpartum visit—the visit typically set aside for counseling about contraception.
- Lack of a quality measure that would “motivate change in clinical practice.”1 One option: Treat family planning as a “vital sign” that needs to be addressed during the annual visit. “This would lead to stronger evidence for effecting change,” the report notes.1
- Lack of adequate communication skills by the provider. According to the NCQA report, “There are strong positive relationships between a health care team member’s communication skills and a patient’s willingness to follow through with medical recommendations.”1 The establishment of a “current counseling approach” that emphasizes the efficiency and effectiveness of LARC methods as well as the tremendous impact an unintended pregnancy would have on a woman’s whole life course would help improve provider-patient communication and increase the likelihood of LARC methods being utilized.1
- Lack of receptivity among some patients. For some women, the person delivering the message is as important as the message itself, depending on social and cultural norms. Sensitivity of health care providers to these nuances of communication can help enhance patient receptivity to the key message. As the NCQA report notes, “Physicians and the health care system are not always the most trusted source of information, and understanding disparities in contraception care will be important in changing patient behavior.”1
- Basic issues such as cost and access to care.1 Not all women are covered by insurance, particularly in states that opted against expanding access to Medicaid. For these women, the cost of LARC methods and insertion may be prohibitive.
Reference
Noncontraceptive benefits include reduced bleeding
The 3 LNG-IUS methods and the subdermal implant offer several benefits beyond contraception. Because of their progestin content, these methods reduce or even eliminate menses. This benefit can be very helpful for women who experience heavy menstrual periods and the consequent risk of anemia. Because of reduced menstrual flow, users of hormonal LARC methods also commonly experience less cramping associated with menses.
Women with endometriosis often benefit from hormonal LARC methods, as the disease is suppressed by the progestin component. Users of IUDs also have a reduced risk of endometrial cancer.
Contraindications to LARC
There are few contraindications to LARC methods, making them an appropriate choice for most women. The US Medical Eligibility Criteria for Contraceptive Use, 2010, published by the Centers for Disease Control and Prevention (CDC), contain guidelines that are based on the best available evidence.9 Contraceptive methods that are labeled as Category 1 or 2 are not contraindicated for most women. Methods that fall into Category 3 (theoretical or proven risks outweigh the advantages) or Category 4 (unacceptable health risk) are contraindicated (TABLE 2).9
IUDs once were thought to expose women to an increased risk of pelvic inflammatory disease, but this fear has long been disproven. Screening for chlamydia can be performed at the time of placement, as recommended annually for women younger than 25 years. Unless there is concern for active cervical or uterine infection, there is no need to delay insertion of an IUD while awaiting test results. In most cases, women found to have positive cultures after insertion can be treated successfully without IUD removal.
Main adverse effect is altered bleeding patterns
Adverse effects vary depending on the method being used. All LARC methods may affect menstrual patterns. For example, clinical trials involving the copper IUD indicate that abnormal heavy bleeding may lead to discontinuation in up to 10% of users.5,10 Amenorrhea or oligomenorrhea is uncommon with this method and rarely leads to discontinuation. For example, in one trial involving more than 900 women using a copper IUD for up to 5 years, there were no discontinuations due to amenorrhea. Dysmenorrhea may arise, but data from clinical trials indicate that its frequency decreases over time. In one trial, the frequency of any menstrual pain decreased from about 9% of users to 5% after 8 months or more of use.
The LNG-IUS also can be associated with abnormal uterine bleeding. In contrast to the copper IUD, LNG devices tend to reduce menstrual bleeding and can be unpredictable. Clinical trials involving the 5-year 52-mg LNG-IUS indicate that bleeding decreases over time, with as many as 70% of users developing amenorrhea or oligomenorrhea.5,11 However, some women using an LNG-IUS experience heavy bleeding— although the frequency of such bleeding tends to be substantially less than that experienced by copper IUD users.7
A lack of comparative trials makes it unclear whether the newer 3-year LNG-IUS devices are associated with a significantly altered bleeding pattern. Noncomparative data from the package insert for Skyla suggest that women using it may have a higher frequency of heavy menstrual bleeding and less amenorrhea than users of the 5-year device.6
Data from a 3-year clinical trial of the newest 52-mg LNG-IUS (Liletta) indicate that bleeding and dysmenorrhea led to discontinuation 1% to 2% of the time.2
Although the concentration of progestincirculating systemically is low with the various LNG-IUS devices, some women may experience symptoms such as mood swings, headaches, acne, and breast tenderness.
Expulsions during the first year of use of the copper IUD and the 3 LNG-IUS devices range from 2% to 10%, with the higher rates associated with immediate postpartum insertion.5
Uterine perforation has been reported in about 1 of every 1,000 insertions. Other adverse events are uncommon.
Clinical trials indicate that about 11% of implant users will discontinue the method due to bleeding abnormalities.12 About 25% to 30% of users will experience heavy or prolonged bleeding, while up to 33% will experience infrequent bleeding or amenorrhea. About 50% of implant users will experience improved bleeding patterns over time.
Other reasons for discontinuation of implant use in a very small percentage of users include emotional lability, weight gain, acne, and headaches.4 Complications due to insertion and removal are rare and include pain, bleeding, and hematoma formation.
Public health impact of LARC methods
An important question in regard to LARC use is: How do we best provide safe and effective contraception for teens and young adult women? There is increasing evidence that, with appropriate counseling and the removal of cost barriers, LARC methods can have a significant public health impact in this population.
The Contraceptive CHOICE Project, a cohort study in a teenage population of women in the St. Louis, Missouri, area, achieved increased utilization of LARC methods and significantly lower rates of pregnancy, birth, and abortion.13 Investigators proactively counseled young women about the advantages of LARC methods and offered them free of charge. As a result, 72% of women in the study chose an IUD or implant as their method of contraception. Pregnancy, birth, and abortion rates among participants were 34.0, 19.4, and 9.7 per 1,000 teens, respectively. By comparison, national statistics during the same time frame for pregnancy, birth, and abortion were 158.5, 94.0, and 41.5 per 1,000 US teens, respectively.13
A similar project in Colorado received $23.6 million in 2009 from an outside donor to make LARC methods more affordable to patients in family planning clinics in the state.14 Between 2009 and 2014, 30,000 contraceptive implants or IUDs were made available at low or no cost to low-income women attending 68 family planning clinics statewide. The use of these methods at participating clinics quadrupled. Further, the teen birth rate declined by 40% between 2009 and 2013—from 37 to 22 births per 1,000 teens.14 Seventy-five percent of this decline was attributable to increased use of these methods. The teen abortion rate declined by 35% in the same time frame.
In 2014, the Colorado governor’s office indicated that the state had saved $42.5 million in health care expenditures associated with teen births. It was estimated that, for every dollar spent on contraceptives, the state saved $5.68 in Medicaid costs. However, a bipartisan bill to continue funding the project has failed so far in 2015 due to concerns among some legislators that these methods—particularly the IUDs—are abortifacients. The reduced cost of the 3-year LNG-IUS (Liletta) and recent guidance from the US Department of Health and Human Services mandating that at least 1 form of contraception in each of the FDA-approved categories must be covered by insurers may help to overcome this barrier.
CASE: Resolved
You counsel the patient about the value of each LARC method, letting her know that they are all highly effective in the prevention of pregnancy. You also let her know how each method would affect her menstrual cycle and acknowledge that she may have a preference for whether the contraceptive is placed in her uterus or under the skin of her arm. She chooses the contraceptive implant, which you insert during the same visit. At a follow-up visit 6 weeks later, she reports satisfaction with the method.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
CASE: Teen patient asks to switch contraceptive methods
A 17-year-old nulliparous woman comes to your clinic for an annual examination. She has no significant health problems, and her examination is normal. She notes that she was started on oral contraceptives (OCs) the year before because of heavy menstrual flow and a desire for birth control but has trouble remembering to take them—though she does usually use condoms. She asks your advice about switching to a different method but indicates that she has lost her health insurance coverage.
What can you offer her as an effective, low-cost contraceptive?
Long-acting reversible contraception (LARC) methods are especially suited for adolescent and young adult women, for whom daily compliance with a shorter-acting contraceptive may be problematic. Five LARC methods are available in the United States, including a new levonorgestrel-releasing intrauterine system (LNG-IUS; Liletta), which received approval from the US Food and Drug Administration (FDA) this year. Like Mirena, Liletta contains 52 mg of levonorgestrel that is released over time. Liletta was introduced by the nonprofit organization Medicines360 and its commercial partner Actavis Pharma in response to evidence that poor women continue to lack access to LARC because of cost or problems with insurance coverage.1
For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs. For health care practices, the reduced price of Liletta may make it feasible for them to offer LARC to more patients. The reduced pricing also makes Liletta an attractive option for women who choose to pay for the device directly rather than use insurance, such as the patient described above.
Patient experience with Liletta also is key. Not surprisingly, Liletta’s clinical trial found patient satisfaction to be similar to that of Mirena users.2 The failure rate is less than 1%, again comparable to Mirena. The rate of pelvic infection with Liletta use was 0.5%, also comparable to previously published data.3
One difference between Liletta and Mirena is that Liletta carries FDA approval for 3 years of contraceptive efficacy, compared with 5 years for Mirena. In order to make Liletta available to US patients now, Medicines360 decided to apply for 3-year contraceptive labeling while 5- and 7-year efficacy data are being collected. Like Mirena, Liletta is expected to provide excellent contraception for at least 5 years.
How to insert Liletta
- While still pinching the insertion tube, slide the tube through the cervical canal until the upper edge of the flange is approximately 1.5 to 2 cm from the cervix. Do not force the inserter. If necessary, dilate the cervical canal. Release your hold on the tenaculum.
- Hold the insertion tube with the fingers of one hand (Hand A) and the rod with the fingers of the other hand (Hand B).
- Holding the rod in place (Hand B), relax your pinch on the tube and pull the insertion tube back with Hand A to the edge of the second indent of the rod. This will allow the IUS arms to unfold in the lower uterine segment (FIGURE). Wait 10 to 15 seconds for the arms of the IUS to open fully.
- Apply gentle traction with the tenaculum before advancing the IUS. With Hand A still holding the proximal end of the tube, advance both the insertion tube and rod simultaneously up to the uterine fundus. You will feel slight resistance when the IUS is at the fundus. Make sure the flange is touching the cervix when the IUS reaches the uterine fundus. Fundal positioning is important to prevent expulsion.
- Hold the rod still (Hand B) while pulling the insertion tube back with Hand A to the ring of the rod. While holding the inserter tube with Hand A, withdraw the rod from the insertion tube all of the way out to prevent the rod from catching on the knot at the lower end of the IUS. Completely remove the insertion tube.
- Using blunt-tipped sharp scissors, cut the IUS threads perpendicular to the thread length, leaving about 3 cm outside of the cervix. Do not apply tension or pull on the threads when cutting to prevent displacing the IUS. Insertion is now complete.
Source: Liletta [package insert]. Actavis Pharma, Parsippany, NJ; 2015.
Skyla is another LARC option for womenseeking an LNG-IUS for contraception. It provides highly effective contraception for at least 3 years through the release of 13.5 mg of levonorgestrel over time. Skyla’s reduced levonorgestrel content, as compared with Mirena and Liletta, means that fewer users will experience amenorrhea (13% vs 25%).
Paragard is a nonhormonal IUD that uses copper for contraceptive efficacy. The device contains a total of 380 mm of copper. Possible mechanisms of action include interference with sperm migration in the uterus and damage to or destruction of ova. It is FDA-approved for at least 10 years of use. The lack of any hormone in Paragard IUDs may make them attractive to women who do not wish to experience amenorrhea.
Nexplanon is a subdermal implant containing 68 mg of etonogestrel; it is approved for at least 3 years of use. It is the only LARC method that does not require a pelvic examination. Providers are required to complete a training course offered by the manufacturer to ensure proper placement and removal technique.
LARC should be a first-line birth control option
The primary indication for LARC is preg-nancy prevention. Because LARC methods are the most effective reversible means to prevent pregnancy—apart from complete abstinence from sexual intercourse—they should be offered as first-line birth control options to patients who do not wish to conceive. The ability to discontinue LARC methods is an attractive option for women who may want to become pregnant in the future, such as the patient in the opening vignette.
Efficacy rates are high
Because LARC methods do not require users to take action daily or prior to intercourse, they carry a risk of pregnancy of less than 1% (TABLE 1)4-7—equal to or better than rates seen with tubal sterilization. In comparison, the OC pill has a typical use contraceptive failure rate of about 8%.
LARC still has a low utilization rate
It is unfortunate that barriers to LARC methods remain in the United States (see, for example, “National organization identifies barriers to LARC,” above). As recently as 2011 to 2013, only 7.2% of US women aged 15 to 44 years used a LARC method.8 Provider inexperience and patient fears surrounding LARC use remain major barriers. In the past, nulliparity and young age were thought to be contraindications to IUD use. Research and experience have demonstrated, however, that IUDs and contraceptive implants are safe for use in young women and those who have not had children.
Cost barriers also have significantly limited the use of LARC methods. Over time, however, these contraceptives have become less costly to patients, and most insurance providers routinely cover LARC devices and insertion fees. The contraceptive mandate of the Affordable Care Act ensures coverage of contraception, including LARC, for interested women. These trends suggest continued improvement in women’s access to LARC.
National organization identifies barriers to LARC
In 2014, the National Committee for Quality Assurance (NCQA), with support from Bayer Healthcare, organized a meeting of key opinion leaders to discuss ways to eliminate barriers to the most effective contraceptive methods, better known as long-acting reversible contraception (LARC). The resultant issue brief, Women’s Health: Approaches to improving unintended pregnancy rates in the United States, identified a number of key barriers:
- Financial and logistical obstacles. The consensus attendees agreed that LARC methods should be offered to all women not planning a pregnancy in the next 2 years, but acknowledged that operational or administrative process issues sometimes interfere with this goal. One of the most prominent of these issues was the lack of opportunity for same-day insertion of LARC. Other issues included the cost to stock LARC methods, a lack of understanding of billing and reimbursement for LARC, reimbursement policies that prohibit billing for the visit and placement on the same day, and an overabundance of paperwork.
- Timing of the contraceptive counseling session. Many women fail to return for the 6-week postpartum visit—the visit typically set aside for counseling about contraception.
- Lack of a quality measure that would “motivate change in clinical practice.”1 One option: Treat family planning as a “vital sign” that needs to be addressed during the annual visit. “This would lead to stronger evidence for effecting change,” the report notes.1
- Lack of adequate communication skills by the provider. According to the NCQA report, “There are strong positive relationships between a health care team member’s communication skills and a patient’s willingness to follow through with medical recommendations.”1 The establishment of a “current counseling approach” that emphasizes the efficiency and effectiveness of LARC methods as well as the tremendous impact an unintended pregnancy would have on a woman’s whole life course would help improve provider-patient communication and increase the likelihood of LARC methods being utilized.1
- Lack of receptivity among some patients. For some women, the person delivering the message is as important as the message itself, depending on social and cultural norms. Sensitivity of health care providers to these nuances of communication can help enhance patient receptivity to the key message. As the NCQA report notes, “Physicians and the health care system are not always the most trusted source of information, and understanding disparities in contraception care will be important in changing patient behavior.”1
- Basic issues such as cost and access to care.1 Not all women are covered by insurance, particularly in states that opted against expanding access to Medicaid. For these women, the cost of LARC methods and insertion may be prohibitive.
Reference
Noncontraceptive benefits include reduced bleeding
The 3 LNG-IUS methods and the subdermal implant offer several benefits beyond contraception. Because of their progestin content, these methods reduce or even eliminate menses. This benefit can be very helpful for women who experience heavy menstrual periods and the consequent risk of anemia. Because of reduced menstrual flow, users of hormonal LARC methods also commonly experience less cramping associated with menses.
Women with endometriosis often benefit from hormonal LARC methods, as the disease is suppressed by the progestin component. Users of IUDs also have a reduced risk of endometrial cancer.
Contraindications to LARC
There are few contraindications to LARC methods, making them an appropriate choice for most women. The US Medical Eligibility Criteria for Contraceptive Use, 2010, published by the Centers for Disease Control and Prevention (CDC), contain guidelines that are based on the best available evidence.9 Contraceptive methods that are labeled as Category 1 or 2 are not contraindicated for most women. Methods that fall into Category 3 (theoretical or proven risks outweigh the advantages) or Category 4 (unacceptable health risk) are contraindicated (TABLE 2).9
IUDs once were thought to expose women to an increased risk of pelvic inflammatory disease, but this fear has long been disproven. Screening for chlamydia can be performed at the time of placement, as recommended annually for women younger than 25 years. Unless there is concern for active cervical or uterine infection, there is no need to delay insertion of an IUD while awaiting test results. In most cases, women found to have positive cultures after insertion can be treated successfully without IUD removal.
Main adverse effect is altered bleeding patterns
Adverse effects vary depending on the method being used. All LARC methods may affect menstrual patterns. For example, clinical trials involving the copper IUD indicate that abnormal heavy bleeding may lead to discontinuation in up to 10% of users.5,10 Amenorrhea or oligomenorrhea is uncommon with this method and rarely leads to discontinuation. For example, in one trial involving more than 900 women using a copper IUD for up to 5 years, there were no discontinuations due to amenorrhea. Dysmenorrhea may arise, but data from clinical trials indicate that its frequency decreases over time. In one trial, the frequency of any menstrual pain decreased from about 9% of users to 5% after 8 months or more of use.
The LNG-IUS also can be associated with abnormal uterine bleeding. In contrast to the copper IUD, LNG devices tend to reduce menstrual bleeding and can be unpredictable. Clinical trials involving the 5-year 52-mg LNG-IUS indicate that bleeding decreases over time, with as many as 70% of users developing amenorrhea or oligomenorrhea.5,11 However, some women using an LNG-IUS experience heavy bleeding— although the frequency of such bleeding tends to be substantially less than that experienced by copper IUD users.7
A lack of comparative trials makes it unclear whether the newer 3-year LNG-IUS devices are associated with a significantly altered bleeding pattern. Noncomparative data from the package insert for Skyla suggest that women using it may have a higher frequency of heavy menstrual bleeding and less amenorrhea than users of the 5-year device.6
Data from a 3-year clinical trial of the newest 52-mg LNG-IUS (Liletta) indicate that bleeding and dysmenorrhea led to discontinuation 1% to 2% of the time.2
Although the concentration of progestincirculating systemically is low with the various LNG-IUS devices, some women may experience symptoms such as mood swings, headaches, acne, and breast tenderness.
Expulsions during the first year of use of the copper IUD and the 3 LNG-IUS devices range from 2% to 10%, with the higher rates associated with immediate postpartum insertion.5
Uterine perforation has been reported in about 1 of every 1,000 insertions. Other adverse events are uncommon.
Clinical trials indicate that about 11% of implant users will discontinue the method due to bleeding abnormalities.12 About 25% to 30% of users will experience heavy or prolonged bleeding, while up to 33% will experience infrequent bleeding or amenorrhea. About 50% of implant users will experience improved bleeding patterns over time.
Other reasons for discontinuation of implant use in a very small percentage of users include emotional lability, weight gain, acne, and headaches.4 Complications due to insertion and removal are rare and include pain, bleeding, and hematoma formation.
Public health impact of LARC methods
An important question in regard to LARC use is: How do we best provide safe and effective contraception for teens and young adult women? There is increasing evidence that, with appropriate counseling and the removal of cost barriers, LARC methods can have a significant public health impact in this population.
The Contraceptive CHOICE Project, a cohort study in a teenage population of women in the St. Louis, Missouri, area, achieved increased utilization of LARC methods and significantly lower rates of pregnancy, birth, and abortion.13 Investigators proactively counseled young women about the advantages of LARC methods and offered them free of charge. As a result, 72% of women in the study chose an IUD or implant as their method of contraception. Pregnancy, birth, and abortion rates among participants were 34.0, 19.4, and 9.7 per 1,000 teens, respectively. By comparison, national statistics during the same time frame for pregnancy, birth, and abortion were 158.5, 94.0, and 41.5 per 1,000 US teens, respectively.13
A similar project in Colorado received $23.6 million in 2009 from an outside donor to make LARC methods more affordable to patients in family planning clinics in the state.14 Between 2009 and 2014, 30,000 contraceptive implants or IUDs were made available at low or no cost to low-income women attending 68 family planning clinics statewide. The use of these methods at participating clinics quadrupled. Further, the teen birth rate declined by 40% between 2009 and 2013—from 37 to 22 births per 1,000 teens.14 Seventy-five percent of this decline was attributable to increased use of these methods. The teen abortion rate declined by 35% in the same time frame.
In 2014, the Colorado governor’s office indicated that the state had saved $42.5 million in health care expenditures associated with teen births. It was estimated that, for every dollar spent on contraceptives, the state saved $5.68 in Medicaid costs. However, a bipartisan bill to continue funding the project has failed so far in 2015 due to concerns among some legislators that these methods—particularly the IUDs—are abortifacients. The reduced cost of the 3-year LNG-IUS (Liletta) and recent guidance from the US Department of Health and Human Services mandating that at least 1 form of contraception in each of the FDA-approved categories must be covered by insurers may help to overcome this barrier.
CASE: Resolved
You counsel the patient about the value of each LARC method, letting her know that they are all highly effective in the prevention of pregnancy. You also let her know how each method would affect her menstrual cycle and acknowledge that she may have a preference for whether the contraceptive is placed in her uterus or under the skin of her arm. She chooses the contraceptive implant, which you insert during the same visit. At a follow-up visit 6 weeks later, she reports satisfaction with the method.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
1. Dehlendorf C, Rodriguez MI, Levy K, Borrero S, Steinauer J.Disparities in family planning. Am J Obstet Gynecol. 2010;202(3):214–220.
2. Eisenberg DL, Schreiber CA, Turok DK, et al. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015;92(1):10–16.
3. Sufrin C, Postlethwaite D, Armstrong MA, et al. Neisseria gonorrhea and Chlamydia trachomatis screening at intrauterine device insertion and pelvic inflammatory disease. Obstet Gynecol. 2012;120(6):1314–1321.
4. Espey E, Ogburn T. Long-acting reversible contraceptives—intrauterine devices and the contraceptive implant. Obstet Gynecol. 2011;117(3):705–719.
5. American College of Obstetricians and Gynecologists. Practice Bulletin No. 121: Long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2011;118(1):184–196.
6. Skyla [package insert]. Bayer Healthcare, Wayne, NJ; 2013.
7. Liletta [package insert]. Actavis Pharma, Parsippany, NJ; 2015.
8. Branum AM, Jones J. Centers for Disease Control and Prevention: NCHS Data Brief No. 188: Trends in Long-Acting Reversible Contraception Use Among US Women Aged 15–44. http://www.cdc.gov/nchs/data/databriefs/db188.htm. Published February 2015. Accessed August 14, 2015.
9. Centers for Disease Control and Prevention. US medical eligibility criteria for contraceptive use, 2010. MMWR Recomm Rep. 2010;59(RR4):1–86.
10. Andersson K, Odlind VL, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use; a randomized comparative trial. Contraception. 1994;49(1):56–72.
11. Sivin I, Stern J, Diaz J, et al. Two years of intrauterine contraception with levonorgestrel and copper: a randomized comparison of the TCu 380Ag and levonorgestrel 20 mcg/day devices. Contraception. 1987;35(3):245–255.
12. Mansour F, Korver T, Marintcheva-Petrova M, Fraser IS. The effects of Implanon on menstrual bleeding patterns. Eur J Contracept Reprod Health Care. 2008;13(suppl 1):13–28.
13. Secura GM, Madden T, McNicholas C, et al. Provision of no-cost, long-acting contraception and teenage pregnancy. N Engl J Med. 2014;371:1316–1323.
14. Tavernise S. Colorado’s effort against teenage pregnancies is a startling success. New York Times. http://www.nytimes.com/2015/07/06/science/colorados-push-against-teenage-pregnancies-is-a-startling-success.html. Published July 6, 2015. Accessed August 17, 2015.
1. Dehlendorf C, Rodriguez MI, Levy K, Borrero S, Steinauer J.Disparities in family planning. Am J Obstet Gynecol. 2010;202(3):214–220.
2. Eisenberg DL, Schreiber CA, Turok DK, et al. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015;92(1):10–16.
3. Sufrin C, Postlethwaite D, Armstrong MA, et al. Neisseria gonorrhea and Chlamydia trachomatis screening at intrauterine device insertion and pelvic inflammatory disease. Obstet Gynecol. 2012;120(6):1314–1321.
4. Espey E, Ogburn T. Long-acting reversible contraceptives—intrauterine devices and the contraceptive implant. Obstet Gynecol. 2011;117(3):705–719.
5. American College of Obstetricians and Gynecologists. Practice Bulletin No. 121: Long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2011;118(1):184–196.
6. Skyla [package insert]. Bayer Healthcare, Wayne, NJ; 2013.
7. Liletta [package insert]. Actavis Pharma, Parsippany, NJ; 2015.
8. Branum AM, Jones J. Centers for Disease Control and Prevention: NCHS Data Brief No. 188: Trends in Long-Acting Reversible Contraception Use Among US Women Aged 15–44. http://www.cdc.gov/nchs/data/databriefs/db188.htm. Published February 2015. Accessed August 14, 2015.
9. Centers for Disease Control and Prevention. US medical eligibility criteria for contraceptive use, 2010. MMWR Recomm Rep. 2010;59(RR4):1–86.
10. Andersson K, Odlind VL, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use; a randomized comparative trial. Contraception. 1994;49(1):56–72.
11. Sivin I, Stern J, Diaz J, et al. Two years of intrauterine contraception with levonorgestrel and copper: a randomized comparison of the TCu 380Ag and levonorgestrel 20 mcg/day devices. Contraception. 1987;35(3):245–255.
12. Mansour F, Korver T, Marintcheva-Petrova M, Fraser IS. The effects of Implanon on menstrual bleeding patterns. Eur J Contracept Reprod Health Care. 2008;13(suppl 1):13–28.
13. Secura GM, Madden T, McNicholas C, et al. Provision of no-cost, long-acting contraception and teenage pregnancy. N Engl J Med. 2014;371:1316–1323.
14. Tavernise S. Colorado’s effort against teenage pregnancies is a startling success. New York Times. http://www.nytimes.com/2015/07/06/science/colorados-push-against-teenage-pregnancies-is-a-startling-success.html. Published July 6, 2015. Accessed August 17, 2015.
In this Article
- A comparative look at 5 LARC methods
- Common barriers to LARC
- How to insert Liletta
Reducing maternal mortality in the United States—Let’s get organized!
A mother’s untimely death in childbirth is a grave loss that sends shock waves of grief across generations of her family and community. As obstetricians practicing in the United States, we face a terrible problem. We have a continually rising rate of maternal death in a country with exceptional medical resources (FIGURE).1 Our national decentralized approach to dealing with maternal mortality is a factor contributing to the decades-long increase in the maternal mortality ratio. Let’s get organized to better respond to this public health crisis.
Medical education— Let’s get focused on maternal mortality
The 140-page Council on Resident Education in Obstetrics and Gynecology CREOG Educational Objectives: Core Curriculum in Obstetrics and Gynecology provides a detailed enumeration of the key learning objectives for residents in obstetrics and gynecology.2 Surprisingly, the CREOG objectives do not mention reducing maternal mortality as an important curricular goal. Learning clinical processes and practices that decrease the risk of maternal mortality should be an important educational goal for all residents training in obstetrics and gynecology.
Nationwide action is needed to address the problem
Many countries have organized widespread efforts to reduce maternal mortality. In the United Kingdom and France there are nationwide reviews of maternal deaths with detailed analyses of clinical events and identification of areas for future improvement. These reviews result in the dissemination of countrywide clinical recommendations that change practice and hopefully reduce the risk of future maternal deaths. For example, following the identification of pulmonary embolism as a leading cause of maternal death in the United Kingdom there was a nationwide effort to increase the use of mechanical and pharmacologic prophylaxis to prevent deep venous thrombosis.
In the United States, experts have proposed that a national program of clinical review of severe maternal morbidity cases should be mandatory. (There are many more cases of “near misses” with severe maternal morbidity than there are maternal deaths.) The greater number of cases available for review should help institutions to quickly recognize potential areas for clinical improvement. One group of experts has recommended that all deliveries in which a pregnant woman received 4 or more units of blood or was admitted to an intensive care unit should be thoroughly reviewed to identify opportunities for clinical improvement.3
In the United Kingdom a contemporary clinical problem that is being addressed in an organized and systematic manner is how to respond to the rising rate of severe maternal morbidity caused by placenta accreta. Experts have concluded that women with a suspected placenta accreta should deliver in regional centers with advanced clinical resources—including an emergency surgical response team, interventional radiology, a high capacity blood bank, and an intensive care unit.
A similar approach has been proposed for managing placenta accreta in the United States.4 The American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal Fetal Medicine (SMFM) have proposed a tiered system of obstetric care with more complex cases being referred to regional perinatal centers.5 Regionalization of trauma services has been an important part of the US health care system for decades. Cases of severe trauma are brought to regional centers equipped to emergently treat complex injuries. A similar system of regulation and regionalization could be adapted for optimizing maternity care.
High-risk clinical events: Is your unit prepared?
In the United States the leading causes of maternal mortality, in descending order, are6−8:
- cardiovascular diseases
- infection
- hemorrhage
- cardiomyopathy
- pulmonary embolism
- hypertension
- amniotic fluid embolism
- stroke
- anesthesia complications.
Over the last decade, the Joint Commission has recommended that birthing centers develop standardized protocols and use simulation to improve the institution’s ability to respond in a timely manner to clinical events that may result in maternal morbidity or death.
The quality of published protocols dealing with hemorrhage, hypertension, and thromboembolism is continuously improving, and every birthing center should have written protocols that are updated on a regular timetable for these common high-risk events.9,10 Does your birthing unit have written protocols to deal with cardiac diseases, infection, obstetric hemorrhage, thromboembolism, and severe hypertension? Are simulation exercises used to strengthen familiarity with the protocols?
High-risk patients
An amazing fact of today’s medical care is that sexually active women of reproductive age who have high-risk medical problems often have not been counseled to use a highly effective contraceptive, resulting in an increased risk of unintended pregnancy and maternal death. For example, adult women with a history of congenital heart disease are known to be at increased risk of death if they become pregnant. In a recent study, women with a history of congenital heart disease had 178 maternal deaths per 100,000 deliveries—a rate approximately 10-fold higher than the US maternal mortality ratio.11 Yet, many of these women are not using a highly effective contraceptive, and this results in a high rate of unplanned pregnancy.12
In order to reduce the risk of unintended pregnancy in women with high-risk medical problems, health systems could make contraception an important “vital sign” for women with high-risk medical conditions.
Race and age matter greatly when it comes to maternal mortality risk
There are major racial differences in pregnancy-related mortality, with black women having much higher rates than white women. In the United States in 2011, the pregnancy-related mortality ratio for white, black, and women of other races was 12.5, 42.8, and 17.3 deaths per 100,000 live births, respectively. This represents a major racial disparity in pregnancy outcomes.1
The age of the mother is an important determinant of the risk of maternal death. Women younger than age 35 years have the lowest risk of maternal death. From 2006 to 2010, pregnant women older than age 40 had a risk of death approximately 3 times greater than women aged 34 or younger.2
References
- Pregnancy Mortality Surveillance System. Centers for Disease Control and Prevention Web site. http://www .cdc.gov/reproductivehealth/maternalinfanthealth/pmss.html. Accessed August 20, 2015.
- Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015;125(1):5−12.
Let’s get organized
In a country with a history of embracing the “live free or die” ethic, it is often difficult for physicians to enthusiastically embrace the need for a higher level of organization and a potential reduction in individual freedom in order to improve health outcomes. And with a US maternal mortality ratio of 1 maternal death for every 5,400 births, many obstetricians will never have one of their patients die in childbirth. In fact, most obstetricians will have only 1 maternal death during their entire career. In this reality, when clinical events occur rarely, it is not possible for any single clinician, working alone, to impact the overall outcomes of those rare events. Therefore, teamwork and national efforts, such as the National Partnership for Maternal Safety,13 will be necessary to reverse our alarming trend of increasing maternal mortality. Let’s get organized to stop the rise of maternal deaths in the United States.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Chescheir NC. Enough already! Obstet Gynecol. 2015;125(1):2−4.
- Council on Resident Education in Obstetrics and Gynecology (CREOG) Educational Objectives: Core Curriculum in Obstetrics and Gynecology. 10th ed. Washington, DC: American College of Obstetricians and Gynecologists; 2013:140.
- Callaghan WM, Grobman WA, Kilpatrick SJ, Main EK, D’Alton M. Facility-based identification of women with severe maternal morbidity: it is time to start. Obstet Gynecol. 2014;123(5):978−981.
- Silver RM, Fox KA, Barton JR, et al. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015;212(5):561−568.
- American College of Obstetricians and Gynecologists and the Society of Maternal Fetal Medicine. Obstetric care consensus No 2: levels of maternal care. Obstet Gynecol. 2015;125(2):502−515.
- Berg CJ, Callaghan WM, Syverson C, Henderson Z. Pregnancy-related mortality in the United States, 1998−2005. Obstet Gynecol. 2010;116(6):1302−1309.
- Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006−2010. Obstet Gynecol. 2015;125(1):5−12.
- Pregnancy Mortality Surveillance System. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.html. Accessed August 20, 2015.
- Shields LE, Wiesner S, Fulton J, Pelletreau B. Comprehensive maternal hemorrhage protocols reduce the use of blood products and improve patient safety. Am J Obstet Gynecol. 2015;212(3):272−280.
- James A. Committee on Practice Bulletins—Obstetrics. Practice bulletin No. 123: thromboembolism in pregnancy. ACOG. Obstet Gynecol. 2011;118(3):718−729.
- Thompson JL, Kuklina EV, Bateman BT, Callaghan WM, James AH, Grotegut CA. Medical and obstetrical outcomes among pregnant women with congenital heart disease. Obstet Gynecol. 2015;126(2):346−354.
- Lindley KJ, Madden T, Cahill AG, Ludbrook PA, Billadello JJ. Contraceptive use and unintended pregnancy in women with congenital heart disease. Obstet Gynecol. 2015;126(2):363−369.
- D’Alton ME, Main EK, Menard MK, Levy BS. The National Partnership for Maternal Safety. Obstet Gynecol. 2014;123(5):973−977.
A mother’s untimely death in childbirth is a grave loss that sends shock waves of grief across generations of her family and community. As obstetricians practicing in the United States, we face a terrible problem. We have a continually rising rate of maternal death in a country with exceptional medical resources (FIGURE).1 Our national decentralized approach to dealing with maternal mortality is a factor contributing to the decades-long increase in the maternal mortality ratio. Let’s get organized to better respond to this public health crisis.
Medical education— Let’s get focused on maternal mortality
The 140-page Council on Resident Education in Obstetrics and Gynecology CREOG Educational Objectives: Core Curriculum in Obstetrics and Gynecology provides a detailed enumeration of the key learning objectives for residents in obstetrics and gynecology.2 Surprisingly, the CREOG objectives do not mention reducing maternal mortality as an important curricular goal. Learning clinical processes and practices that decrease the risk of maternal mortality should be an important educational goal for all residents training in obstetrics and gynecology.
Nationwide action is needed to address the problem
Many countries have organized widespread efforts to reduce maternal mortality. In the United Kingdom and France there are nationwide reviews of maternal deaths with detailed analyses of clinical events and identification of areas for future improvement. These reviews result in the dissemination of countrywide clinical recommendations that change practice and hopefully reduce the risk of future maternal deaths. For example, following the identification of pulmonary embolism as a leading cause of maternal death in the United Kingdom there was a nationwide effort to increase the use of mechanical and pharmacologic prophylaxis to prevent deep venous thrombosis.
In the United States, experts have proposed that a national program of clinical review of severe maternal morbidity cases should be mandatory. (There are many more cases of “near misses” with severe maternal morbidity than there are maternal deaths.) The greater number of cases available for review should help institutions to quickly recognize potential areas for clinical improvement. One group of experts has recommended that all deliveries in which a pregnant woman received 4 or more units of blood or was admitted to an intensive care unit should be thoroughly reviewed to identify opportunities for clinical improvement.3
In the United Kingdom a contemporary clinical problem that is being addressed in an organized and systematic manner is how to respond to the rising rate of severe maternal morbidity caused by placenta accreta. Experts have concluded that women with a suspected placenta accreta should deliver in regional centers with advanced clinical resources—including an emergency surgical response team, interventional radiology, a high capacity blood bank, and an intensive care unit.
A similar approach has been proposed for managing placenta accreta in the United States.4 The American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal Fetal Medicine (SMFM) have proposed a tiered system of obstetric care with more complex cases being referred to regional perinatal centers.5 Regionalization of trauma services has been an important part of the US health care system for decades. Cases of severe trauma are brought to regional centers equipped to emergently treat complex injuries. A similar system of regulation and regionalization could be adapted for optimizing maternity care.
High-risk clinical events: Is your unit prepared?
In the United States the leading causes of maternal mortality, in descending order, are6−8:
- cardiovascular diseases
- infection
- hemorrhage
- cardiomyopathy
- pulmonary embolism
- hypertension
- amniotic fluid embolism
- stroke
- anesthesia complications.
Over the last decade, the Joint Commission has recommended that birthing centers develop standardized protocols and use simulation to improve the institution’s ability to respond in a timely manner to clinical events that may result in maternal morbidity or death.
The quality of published protocols dealing with hemorrhage, hypertension, and thromboembolism is continuously improving, and every birthing center should have written protocols that are updated on a regular timetable for these common high-risk events.9,10 Does your birthing unit have written protocols to deal with cardiac diseases, infection, obstetric hemorrhage, thromboembolism, and severe hypertension? Are simulation exercises used to strengthen familiarity with the protocols?
High-risk patients
An amazing fact of today’s medical care is that sexually active women of reproductive age who have high-risk medical problems often have not been counseled to use a highly effective contraceptive, resulting in an increased risk of unintended pregnancy and maternal death. For example, adult women with a history of congenital heart disease are known to be at increased risk of death if they become pregnant. In a recent study, women with a history of congenital heart disease had 178 maternal deaths per 100,000 deliveries—a rate approximately 10-fold higher than the US maternal mortality ratio.11 Yet, many of these women are not using a highly effective contraceptive, and this results in a high rate of unplanned pregnancy.12
In order to reduce the risk of unintended pregnancy in women with high-risk medical problems, health systems could make contraception an important “vital sign” for women with high-risk medical conditions.
Race and age matter greatly when it comes to maternal mortality risk
There are major racial differences in pregnancy-related mortality, with black women having much higher rates than white women. In the United States in 2011, the pregnancy-related mortality ratio for white, black, and women of other races was 12.5, 42.8, and 17.3 deaths per 100,000 live births, respectively. This represents a major racial disparity in pregnancy outcomes.1
The age of the mother is an important determinant of the risk of maternal death. Women younger than age 35 years have the lowest risk of maternal death. From 2006 to 2010, pregnant women older than age 40 had a risk of death approximately 3 times greater than women aged 34 or younger.2
References
- Pregnancy Mortality Surveillance System. Centers for Disease Control and Prevention Web site. http://www .cdc.gov/reproductivehealth/maternalinfanthealth/pmss.html. Accessed August 20, 2015.
- Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015;125(1):5−12.
Let’s get organized
In a country with a history of embracing the “live free or die” ethic, it is often difficult for physicians to enthusiastically embrace the need for a higher level of organization and a potential reduction in individual freedom in order to improve health outcomes. And with a US maternal mortality ratio of 1 maternal death for every 5,400 births, many obstetricians will never have one of their patients die in childbirth. In fact, most obstetricians will have only 1 maternal death during their entire career. In this reality, when clinical events occur rarely, it is not possible for any single clinician, working alone, to impact the overall outcomes of those rare events. Therefore, teamwork and national efforts, such as the National Partnership for Maternal Safety,13 will be necessary to reverse our alarming trend of increasing maternal mortality. Let’s get organized to stop the rise of maternal deaths in the United States.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
A mother’s untimely death in childbirth is a grave loss that sends shock waves of grief across generations of her family and community. As obstetricians practicing in the United States, we face a terrible problem. We have a continually rising rate of maternal death in a country with exceptional medical resources (FIGURE).1 Our national decentralized approach to dealing with maternal mortality is a factor contributing to the decades-long increase in the maternal mortality ratio. Let’s get organized to better respond to this public health crisis.
Medical education— Let’s get focused on maternal mortality
The 140-page Council on Resident Education in Obstetrics and Gynecology CREOG Educational Objectives: Core Curriculum in Obstetrics and Gynecology provides a detailed enumeration of the key learning objectives for residents in obstetrics and gynecology.2 Surprisingly, the CREOG objectives do not mention reducing maternal mortality as an important curricular goal. Learning clinical processes and practices that decrease the risk of maternal mortality should be an important educational goal for all residents training in obstetrics and gynecology.
Nationwide action is needed to address the problem
Many countries have organized widespread efforts to reduce maternal mortality. In the United Kingdom and France there are nationwide reviews of maternal deaths with detailed analyses of clinical events and identification of areas for future improvement. These reviews result in the dissemination of countrywide clinical recommendations that change practice and hopefully reduce the risk of future maternal deaths. For example, following the identification of pulmonary embolism as a leading cause of maternal death in the United Kingdom there was a nationwide effort to increase the use of mechanical and pharmacologic prophylaxis to prevent deep venous thrombosis.
In the United States, experts have proposed that a national program of clinical review of severe maternal morbidity cases should be mandatory. (There are many more cases of “near misses” with severe maternal morbidity than there are maternal deaths.) The greater number of cases available for review should help institutions to quickly recognize potential areas for clinical improvement. One group of experts has recommended that all deliveries in which a pregnant woman received 4 or more units of blood or was admitted to an intensive care unit should be thoroughly reviewed to identify opportunities for clinical improvement.3
In the United Kingdom a contemporary clinical problem that is being addressed in an organized and systematic manner is how to respond to the rising rate of severe maternal morbidity caused by placenta accreta. Experts have concluded that women with a suspected placenta accreta should deliver in regional centers with advanced clinical resources—including an emergency surgical response team, interventional radiology, a high capacity blood bank, and an intensive care unit.
A similar approach has been proposed for managing placenta accreta in the United States.4 The American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal Fetal Medicine (SMFM) have proposed a tiered system of obstetric care with more complex cases being referred to regional perinatal centers.5 Regionalization of trauma services has been an important part of the US health care system for decades. Cases of severe trauma are brought to regional centers equipped to emergently treat complex injuries. A similar system of regulation and regionalization could be adapted for optimizing maternity care.
High-risk clinical events: Is your unit prepared?
In the United States the leading causes of maternal mortality, in descending order, are6−8:
- cardiovascular diseases
- infection
- hemorrhage
- cardiomyopathy
- pulmonary embolism
- hypertension
- amniotic fluid embolism
- stroke
- anesthesia complications.
Over the last decade, the Joint Commission has recommended that birthing centers develop standardized protocols and use simulation to improve the institution’s ability to respond in a timely manner to clinical events that may result in maternal morbidity or death.
The quality of published protocols dealing with hemorrhage, hypertension, and thromboembolism is continuously improving, and every birthing center should have written protocols that are updated on a regular timetable for these common high-risk events.9,10 Does your birthing unit have written protocols to deal with cardiac diseases, infection, obstetric hemorrhage, thromboembolism, and severe hypertension? Are simulation exercises used to strengthen familiarity with the protocols?
High-risk patients
An amazing fact of today’s medical care is that sexually active women of reproductive age who have high-risk medical problems often have not been counseled to use a highly effective contraceptive, resulting in an increased risk of unintended pregnancy and maternal death. For example, adult women with a history of congenital heart disease are known to be at increased risk of death if they become pregnant. In a recent study, women with a history of congenital heart disease had 178 maternal deaths per 100,000 deliveries—a rate approximately 10-fold higher than the US maternal mortality ratio.11 Yet, many of these women are not using a highly effective contraceptive, and this results in a high rate of unplanned pregnancy.12
In order to reduce the risk of unintended pregnancy in women with high-risk medical problems, health systems could make contraception an important “vital sign” for women with high-risk medical conditions.
Race and age matter greatly when it comes to maternal mortality risk
There are major racial differences in pregnancy-related mortality, with black women having much higher rates than white women. In the United States in 2011, the pregnancy-related mortality ratio for white, black, and women of other races was 12.5, 42.8, and 17.3 deaths per 100,000 live births, respectively. This represents a major racial disparity in pregnancy outcomes.1
The age of the mother is an important determinant of the risk of maternal death. Women younger than age 35 years have the lowest risk of maternal death. From 2006 to 2010, pregnant women older than age 40 had a risk of death approximately 3 times greater than women aged 34 or younger.2
References
- Pregnancy Mortality Surveillance System. Centers for Disease Control and Prevention Web site. http://www .cdc.gov/reproductivehealth/maternalinfanthealth/pmss.html. Accessed August 20, 2015.
- Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015;125(1):5−12.
Let’s get organized
In a country with a history of embracing the “live free or die” ethic, it is often difficult for physicians to enthusiastically embrace the need for a higher level of organization and a potential reduction in individual freedom in order to improve health outcomes. And with a US maternal mortality ratio of 1 maternal death for every 5,400 births, many obstetricians will never have one of their patients die in childbirth. In fact, most obstetricians will have only 1 maternal death during their entire career. In this reality, when clinical events occur rarely, it is not possible for any single clinician, working alone, to impact the overall outcomes of those rare events. Therefore, teamwork and national efforts, such as the National Partnership for Maternal Safety,13 will be necessary to reverse our alarming trend of increasing maternal mortality. Let’s get organized to stop the rise of maternal deaths in the United States.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Chescheir NC. Enough already! Obstet Gynecol. 2015;125(1):2−4.
- Council on Resident Education in Obstetrics and Gynecology (CREOG) Educational Objectives: Core Curriculum in Obstetrics and Gynecology. 10th ed. Washington, DC: American College of Obstetricians and Gynecologists; 2013:140.
- Callaghan WM, Grobman WA, Kilpatrick SJ, Main EK, D’Alton M. Facility-based identification of women with severe maternal morbidity: it is time to start. Obstet Gynecol. 2014;123(5):978−981.
- Silver RM, Fox KA, Barton JR, et al. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015;212(5):561−568.
- American College of Obstetricians and Gynecologists and the Society of Maternal Fetal Medicine. Obstetric care consensus No 2: levels of maternal care. Obstet Gynecol. 2015;125(2):502−515.
- Berg CJ, Callaghan WM, Syverson C, Henderson Z. Pregnancy-related mortality in the United States, 1998−2005. Obstet Gynecol. 2010;116(6):1302−1309.
- Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006−2010. Obstet Gynecol. 2015;125(1):5−12.
- Pregnancy Mortality Surveillance System. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.html. Accessed August 20, 2015.
- Shields LE, Wiesner S, Fulton J, Pelletreau B. Comprehensive maternal hemorrhage protocols reduce the use of blood products and improve patient safety. Am J Obstet Gynecol. 2015;212(3):272−280.
- James A. Committee on Practice Bulletins—Obstetrics. Practice bulletin No. 123: thromboembolism in pregnancy. ACOG. Obstet Gynecol. 2011;118(3):718−729.
- Thompson JL, Kuklina EV, Bateman BT, Callaghan WM, James AH, Grotegut CA. Medical and obstetrical outcomes among pregnant women with congenital heart disease. Obstet Gynecol. 2015;126(2):346−354.
- Lindley KJ, Madden T, Cahill AG, Ludbrook PA, Billadello JJ. Contraceptive use and unintended pregnancy in women with congenital heart disease. Obstet Gynecol. 2015;126(2):363−369.
- D’Alton ME, Main EK, Menard MK, Levy BS. The National Partnership for Maternal Safety. Obstet Gynecol. 2014;123(5):973−977.
- Chescheir NC. Enough already! Obstet Gynecol. 2015;125(1):2−4.
- Council on Resident Education in Obstetrics and Gynecology (CREOG) Educational Objectives: Core Curriculum in Obstetrics and Gynecology. 10th ed. Washington, DC: American College of Obstetricians and Gynecologists; 2013:140.
- Callaghan WM, Grobman WA, Kilpatrick SJ, Main EK, D’Alton M. Facility-based identification of women with severe maternal morbidity: it is time to start. Obstet Gynecol. 2014;123(5):978−981.
- Silver RM, Fox KA, Barton JR, et al. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015;212(5):561−568.
- American College of Obstetricians and Gynecologists and the Society of Maternal Fetal Medicine. Obstetric care consensus No 2: levels of maternal care. Obstet Gynecol. 2015;125(2):502−515.
- Berg CJ, Callaghan WM, Syverson C, Henderson Z. Pregnancy-related mortality in the United States, 1998−2005. Obstet Gynecol. 2010;116(6):1302−1309.
- Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006−2010. Obstet Gynecol. 2015;125(1):5−12.
- Pregnancy Mortality Surveillance System. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.html. Accessed August 20, 2015.
- Shields LE, Wiesner S, Fulton J, Pelletreau B. Comprehensive maternal hemorrhage protocols reduce the use of blood products and improve patient safety. Am J Obstet Gynecol. 2015;212(3):272−280.
- James A. Committee on Practice Bulletins—Obstetrics. Practice bulletin No. 123: thromboembolism in pregnancy. ACOG. Obstet Gynecol. 2011;118(3):718−729.
- Thompson JL, Kuklina EV, Bateman BT, Callaghan WM, James AH, Grotegut CA. Medical and obstetrical outcomes among pregnant women with congenital heart disease. Obstet Gynecol. 2015;126(2):346−354.
- Lindley KJ, Madden T, Cahill AG, Ludbrook PA, Billadello JJ. Contraceptive use and unintended pregnancy in women with congenital heart disease. Obstet Gynecol. 2015;126(2):363−369.
- D’Alton ME, Main EK, Menard MK, Levy BS. The National Partnership for Maternal Safety. Obstet Gynecol. 2014;123(5):973−977.