Gynecology

Neither age nor previous hormone therapy had statistically significant associations with the effect of intravaginal prasterone on dyspareunia severity, according to a new subgroup analysis of clinical trial data. In a trend that did not reach statistical significance, though, women who were further away from menopause reported numerically smaller improvements in dyspareunia, compared with baseline values, said David F. Archer, MD.

“This was an unexpected finding,” he said in an interview.

In a subgroup analysis of data from two clinical trials of intravaginal prasterone (Intrarosa), Dr. Archer and his colleagues sought to investigate whether age, time since menopause, or any previous use of hormone replacement therapy influenced prasterone’s efficacy in treating dyspareunia.

Dr. Archer and his collaborators pooled data from two prospective, randomized, double-blind, placebo-controlled trials (NCT02013544 and NCT01256684) of intravaginal prasterone dosed at 0.50%, 6.5 mg once daily for 12 weeks; he presented the subgroup analyses at the annual meeting of the North American Menopause Society in San Diego.

For each subgroup, Dr. Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and his coinvestigators compared the mean differences in dyspareunia severity score of women who received prasterone and those who received placebo.

All subgroup analyses used the endpoint of improvement in moderate to severe dyspareunia or whether dyspareunia was the most bothersome symptoms for the women participating in the study. The investigators began by looking at the subgroup of 460 women who were 56 years and older at baseline and compared them with the 180 younger participants.

The 283 older participants who received prasterone saw a decrease of 0.36 points in a dyspareunia severity score versus a 0.44 point decrease for the 123 women aged 55 and younger who received prasterone, a nonsignificant difference between subgroups. The decrease compared with placebo-takers was significant in both cases, however (P = .0003 and P =.0031, respectively).

Looking at time since menopause, Dr. Archer and his collaborators divided participants into 33 individuals who were 1 or 2 years post menopause, 86 women who were 3-5 years post menopause, and 521 women who had experienced menopause at least 6 years before study baseline.

In this analysis, 22 of the earliest postmenopause women received prasterone, seeing a 1.59 point drop in dyspareunia severity. For the 59 women in the prasterone study arms who were 3-5 year past menopause, the decrease from baseline was 0.59 points. Finally, among the 325 women who received prasterone and experienced menopause 6 or more years ago, the decrease was 0.27 points.

Although there was a numeric difference in the change in dyspareunia score severity among these groups, the differences were not statistically significant, said Dr. Archer. Again, though, those who took prasterone had a significant reduction in dyspareunia severity scores when compared with those taking placebo (P less than .0001, P = .0136, and P = .0024, respectively).

In the prasterone study arms, 184 had previously used hormone therapy, and 222 had not. After 12 weeks of intravaginal prasterone, there was no statistically significant difference between the two subgroups, with a decreases in dyspareunia severity scores of 0.45 and 0.32, respectively. The decreases in severity scores when compared with those among women who took placebo were again statistically significant for both subgroups, however (P = .0002 and P = .0057, respectively).

Prasterone is a steroid that is also known as dehydroepiandrosterone (DHEA) and is an endogenous hormone that is a precursor for estrogens and androgens. Prasterone’s mechanism of action to reduce vulvar and vaginal atrophy is not completely understood, according to the Food and Drug Administration.

“The nonstatistically significant smaller effect on dyspareunia observed when treatment is initiated after a longer period after menopause suggests that a longer treatment period could be needed to achieve optimal benefit and that treatment of dyspareunia should be initiated as early as possible after menopause,” said Dr. Archer.

Dr. Archer reported grant support from and consulting relationships with several pharmaceutical companies, including Endoceutics, the producer of Intrarosa intravaginal prasterone.

koakes@mdedge.com

Neither age nor previous hormone therapy had statistically significant associations with the effect of intravaginal prasterone on dyspareunia severity, according to a new subgroup analysis of clinical trial data. In a trend that did not reach statistical significance, though, women who were further away from menopause reported numerically smaller improvements in dyspareunia, compared with baseline values, said David F. Archer, MD.

“This was an unexpected finding,” he said in an interview.

In a subgroup analysis of data from two clinical trials of intravaginal prasterone (Intrarosa), Dr. Archer and his colleagues sought to investigate whether age, time since menopause, or any previous use of hormone replacement therapy influenced prasterone’s efficacy in treating dyspareunia.

Dr. Archer and his collaborators pooled data from two prospective, randomized, double-blind, placebo-controlled trials (NCT02013544 and NCT01256684) of intravaginal prasterone dosed at 0.50%, 6.5 mg once daily for 12 weeks; he presented the subgroup analyses at the annual meeting of the North American Menopause Society in San Diego.

For each subgroup, Dr. Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and his coinvestigators compared the mean differences in dyspareunia severity score of women who received prasterone and those who received placebo.

All subgroup analyses used the endpoint of improvement in moderate to severe dyspareunia or whether dyspareunia was the most bothersome symptoms for the women participating in the study. The investigators began by looking at the subgroup of 460 women who were 56 years and older at baseline and compared them with the 180 younger participants.

The 283 older participants who received prasterone saw a decrease of 0.36 points in a dyspareunia severity score versus a 0.44 point decrease for the 123 women aged 55 and younger who received prasterone, a nonsignificant difference between subgroups. The decrease compared with placebo-takers was significant in both cases, however (P = .0003 and P =.0031, respectively).

Looking at time since menopause, Dr. Archer and his collaborators divided participants into 33 individuals who were 1 or 2 years post menopause, 86 women who were 3-5 years post menopause, and 521 women who had experienced menopause at least 6 years before study baseline.

In this analysis, 22 of the earliest postmenopause women received prasterone, seeing a 1.59 point drop in dyspareunia severity. For the 59 women in the prasterone study arms who were 3-5 year past menopause, the decrease from baseline was 0.59 points. Finally, among the 325 women who received prasterone and experienced menopause 6 or more years ago, the decrease was 0.27 points.

Although there was a numeric difference in the change in dyspareunia score severity among these groups, the differences were not statistically significant, said Dr. Archer. Again, though, those who took prasterone had a significant reduction in dyspareunia severity scores when compared with those taking placebo (P less than .0001, P = .0136, and P = .0024, respectively).

In the prasterone study arms, 184 had previously used hormone therapy, and 222 had not. After 12 weeks of intravaginal prasterone, there was no statistically significant difference between the two subgroups, with a decreases in dyspareunia severity scores of 0.45 and 0.32, respectively. The decreases in severity scores when compared with those among women who took placebo were again statistically significant for both subgroups, however (P = .0002 and P = .0057, respectively).

Prasterone is a steroid that is also known as dehydroepiandrosterone (DHEA) and is an endogenous hormone that is a precursor for estrogens and androgens. Prasterone’s mechanism of action to reduce vulvar and vaginal atrophy is not completely understood, according to the Food and Drug Administration.

“The nonstatistically significant smaller effect on dyspareunia observed when treatment is initiated after a longer period after menopause suggests that a longer treatment period could be needed to achieve optimal benefit and that treatment of dyspareunia should be initiated as early as possible after menopause,” said Dr. Archer.

Dr. Archer reported grant support from and consulting relationships with several pharmaceutical companies, including Endoceutics, the producer of Intrarosa intravaginal prasterone.

koakes@mdedge.com

Neither age nor previous hormone therapy had statistically significant associations with the effect of intravaginal prasterone on dyspareunia severity, according to a new subgroup analysis of clinical trial data. In a trend that did not reach statistical significance, though, women who were further away from menopause reported numerically smaller improvements in dyspareunia, compared with baseline values, said David F. Archer, MD.

“This was an unexpected finding,” he said in an interview.

In a subgroup analysis of data from two clinical trials of intravaginal prasterone (Intrarosa), Dr. Archer and his colleagues sought to investigate whether age, time since menopause, or any previous use of hormone replacement therapy influenced prasterone’s efficacy in treating dyspareunia.

Dr. Archer and his collaborators pooled data from two prospective, randomized, double-blind, placebo-controlled trials (NCT02013544 and NCT01256684) of intravaginal prasterone dosed at 0.50%, 6.5 mg once daily for 12 weeks; he presented the subgroup analyses at the annual meeting of the North American Menopause Society in San Diego.

For each subgroup, Dr. Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School, Norfolk, and his coinvestigators compared the mean differences in dyspareunia severity score of women who received prasterone and those who received placebo.

All subgroup analyses used the endpoint of improvement in moderate to severe dyspareunia or whether dyspareunia was the most bothersome symptoms for the women participating in the study. The investigators began by looking at the subgroup of 460 women who were 56 years and older at baseline and compared them with the 180 younger participants.

The 283 older participants who received prasterone saw a decrease of 0.36 points in a dyspareunia severity score versus a 0.44 point decrease for the 123 women aged 55 and younger who received prasterone, a nonsignificant difference between subgroups. The decrease compared with placebo-takers was significant in both cases, however (P = .0003 and P =.0031, respectively).

Looking at time since menopause, Dr. Archer and his collaborators divided participants into 33 individuals who were 1 or 2 years post menopause, 86 women who were 3-5 years post menopause, and 521 women who had experienced menopause at least 6 years before study baseline.

In this analysis, 22 of the earliest postmenopause women received prasterone, seeing a 1.59 point drop in dyspareunia severity. For the 59 women in the prasterone study arms who were 3-5 year past menopause, the decrease from baseline was 0.59 points. Finally, among the 325 women who received prasterone and experienced menopause 6 or more years ago, the decrease was 0.27 points.

Although there was a numeric difference in the change in dyspareunia score severity among these groups, the differences were not statistically significant, said Dr. Archer. Again, though, those who took prasterone had a significant reduction in dyspareunia severity scores when compared with those taking placebo (P less than .0001, P = .0136, and P = .0024, respectively).

In the prasterone study arms, 184 had previously used hormone therapy, and 222 had not. After 12 weeks of intravaginal prasterone, there was no statistically significant difference between the two subgroups, with a decreases in dyspareunia severity scores of 0.45 and 0.32, respectively. The decreases in severity scores when compared with those among women who took placebo were again statistically significant for both subgroups, however (P = .0002 and P = .0057, respectively).

Prasterone is a steroid that is also known as dehydroepiandrosterone (DHEA) and is an endogenous hormone that is a precursor for estrogens and androgens. Prasterone’s mechanism of action to reduce vulvar and vaginal atrophy is not completely understood, according to the Food and Drug Administration.

“The nonstatistically significant smaller effect on dyspareunia observed when treatment is initiated after a longer period after menopause suggests that a longer treatment period could be needed to achieve optimal benefit and that treatment of dyspareunia should be initiated as early as possible after menopause,” said Dr. Archer.

Dr. Archer reported grant support from and consulting relationships with several pharmaceutical companies, including Endoceutics, the producer of Intrarosa intravaginal prasterone.

koakes@mdedge.com

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

Hemorrhage; bladder laceration during hysterectomy

A 46-year-old woman reported increasingly frequent and painful menstrual periods to her Gyn. Estrogen-progestin contraceptives were relatively contraindicated because of the patient’s hypertension. The Gyn performed hysteroscopic resection of a submucosal fibroid, dilation and curettage, and endometrial ablation. He attempted to morcellate the 2-cm fibroid from the anterior wall. Blood loss during surgery was noted to be less than 100 mL.

The patient began to hemorrhage immediately after surgery; nurses informed the Gyn of this multiple times over the next several hours. After 7 hours, the Gyn examined the patient, found that she was in hemorrhagic shock, and advised a hysterectomy was necessary. During surgery, the Gyn lacerated the patient’s bladder twice, which required a urologist to repair. Postoperatively, the patient had a stroke, respiratory failure, and kidney failure.

PATIENT'S CLAIM: The Gyn’s morcellation technique was negligent. He did not respond to the nurses for 7 hours. If he had responded earlier, she might not have lost her uterus. He was also negligent for injuring the patient’s bladder during the second surgery.

PHYSICIAN'S DEFENSE: The case was settled during mediation.

VERDICT: A confidential North Carolina settlement was reached.

Bowel injured during BSO

In 2013, a 52-year-old woman underwent bilateral salpingo-oophorectomy (BSO) performed by a Gyn. Postoperatively, she was found to have a 1.5-cm bowel perforation. After surgical repair, she developed a wound infection and wound breakdown. She was treated with a vacuum-assisted wound closure device. She later developed a ventral hernia and an intra-abdominal abscess leading to a colostomy, which eventually was reversed. At trial, she had a low-output bowel-to-skin fistula and extensive abdominal scarring.

PATIENT'S CLAIM: The surgeon should have known to perform open BSO rather than laparoscopic surgery based on her 3 prior abdominal surgeries that would have left severe adhesions. He caused a perforation and/or thermal injury to the sigmoid colon during the BSO. He should have consulted a general surgeon when encountering the adhesions. The surgeon failed to readmit her on a timely basis for treatment of the suspected bowel injury.

PHYSICIAN'S DEFENSE: The severe adhesions encountered during BSO surgery could not have been predicted; no adhesions were noted during a 2004 surgery. The adhesions precluded procedure completion. He attempted to lyse the adhesions to create a visual field for removing the ovaries but they could not be visualized. After using a harmonic scalpel for lysis, he inspected the bowel portions that he could see and found no thermal injury or perforation.

VERDICT: An Illinois defense verdict was returned.

Multiple injuries after LVH

A woman was found to have a 4-cm uterine fibroid in April 2007. She received medical management.

In May 2008, she reported left lower quadrant pain to her Gyn. A pelvic ultrasound showed an increase in the fibroid’s diameter to 5.8 cm. On December 4 she underwent laparoscopic-assisted vaginal hysterectomy (LVH). The Gyn performed intraoperative cystoscopy. The patient was discharged the following day.

Over the next several weeks, the patient experienced urinary tract symptoms that progressed to rust-colored urine and incontinence. On December 31 she was found to have bilateral vesicovaginal fistulas. By early April 2009, urologists had placed ureteral stents on 2 separate occasions and performed 2 bilateral reimplantation procedures. On April 28, 2009, a urologist placed a stent in the right ureter but was unable to place a stent in the left ureter. The right stent was removed prior to another reconstructive surgery on August 18. Two stents were also placed on August 26 and were removed on October 6. She underwent annual ultrasounds that revealed minimal hydronephrosis. Except for urinary frequency, the patient’s symptoms had subsided by trial.

PATIENT'S CLAIM: The Gyn fell below the standard of care during the LVH when he negligently cauterized and/or burned the patient’s ureters.

PHYSICIAN'S DEFENSE: The Gyn denied negligence. She argued that, following the cystoscopy, both of the patient’s ureteral orifices discharged indigo carmine–stained urine, an indication that there was no injury to the ureters.

VERDICT: A Nevada defense verdict was returned.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

Hemorrhage; bladder laceration during hysterectomy

A 46-year-old woman reported increasingly frequent and painful menstrual periods to her Gyn. Estrogen-progestin contraceptives were relatively contraindicated because of the patient’s hypertension. The Gyn performed hysteroscopic resection of a submucosal fibroid, dilation and curettage, and endometrial ablation. He attempted to morcellate the 2-cm fibroid from the anterior wall. Blood loss during surgery was noted to be less than 100 mL.

The patient began to hemorrhage immediately after surgery; nurses informed the Gyn of this multiple times over the next several hours. After 7 hours, the Gyn examined the patient, found that she was in hemorrhagic shock, and advised a hysterectomy was necessary. During surgery, the Gyn lacerated the patient’s bladder twice, which required a urologist to repair. Postoperatively, the patient had a stroke, respiratory failure, and kidney failure.

PATIENT'S CLAIM: The Gyn’s morcellation technique was negligent. He did not respond to the nurses for 7 hours. If he had responded earlier, she might not have lost her uterus. He was also negligent for injuring the patient’s bladder during the second surgery.

PHYSICIAN'S DEFENSE: The case was settled during mediation.

VERDICT: A confidential North Carolina settlement was reached.

Bowel injured during BSO

In 2013, a 52-year-old woman underwent bilateral salpingo-oophorectomy (BSO) performed by a Gyn. Postoperatively, she was found to have a 1.5-cm bowel perforation. After surgical repair, she developed a wound infection and wound breakdown. She was treated with a vacuum-assisted wound closure device. She later developed a ventral hernia and an intra-abdominal abscess leading to a colostomy, which eventually was reversed. At trial, she had a low-output bowel-to-skin fistula and extensive abdominal scarring.

PATIENT'S CLAIM: The surgeon should have known to perform open BSO rather than laparoscopic surgery based on her 3 prior abdominal surgeries that would have left severe adhesions. He caused a perforation and/or thermal injury to the sigmoid colon during the BSO. He should have consulted a general surgeon when encountering the adhesions. The surgeon failed to readmit her on a timely basis for treatment of the suspected bowel injury.

PHYSICIAN'S DEFENSE: The severe adhesions encountered during BSO surgery could not have been predicted; no adhesions were noted during a 2004 surgery. The adhesions precluded procedure completion. He attempted to lyse the adhesions to create a visual field for removing the ovaries but they could not be visualized. After using a harmonic scalpel for lysis, he inspected the bowel portions that he could see and found no thermal injury or perforation.

VERDICT: An Illinois defense verdict was returned.

Multiple injuries after LVH

A woman was found to have a 4-cm uterine fibroid in April 2007. She received medical management.

In May 2008, she reported left lower quadrant pain to her Gyn. A pelvic ultrasound showed an increase in the fibroid’s diameter to 5.8 cm. On December 4 she underwent laparoscopic-assisted vaginal hysterectomy (LVH). The Gyn performed intraoperative cystoscopy. The patient was discharged the following day.

Over the next several weeks, the patient experienced urinary tract symptoms that progressed to rust-colored urine and incontinence. On December 31 she was found to have bilateral vesicovaginal fistulas. By early April 2009, urologists had placed ureteral stents on 2 separate occasions and performed 2 bilateral reimplantation procedures. On April 28, 2009, a urologist placed a stent in the right ureter but was unable to place a stent in the left ureter. The right stent was removed prior to another reconstructive surgery on August 18. Two stents were also placed on August 26 and were removed on October 6. She underwent annual ultrasounds that revealed minimal hydronephrosis. Except for urinary frequency, the patient’s symptoms had subsided by trial.

PATIENT'S CLAIM: The Gyn fell below the standard of care during the LVH when he negligently cauterized and/or burned the patient’s ureters.

PHYSICIAN'S DEFENSE: The Gyn denied negligence. She argued that, following the cystoscopy, both of the patient’s ureteral orifices discharged indigo carmine–stained urine, an indication that there was no injury to the ureters.

VERDICT: A Nevada defense verdict was returned.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

Hemorrhage; bladder laceration during hysterectomy

A 46-year-old woman reported increasingly frequent and painful menstrual periods to her Gyn. Estrogen-progestin contraceptives were relatively contraindicated because of the patient’s hypertension. The Gyn performed hysteroscopic resection of a submucosal fibroid, dilation and curettage, and endometrial ablation. He attempted to morcellate the 2-cm fibroid from the anterior wall. Blood loss during surgery was noted to be less than 100 mL.

The patient began to hemorrhage immediately after surgery; nurses informed the Gyn of this multiple times over the next several hours. After 7 hours, the Gyn examined the patient, found that she was in hemorrhagic shock, and advised a hysterectomy was necessary. During surgery, the Gyn lacerated the patient’s bladder twice, which required a urologist to repair. Postoperatively, the patient had a stroke, respiratory failure, and kidney failure.

PATIENT'S CLAIM: The Gyn’s morcellation technique was negligent. He did not respond to the nurses for 7 hours. If he had responded earlier, she might not have lost her uterus. He was also negligent for injuring the patient’s bladder during the second surgery.

PHYSICIAN'S DEFENSE: The case was settled during mediation.

VERDICT: A confidential North Carolina settlement was reached.

Bowel injured during BSO

In 2013, a 52-year-old woman underwent bilateral salpingo-oophorectomy (BSO) performed by a Gyn. Postoperatively, she was found to have a 1.5-cm bowel perforation. After surgical repair, she developed a wound infection and wound breakdown. She was treated with a vacuum-assisted wound closure device. She later developed a ventral hernia and an intra-abdominal abscess leading to a colostomy, which eventually was reversed. At trial, she had a low-output bowel-to-skin fistula and extensive abdominal scarring.

PATIENT'S CLAIM: The surgeon should have known to perform open BSO rather than laparoscopic surgery based on her 3 prior abdominal surgeries that would have left severe adhesions. He caused a perforation and/or thermal injury to the sigmoid colon during the BSO. He should have consulted a general surgeon when encountering the adhesions. The surgeon failed to readmit her on a timely basis for treatment of the suspected bowel injury.

PHYSICIAN'S DEFENSE: The severe adhesions encountered during BSO surgery could not have been predicted; no adhesions were noted during a 2004 surgery. The adhesions precluded procedure completion. He attempted to lyse the adhesions to create a visual field for removing the ovaries but they could not be visualized. After using a harmonic scalpel for lysis, he inspected the bowel portions that he could see and found no thermal injury or perforation.

VERDICT: An Illinois defense verdict was returned.

Multiple injuries after LVH

A woman was found to have a 4-cm uterine fibroid in April 2007. She received medical management.

In May 2008, she reported left lower quadrant pain to her Gyn. A pelvic ultrasound showed an increase in the fibroid’s diameter to 5.8 cm. On December 4 she underwent laparoscopic-assisted vaginal hysterectomy (LVH). The Gyn performed intraoperative cystoscopy. The patient was discharged the following day.

Over the next several weeks, the patient experienced urinary tract symptoms that progressed to rust-colored urine and incontinence. On December 31 she was found to have bilateral vesicovaginal fistulas. By early April 2009, urologists had placed ureteral stents on 2 separate occasions and performed 2 bilateral reimplantation procedures. On April 28, 2009, a urologist placed a stent in the right ureter but was unable to place a stent in the left ureter. The right stent was removed prior to another reconstructive surgery on August 18. Two stents were also placed on August 26 and were removed on October 6. She underwent annual ultrasounds that revealed minimal hydronephrosis. Except for urinary frequency, the patient’s symptoms had subsided by trial.

PATIENT'S CLAIM: The Gyn fell below the standard of care during the LVH when he negligently cauterized and/or burned the patient’s ureters.

PHYSICIAN'S DEFENSE: The Gyn denied negligence. She argued that, following the cystoscopy, both of the patient’s ureteral orifices discharged indigo carmine–stained urine, an indication that there was no injury to the ureters.

VERDICT: A Nevada defense verdict was returned.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

Agrees that OC use clearly reduces mortality

Recent evidence from long-term observations of hundreds of thousands of women, in 10 European countries, clearly demonstrated that the use of oral contraceptives (OCs) reduced mortality by roughly 10%.^1,2 Newer OCs increase women’s overall survival. 

In comparison, reducing obesity by 5 body mass index points would reduce mortality by only 5%, from 1.05 to 1.³

Dr. Stavros Saripanidis
Thessaloniki, Greece

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.

Agrees that OC use clearly reduces mortality

Recent evidence from long-term observations of hundreds of thousands of women, in 10 European countries, clearly demonstrated that the use of oral contraceptives (OCs) reduced mortality by roughly 10%.^1,2 Newer OCs increase women’s overall survival. 

In comparison, reducing obesity by 5 body mass index points would reduce mortality by only 5%, from 1.05 to 1.³

Dr. Stavros Saripanidis
Thessaloniki, Greece

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.

Agrees that OC use clearly reduces mortality

Recent evidence from long-term observations of hundreds of thousands of women, in 10 European countries, clearly demonstrated that the use of oral contraceptives (OCs) reduced mortality by roughly 10%.^1,2 Newer OCs increase women’s overall survival. 

In comparison, reducing obesity by 5 body mass index points would reduce mortality by only 5%, from 1.05 to 1.³

Dr. Stavros Saripanidis
Thessaloniki, Greece

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.

Multiple payment systems impede universal HPV screening access 

Unless the issue of multiple systems of payment and access (that is, multiple insurance companies and providers) can be resolved in the United States, I do not believe there will be an advancement across the board for human papillomavirus (HPV) screening. In my opinion, we need to work toward access to health care for all and a single-payer system.

C.L. Conrad-Forrest, MD
Davis, California

Dr. Barbieri responds

I agree with Dr. Conrad-Forrest that improving cervical cancer screening would be advanced by interoperable electronic medical records and health systems that are designed to manage population health. I predict that a large integrated health system will be the first to adopt the use of high-risk HPV testing to screen for cervical cancer in the United States.

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.

Multiple payment systems impede universal HPV screening access 

Unless the issue of multiple systems of payment and access (that is, multiple insurance companies and providers) can be resolved in the United States, I do not believe there will be an advancement across the board for human papillomavirus (HPV) screening. In my opinion, we need to work toward access to health care for all and a single-payer system.

C.L. Conrad-Forrest, MD
Davis, California

Dr. Barbieri responds

I agree with Dr. Conrad-Forrest that improving cervical cancer screening would be advanced by interoperable electronic medical records and health systems that are designed to manage population health. I predict that a large integrated health system will be the first to adopt the use of high-risk HPV testing to screen for cervical cancer in the United States.

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.

Multiple payment systems impede universal HPV screening access 

Unless the issue of multiple systems of payment and access (that is, multiple insurance companies and providers) can be resolved in the United States, I do not believe there will be an advancement across the board for human papillomavirus (HPV) screening. In my opinion, we need to work toward access to health care for all and a single-payer system.

C.L. Conrad-Forrest, MD
Davis, California

Dr. Barbieri responds

I agree with Dr. Conrad-Forrest that improving cervical cancer screening would be advanced by interoperable electronic medical records and health systems that are designed to manage population health. I predict that a large integrated health system will be the first to adopt the use of high-risk HPV testing to screen for cervical cancer in the United States.

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.

A well-woman visit with an ob.gyn. should include preventive services and counseling, according to an updated committee opinion from the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice.

Alexander Raths/Fotolia.com

“A well-woman visit provides an excellent opportunity to counsel patients about maintaining a healthy lifestyle and minimizing health risks,” according to the opinion, published in Obstetrics & Gynecology. The updated opinion coincides with the release of the new Well-Woman Chart from the Women’s Preventive Services Initiative.

Previous research suggests that many women prefer an ob.gyn. or other women’s health care specialist not only for reproductive health care but also for services such as cervical cancer screening, contraception, and treatment for sexually transmitted infections, the committee members wrote. Although surveys of ob.gyns. show that most provide some level of overall health and primary care, the screening and other clinical preventive services were not consistent.

The committee opinion consequently recommends that the “periodic well-woman care visit should include screening, evaluation and counseling, and immunizations based on age and risk factors.” However, the committee acknowledged that the interval for specific services varies among patients, as does the scope of services provided in different settings.

“Taking a comprehensive history (specifically obtaining detailed information on symptoms and past medical and gynecologic history) will inform if certain components of the physical examination, including breast or pelvic examination, are indicated at that visit and will inform shared decision making for these examinations,” committee members wrote. Topics that should be addressed during lifespan include sexual health (which may include contraception, prepregnancy counseling, sexually transmitted infections, and infertility), vulvovaginal symptoms, and bone health.

Not all components of a physical may be required at a well-woman visit, but ob.gyns. can play a key role by encouraging and facilitating healthy behaviors, counseling on preventive health strategies, and engaging women in shared decision-making. Screening for smoking, poor diet, and lack of physical activity are important. Ob.gyns. also can be part of the team-based care for women that may include physician assistants, nurse practitioners, and other medical professionals.

The most notable change from the previous opinion is that it coincides with the Women’s Preventive Services Initiative’s release of a Well-Woman Chart, which is designed to help ob.gyns. navigate the implementation of ACOG’s well-woman guidance, Christopher Zahn, MD, vice president of practice activities for ACOG, said in an interview.

“In tandem, these documents support ob.gyns. and other women’s health care providers’ efforts to make well-woman visits more personalized care that prioritizes shared decision-making over a woman’s lifetime,” he said. The opinion statement also includes the Women’s Preventive Services Initiative as a source of information for recommendations on well-woman care, and includes new guidance on the elements of a physical exam, including the pelvic exam.

“Ob.gyns. care for women over their lifetime, and increasingly this includes a lot of preventive care. The committee opinion details ACOG’s overall approach to well-women care and the role of the ob.gyn. as a provider of preventive services,” said Dr. Zahn. “The accompanying well-woman chart, targeted to providers, summarizes needed preventive services ensuring that time can be spent effectively and productively during each well-woman visit. By centering shared decision making and care tailored to each woman’s health care needs at every life stage, the well-woman visit is a fundamental part of the patient-provider relationship.”

Dr. Zahn noted that ongoing, high-quality research is essential to determine what strategies are most effective for women’s preventive care needs at every life stage. “Further research is also needed to identify screening strategies for women in certain higher risk groups and to reduce disparities in outcomes in certain populations of women. From cancer screening to new contraceptive methods, to managing symptoms of menopause, the more research we have to support our recommendations for these services, the more effectively we can care for women and help to keep them healthy for many, many years,” he emphasized.

The committee recommended additional resources for ob.gyns. and other health care providers, as well as for patients. The resources are available online at www.acog.org/More-Info/WellWoman.

The new opinion statement, which replaces the previous opinion issued in 2012, was developed by the ACOG Committee on Gynecologic Practice in collaboration with committee member Catherine Witkop, MD, MPH, of the Uniformed Health Sciences University in Bethesda, Md. The committee members had no relevant financial conflicts to disclose.
 

A well-woman visit with an ob.gyn. should include preventive services and counseling, according to an updated committee opinion from the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice.

Alexander Raths/Fotolia.com

“A well-woman visit provides an excellent opportunity to counsel patients about maintaining a healthy lifestyle and minimizing health risks,” according to the opinion, published in Obstetrics & Gynecology. The updated opinion coincides with the release of the new Well-Woman Chart from the Women’s Preventive Services Initiative.

Previous research suggests that many women prefer an ob.gyn. or other women’s health care specialist not only for reproductive health care but also for services such as cervical cancer screening, contraception, and treatment for sexually transmitted infections, the committee members wrote. Although surveys of ob.gyns. show that most provide some level of overall health and primary care, the screening and other clinical preventive services were not consistent.

The committee opinion consequently recommends that the “periodic well-woman care visit should include screening, evaluation and counseling, and immunizations based on age and risk factors.” However, the committee acknowledged that the interval for specific services varies among patients, as does the scope of services provided in different settings.

“Taking a comprehensive history (specifically obtaining detailed information on symptoms and past medical and gynecologic history) will inform if certain components of the physical examination, including breast or pelvic examination, are indicated at that visit and will inform shared decision making for these examinations,” committee members wrote. Topics that should be addressed during lifespan include sexual health (which may include contraception, prepregnancy counseling, sexually transmitted infections, and infertility), vulvovaginal symptoms, and bone health.

Not all components of a physical may be required at a well-woman visit, but ob.gyns. can play a key role by encouraging and facilitating healthy behaviors, counseling on preventive health strategies, and engaging women in shared decision-making. Screening for smoking, poor diet, and lack of physical activity are important. Ob.gyns. also can be part of the team-based care for women that may include physician assistants, nurse practitioners, and other medical professionals.

The most notable change from the previous opinion is that it coincides with the Women’s Preventive Services Initiative’s release of a Well-Woman Chart, which is designed to help ob.gyns. navigate the implementation of ACOG’s well-woman guidance, Christopher Zahn, MD, vice president of practice activities for ACOG, said in an interview.

“In tandem, these documents support ob.gyns. and other women’s health care providers’ efforts to make well-woman visits more personalized care that prioritizes shared decision-making over a woman’s lifetime,” he said. The opinion statement also includes the Women’s Preventive Services Initiative as a source of information for recommendations on well-woman care, and includes new guidance on the elements of a physical exam, including the pelvic exam.

“Ob.gyns. care for women over their lifetime, and increasingly this includes a lot of preventive care. The committee opinion details ACOG’s overall approach to well-women care and the role of the ob.gyn. as a provider of preventive services,” said Dr. Zahn. “The accompanying well-woman chart, targeted to providers, summarizes needed preventive services ensuring that time can be spent effectively and productively during each well-woman visit. By centering shared decision making and care tailored to each woman’s health care needs at every life stage, the well-woman visit is a fundamental part of the patient-provider relationship.”

Dr. Zahn noted that ongoing, high-quality research is essential to determine what strategies are most effective for women’s preventive care needs at every life stage. “Further research is also needed to identify screening strategies for women in certain higher risk groups and to reduce disparities in outcomes in certain populations of women. From cancer screening to new contraceptive methods, to managing symptoms of menopause, the more research we have to support our recommendations for these services, the more effectively we can care for women and help to keep them healthy for many, many years,” he emphasized.

The committee recommended additional resources for ob.gyns. and other health care providers, as well as for patients. The resources are available online at www.acog.org/More-Info/WellWoman.

The new opinion statement, which replaces the previous opinion issued in 2012, was developed by the ACOG Committee on Gynecologic Practice in collaboration with committee member Catherine Witkop, MD, MPH, of the Uniformed Health Sciences University in Bethesda, Md. The committee members had no relevant financial conflicts to disclose.
 

A well-woman visit with an ob.gyn. should include preventive services and counseling, according to an updated committee opinion from the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice.

Alexander Raths/Fotolia.com

“A well-woman visit provides an excellent opportunity to counsel patients about maintaining a healthy lifestyle and minimizing health risks,” according to the opinion, published in Obstetrics & Gynecology. The updated opinion coincides with the release of the new Well-Woman Chart from the Women’s Preventive Services Initiative.

Previous research suggests that many women prefer an ob.gyn. or other women’s health care specialist not only for reproductive health care but also for services such as cervical cancer screening, contraception, and treatment for sexually transmitted infections, the committee members wrote. Although surveys of ob.gyns. show that most provide some level of overall health and primary care, the screening and other clinical preventive services were not consistent.

The committee opinion consequently recommends that the “periodic well-woman care visit should include screening, evaluation and counseling, and immunizations based on age and risk factors.” However, the committee acknowledged that the interval for specific services varies among patients, as does the scope of services provided in different settings.

“Taking a comprehensive history (specifically obtaining detailed information on symptoms and past medical and gynecologic history) will inform if certain components of the physical examination, including breast or pelvic examination, are indicated at that visit and will inform shared decision making for these examinations,” committee members wrote. Topics that should be addressed during lifespan include sexual health (which may include contraception, prepregnancy counseling, sexually transmitted infections, and infertility), vulvovaginal symptoms, and bone health.

Not all components of a physical may be required at a well-woman visit, but ob.gyns. can play a key role by encouraging and facilitating healthy behaviors, counseling on preventive health strategies, and engaging women in shared decision-making. Screening for smoking, poor diet, and lack of physical activity are important. Ob.gyns. also can be part of the team-based care for women that may include physician assistants, nurse practitioners, and other medical professionals.

The most notable change from the previous opinion is that it coincides with the Women’s Preventive Services Initiative’s release of a Well-Woman Chart, which is designed to help ob.gyns. navigate the implementation of ACOG’s well-woman guidance, Christopher Zahn, MD, vice president of practice activities for ACOG, said in an interview.

“In tandem, these documents support ob.gyns. and other women’s health care providers’ efforts to make well-woman visits more personalized care that prioritizes shared decision-making over a woman’s lifetime,” he said. The opinion statement also includes the Women’s Preventive Services Initiative as a source of information for recommendations on well-woman care, and includes new guidance on the elements of a physical exam, including the pelvic exam.

“Ob.gyns. care for women over their lifetime, and increasingly this includes a lot of preventive care. The committee opinion details ACOG’s overall approach to well-women care and the role of the ob.gyn. as a provider of preventive services,” said Dr. Zahn. “The accompanying well-woman chart, targeted to providers, summarizes needed preventive services ensuring that time can be spent effectively and productively during each well-woman visit. By centering shared decision making and care tailored to each woman’s health care needs at every life stage, the well-woman visit is a fundamental part of the patient-provider relationship.”

Dr. Zahn noted that ongoing, high-quality research is essential to determine what strategies are most effective for women’s preventive care needs at every life stage. “Further research is also needed to identify screening strategies for women in certain higher risk groups and to reduce disparities in outcomes in certain populations of women. From cancer screening to new contraceptive methods, to managing symptoms of menopause, the more research we have to support our recommendations for these services, the more effectively we can care for women and help to keep them healthy for many, many years,” he emphasized.

The committee recommended additional resources for ob.gyns. and other health care providers, as well as for patients. The resources are available online at www.acog.org/More-Info/WellWoman.

The new opinion statement, which replaces the previous opinion issued in 2012, was developed by the ACOG Committee on Gynecologic Practice in collaboration with committee member Catherine Witkop, MD, MPH, of the Uniformed Health Sciences University in Bethesda, Md. The committee members had no relevant financial conflicts to disclose.
 

Minimally invasive surgeons have been intrigued for more than 2 decades by the clinical aspects and benefits of minilaparoscopy. Miniature instruments (2-3.5 mm) were introduced starting in the late 1980s, and through the 1990s minilaparoscopic procedures were performed across multiple specialties. However, the instrumentation available at the time had limited durability and functionality (for example, a lack of electrosurgical capability), and clinical experience and resulting data were sparse. The minilaparoscopic approach failed to gain momentum and was never widely adopted.

In the past 5-10 years, with new innovations in technology and improved instrumentation, minilaparoscopy is undergoing a renaissance in surgical circles. Medical device companies have developed numerous electrosurgical and other advanced energy options as well as a variety of needle holders, graspers, and other instruments – all with diameters of 3.5 mm or less and with significantly more durability than the earlier generation of mini-instruments. While surgeons oftentimes still use larger telescopes for better visualization, 2- to 3.5-mm telescopes are available in various lengths and angles, and optic quality is continually improving.

The minilaparoscopic approach is more similar to conventional laparoscopy than laparoendoscopic single-site surgery, which has not met early expectations. It is a more logical next step in the evolution of minimally invasive surgery and its goals of further reducing surgical trauma and improving cosmesis. I am performing hysterectomies in which I place two 5-mm nonbladed trocars through incisions inside the umbilicus and a minilaparoscopic percutaneous cannula below the bikini line; it is a “hybrid” procedure, in essence, that incorporates the use of mini-instrumentation.

Courtesy of Steven McCarus, MD

In addition to diagnostic laparoscopy, I also use minilaparoscopy for some of my patients who need ovarian cystectomy, oophorectomy, appendectomy, treatment of early-stage endometriosis or adhesiolysis. Throughout the world and across multiple specialties, it is being adopted for a wide range of adult and pediatric procedures, from abdominopelvic adhesions and inguinal hernia repair to cholecystectomy, and even to enhance diagnosis in the ED or ICU.¹

The importance of surgical scars

The resurgence of interest in minilaparoscopy has been driven largely by its clinical advantages. From a clinical standpoint, less intrusion through the abdominal wall with the use of smaller instruments and fewer insertion points generally means less surgical trauma, and less analgesic medication and postoperative pain, for instance, as well as fewer vascular injuries and a more minimal risk of adhesions. Scar cosmesis also has been viewed as an advantage, just as it was when the abdominal hysterectomy was being replaced by laparoscopic hysterectomy starting in 1989. Still, for me, the clinical aspects have long been at the forefront.

My interest in providing my patients the very best cosmetic results changed after we surveyed patients who were scheduled for a hysterectomy in my practice over the span of 1 year. All patients seen during that time (from November 2012 to November 2013) were asked to complete a questionnaire on their knowledge of hysterectomy incisional scars, their perceptions, and their desires. Almost all of the 200 women who completed the survey – 93% – indicated that cosmetic issues such as scars are important to them (“slightly,” “moderately,” “quite,” or “extremely” important), and of these, 24% chose “extremely important.”

Courtesy of Steven McCarus, MD

Asked how they feel about the appearance of their scars from prior abdominal surgery, 58% indicated the appearance bothered them to some extent, and 11% said they were “extremely” bothered. Almost all of the 200 patients – 92% – said they would be interested in a surgery that would leave no scars, and 45% said they were “extremely” interested.²

The findings juxtaposed the clinical benefits of more minimally invasive surgery – what had been foremost on my mind – with patients’ attention to and concern about scars. The study demonstrated that patient preferences are just as compelling, if not more, than what the surgeon wants. It showed, moreover, how important it is to discuss hysterectomy incision options – and patient preferences regarding incision location, size, and number – prior to surgery.

When asked about their familiarity with the locations of skin incisions in different hysterectomy procedures (abdominal, vaginal, laparoscopic, robotic, and mini), between 25% and 56% indicated they were not at all familiar with them. Familiarity was greatest with incisions in traditional laparoscopic hysterectomy. Yet patients want to have that knowledge: Almost all of the survey participants – 93% – indicated it is important to discuss the location, number, and size of incisions prior to surgery, and 59% said it is “extremely” important.

Patients also were asked to rank a short list of incision locations (above or below the belly button, and above or below the bikini line) from the least desirable to most desirable, and the results suggest just how different personal preferences can be. The most-desirable incision location was below the bikini line for 68% of patients, followed by above the belly button for 16%. The least-desirable location was above the belly button for 69%, followed by below the bikini line for 15%. Asked whether it is cosmetically superior for one’s incisions to be low (below the bikini line), 86% said they agreed.

Other research has similarly shown that cosmesis is important for women undergoing gynecologic surgery. For instance, women in another single-practice study were more likely to prefer single-site and traditional laparoscopic incisions over robotic ones when they were shown photos of an abdomen marked up with the incision lengths and locations typical for each of these three approaches.³ And notably, there has been research looking at the psychological impact of incisional scars specifically in patients who are morbidly obese.

While we may not be accustomed to discussing incisions and scars, it behooves us as surgeons to consider initiating a conversation about incisions with all our patients – regardless of their body mass index and prior surgical history – during the preoperative evaluation.
 

My hysterectomy approach

I have utilized one of the most recent developments in minilaparoscopy instrumentation – the MiniLap percutaneous surgical system (Teleflex) – to develop a mini technique for hysterectomy I’ve trademarked as the Cosmetic Hysterectomy. The percutaneous system has an outer diameter of 2.3 mm, integrated needle tips that facilitate insertion without a trocar, and a selection of integrated graspers (e.g., a miniature clutch or alligator) that open up to 12.5 mm and can be advanced and retracted through the cannula. The graspers can be locked onto the tissue, and the system itself can be stabilized extracorporeally so that it can be hands free.

For the hysterectomy, I make two 5-mm vertical incisions within the umbilicus – one for a nonbladed 5-mm trocar at 12 o’clock and the other for a second nonbladed 5-mm trocar at 6 o’clock, penetrating the fascia. The trocars house a 30-degree extra-long laparoscope with camera attached, and an advanced bipolar electrosurgery device.

The minilaparoscopic cannula is inserted in the lower-abdominal area through a single 1-mm stab incision, and one or two instruments can be placed as needed. Tissues can be removed vaginally once dissection is completed, and the vaginal cuff can be closed laparoscopically or vaginally. The edges of the minilaparoscopic cannula are approximated together and held with surgical glue or a sterile skin-closure strip. There is no need to close the fascia.⁴

The percutaneous system opens new windows for minimally invasive surgery. It can be moved and used in several locations throughout a surgical procedure such that we can achieve more patient-specific “incisional mapping,” as I’m now calling it, rather than uniformly utilizing standard trocar placement sites.

Even without use of this particular innovation, the use of smaller instruments is proving both feasible and advantageous. A study that randomized 75 women scheduled for a hysterectomy to traditional laparoscopy (with a 5- to 10-mm port size) or minilaparoscopy (with a 3-mm port size) found no statistically significant differences in blood loss, hemoglobin drop, pain scores, or analgesic use. The authors concluded that the smaller port sizes did not affect the ability to perform the procedure. Moreover, they noted, the minilaparoscopy group had consistently smaller scars and better cosmesis.⁵

Another retrospective study of perioperative outcomes with standard laparoscopic, minilaparoscopic, and laparoendoscopic single-site hysterectomy found that postoperative pain control and the need for analgesic medication was significantly less with minilaparoscopy and laparoendoscopic single-site (LESS) hysterectomy, compared with traditional laparoscopy. Pain and medication in patients undergoing minilaparoscopy was reduced by more than 50%, compared with the traditional laparoscopy group, which suggests less operative trauma.⁶

In my practice, postoperative analgesia is simply intranasal ketorolac tromethamine (Sprix) and/or long-acting tramadol (Conzip); opioids have been eliminated in all minilaparoscopic procedures. We have had no complications, including no trocar-site bleeding, nerve entrapments, trocar-site herniations, or infections. Not every patient is a candidate for consideration of a minilaparoscopic hysterectomy, of course. The patient who has extensive adhesions from multiple previous surgeries or a large uterus with fibroids, for instance, should be treated with traditional laparoscopy regardless of her concerns regarding cosmesis.

No two surgeons are alike; each has his/her own ideas, skill sets, and approaches. Minilaparoscopy may not be for everyone, but given the number of durable miniature instruments now available, it’s an approach to consider integrating into a variety of gynecologic procedures.

For a right salpingo-oophorectomy, for instance, a 3-mm trocar placed at 12 o’clock through the umbilicus can accommodate a 3-mm scope with a high-definition camera, and an 11-mm trocar placed at 6 o’clock can house an energy device. In the right and left lower quadrants, two additional 3-mm trocars can be placed – one to accommodate a grasping instrument and the other to house the scope after the fallopian tube has been transected. A specimen bag can be passed through the 11-mm trocar in the umbilicus for removal of the ovary and tube. With the umbilicus hiding the largest of scars, the procedure is less invasive with better cosmetic results.

Dr. McCarus disclosed that he is a consultant for Ethicon.
 

References

1. Surg Technol Int. 2015 Nov;27:19-30.

2. Surg Technol Int. 2014 Nov;25:150-6.

3. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):640-3.

4. Surg Technol Int 2013 Sep;23:129-32.

5. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.

6. Surg Endosc. 2012 Dec;26(12):3592-6.

Minimally invasive surgeons have been intrigued for more than 2 decades by the clinical aspects and benefits of minilaparoscopy. Miniature instruments (2-3.5 mm) were introduced starting in the late 1980s, and through the 1990s minilaparoscopic procedures were performed across multiple specialties. However, the instrumentation available at the time had limited durability and functionality (for example, a lack of electrosurgical capability), and clinical experience and resulting data were sparse. The minilaparoscopic approach failed to gain momentum and was never widely adopted.

In the past 5-10 years, with new innovations in technology and improved instrumentation, minilaparoscopy is undergoing a renaissance in surgical circles. Medical device companies have developed numerous electrosurgical and other advanced energy options as well as a variety of needle holders, graspers, and other instruments – all with diameters of 3.5 mm or less and with significantly more durability than the earlier generation of mini-instruments. While surgeons oftentimes still use larger telescopes for better visualization, 2- to 3.5-mm telescopes are available in various lengths and angles, and optic quality is continually improving.

The minilaparoscopic approach is more similar to conventional laparoscopy than laparoendoscopic single-site surgery, which has not met early expectations. It is a more logical next step in the evolution of minimally invasive surgery and its goals of further reducing surgical trauma and improving cosmesis. I am performing hysterectomies in which I place two 5-mm nonbladed trocars through incisions inside the umbilicus and a minilaparoscopic percutaneous cannula below the bikini line; it is a “hybrid” procedure, in essence, that incorporates the use of mini-instrumentation.

Courtesy of Steven McCarus, MD

In addition to diagnostic laparoscopy, I also use minilaparoscopy for some of my patients who need ovarian cystectomy, oophorectomy, appendectomy, treatment of early-stage endometriosis or adhesiolysis. Throughout the world and across multiple specialties, it is being adopted for a wide range of adult and pediatric procedures, from abdominopelvic adhesions and inguinal hernia repair to cholecystectomy, and even to enhance diagnosis in the ED or ICU.¹

The importance of surgical scars

The resurgence of interest in minilaparoscopy has been driven largely by its clinical advantages. From a clinical standpoint, less intrusion through the abdominal wall with the use of smaller instruments and fewer insertion points generally means less surgical trauma, and less analgesic medication and postoperative pain, for instance, as well as fewer vascular injuries and a more minimal risk of adhesions. Scar cosmesis also has been viewed as an advantage, just as it was when the abdominal hysterectomy was being replaced by laparoscopic hysterectomy starting in 1989. Still, for me, the clinical aspects have long been at the forefront.

My interest in providing my patients the very best cosmetic results changed after we surveyed patients who were scheduled for a hysterectomy in my practice over the span of 1 year. All patients seen during that time (from November 2012 to November 2013) were asked to complete a questionnaire on their knowledge of hysterectomy incisional scars, their perceptions, and their desires. Almost all of the 200 women who completed the survey – 93% – indicated that cosmetic issues such as scars are important to them (“slightly,” “moderately,” “quite,” or “extremely” important), and of these, 24% chose “extremely important.”

Courtesy of Steven McCarus, MD

Asked how they feel about the appearance of their scars from prior abdominal surgery, 58% indicated the appearance bothered them to some extent, and 11% said they were “extremely” bothered. Almost all of the 200 patients – 92% – said they would be interested in a surgery that would leave no scars, and 45% said they were “extremely” interested.²

The findings juxtaposed the clinical benefits of more minimally invasive surgery – what had been foremost on my mind – with patients’ attention to and concern about scars. The study demonstrated that patient preferences are just as compelling, if not more, than what the surgeon wants. It showed, moreover, how important it is to discuss hysterectomy incision options – and patient preferences regarding incision location, size, and number – prior to surgery.

When asked about their familiarity with the locations of skin incisions in different hysterectomy procedures (abdominal, vaginal, laparoscopic, robotic, and mini), between 25% and 56% indicated they were not at all familiar with them. Familiarity was greatest with incisions in traditional laparoscopic hysterectomy. Yet patients want to have that knowledge: Almost all of the survey participants – 93% – indicated it is important to discuss the location, number, and size of incisions prior to surgery, and 59% said it is “extremely” important.

Patients also were asked to rank a short list of incision locations (above or below the belly button, and above or below the bikini line) from the least desirable to most desirable, and the results suggest just how different personal preferences can be. The most-desirable incision location was below the bikini line for 68% of patients, followed by above the belly button for 16%. The least-desirable location was above the belly button for 69%, followed by below the bikini line for 15%. Asked whether it is cosmetically superior for one’s incisions to be low (below the bikini line), 86% said they agreed.

Other research has similarly shown that cosmesis is important for women undergoing gynecologic surgery. For instance, women in another single-practice study were more likely to prefer single-site and traditional laparoscopic incisions over robotic ones when they were shown photos of an abdomen marked up with the incision lengths and locations typical for each of these three approaches.³ And notably, there has been research looking at the psychological impact of incisional scars specifically in patients who are morbidly obese.

While we may not be accustomed to discussing incisions and scars, it behooves us as surgeons to consider initiating a conversation about incisions with all our patients – regardless of their body mass index and prior surgical history – during the preoperative evaluation.
 

My hysterectomy approach

I have utilized one of the most recent developments in minilaparoscopy instrumentation – the MiniLap percutaneous surgical system (Teleflex) – to develop a mini technique for hysterectomy I’ve trademarked as the Cosmetic Hysterectomy. The percutaneous system has an outer diameter of 2.3 mm, integrated needle tips that facilitate insertion without a trocar, and a selection of integrated graspers (e.g., a miniature clutch or alligator) that open up to 12.5 mm and can be advanced and retracted through the cannula. The graspers can be locked onto the tissue, and the system itself can be stabilized extracorporeally so that it can be hands free.

For the hysterectomy, I make two 5-mm vertical incisions within the umbilicus – one for a nonbladed 5-mm trocar at 12 o’clock and the other for a second nonbladed 5-mm trocar at 6 o’clock, penetrating the fascia. The trocars house a 30-degree extra-long laparoscope with camera attached, and an advanced bipolar electrosurgery device.

The minilaparoscopic cannula is inserted in the lower-abdominal area through a single 1-mm stab incision, and one or two instruments can be placed as needed. Tissues can be removed vaginally once dissection is completed, and the vaginal cuff can be closed laparoscopically or vaginally. The edges of the minilaparoscopic cannula are approximated together and held with surgical glue or a sterile skin-closure strip. There is no need to close the fascia.⁴

The percutaneous system opens new windows for minimally invasive surgery. It can be moved and used in several locations throughout a surgical procedure such that we can achieve more patient-specific “incisional mapping,” as I’m now calling it, rather than uniformly utilizing standard trocar placement sites.

Even without use of this particular innovation, the use of smaller instruments is proving both feasible and advantageous. A study that randomized 75 women scheduled for a hysterectomy to traditional laparoscopy (with a 5- to 10-mm port size) or minilaparoscopy (with a 3-mm port size) found no statistically significant differences in blood loss, hemoglobin drop, pain scores, or analgesic use. The authors concluded that the smaller port sizes did not affect the ability to perform the procedure. Moreover, they noted, the minilaparoscopy group had consistently smaller scars and better cosmesis.⁵

Another retrospective study of perioperative outcomes with standard laparoscopic, minilaparoscopic, and laparoendoscopic single-site hysterectomy found that postoperative pain control and the need for analgesic medication was significantly less with minilaparoscopy and laparoendoscopic single-site (LESS) hysterectomy, compared with traditional laparoscopy. Pain and medication in patients undergoing minilaparoscopy was reduced by more than 50%, compared with the traditional laparoscopy group, which suggests less operative trauma.⁶

In my practice, postoperative analgesia is simply intranasal ketorolac tromethamine (Sprix) and/or long-acting tramadol (Conzip); opioids have been eliminated in all minilaparoscopic procedures. We have had no complications, including no trocar-site bleeding, nerve entrapments, trocar-site herniations, or infections. Not every patient is a candidate for consideration of a minilaparoscopic hysterectomy, of course. The patient who has extensive adhesions from multiple previous surgeries or a large uterus with fibroids, for instance, should be treated with traditional laparoscopy regardless of her concerns regarding cosmesis.

No two surgeons are alike; each has his/her own ideas, skill sets, and approaches. Minilaparoscopy may not be for everyone, but given the number of durable miniature instruments now available, it’s an approach to consider integrating into a variety of gynecologic procedures.

For a right salpingo-oophorectomy, for instance, a 3-mm trocar placed at 12 o’clock through the umbilicus can accommodate a 3-mm scope with a high-definition camera, and an 11-mm trocar placed at 6 o’clock can house an energy device. In the right and left lower quadrants, two additional 3-mm trocars can be placed – one to accommodate a grasping instrument and the other to house the scope after the fallopian tube has been transected. A specimen bag can be passed through the 11-mm trocar in the umbilicus for removal of the ovary and tube. With the umbilicus hiding the largest of scars, the procedure is less invasive with better cosmetic results.

Dr. McCarus disclosed that he is a consultant for Ethicon.
 

References

1. Surg Technol Int. 2015 Nov;27:19-30.

2. Surg Technol Int. 2014 Nov;25:150-6.

3. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):640-3.

4. Surg Technol Int 2013 Sep;23:129-32.

5. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.

6. Surg Endosc. 2012 Dec;26(12):3592-6.

Minimally invasive surgeons have been intrigued for more than 2 decades by the clinical aspects and benefits of minilaparoscopy. Miniature instruments (2-3.5 mm) were introduced starting in the late 1980s, and through the 1990s minilaparoscopic procedures were performed across multiple specialties. However, the instrumentation available at the time had limited durability and functionality (for example, a lack of electrosurgical capability), and clinical experience and resulting data were sparse. The minilaparoscopic approach failed to gain momentum and was never widely adopted.

In the past 5-10 years, with new innovations in technology and improved instrumentation, minilaparoscopy is undergoing a renaissance in surgical circles. Medical device companies have developed numerous electrosurgical and other advanced energy options as well as a variety of needle holders, graspers, and other instruments – all with diameters of 3.5 mm or less and with significantly more durability than the earlier generation of mini-instruments. While surgeons oftentimes still use larger telescopes for better visualization, 2- to 3.5-mm telescopes are available in various lengths and angles, and optic quality is continually improving.

The minilaparoscopic approach is more similar to conventional laparoscopy than laparoendoscopic single-site surgery, which has not met early expectations. It is a more logical next step in the evolution of minimally invasive surgery and its goals of further reducing surgical trauma and improving cosmesis. I am performing hysterectomies in which I place two 5-mm nonbladed trocars through incisions inside the umbilicus and a minilaparoscopic percutaneous cannula below the bikini line; it is a “hybrid” procedure, in essence, that incorporates the use of mini-instrumentation.

Courtesy of Steven McCarus, MD

In addition to diagnostic laparoscopy, I also use minilaparoscopy for some of my patients who need ovarian cystectomy, oophorectomy, appendectomy, treatment of early-stage endometriosis or adhesiolysis. Throughout the world and across multiple specialties, it is being adopted for a wide range of adult and pediatric procedures, from abdominopelvic adhesions and inguinal hernia repair to cholecystectomy, and even to enhance diagnosis in the ED or ICU.¹

The importance of surgical scars

The resurgence of interest in minilaparoscopy has been driven largely by its clinical advantages. From a clinical standpoint, less intrusion through the abdominal wall with the use of smaller instruments and fewer insertion points generally means less surgical trauma, and less analgesic medication and postoperative pain, for instance, as well as fewer vascular injuries and a more minimal risk of adhesions. Scar cosmesis also has been viewed as an advantage, just as it was when the abdominal hysterectomy was being replaced by laparoscopic hysterectomy starting in 1989. Still, for me, the clinical aspects have long been at the forefront.

My interest in providing my patients the very best cosmetic results changed after we surveyed patients who were scheduled for a hysterectomy in my practice over the span of 1 year. All patients seen during that time (from November 2012 to November 2013) were asked to complete a questionnaire on their knowledge of hysterectomy incisional scars, their perceptions, and their desires. Almost all of the 200 women who completed the survey – 93% – indicated that cosmetic issues such as scars are important to them (“slightly,” “moderately,” “quite,” or “extremely” important), and of these, 24% chose “extremely important.”

Courtesy of Steven McCarus, MD

Asked how they feel about the appearance of their scars from prior abdominal surgery, 58% indicated the appearance bothered them to some extent, and 11% said they were “extremely” bothered. Almost all of the 200 patients – 92% – said they would be interested in a surgery that would leave no scars, and 45% said they were “extremely” interested.²

The findings juxtaposed the clinical benefits of more minimally invasive surgery – what had been foremost on my mind – with patients’ attention to and concern about scars. The study demonstrated that patient preferences are just as compelling, if not more, than what the surgeon wants. It showed, moreover, how important it is to discuss hysterectomy incision options – and patient preferences regarding incision location, size, and number – prior to surgery.

When asked about their familiarity with the locations of skin incisions in different hysterectomy procedures (abdominal, vaginal, laparoscopic, robotic, and mini), between 25% and 56% indicated they were not at all familiar with them. Familiarity was greatest with incisions in traditional laparoscopic hysterectomy. Yet patients want to have that knowledge: Almost all of the survey participants – 93% – indicated it is important to discuss the location, number, and size of incisions prior to surgery, and 59% said it is “extremely” important.

Patients also were asked to rank a short list of incision locations (above or below the belly button, and above or below the bikini line) from the least desirable to most desirable, and the results suggest just how different personal preferences can be. The most-desirable incision location was below the bikini line for 68% of patients, followed by above the belly button for 16%. The least-desirable location was above the belly button for 69%, followed by below the bikini line for 15%. Asked whether it is cosmetically superior for one’s incisions to be low (below the bikini line), 86% said they agreed.

Other research has similarly shown that cosmesis is important for women undergoing gynecologic surgery. For instance, women in another single-practice study were more likely to prefer single-site and traditional laparoscopic incisions over robotic ones when they were shown photos of an abdomen marked up with the incision lengths and locations typical for each of these three approaches.³ And notably, there has been research looking at the psychological impact of incisional scars specifically in patients who are morbidly obese.

While we may not be accustomed to discussing incisions and scars, it behooves us as surgeons to consider initiating a conversation about incisions with all our patients – regardless of their body mass index and prior surgical history – during the preoperative evaluation.
 

My hysterectomy approach

I have utilized one of the most recent developments in minilaparoscopy instrumentation – the MiniLap percutaneous surgical system (Teleflex) – to develop a mini technique for hysterectomy I’ve trademarked as the Cosmetic Hysterectomy. The percutaneous system has an outer diameter of 2.3 mm, integrated needle tips that facilitate insertion without a trocar, and a selection of integrated graspers (e.g., a miniature clutch or alligator) that open up to 12.5 mm and can be advanced and retracted through the cannula. The graspers can be locked onto the tissue, and the system itself can be stabilized extracorporeally so that it can be hands free.

For the hysterectomy, I make two 5-mm vertical incisions within the umbilicus – one for a nonbladed 5-mm trocar at 12 o’clock and the other for a second nonbladed 5-mm trocar at 6 o’clock, penetrating the fascia. The trocars house a 30-degree extra-long laparoscope with camera attached, and an advanced bipolar electrosurgery device.

The minilaparoscopic cannula is inserted in the lower-abdominal area through a single 1-mm stab incision, and one or two instruments can be placed as needed. Tissues can be removed vaginally once dissection is completed, and the vaginal cuff can be closed laparoscopically or vaginally. The edges of the minilaparoscopic cannula are approximated together and held with surgical glue or a sterile skin-closure strip. There is no need to close the fascia.⁴

The percutaneous system opens new windows for minimally invasive surgery. It can be moved and used in several locations throughout a surgical procedure such that we can achieve more patient-specific “incisional mapping,” as I’m now calling it, rather than uniformly utilizing standard trocar placement sites.

Even without use of this particular innovation, the use of smaller instruments is proving both feasible and advantageous. A study that randomized 75 women scheduled for a hysterectomy to traditional laparoscopy (with a 5- to 10-mm port size) or minilaparoscopy (with a 3-mm port size) found no statistically significant differences in blood loss, hemoglobin drop, pain scores, or analgesic use. The authors concluded that the smaller port sizes did not affect the ability to perform the procedure. Moreover, they noted, the minilaparoscopy group had consistently smaller scars and better cosmesis.⁵

Another retrospective study of perioperative outcomes with standard laparoscopic, minilaparoscopic, and laparoendoscopic single-site hysterectomy found that postoperative pain control and the need for analgesic medication was significantly less with minilaparoscopy and laparoendoscopic single-site (LESS) hysterectomy, compared with traditional laparoscopy. Pain and medication in patients undergoing minilaparoscopy was reduced by more than 50%, compared with the traditional laparoscopy group, which suggests less operative trauma.⁶

In my practice, postoperative analgesia is simply intranasal ketorolac tromethamine (Sprix) and/or long-acting tramadol (Conzip); opioids have been eliminated in all minilaparoscopic procedures. We have had no complications, including no trocar-site bleeding, nerve entrapments, trocar-site herniations, or infections. Not every patient is a candidate for consideration of a minilaparoscopic hysterectomy, of course. The patient who has extensive adhesions from multiple previous surgeries or a large uterus with fibroids, for instance, should be treated with traditional laparoscopy regardless of her concerns regarding cosmesis.

No two surgeons are alike; each has his/her own ideas, skill sets, and approaches. Minilaparoscopy may not be for everyone, but given the number of durable miniature instruments now available, it’s an approach to consider integrating into a variety of gynecologic procedures.

For a right salpingo-oophorectomy, for instance, a 3-mm trocar placed at 12 o’clock through the umbilicus can accommodate a 3-mm scope with a high-definition camera, and an 11-mm trocar placed at 6 o’clock can house an energy device. In the right and left lower quadrants, two additional 3-mm trocars can be placed – one to accommodate a grasping instrument and the other to house the scope after the fallopian tube has been transected. A specimen bag can be passed through the 11-mm trocar in the umbilicus for removal of the ovary and tube. With the umbilicus hiding the largest of scars, the procedure is less invasive with better cosmetic results.

Dr. McCarus disclosed that he is a consultant for Ethicon.
 

References

1. Surg Technol Int. 2015 Nov;27:19-30.

2. Surg Technol Int. 2014 Nov;25:150-6.

3. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):640-3.

4. Surg Technol Int 2013 Sep;23:129-32.

5. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.

6. Surg Endosc. 2012 Dec;26(12):3592-6.

With the wax and wane in the popularity of single-port surgery and with the advent of improved instrumentation, minilaparoscopy would appear to be the next long-lasting surgical technique to enhance postsurgical cosmetic appearance. For this reason, it is surprising that the use of minilaparoscopy has not been acknowledged and evaluated as a viable option more often in general surgery and urology. This, despite the fact that the use of this technique in hysterectomy was described nearly 20 years ago.¹

Our minimally invasive gynecologic surgery (MIGS) team has utilized minilaparoscopy for diagnostic laparoscopy, lysis of adhesions, treatment of stage I, II, and occasionally stage III endometriosis, ovarian cystectomy, ureterolysis, presacral neurectomy, and total laparoscopic hysterectomy – as has our guest author Steven McCarus, MD. When performing hysterectomy via minilaparoscopy, our team closes the vaginal cuff laparoscopically, placing the suture transvaginally.

By removing the fibroid via a colpotomy incision, the Italian MIGS surgeon Fabio Ghezzi, MD, is able to perform myomectomy and hysterectomy routinely via minilaparoscopy.² Articles have been published regarding the feasibility of performing minilaparoscopic surgery for both the treatment of benign adnexal mases³ and endometriosis.⁴

Dr. McCarus presents compelling evidence regarding the cosmetic advantage of minilaparoscopy, but the reported impact on pain has been variable: As Alyssa Small Layne et al. states, “Some studies associate minilaparoscopy with decreased pain, whereas others did not find a difference.”⁵ In part, this is attributable to the fact that no matter what technique is performed, the pathology must be excised. However, it is my belief that with improvements in instrumentation – as noted by Dr. McCarus and our collected added experience – the postoperative pain profile for the patient undergoing minilaparoscopy will change dramatically.

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Dr. McCarus, who is the chief of gynecological surgery at Florida Hospital Celebration Health, Celebration. With over 25 years of experience, Dr. McCarus is nationally known as a leader in the practice of minimally invasive gynecologic surgery.

It is a pleasure to welcome Dr. McCarus to this edition of the Master Class in Gynecologic Surgery.
 

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class.

References

1. J Am Assoc Gynecol Laparosc. 1999 Feb;6(1):97-100.

2. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.

3. J Clin Med Res. 2017 Jul;9(7):613-7.

4. Gynecol Minim Invasive Ther. 2013 Aug;2(3):85-8.

5. Curr Opin Obstet Gynecol. 2016 Aug;28(4):255-60.

With the wax and wane in the popularity of single-port surgery and with the advent of improved instrumentation, minilaparoscopy would appear to be the next long-lasting surgical technique to enhance postsurgical cosmetic appearance. For this reason, it is surprising that the use of minilaparoscopy has not been acknowledged and evaluated as a viable option more often in general surgery and urology. This, despite the fact that the use of this technique in hysterectomy was described nearly 20 years ago.¹

Our minimally invasive gynecologic surgery (MIGS) team has utilized minilaparoscopy for diagnostic laparoscopy, lysis of adhesions, treatment of stage I, II, and occasionally stage III endometriosis, ovarian cystectomy, ureterolysis, presacral neurectomy, and total laparoscopic hysterectomy – as has our guest author Steven McCarus, MD. When performing hysterectomy via minilaparoscopy, our team closes the vaginal cuff laparoscopically, placing the suture transvaginally.

By removing the fibroid via a colpotomy incision, the Italian MIGS surgeon Fabio Ghezzi, MD, is able to perform myomectomy and hysterectomy routinely via minilaparoscopy.² Articles have been published regarding the feasibility of performing minilaparoscopic surgery for both the treatment of benign adnexal mases³ and endometriosis.⁴

Dr. McCarus presents compelling evidence regarding the cosmetic advantage of minilaparoscopy, but the reported impact on pain has been variable: As Alyssa Small Layne et al. states, “Some studies associate minilaparoscopy with decreased pain, whereas others did not find a difference.”⁵ In part, this is attributable to the fact that no matter what technique is performed, the pathology must be excised. However, it is my belief that with improvements in instrumentation – as noted by Dr. McCarus and our collected added experience – the postoperative pain profile for the patient undergoing minilaparoscopy will change dramatically.

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Dr. McCarus, who is the chief of gynecological surgery at Florida Hospital Celebration Health, Celebration. With over 25 years of experience, Dr. McCarus is nationally known as a leader in the practice of minimally invasive gynecologic surgery.

It is a pleasure to welcome Dr. McCarus to this edition of the Master Class in Gynecologic Surgery.
 

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class.

References

1. J Am Assoc Gynecol Laparosc. 1999 Feb;6(1):97-100.

2. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.

3. J Clin Med Res. 2017 Jul;9(7):613-7.

4. Gynecol Minim Invasive Ther. 2013 Aug;2(3):85-8.

5. Curr Opin Obstet Gynecol. 2016 Aug;28(4):255-60.

With the wax and wane in the popularity of single-port surgery and with the advent of improved instrumentation, minilaparoscopy would appear to be the next long-lasting surgical technique to enhance postsurgical cosmetic appearance. For this reason, it is surprising that the use of minilaparoscopy has not been acknowledged and evaluated as a viable option more often in general surgery and urology. This, despite the fact that the use of this technique in hysterectomy was described nearly 20 years ago.¹

Our minimally invasive gynecologic surgery (MIGS) team has utilized minilaparoscopy for diagnostic laparoscopy, lysis of adhesions, treatment of stage I, II, and occasionally stage III endometriosis, ovarian cystectomy, ureterolysis, presacral neurectomy, and total laparoscopic hysterectomy – as has our guest author Steven McCarus, MD. When performing hysterectomy via minilaparoscopy, our team closes the vaginal cuff laparoscopically, placing the suture transvaginally.

By removing the fibroid via a colpotomy incision, the Italian MIGS surgeon Fabio Ghezzi, MD, is able to perform myomectomy and hysterectomy routinely via minilaparoscopy.² Articles have been published regarding the feasibility of performing minilaparoscopic surgery for both the treatment of benign adnexal mases³ and endometriosis.⁴

Dr. McCarus presents compelling evidence regarding the cosmetic advantage of minilaparoscopy, but the reported impact on pain has been variable: As Alyssa Small Layne et al. states, “Some studies associate minilaparoscopy with decreased pain, whereas others did not find a difference.”⁵ In part, this is attributable to the fact that no matter what technique is performed, the pathology must be excised. However, it is my belief that with improvements in instrumentation – as noted by Dr. McCarus and our collected added experience – the postoperative pain profile for the patient undergoing minilaparoscopy will change dramatically.

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Dr. McCarus, who is the chief of gynecological surgery at Florida Hospital Celebration Health, Celebration. With over 25 years of experience, Dr. McCarus is nationally known as a leader in the practice of minimally invasive gynecologic surgery.

It is a pleasure to welcome Dr. McCarus to this edition of the Master Class in Gynecologic Surgery.
 

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class.

References

1. J Am Assoc Gynecol Laparosc. 1999 Feb;6(1):97-100.

2. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):455-61.

3. J Clin Med Res. 2017 Jul;9(7):613-7.

4. Gynecol Minim Invasive Ther. 2013 Aug;2(3):85-8.

5. Curr Opin Obstet Gynecol. 2016 Aug;28(4):255-60.

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

mlesney@mdedge.com

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

mlesney@mdedge.com

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

mlesney@mdedge.com