OBG Management

Fear of potential pain caused by insertion of an intrauterine device (IUD) prevents some women from using this highly effective and safe contraceptive method. Recently, investigators conducted a randomized, placebo-controlled trial to assess whether vaginal lidocaine gel administered shortly before IUD placement was associated with a decrease from baseline in patient-reported pain scores.¹

In this blinded trial, Rapkinand colleagues randomly assigned nulliparous women presenting for IUD placement (either the copper T380A IUD or the 52-mg levonorgestrel-releasing IUD) at faculty and resident clinics at a US urban academic center to place 4 mL of 2% lidocaine gel or placebo gel vaginally (using an applicator) 5 to 15 minutes prior to IUD placement.¹ A 100-mm visual analog scale (VAS) was used to assess pain at each step of the procedure, including at baseline (before speculum insertion), after speculum placement, tenaculum placement, uterine sound, IUD insertion, and 5 minutes after speculum removal.

Among the 58 evaluable participants, the mean age was 23 years in the lidocaine group and 24 years in the placebo group; more than 80% of the women were white.

The study’s primary outcome was change in pain experience from baseline to IUD insertion. Pain was measured on a VAS from 0 mm (no pain) to 100 mm (worst pain in my life). Secondary outcomes included patient acceptability of gel self-insertion, physician-reported ease of IUD insertion, and need for pain medication for up to 7 days after IUD insertion.

Related article:
Liletta gets a new inserter: Steps for successful placement

What the investigators found

The mean change in pain scores with IUD placement was 61 mm for the lidocaine group and 69 mm for the placebo group (P = .06). Thus, no difference in the primary outcome was found between the 2 groups. However, women who received the lidocaine gel treatment experiencedsignificantly less pain with tenaculum placement than those who received placebo gel (32 mm vs 56 mm; P = .02), and they were substantially less likely to require cervical dilation (3.3% vs 34.5%; P = .002), an often painful procedure.

Related article:
Does the injection of ketorolac prior to IUD placement reduce pain?
 

Patient acceptability and satisfaction. Five minutes after the IUD placement procedure, approximately two-thirds of women in both groups indicated that they experienced an acceptable level of discomfort, and more than three-quarters indicated that they were satisfied with the placement procedure. Fully 67% of the lidocaine group and 68% of the placebo group indicated definitely or probably yes when asked if the level of discomfort they experienced was acceptable, with 27% and 21%, respectively, responding as neutral. When asked if getting the IUD was worth the level of discomfort experienced, 73% of the lidocaine group and 82% of the placebo group responded “yes,” while 23% and 18%, respectively, were unsure.

Pearls for practice

As this study showed, self-administered lidocaine vaginal gel did not alter the primary outcome (pain with IUD placement), but the reduced need for cervical dilation is a promising finding and warrants additional study.

Tip. Interestingly, the placebo-treated women experienced pain intensity with cervical tenaculum placement similar to that associated with IUD placement. This finding illuminates the fact that IUD placement is not the only action that can produce pain. For this reason, I use a finer, single-tooth tenaculum designed for use with sonohysterograms (Goldstein Grasp Cervical Stabilizer).² This instrument appears to cause less pain and bleeding than conventional tenacula.

Related article:
How to identify and localize IUDs on ultrasound
 

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.

Fear of potential pain caused by insertion of an intrauterine device (IUD) prevents some women from using this highly effective and safe contraceptive method. Recently, investigators conducted a randomized, placebo-controlled trial to assess whether vaginal lidocaine gel administered shortly before IUD placement was associated with a decrease from baseline in patient-reported pain scores.¹

In this blinded trial, Rapkinand colleagues randomly assigned nulliparous women presenting for IUD placement (either the copper T380A IUD or the 52-mg levonorgestrel-releasing IUD) at faculty and resident clinics at a US urban academic center to place 4 mL of 2% lidocaine gel or placebo gel vaginally (using an applicator) 5 to 15 minutes prior to IUD placement.¹ A 100-mm visual analog scale (VAS) was used to assess pain at each step of the procedure, including at baseline (before speculum insertion), after speculum placement, tenaculum placement, uterine sound, IUD insertion, and 5 minutes after speculum removal.

Among the 58 evaluable participants, the mean age was 23 years in the lidocaine group and 24 years in the placebo group; more than 80% of the women were white.

The study’s primary outcome was change in pain experience from baseline to IUD insertion. Pain was measured on a VAS from 0 mm (no pain) to 100 mm (worst pain in my life). Secondary outcomes included patient acceptability of gel self-insertion, physician-reported ease of IUD insertion, and need for pain medication for up to 7 days after IUD insertion.

Related article:
Liletta gets a new inserter: Steps for successful placement

What the investigators found

The mean change in pain scores with IUD placement was 61 mm for the lidocaine group and 69 mm for the placebo group (P = .06). Thus, no difference in the primary outcome was found between the 2 groups. However, women who received the lidocaine gel treatment experiencedsignificantly less pain with tenaculum placement than those who received placebo gel (32 mm vs 56 mm; P = .02), and they were substantially less likely to require cervical dilation (3.3% vs 34.5%; P = .002), an often painful procedure.

Related article:
Does the injection of ketorolac prior to IUD placement reduce pain?
 

Patient acceptability and satisfaction. Five minutes after the IUD placement procedure, approximately two-thirds of women in both groups indicated that they experienced an acceptable level of discomfort, and more than three-quarters indicated that they were satisfied with the placement procedure. Fully 67% of the lidocaine group and 68% of the placebo group indicated definitely or probably yes when asked if the level of discomfort they experienced was acceptable, with 27% and 21%, respectively, responding as neutral. When asked if getting the IUD was worth the level of discomfort experienced, 73% of the lidocaine group and 82% of the placebo group responded “yes,” while 23% and 18%, respectively, were unsure.

Pearls for practice

As this study showed, self-administered lidocaine vaginal gel did not alter the primary outcome (pain with IUD placement), but the reduced need for cervical dilation is a promising finding and warrants additional study.

Tip. Interestingly, the placebo-treated women experienced pain intensity with cervical tenaculum placement similar to that associated with IUD placement. This finding illuminates the fact that IUD placement is not the only action that can produce pain. For this reason, I use a finer, single-tooth tenaculum designed for use with sonohysterograms (Goldstein Grasp Cervical Stabilizer).² This instrument appears to cause less pain and bleeding than conventional tenacula.

Related article:
How to identify and localize IUDs on ultrasound
 

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.

Fear of potential pain caused by insertion of an intrauterine device (IUD) prevents some women from using this highly effective and safe contraceptive method. Recently, investigators conducted a randomized, placebo-controlled trial to assess whether vaginal lidocaine gel administered shortly before IUD placement was associated with a decrease from baseline in patient-reported pain scores.¹

In this blinded trial, Rapkinand colleagues randomly assigned nulliparous women presenting for IUD placement (either the copper T380A IUD or the 52-mg levonorgestrel-releasing IUD) at faculty and resident clinics at a US urban academic center to place 4 mL of 2% lidocaine gel or placebo gel vaginally (using an applicator) 5 to 15 minutes prior to IUD placement.¹ A 100-mm visual analog scale (VAS) was used to assess pain at each step of the procedure, including at baseline (before speculum insertion), after speculum placement, tenaculum placement, uterine sound, IUD insertion, and 5 minutes after speculum removal.

Among the 58 evaluable participants, the mean age was 23 years in the lidocaine group and 24 years in the placebo group; more than 80% of the women were white.

The study’s primary outcome was change in pain experience from baseline to IUD insertion. Pain was measured on a VAS from 0 mm (no pain) to 100 mm (worst pain in my life). Secondary outcomes included patient acceptability of gel self-insertion, physician-reported ease of IUD insertion, and need for pain medication for up to 7 days after IUD insertion.

Related article:
Liletta gets a new inserter: Steps for successful placement

What the investigators found

The mean change in pain scores with IUD placement was 61 mm for the lidocaine group and 69 mm for the placebo group (P = .06). Thus, no difference in the primary outcome was found between the 2 groups. However, women who received the lidocaine gel treatment experiencedsignificantly less pain with tenaculum placement than those who received placebo gel (32 mm vs 56 mm; P = .02), and they were substantially less likely to require cervical dilation (3.3% vs 34.5%; P = .002), an often painful procedure.

Related article:
Does the injection of ketorolac prior to IUD placement reduce pain?
 

Patient acceptability and satisfaction. Five minutes after the IUD placement procedure, approximately two-thirds of women in both groups indicated that they experienced an acceptable level of discomfort, and more than three-quarters indicated that they were satisfied with the placement procedure. Fully 67% of the lidocaine group and 68% of the placebo group indicated definitely or probably yes when asked if the level of discomfort they experienced was acceptable, with 27% and 21%, respectively, responding as neutral. When asked if getting the IUD was worth the level of discomfort experienced, 73% of the lidocaine group and 82% of the placebo group responded “yes,” while 23% and 18%, respectively, were unsure.

Pearls for practice

As this study showed, self-administered lidocaine vaginal gel did not alter the primary outcome (pain with IUD placement), but the reduced need for cervical dilation is a promising finding and warrants additional study.

Tip. Interestingly, the placebo-treated women experienced pain intensity with cervical tenaculum placement similar to that associated with IUD placement. This finding illuminates the fact that IUD placement is not the only action that can produce pain. For this reason, I use a finer, single-tooth tenaculum designed for use with sonohysterograms (Goldstein Grasp Cervical Stabilizer).² This instrument appears to cause less pain and bleeding than conventional tenacula.

Related article:
How to identify and localize IUDs on ultrasound
 

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.

CASE: After routine mammography results, DCIS found

A 49-year-old woman (G2 P2002) with a history of fibrocystic breast disease presented with a left breast mass that she found a month ago on self-examination. The patient faithfully had obtained routine mammograms since age 40. This year, after reporting the mass and with spot films obtained as recommended by the radiologist, a new cluster of microcalcifications was identified on the report: “spot compression” assessment identified a 3-cm mass and noted “s/p breast augmentation.”

The radiologist interpreted the spot films to be benign. His report stated that “15% of breast cancers are not detected by mammogram and breast self-exam is recommended monthly from 40 years of age.”

The gynecologist recommended a 6-month follow up. When the patient complied, the radiologist’s report again noted calcifications believed to be nonmalignant. Six months later, the patient presented with bloody nipple discharge from her left breast with apparent “eczema-like” lesions on the areola. The patient noted that her “left implant felt different.”

The patient’s surgical history included breast augmentation “years ago.” Her family history was negative for breast cancer. Her medications included hormone therapy (conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg daily) for vaginal atrophy. Other medical conditions included irritable bowel syndrome (managed with diet), anxiety and mood swings (for which she was taking sertraline), decreased libido, and irregular vaginal bleeding (after the patient refused endometrial sampling, she was switched to oral contraceptives to address the problem). In addition, her hypertension was being treated with hydrochlorothiazide.

At the gynecologist’s suggestion, a dermatology consultation was obtained.

The dermatologist gave a diagnosis of Paget disease with high-grade ductal carcinoma-in-situ (DCIS). The interval from screening mammogram to DCIS diagnosis had been 8 months. The dermatologist referred the patient to a breast surgeon. A discussion ensued between the breast surgeon and the dermatologist concerning the difficulty of making a diagnosis of breast cancer in a woman with breast augmentation.

The patient underwent modified radical mastectomy, and histopathology revealed DCIS with clear margins; lymph nodes were negative.

The patient filed a malpractice suit against the gynecologist related to the delayed breast mass evaluation and management. She remained upset that when she called the gynecologist’s office to convey her concerns regarding the left nipple discharge and implant concerns, “she was blown off.” She felt there was a clear “failure to communicate on critical matters of her health.” She alleged that the gynecologist, not the dermatologist, should have referred her to a breast surgeon.

WHAT'S THE VERDICT?

In the end, the patient decided not to pursue the lawsuit.

Related article:
Who is liable when a surgical error occurs?

Medical considerations

Breast cancer is the most common female malignancy, with 232,340 cases occurring annually in the United States. It is the second leading cause of cancer-related death in US women.¹ For this case discussion, we review the role of breast cancer screening, including breast self-examination and mammography.

Is breast self-examination recommended?

Recently, medical care has evolved from “breast self-examination” (BSE) to “breast self-awareness.”² The concept of BSE and concerns about it stem in part from “the Shanghai study.”³ In this prospective randomized trial, 266,064 female textile workers were randomly assigned to “rigorous and repetitive training in BSE” versus no instruction and no BSE performance. The former group had twice as many breast biopsies than the latter group (2,761 biopsies in the BSE group vs 1,505 in the control group). There was no difference in the number of breast cancers diagnosed among the groups—864 in the BSE group and 896 in the control group (relative risk [RR], 0.97; 95% confidence interval [CI], 0.88–1.06; P = .47). Other studies also support lack of efficacy regarding BSE.⁴

The potential for psychological harm, unnecessary biopsy, and additional imaging in association with false-positive findings is a concern² (TABLE). The American College of Obstetricians and Gynecologists (ACOG) states, “breast self-examination may be appropriate for certain high-risk populations and for other women who chose to follow this approach.”^2,5,6 The US Preventive Services Task Force (USPSTF) guidelines say that there is “insufficient evidence to assess risks vs benefits, including harms,” and recommends against teaching BSE.⁷ The American Cancer Society puts BSE in the “optional” category.^2,8

Is there a middle of the road strategy? Perhaps. The concept of breast-awareness was developed so that women understand how their breasts look and feel.^2,5 The concept does not advocate monthly BSE. The Mayo Clinic reported that, of 592 breast cancers, 57% were detected following abnormal screening mammography, 30% by BSE and 14% by clinical examination by a clinician. Furthermore, 38% of women with a palpable abnormality had a normal mammogram within the preceding 13 months.⁹ McBride and colleagues aptly addressed this: “Healthcare providers can educate their patients that breast awareness, in essence, is a two-step process. First, it requires that women be familiar with their breasts and aware of new changes and, second, have an understanding of the implications of these changes which includes informing their health care provider promptly.”¹⁰ The concept of “know what is normal for you” as conveyed by The Susan G. Komen Foundation succinctly encourages communication with patients.^2,11

Mammography

The latest technique in mammography is digital or 3D mammography, also known as tomosynthesis. The technique is similar to 2D mammography with the addition of digital cameras. A study published in the radiology literature noted that the 2 methods were equivalent.¹² One possible advantage of 3D mammography is that the 3D images are stored in computer files and are more easily incorporated into the electronic medical record.

What about mammography after breast augmentation?

While breast augmentation is not associated with an increase in breast cancer,¹³ mammography following breast augmentation can be more difficult to interpret and may result in a delay in diagnosis. In a prospective study of asymptomatic women who were diagnosed with breast cancer, 137 had augmentation and 685 did not. Miglioretti and colleagues noted that the sensitivity of screening mammography was lower in the augmentation cohort.¹⁴ To enhance accuracy, breast implant displacement views (in which the breast tissue is pulled forward and the implant is displaced posteriorly to improve visualization) have been recommended.¹⁵ A retrospective review provides data reporting no effect on interpretation of mammograms following augmentation.¹⁶ The American Cancer Society recommends the same screening for women with implants as without implants, starting at age 40 years.¹⁷

Paget disease of the breast

Paget disease of the breast was first described by Sir James Paget in 1874. He also defined Paget disease of extramammary tissue, bone, vulva, and penis. Paget disease of the breast is a rare type of cancer in which the skin and nipple are involved frequently in association with DCIS or invasive breast cancer. The skin has an eczema-like appearance. Characteristic Paget (malignant) cells are large with clear cytoplasm (clear halo) and eccentric, hyperchromatic nuclei throughout the dermis. Assessment includes mammography and biopsy with immunohistochemical staining. Treatment varies by case and can include lumpectomy or mastectomy and chemotherapy and/or radiation therapy. Medications, including tamoxifen and anastrazole, have been recommended. Prognosis depends on nodal involvement. The disease is more common in women older than age 50.¹⁸

Related article:
The medicolegal considerations of interacting with your patients online

Legal issues: What was the gynecologist’s obligation?

The question remains, did the gynecologist have an obligation to obtain diagnostic mammography and ultrasound of the breast? Would it have been prudent for immediate referral to a breast surgeon? These are critical questions.

Negligence and the standard of care

The malpractice lawsuit against this gynecologist is based on negligence. In essence, it is a claim that the management provided fell below a standard of care that would be given by a reasonably careful and prudent gynecologist under the circumstances. This generally means that the care was less than the profession itself would find acceptable. Here the claim is essentially a diagnostic error claim, a common basis of malpractice.¹⁹ The delay in diagnosing breast cancer is a leading cause of malpractice claims against gynecologists.^20,21

It is axiomatic that not all bad outcomes are the result of error, and not all errors are a result of an unacceptable standard of care. It is only bad outcomes resulting from careless or negligent errors that give rise to malpractice. But malpractice claims are often filed without knowing whether or not there was negligence—and, as we will see, many of those claims are without merit.

Was there negligence?

Ordinarily the plaintiff/patient must demonstrate that the care by the physician fell below the standard of care and, as a result, the patient suffered an injury. Stated another way, the plaintiff must show that the physician’s actions were unreasonable given all of the circumstances. In this case, the plaintiff must demonstrate that the gynecologist’s care was not appropriate. Failure to refer to another physician or provide additional testing is likely to be the major claim for negligence or inappropriate care.

Did that negligence cause injury?

Even if the plaintiff can demonstrate that the care was negligent, to prevail the plaintiff must also demonstrate that that negligence caused the injury—and that might be difficult.

What injury was caused by the delay in discovering the cancer? It did not apparently lead to the patient’s death. Can it be proven that the delay clearly shortened the patient’s life expectancy or required additional expensive and painful treatment? That may be difficult to demonstrate.

Causation. The causation factor could appear in many cancer or similar medical cases. On one hand, causation is a critical matter, but on the other hand, delay in treating cancer might have a very adverse effect on patients.

In recent years, about half the states have solved this dilemma by recognizing the concept of “loss of chance.”²² Essentially, this means that the health care provider, by delaying treatment, diminished the possibility that the patient would survive or recover fully.

There are significant variations among states in the loss-of-chance concept, many being quite technical.²² Thus, it is possible that a delay that reduced the chance of recovery or survival could be the injury and causal connection between the injury and the negligence. Even in states that recognize the loss-of-chance concept, the patient still must prove loss of chance.

Lessons learned from this case study

• Breast self-awareness has replaced (substituted) breast self-examination
• ACOG recommends breast mammography beginning at age 40 years
• Breast augmentation affects mammographic interpretation
• Prehaps if better communication had been provided initially, the patient would not have sought legal counsel or filed a weak suit

Related article:
Is the smartphone recording while the patient is under anesthesia?

Is this a strong malpractice case?

In the case presented here, it is not clear that the patient could show a meaningful loss of chance. If there is a delay in the breast cancer diagnosis, tumor doubling time would be an issue. While it is impossible to assess growth rate when a breast cancer is in its preclinical microscopic stage, doubling time can be 100 to 200 days. Therefore, it would take 20 years for the tumor to reach a 1- to 2-cm diameter. A log-normal distribution has been suggested for determining tumor growth.²³

Although the facts in this case are sketchy, this does not look like a strong malpractice case. Given the expense, difficulty, and length of time it takes to pursue a malpractice case (especially for someone battling cancer), an obvious question is: Why would a patient file a lawsuit in these circumstances? There is no single answer to that, but the hope of getting rich is unlikely a primary motivation. Ironically, many malpractice cases are filed in which there was no error (or at least no negligent error).²⁴

The search for what really happened, or why the bad event happened, is key. In other circumstances, it may be a desire for revenge or to protect other patients from similar bad results. Studies repeatedly have shown a somewhat limited correlation between negligent error and the decision to file a malpractice claim.^24–26 In this case, the patient’s sense of being “blown off” during a particularly difficult time may represent the reason why she filed a malpractice lawsuit. Communication gaffes and poor physician-patient relationships undoubtedly contribute to medical malpractice claims.^27,28 Improving communication with patients probably improves care, but it also almost certainly reduces the risk of a malpractice claim.²⁹

Why a lawyer would accept this case is also unclear, but that is an issue for another day. Also for another day is the issue of product liability concerning breast implants. Those legal issues and related liability, primarily directed to the manufacturers of the implants, are interesting topics. They are also complex and will be the subject of a future article.

Finally, the patient’s decision to not pursue her lawsuit does not come as a surprise. A relatively small percentage of malpractice claims result in any meaningful financial recovery for the plaintiff. Few cases go to trial, and of those that do result in a verdict, about 75% of the verdicts are in favor of the physician.^25,30 Many cases just fade away, either because the plaintiff never pursues them or because they are dismissed by a court at an early stage. Nonetheless, for the physician, even winning a malpractice case is disruptive and difficult. So in addition to ensuring careful, quality, and up-to-date care, a physician should seek to maintain good relationships and communication with patients to reduce the probability of even weak lawsuits being filed.

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.

CASE: After routine mammography results, DCIS found

A 49-year-old woman (G2 P2002) with a history of fibrocystic breast disease presented with a left breast mass that she found a month ago on self-examination. The patient faithfully had obtained routine mammograms since age 40. This year, after reporting the mass and with spot films obtained as recommended by the radiologist, a new cluster of microcalcifications was identified on the report: “spot compression” assessment identified a 3-cm mass and noted “s/p breast augmentation.”

The radiologist interpreted the spot films to be benign. His report stated that “15% of breast cancers are not detected by mammogram and breast self-exam is recommended monthly from 40 years of age.”

The gynecologist recommended a 6-month follow up. When the patient complied, the radiologist’s report again noted calcifications believed to be nonmalignant. Six months later, the patient presented with bloody nipple discharge from her left breast with apparent “eczema-like” lesions on the areola. The patient noted that her “left implant felt different.”

The patient’s surgical history included breast augmentation “years ago.” Her family history was negative for breast cancer. Her medications included hormone therapy (conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg daily) for vaginal atrophy. Other medical conditions included irritable bowel syndrome (managed with diet), anxiety and mood swings (for which she was taking sertraline), decreased libido, and irregular vaginal bleeding (after the patient refused endometrial sampling, she was switched to oral contraceptives to address the problem). In addition, her hypertension was being treated with hydrochlorothiazide.

At the gynecologist’s suggestion, a dermatology consultation was obtained.

The dermatologist gave a diagnosis of Paget disease with high-grade ductal carcinoma-in-situ (DCIS). The interval from screening mammogram to DCIS diagnosis had been 8 months. The dermatologist referred the patient to a breast surgeon. A discussion ensued between the breast surgeon and the dermatologist concerning the difficulty of making a diagnosis of breast cancer in a woman with breast augmentation.

The patient underwent modified radical mastectomy, and histopathology revealed DCIS with clear margins; lymph nodes were negative.

The patient filed a malpractice suit against the gynecologist related to the delayed breast mass evaluation and management. She remained upset that when she called the gynecologist’s office to convey her concerns regarding the left nipple discharge and implant concerns, “she was blown off.” She felt there was a clear “failure to communicate on critical matters of her health.” She alleged that the gynecologist, not the dermatologist, should have referred her to a breast surgeon.

WHAT'S THE VERDICT?

In the end, the patient decided not to pursue the lawsuit.

Related article:
Who is liable when a surgical error occurs?

Medical considerations

Breast cancer is the most common female malignancy, with 232,340 cases occurring annually in the United States. It is the second leading cause of cancer-related death in US women.¹ For this case discussion, we review the role of breast cancer screening, including breast self-examination and mammography.

Is breast self-examination recommended?

Recently, medical care has evolved from “breast self-examination” (BSE) to “breast self-awareness.”² The concept of BSE and concerns about it stem in part from “the Shanghai study.”³ In this prospective randomized trial, 266,064 female textile workers were randomly assigned to “rigorous and repetitive training in BSE” versus no instruction and no BSE performance. The former group had twice as many breast biopsies than the latter group (2,761 biopsies in the BSE group vs 1,505 in the control group). There was no difference in the number of breast cancers diagnosed among the groups—864 in the BSE group and 896 in the control group (relative risk [RR], 0.97; 95% confidence interval [CI], 0.88–1.06; P = .47). Other studies also support lack of efficacy regarding BSE.⁴

The potential for psychological harm, unnecessary biopsy, and additional imaging in association with false-positive findings is a concern² (TABLE). The American College of Obstetricians and Gynecologists (ACOG) states, “breast self-examination may be appropriate for certain high-risk populations and for other women who chose to follow this approach.”^2,5,6 The US Preventive Services Task Force (USPSTF) guidelines say that there is “insufficient evidence to assess risks vs benefits, including harms,” and recommends against teaching BSE.⁷ The American Cancer Society puts BSE in the “optional” category.^2,8

Is there a middle of the road strategy? Perhaps. The concept of breast-awareness was developed so that women understand how their breasts look and feel.^2,5 The concept does not advocate monthly BSE. The Mayo Clinic reported that, of 592 breast cancers, 57% were detected following abnormal screening mammography, 30% by BSE and 14% by clinical examination by a clinician. Furthermore, 38% of women with a palpable abnormality had a normal mammogram within the preceding 13 months.⁹ McBride and colleagues aptly addressed this: “Healthcare providers can educate their patients that breast awareness, in essence, is a two-step process. First, it requires that women be familiar with their breasts and aware of new changes and, second, have an understanding of the implications of these changes which includes informing their health care provider promptly.”¹⁰ The concept of “know what is normal for you” as conveyed by The Susan G. Komen Foundation succinctly encourages communication with patients.^2,11

Mammography

The latest technique in mammography is digital or 3D mammography, also known as tomosynthesis. The technique is similar to 2D mammography with the addition of digital cameras. A study published in the radiology literature noted that the 2 methods were equivalent.¹² One possible advantage of 3D mammography is that the 3D images are stored in computer files and are more easily incorporated into the electronic medical record.

What about mammography after breast augmentation?

While breast augmentation is not associated with an increase in breast cancer,¹³ mammography following breast augmentation can be more difficult to interpret and may result in a delay in diagnosis. In a prospective study of asymptomatic women who were diagnosed with breast cancer, 137 had augmentation and 685 did not. Miglioretti and colleagues noted that the sensitivity of screening mammography was lower in the augmentation cohort.¹⁴ To enhance accuracy, breast implant displacement views (in which the breast tissue is pulled forward and the implant is displaced posteriorly to improve visualization) have been recommended.¹⁵ A retrospective review provides data reporting no effect on interpretation of mammograms following augmentation.¹⁶ The American Cancer Society recommends the same screening for women with implants as without implants, starting at age 40 years.¹⁷

Paget disease of the breast

Paget disease of the breast was first described by Sir James Paget in 1874. He also defined Paget disease of extramammary tissue, bone, vulva, and penis. Paget disease of the breast is a rare type of cancer in which the skin and nipple are involved frequently in association with DCIS or invasive breast cancer. The skin has an eczema-like appearance. Characteristic Paget (malignant) cells are large with clear cytoplasm (clear halo) and eccentric, hyperchromatic nuclei throughout the dermis. Assessment includes mammography and biopsy with immunohistochemical staining. Treatment varies by case and can include lumpectomy or mastectomy and chemotherapy and/or radiation therapy. Medications, including tamoxifen and anastrazole, have been recommended. Prognosis depends on nodal involvement. The disease is more common in women older than age 50.¹⁸

Related article:
The medicolegal considerations of interacting with your patients online

Legal issues: What was the gynecologist’s obligation?

The question remains, did the gynecologist have an obligation to obtain diagnostic mammography and ultrasound of the breast? Would it have been prudent for immediate referral to a breast surgeon? These are critical questions.

Negligence and the standard of care

The malpractice lawsuit against this gynecologist is based on negligence. In essence, it is a claim that the management provided fell below a standard of care that would be given by a reasonably careful and prudent gynecologist under the circumstances. This generally means that the care was less than the profession itself would find acceptable. Here the claim is essentially a diagnostic error claim, a common basis of malpractice.¹⁹ The delay in diagnosing breast cancer is a leading cause of malpractice claims against gynecologists.^20,21

It is axiomatic that not all bad outcomes are the result of error, and not all errors are a result of an unacceptable standard of care. It is only bad outcomes resulting from careless or negligent errors that give rise to malpractice. But malpractice claims are often filed without knowing whether or not there was negligence—and, as we will see, many of those claims are without merit.

Was there negligence?

Ordinarily the plaintiff/patient must demonstrate that the care by the physician fell below the standard of care and, as a result, the patient suffered an injury. Stated another way, the plaintiff must show that the physician’s actions were unreasonable given all of the circumstances. In this case, the plaintiff must demonstrate that the gynecologist’s care was not appropriate. Failure to refer to another physician or provide additional testing is likely to be the major claim for negligence or inappropriate care.

Did that negligence cause injury?

Even if the plaintiff can demonstrate that the care was negligent, to prevail the plaintiff must also demonstrate that that negligence caused the injury—and that might be difficult.

What injury was caused by the delay in discovering the cancer? It did not apparently lead to the patient’s death. Can it be proven that the delay clearly shortened the patient’s life expectancy or required additional expensive and painful treatment? That may be difficult to demonstrate.

Causation. The causation factor could appear in many cancer or similar medical cases. On one hand, causation is a critical matter, but on the other hand, delay in treating cancer might have a very adverse effect on patients.

In recent years, about half the states have solved this dilemma by recognizing the concept of “loss of chance.”²² Essentially, this means that the health care provider, by delaying treatment, diminished the possibility that the patient would survive or recover fully.

There are significant variations among states in the loss-of-chance concept, many being quite technical.²² Thus, it is possible that a delay that reduced the chance of recovery or survival could be the injury and causal connection between the injury and the negligence. Even in states that recognize the loss-of-chance concept, the patient still must prove loss of chance.

Lessons learned from this case study

• Breast self-awareness has replaced (substituted) breast self-examination
• ACOG recommends breast mammography beginning at age 40 years
• Breast augmentation affects mammographic interpretation
• Prehaps if better communication had been provided initially, the patient would not have sought legal counsel or filed a weak suit

Related article:
Is the smartphone recording while the patient is under anesthesia?

Is this a strong malpractice case?

In the case presented here, it is not clear that the patient could show a meaningful loss of chance. If there is a delay in the breast cancer diagnosis, tumor doubling time would be an issue. While it is impossible to assess growth rate when a breast cancer is in its preclinical microscopic stage, doubling time can be 100 to 200 days. Therefore, it would take 20 years for the tumor to reach a 1- to 2-cm diameter. A log-normal distribution has been suggested for determining tumor growth.²³

Although the facts in this case are sketchy, this does not look like a strong malpractice case. Given the expense, difficulty, and length of time it takes to pursue a malpractice case (especially for someone battling cancer), an obvious question is: Why would a patient file a lawsuit in these circumstances? There is no single answer to that, but the hope of getting rich is unlikely a primary motivation. Ironically, many malpractice cases are filed in which there was no error (or at least no negligent error).²⁴

The search for what really happened, or why the bad event happened, is key. In other circumstances, it may be a desire for revenge or to protect other patients from similar bad results. Studies repeatedly have shown a somewhat limited correlation between negligent error and the decision to file a malpractice claim.^24–26 In this case, the patient’s sense of being “blown off” during a particularly difficult time may represent the reason why she filed a malpractice lawsuit. Communication gaffes and poor physician-patient relationships undoubtedly contribute to medical malpractice claims.^27,28 Improving communication with patients probably improves care, but it also almost certainly reduces the risk of a malpractice claim.²⁹

Why a lawyer would accept this case is also unclear, but that is an issue for another day. Also for another day is the issue of product liability concerning breast implants. Those legal issues and related liability, primarily directed to the manufacturers of the implants, are interesting topics. They are also complex and will be the subject of a future article.

Finally, the patient’s decision to not pursue her lawsuit does not come as a surprise. A relatively small percentage of malpractice claims result in any meaningful financial recovery for the plaintiff. Few cases go to trial, and of those that do result in a verdict, about 75% of the verdicts are in favor of the physician.^25,30 Many cases just fade away, either because the plaintiff never pursues them or because they are dismissed by a court at an early stage. Nonetheless, for the physician, even winning a malpractice case is disruptive and difficult. So in addition to ensuring careful, quality, and up-to-date care, a physician should seek to maintain good relationships and communication with patients to reduce the probability of even weak lawsuits being filed.

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.

CASE: After routine mammography results, DCIS found

A 49-year-old woman (G2 P2002) with a history of fibrocystic breast disease presented with a left breast mass that she found a month ago on self-examination. The patient faithfully had obtained routine mammograms since age 40. This year, after reporting the mass and with spot films obtained as recommended by the radiologist, a new cluster of microcalcifications was identified on the report: “spot compression” assessment identified a 3-cm mass and noted “s/p breast augmentation.”

The radiologist interpreted the spot films to be benign. His report stated that “15% of breast cancers are not detected by mammogram and breast self-exam is recommended monthly from 40 years of age.”

The gynecologist recommended a 6-month follow up. When the patient complied, the radiologist’s report again noted calcifications believed to be nonmalignant. Six months later, the patient presented with bloody nipple discharge from her left breast with apparent “eczema-like” lesions on the areola. The patient noted that her “left implant felt different.”

The patient’s surgical history included breast augmentation “years ago.” Her family history was negative for breast cancer. Her medications included hormone therapy (conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg daily) for vaginal atrophy. Other medical conditions included irritable bowel syndrome (managed with diet), anxiety and mood swings (for which she was taking sertraline), decreased libido, and irregular vaginal bleeding (after the patient refused endometrial sampling, she was switched to oral contraceptives to address the problem). In addition, her hypertension was being treated with hydrochlorothiazide.

At the gynecologist’s suggestion, a dermatology consultation was obtained.

The dermatologist gave a diagnosis of Paget disease with high-grade ductal carcinoma-in-situ (DCIS). The interval from screening mammogram to DCIS diagnosis had been 8 months. The dermatologist referred the patient to a breast surgeon. A discussion ensued between the breast surgeon and the dermatologist concerning the difficulty of making a diagnosis of breast cancer in a woman with breast augmentation.

The patient underwent modified radical mastectomy, and histopathology revealed DCIS with clear margins; lymph nodes were negative.

The patient filed a malpractice suit against the gynecologist related to the delayed breast mass evaluation and management. She remained upset that when she called the gynecologist’s office to convey her concerns regarding the left nipple discharge and implant concerns, “she was blown off.” She felt there was a clear “failure to communicate on critical matters of her health.” She alleged that the gynecologist, not the dermatologist, should have referred her to a breast surgeon.

WHAT'S THE VERDICT?

In the end, the patient decided not to pursue the lawsuit.

Related article:
Who is liable when a surgical error occurs?

Medical considerations

Breast cancer is the most common female malignancy, with 232,340 cases occurring annually in the United States. It is the second leading cause of cancer-related death in US women.¹ For this case discussion, we review the role of breast cancer screening, including breast self-examination and mammography.

Is breast self-examination recommended?

Recently, medical care has evolved from “breast self-examination” (BSE) to “breast self-awareness.”² The concept of BSE and concerns about it stem in part from “the Shanghai study.”³ In this prospective randomized trial, 266,064 female textile workers were randomly assigned to “rigorous and repetitive training in BSE” versus no instruction and no BSE performance. The former group had twice as many breast biopsies than the latter group (2,761 biopsies in the BSE group vs 1,505 in the control group). There was no difference in the number of breast cancers diagnosed among the groups—864 in the BSE group and 896 in the control group (relative risk [RR], 0.97; 95% confidence interval [CI], 0.88–1.06; P = .47). Other studies also support lack of efficacy regarding BSE.⁴

The potential for psychological harm, unnecessary biopsy, and additional imaging in association with false-positive findings is a concern² (TABLE). The American College of Obstetricians and Gynecologists (ACOG) states, “breast self-examination may be appropriate for certain high-risk populations and for other women who chose to follow this approach.”^2,5,6 The US Preventive Services Task Force (USPSTF) guidelines say that there is “insufficient evidence to assess risks vs benefits, including harms,” and recommends against teaching BSE.⁷ The American Cancer Society puts BSE in the “optional” category.^2,8

Is there a middle of the road strategy? Perhaps. The concept of breast-awareness was developed so that women understand how their breasts look and feel.^2,5 The concept does not advocate monthly BSE. The Mayo Clinic reported that, of 592 breast cancers, 57% were detected following abnormal screening mammography, 30% by BSE and 14% by clinical examination by a clinician. Furthermore, 38% of women with a palpable abnormality had a normal mammogram within the preceding 13 months.⁹ McBride and colleagues aptly addressed this: “Healthcare providers can educate their patients that breast awareness, in essence, is a two-step process. First, it requires that women be familiar with their breasts and aware of new changes and, second, have an understanding of the implications of these changes which includes informing their health care provider promptly.”¹⁰ The concept of “know what is normal for you” as conveyed by The Susan G. Komen Foundation succinctly encourages communication with patients.^2,11

Mammography

The latest technique in mammography is digital or 3D mammography, also known as tomosynthesis. The technique is similar to 2D mammography with the addition of digital cameras. A study published in the radiology literature noted that the 2 methods were equivalent.¹² One possible advantage of 3D mammography is that the 3D images are stored in computer files and are more easily incorporated into the electronic medical record.

What about mammography after breast augmentation?

While breast augmentation is not associated with an increase in breast cancer,¹³ mammography following breast augmentation can be more difficult to interpret and may result in a delay in diagnosis. In a prospective study of asymptomatic women who were diagnosed with breast cancer, 137 had augmentation and 685 did not. Miglioretti and colleagues noted that the sensitivity of screening mammography was lower in the augmentation cohort.¹⁴ To enhance accuracy, breast implant displacement views (in which the breast tissue is pulled forward and the implant is displaced posteriorly to improve visualization) have been recommended.¹⁵ A retrospective review provides data reporting no effect on interpretation of mammograms following augmentation.¹⁶ The American Cancer Society recommends the same screening for women with implants as without implants, starting at age 40 years.¹⁷

Paget disease of the breast

Paget disease of the breast was first described by Sir James Paget in 1874. He also defined Paget disease of extramammary tissue, bone, vulva, and penis. Paget disease of the breast is a rare type of cancer in which the skin and nipple are involved frequently in association with DCIS or invasive breast cancer. The skin has an eczema-like appearance. Characteristic Paget (malignant) cells are large with clear cytoplasm (clear halo) and eccentric, hyperchromatic nuclei throughout the dermis. Assessment includes mammography and biopsy with immunohistochemical staining. Treatment varies by case and can include lumpectomy or mastectomy and chemotherapy and/or radiation therapy. Medications, including tamoxifen and anastrazole, have been recommended. Prognosis depends on nodal involvement. The disease is more common in women older than age 50.¹⁸

Related article:
The medicolegal considerations of interacting with your patients online

Legal issues: What was the gynecologist’s obligation?

The question remains, did the gynecologist have an obligation to obtain diagnostic mammography and ultrasound of the breast? Would it have been prudent for immediate referral to a breast surgeon? These are critical questions.

Negligence and the standard of care

The malpractice lawsuit against this gynecologist is based on negligence. In essence, it is a claim that the management provided fell below a standard of care that would be given by a reasonably careful and prudent gynecologist under the circumstances. This generally means that the care was less than the profession itself would find acceptable. Here the claim is essentially a diagnostic error claim, a common basis of malpractice.¹⁹ The delay in diagnosing breast cancer is a leading cause of malpractice claims against gynecologists.^20,21

It is axiomatic that not all bad outcomes are the result of error, and not all errors are a result of an unacceptable standard of care. It is only bad outcomes resulting from careless or negligent errors that give rise to malpractice. But malpractice claims are often filed without knowing whether or not there was negligence—and, as we will see, many of those claims are without merit.

Was there negligence?

Ordinarily the plaintiff/patient must demonstrate that the care by the physician fell below the standard of care and, as a result, the patient suffered an injury. Stated another way, the plaintiff must show that the physician’s actions were unreasonable given all of the circumstances. In this case, the plaintiff must demonstrate that the gynecologist’s care was not appropriate. Failure to refer to another physician or provide additional testing is likely to be the major claim for negligence or inappropriate care.

Did that negligence cause injury?

Even if the plaintiff can demonstrate that the care was negligent, to prevail the plaintiff must also demonstrate that that negligence caused the injury—and that might be difficult.

What injury was caused by the delay in discovering the cancer? It did not apparently lead to the patient’s death. Can it be proven that the delay clearly shortened the patient’s life expectancy or required additional expensive and painful treatment? That may be difficult to demonstrate.

Causation. The causation factor could appear in many cancer or similar medical cases. On one hand, causation is a critical matter, but on the other hand, delay in treating cancer might have a very adverse effect on patients.

In recent years, about half the states have solved this dilemma by recognizing the concept of “loss of chance.”²² Essentially, this means that the health care provider, by delaying treatment, diminished the possibility that the patient would survive or recover fully.

There are significant variations among states in the loss-of-chance concept, many being quite technical.²² Thus, it is possible that a delay that reduced the chance of recovery or survival could be the injury and causal connection between the injury and the negligence. Even in states that recognize the loss-of-chance concept, the patient still must prove loss of chance.

Lessons learned from this case study

• Breast self-awareness has replaced (substituted) breast self-examination
• ACOG recommends breast mammography beginning at age 40 years
• Breast augmentation affects mammographic interpretation
• Prehaps if better communication had been provided initially, the patient would not have sought legal counsel or filed a weak suit

Related article:
Is the smartphone recording while the patient is under anesthesia?

Is this a strong malpractice case?

In the case presented here, it is not clear that the patient could show a meaningful loss of chance. If there is a delay in the breast cancer diagnosis, tumor doubling time would be an issue. While it is impossible to assess growth rate when a breast cancer is in its preclinical microscopic stage, doubling time can be 100 to 200 days. Therefore, it would take 20 years for the tumor to reach a 1- to 2-cm diameter. A log-normal distribution has been suggested for determining tumor growth.²³

Although the facts in this case are sketchy, this does not look like a strong malpractice case. Given the expense, difficulty, and length of time it takes to pursue a malpractice case (especially for someone battling cancer), an obvious question is: Why would a patient file a lawsuit in these circumstances? There is no single answer to that, but the hope of getting rich is unlikely a primary motivation. Ironically, many malpractice cases are filed in which there was no error (or at least no negligent error).²⁴

The search for what really happened, or why the bad event happened, is key. In other circumstances, it may be a desire for revenge or to protect other patients from similar bad results. Studies repeatedly have shown a somewhat limited correlation between negligent error and the decision to file a malpractice claim.^24–26 In this case, the patient’s sense of being “blown off” during a particularly difficult time may represent the reason why she filed a malpractice lawsuit. Communication gaffes and poor physician-patient relationships undoubtedly contribute to medical malpractice claims.^27,28 Improving communication with patients probably improves care, but it also almost certainly reduces the risk of a malpractice claim.²⁹

Why a lawyer would accept this case is also unclear, but that is an issue for another day. Also for another day is the issue of product liability concerning breast implants. Those legal issues and related liability, primarily directed to the manufacturers of the implants, are interesting topics. They are also complex and will be the subject of a future article.

Finally, the patient’s decision to not pursue her lawsuit does not come as a surprise. A relatively small percentage of malpractice claims result in any meaningful financial recovery for the plaintiff. Few cases go to trial, and of those that do result in a verdict, about 75% of the verdicts are in favor of the physician.^25,30 Many cases just fade away, either because the plaintiff never pursues them or because they are dismissed by a court at an early stage. Nonetheless, for the physician, even winning a malpractice case is disruptive and difficult. So in addition to ensuring careful, quality, and up-to-date care, a physician should seek to maintain good relationships and communication with patients to reduce the probability of even weak lawsuits being filed.

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.

During vaginal delivery spontaneous perineal trauma and extension of episiotomy incisions are common. A severe perineal laceration that extends into or through the anal sphincter complex is referred to as an obstetric anal sphincter injury (OASIS) and requires meticulous repair. Following the repair of an OASIS, serious wound complications, including dehiscence and infection, may occur. In Europe the reported rate of OASIS varies widely among countries, with a rate of 0.1% in Romania, possibly due to underreporting, and 4.9% in Iceland.¹ In the United States the rates of 3rd- and 4th-degree lacerations were reported to be 3.3% and 1.1%, respectively.²

Risk factors for OASIS include forceps delivery (odds ratio [OR], 5.50), vacuum-assisted delivery (OR, 3.98), and midline episiotomy (OR, 3.82).³ Additional risk factors for severe perineal injury at vaginal delivery include nulliparity (adjusted odds ratio [aOR], 2.58), delivery from a persistent occiput posterior position (aOR, 2.24), and above-average newborn birth weight (aOR, 1.28).⁴

In a meta-analysis of randomized trials, the researchers reported that restrictive use of episiotomy reduced the risk of severe perineal trauma (relative risk [RR], 0.67) but increased the risk of anterior perineal trauma (RR, 1.84).⁵ The American College of Obstetricians and Gynecologists (ACOG) recommends that episiotomy should not be a routine practice and is best restricted to use in a limited number of cases where fetal and maternal benefit is likely.⁶ In addition, ACOG recommends that if episiotomy is indicated, a mediolateral incision is favored over a midline incision. In my practice I perform only mediolateral episiotomy incisions. However, mediolateral episiotomy may be associated with an increased risk of postpartum perineal pain and dyspareunia.⁷ Use of warm compresses applied to the perineum during the second stage of labor may reduce the risk of 3rd- and 4th-degree lacerations.⁸ Techniques to ensure that the fetal head and shoulders are birthed in a slow and controlled fashion may decrease the risk of OASIS.⁹ See the TABLE, “Four maneuvers to control and slow the birth of the fetal head.”^10–14

Related article:
Stop performing median episiotomy!

Wound complications following the repair of a 3rd- or 4th-degree laceration are reported to occur in approximately 5% to 10% of cases.¹⁵ The most common wound complications are dehiscence, infection, abscess formation, pain, sexual dysfunction, and anal incontinence. Minor wound complications, including superficial epithelial separation, can be managed expectantly. However, major wound complications need intensive treatment.

In one study of 21 women who had a major wound complication following the repair of a 4th-degree laceration, 53% had dehiscence plus infection, 33% had dehiscence alone, and 14% had infection alone.¹⁶ Major wound complications present at a mean of 5 days after delivery, with a wide range from 1 to 17 days following delivery.¹⁷ In a study of 144 cases of wound breakdown following a perineal laceration repair, the major risk factors for wound breakdown were episiotomy (aOR, 11.1), smoking (aOR, 6.4), midwife repair of laceration (aOR, 4.7), use of chromic suture (aOR, 3.9), and operative vaginal delivery (aOR, 3.4).¹⁸ In one study of 66 women with a wound complication following the repair of a 3rd- or 4th-degree laceration, clinical risk factors for a wound complication were cigarette smoking (OR, 4.04), 4th-degree laceration (OR, 1.89), and operative vaginal delivery (OR, 1.76).¹⁹ The use of intrapartum antibiotics appears to be protective (OR, 0.29) against wound complications following a major perineal laceration.¹⁹

Approach to the patient with a dehisced and infected perineal wound

Historically, wound dehiscence fol­­­lowing surgical repair of a perineal injury was managed by allowing the wound to slowly close. This approach adversely impacts the quality of life of the affected woman because it may take weeks for the wound to heal. One small random­ized trial¹⁷ and multiple case series^20–24 report that an active multistep management algorithm permits early closure of the majority of these wounds, thereby accelerating the patient’s full recovery. Delayed primary (within 72 hours postpartum) or early secondary reconstruction (within 14 days of delivery) has been demonstrated to be safe with acceptable long-term functional out­-­comes.²⁵ The modern approach to the treatment of a patient with an infected wound dehiscence following a severe perineal injury involves 3 steps.

Related article:
It’s time to restrict the use of episiotomy

Step 1. Restore tissue to health

The dehisced wound is cultured and, if infection is present, treatment is initiated with intravenous antibiotics appropriate for an infection with colorectal flora. One antibiotic option includes a cephalosporin (cefotetan 2 g IV every 6 hours) plus metronidazole (500 mg IV every 8 hours).

In the operating room, the wound should be thoroughly assessed, cleansed, and debrided. This step includes irrigation of the wound with a warm fluid, mechanical debridement, and sharp dissection of necrotic tissue. If the wound is infected, removal of stitches that are visible in the open wound is recommended.

Often more than one session of debridement may be needed to obtain wound edges that are free from exudate and show granulation at the wound margins. Between debridement sessions, wet-to-dry dressings are utilized. Two to 10 days of wound care may be needed before an attempt is made to close the wound. The wound is suitable for repair when there is no infected tissue and granulation tissue is present. Some surgeons prefer a mechanical bowel preparation regimen just before surgically closing the open wound. This may prevent early bowel movements and provide for tissue healing after surgery.²⁶ The same preparations recommended for colonoscopy can be considered prior to surgical repair.

Step 2. Surgically close the wound

The wound is surgically closed in the operating room. If in Step 1 the assessment of the wound shows major trauma, assistance from a urogynecologist may be warranted. Surgical management of a perineal wound dehiscence requires a clear understanding of perineal anatomy and the structures contained between the vagina and the anorectum.

Six key structures may be involved in perineal injury: the anorectal mucosa, internal anal sphincter, external anal sphincter, vaginal wall and perineal skin, bulbocavernosus muscle, and transverse perineal muscles. It is important to definitively identify the individual structures that need to be repaired. Careful dissection is then carried out to mobilize these structures for repair. Additional debridement may be necessary to remove excess granulation tissue.

Anorectal mucosa repair. With repair of a 4th-degree perineal wound dehiscence, the apex of the defect in the anorectal mucosa is identified. The defect is repaired beginning at the apex using closely spaced interrupted sutures or a running suture of 3-0 or 4-0 polyglactin 910. Adequate tissue bites that will resist tearing should be taken. If interrupted sutures are used, tying the knots within the anorectal canal prevents them from being located within the healing wound.

Internal anal sphincter repair. After the anorectal mucosa is closed, attention is turned to reapproximation of the internal anal sphincter. The ends of a torn internal anal sphincter are often located lateral to the anorectal mucosa and appear as shiny gray-white fibrous tissue. The surgeon’s gloved index finger can be placed within the anorectal canal to aid in identification of the internal anal sphincter, as it tends to have a rubbery feel. Additionally, while the surgeon’s gloved index finger is in the anorectal canal, the surgeon’s gloved thumb can be used to retract the anorectal mucosa slightly medial and inferior so that adequate bites of the internal anal sphincter can be taken on each side.

Alternatively, Allis clamps canbe placed on the ends of the retracted internal anal sphincter to facilitate repair. Suture selection for repair of the internal anal sphincter can include 3-0 polyglactin 910 or 3-0 monofilament, delayed-absorbable suture such as polydioxanone sulfate (PDS). Some surgeons prefer delayed-absorbable suture (PDS) for this layer given the internal anal sphincter is constantly contracting and relaxing as it samples stool.²⁶ This layer also can be closed with either interrupted sutures or a running suture.

External anal sphincter repair. After the anorectal mucosa and internal anal sphincter defects are reapproximated, attention is turned to the external anal sphincter. Like the internal anal sphincter, the ends of the external anal sphincter are often retracted laterally and must be definitively identified and mobilized in order to ensure an adequate tension-free repair. It is important to include the fascial sheath in the repair of the external anal sphincter.²⁷ Allis clamps can be used to grasp the ends of the torn muscle after they are identified.

We recommend 0 or 2-0 PDS for repair of the external sphincter. Repair can be performed using either an end-to-end or overlapping technique. An end-to-end repair traditionally involves reapproximating the ends of the torn muscle and its overlying fascial sheath using interrupted sutures placed at four quadrants (12:00, 3:00, 6:00, 9:00).

In contrast, in an overlapping repair, the ends of the muscle are brought together with mattress sutures. Suture is passed top down through the medial aspect of the more superior muscle flap and top down through the inferior muscle flap more laterally. The same suture is then passed bottom up through the inferior muscle flap more laterally and finally bottom up through the medial aspect of the more superior muscle flap. Two to four mattress sutures are usually placed. After all sutures are placed, they are tied securely.

An overlapping repair results in a greater amount of tissue contact between the two torn muscle ends. However, adequate mobility of the external anal sphincter is necessary to perform this type of repair.

Vaginal wall and perineal body repair. After the anal sphincters have been repaired, the vaginal wall and remainder of the perineal body are reconstructed using the same techniques involved in a 2nd-degree laceration repair. Care must be taken to retrieve and reapproximate the torn ends of the bulbocavernosus muscles, which are also often retracted laterally and superiorly. After the bulbocavernosus and transverse perineal muscles are brought together in the midline, the posterior vaginal wall should be perpendicular to the perineum.

An alternative to surgical closure of a 2nd-degree dehiscence is the use of vacuum-assisted wound closure. Disadvantages of this approach include difficulty in maintaining a vacuum seal in the perineal region and the risk of wound contamination with feces. In one case report, 3 weeks of vacuum-assisted wound closure resulted in healing of a 10-cm wound dehiscence that occurred 5 days following a forceps-assisted vaginal delivery with a mediolateral episiotomy.²⁸

Step 3. Ensure complete healing of the wound

Superb postoperative wound care helps to ensure a quick return to full recovery. Wound care should include regularly scheduled sitz baths (at least 3 times daily) followed by drying the perineum. It is preferable to provide a liquid diet that avoids frequent bowel movements in the initial 3 postoperative days. Stool softeners and fiber supplementation are recommended when a full diet is resumed. Some surgeons have found mineral oil (1 to 2 tablespoons daily) effective in producing soft stools that are easy to pass.²⁶ Ensuring soft stool consistency is important to help prevent repair breakdown that may occur with passage of hard stools, fecal impaction, and/or straining during defecation.

We recommend follow-up 1 to 2 weeks after surgery to assess wound healing. No vaginal intercourseis permitted until complete healing is achieved.

Use a surgical checklist

All obstetricians and midwives strive to reduce the risk of OASIS at vaginal birth. When OASIS occurs, it is often useful to use a surgical checklist to ensure the execution of all steps in the management of the repair and recovery process.²⁹ It is heartbreaking to see an OASIS repair breakdown in the week following a vaginal delivery. But by following the 3 steps outlined here, the secondary repair is likely to be successful and will quickly return most patients to full health.

Related article:
Develop and use a checklist for 3rd- and 4th-degree perineal lacerations

The authors report no financial relationships relevant to this article.

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.

During vaginal delivery spontaneous perineal trauma and extension of episiotomy incisions are common. A severe perineal laceration that extends into or through the anal sphincter complex is referred to as an obstetric anal sphincter injury (OASIS) and requires meticulous repair. Following the repair of an OASIS, serious wound complications, including dehiscence and infection, may occur. In Europe the reported rate of OASIS varies widely among countries, with a rate of 0.1% in Romania, possibly due to underreporting, and 4.9% in Iceland.¹ In the United States the rates of 3rd- and 4th-degree lacerations were reported to be 3.3% and 1.1%, respectively.²

Risk factors for OASIS include forceps delivery (odds ratio [OR], 5.50), vacuum-assisted delivery (OR, 3.98), and midline episiotomy (OR, 3.82).³ Additional risk factors for severe perineal injury at vaginal delivery include nulliparity (adjusted odds ratio [aOR], 2.58), delivery from a persistent occiput posterior position (aOR, 2.24), and above-average newborn birth weight (aOR, 1.28).⁴

In a meta-analysis of randomized trials, the researchers reported that restrictive use of episiotomy reduced the risk of severe perineal trauma (relative risk [RR], 0.67) but increased the risk of anterior perineal trauma (RR, 1.84).⁵ The American College of Obstetricians and Gynecologists (ACOG) recommends that episiotomy should not be a routine practice and is best restricted to use in a limited number of cases where fetal and maternal benefit is likely.⁶ In addition, ACOG recommends that if episiotomy is indicated, a mediolateral incision is favored over a midline incision. In my practice I perform only mediolateral episiotomy incisions. However, mediolateral episiotomy may be associated with an increased risk of postpartum perineal pain and dyspareunia.⁷ Use of warm compresses applied to the perineum during the second stage of labor may reduce the risk of 3rd- and 4th-degree lacerations.⁸ Techniques to ensure that the fetal head and shoulders are birthed in a slow and controlled fashion may decrease the risk of OASIS.⁹ See the TABLE, “Four maneuvers to control and slow the birth of the fetal head.”^10–14

Related article:
Stop performing median episiotomy!

Wound complications following the repair of a 3rd- or 4th-degree laceration are reported to occur in approximately 5% to 10% of cases.¹⁵ The most common wound complications are dehiscence, infection, abscess formation, pain, sexual dysfunction, and anal incontinence. Minor wound complications, including superficial epithelial separation, can be managed expectantly. However, major wound complications need intensive treatment.

In one study of 21 women who had a major wound complication following the repair of a 4th-degree laceration, 53% had dehiscence plus infection, 33% had dehiscence alone, and 14% had infection alone.¹⁶ Major wound complications present at a mean of 5 days after delivery, with a wide range from 1 to 17 days following delivery.¹⁷ In a study of 144 cases of wound breakdown following a perineal laceration repair, the major risk factors for wound breakdown were episiotomy (aOR, 11.1), smoking (aOR, 6.4), midwife repair of laceration (aOR, 4.7), use of chromic suture (aOR, 3.9), and operative vaginal delivery (aOR, 3.4).¹⁸ In one study of 66 women with a wound complication following the repair of a 3rd- or 4th-degree laceration, clinical risk factors for a wound complication were cigarette smoking (OR, 4.04), 4th-degree laceration (OR, 1.89), and operative vaginal delivery (OR, 1.76).¹⁹ The use of intrapartum antibiotics appears to be protective (OR, 0.29) against wound complications following a major perineal laceration.¹⁹

Approach to the patient with a dehisced and infected perineal wound

Historically, wound dehiscence fol­­­lowing surgical repair of a perineal injury was managed by allowing the wound to slowly close. This approach adversely impacts the quality of life of the affected woman because it may take weeks for the wound to heal. One small random­ized trial¹⁷ and multiple case series^20–24 report that an active multistep management algorithm permits early closure of the majority of these wounds, thereby accelerating the patient’s full recovery. Delayed primary (within 72 hours postpartum) or early secondary reconstruction (within 14 days of delivery) has been demonstrated to be safe with acceptable long-term functional out­-­comes.²⁵ The modern approach to the treatment of a patient with an infected wound dehiscence following a severe perineal injury involves 3 steps.

Related article:
It’s time to restrict the use of episiotomy

Step 1. Restore tissue to health

The dehisced wound is cultured and, if infection is present, treatment is initiated with intravenous antibiotics appropriate for an infection with colorectal flora. One antibiotic option includes a cephalosporin (cefotetan 2 g IV every 6 hours) plus metronidazole (500 mg IV every 8 hours).

In the operating room, the wound should be thoroughly assessed, cleansed, and debrided. This step includes irrigation of the wound with a warm fluid, mechanical debridement, and sharp dissection of necrotic tissue. If the wound is infected, removal of stitches that are visible in the open wound is recommended.

Often more than one session of debridement may be needed to obtain wound edges that are free from exudate and show granulation at the wound margins. Between debridement sessions, wet-to-dry dressings are utilized. Two to 10 days of wound care may be needed before an attempt is made to close the wound. The wound is suitable for repair when there is no infected tissue and granulation tissue is present. Some surgeons prefer a mechanical bowel preparation regimen just before surgically closing the open wound. This may prevent early bowel movements and provide for tissue healing after surgery.²⁶ The same preparations recommended for colonoscopy can be considered prior to surgical repair.

Step 2. Surgically close the wound

The wound is surgically closed in the operating room. If in Step 1 the assessment of the wound shows major trauma, assistance from a urogynecologist may be warranted. Surgical management of a perineal wound dehiscence requires a clear understanding of perineal anatomy and the structures contained between the vagina and the anorectum.

Six key structures may be involved in perineal injury: the anorectal mucosa, internal anal sphincter, external anal sphincter, vaginal wall and perineal skin, bulbocavernosus muscle, and transverse perineal muscles. It is important to definitively identify the individual structures that need to be repaired. Careful dissection is then carried out to mobilize these structures for repair. Additional debridement may be necessary to remove excess granulation tissue.

Anorectal mucosa repair. With repair of a 4th-degree perineal wound dehiscence, the apex of the defect in the anorectal mucosa is identified. The defect is repaired beginning at the apex using closely spaced interrupted sutures or a running suture of 3-0 or 4-0 polyglactin 910. Adequate tissue bites that will resist tearing should be taken. If interrupted sutures are used, tying the knots within the anorectal canal prevents them from being located within the healing wound.

Internal anal sphincter repair. After the anorectal mucosa is closed, attention is turned to reapproximation of the internal anal sphincter. The ends of a torn internal anal sphincter are often located lateral to the anorectal mucosa and appear as shiny gray-white fibrous tissue. The surgeon’s gloved index finger can be placed within the anorectal canal to aid in identification of the internal anal sphincter, as it tends to have a rubbery feel. Additionally, while the surgeon’s gloved index finger is in the anorectal canal, the surgeon’s gloved thumb can be used to retract the anorectal mucosa slightly medial and inferior so that adequate bites of the internal anal sphincter can be taken on each side.

Alternatively, Allis clamps canbe placed on the ends of the retracted internal anal sphincter to facilitate repair. Suture selection for repair of the internal anal sphincter can include 3-0 polyglactin 910 or 3-0 monofilament, delayed-absorbable suture such as polydioxanone sulfate (PDS). Some surgeons prefer delayed-absorbable suture (PDS) for this layer given the internal anal sphincter is constantly contracting and relaxing as it samples stool.²⁶ This layer also can be closed with either interrupted sutures or a running suture.

External anal sphincter repair. After the anorectal mucosa and internal anal sphincter defects are reapproximated, attention is turned to the external anal sphincter. Like the internal anal sphincter, the ends of the external anal sphincter are often retracted laterally and must be definitively identified and mobilized in order to ensure an adequate tension-free repair. It is important to include the fascial sheath in the repair of the external anal sphincter.²⁷ Allis clamps can be used to grasp the ends of the torn muscle after they are identified.

We recommend 0 or 2-0 PDS for repair of the external sphincter. Repair can be performed using either an end-to-end or overlapping technique. An end-to-end repair traditionally involves reapproximating the ends of the torn muscle and its overlying fascial sheath using interrupted sutures placed at four quadrants (12:00, 3:00, 6:00, 9:00).

In contrast, in an overlapping repair, the ends of the muscle are brought together with mattress sutures. Suture is passed top down through the medial aspect of the more superior muscle flap and top down through the inferior muscle flap more laterally. The same suture is then passed bottom up through the inferior muscle flap more laterally and finally bottom up through the medial aspect of the more superior muscle flap. Two to four mattress sutures are usually placed. After all sutures are placed, they are tied securely.

An overlapping repair results in a greater amount of tissue contact between the two torn muscle ends. However, adequate mobility of the external anal sphincter is necessary to perform this type of repair.

Vaginal wall and perineal body repair. After the anal sphincters have been repaired, the vaginal wall and remainder of the perineal body are reconstructed using the same techniques involved in a 2nd-degree laceration repair. Care must be taken to retrieve and reapproximate the torn ends of the bulbocavernosus muscles, which are also often retracted laterally and superiorly. After the bulbocavernosus and transverse perineal muscles are brought together in the midline, the posterior vaginal wall should be perpendicular to the perineum.

An alternative to surgical closure of a 2nd-degree dehiscence is the use of vacuum-assisted wound closure. Disadvantages of this approach include difficulty in maintaining a vacuum seal in the perineal region and the risk of wound contamination with feces. In one case report, 3 weeks of vacuum-assisted wound closure resulted in healing of a 10-cm wound dehiscence that occurred 5 days following a forceps-assisted vaginal delivery with a mediolateral episiotomy.²⁸

Step 3. Ensure complete healing of the wound

Superb postoperative wound care helps to ensure a quick return to full recovery. Wound care should include regularly scheduled sitz baths (at least 3 times daily) followed by drying the perineum. It is preferable to provide a liquid diet that avoids frequent bowel movements in the initial 3 postoperative days. Stool softeners and fiber supplementation are recommended when a full diet is resumed. Some surgeons have found mineral oil (1 to 2 tablespoons daily) effective in producing soft stools that are easy to pass.²⁶ Ensuring soft stool consistency is important to help prevent repair breakdown that may occur with passage of hard stools, fecal impaction, and/or straining during defecation.

We recommend follow-up 1 to 2 weeks after surgery to assess wound healing. No vaginal intercourseis permitted until complete healing is achieved.

Use a surgical checklist

All obstetricians and midwives strive to reduce the risk of OASIS at vaginal birth. When OASIS occurs, it is often useful to use a surgical checklist to ensure the execution of all steps in the management of the repair and recovery process.²⁹ It is heartbreaking to see an OASIS repair breakdown in the week following a vaginal delivery. But by following the 3 steps outlined here, the secondary repair is likely to be successful and will quickly return most patients to full health.

Related article:
Develop and use a checklist for 3rd- and 4th-degree perineal lacerations

The authors report no financial relationships relevant to this article.

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.

During vaginal delivery spontaneous perineal trauma and extension of episiotomy incisions are common. A severe perineal laceration that extends into or through the anal sphincter complex is referred to as an obstetric anal sphincter injury (OASIS) and requires meticulous repair. Following the repair of an OASIS, serious wound complications, including dehiscence and infection, may occur. In Europe the reported rate of OASIS varies widely among countries, with a rate of 0.1% in Romania, possibly due to underreporting, and 4.9% in Iceland.¹ In the United States the rates of 3rd- and 4th-degree lacerations were reported to be 3.3% and 1.1%, respectively.²

Risk factors for OASIS include forceps delivery (odds ratio [OR], 5.50), vacuum-assisted delivery (OR, 3.98), and midline episiotomy (OR, 3.82).³ Additional risk factors for severe perineal injury at vaginal delivery include nulliparity (adjusted odds ratio [aOR], 2.58), delivery from a persistent occiput posterior position (aOR, 2.24), and above-average newborn birth weight (aOR, 1.28).⁴

In a meta-analysis of randomized trials, the researchers reported that restrictive use of episiotomy reduced the risk of severe perineal trauma (relative risk [RR], 0.67) but increased the risk of anterior perineal trauma (RR, 1.84).⁵ The American College of Obstetricians and Gynecologists (ACOG) recommends that episiotomy should not be a routine practice and is best restricted to use in a limited number of cases where fetal and maternal benefit is likely.⁶ In addition, ACOG recommends that if episiotomy is indicated, a mediolateral incision is favored over a midline incision. In my practice I perform only mediolateral episiotomy incisions. However, mediolateral episiotomy may be associated with an increased risk of postpartum perineal pain and dyspareunia.⁷ Use of warm compresses applied to the perineum during the second stage of labor may reduce the risk of 3rd- and 4th-degree lacerations.⁸ Techniques to ensure that the fetal head and shoulders are birthed in a slow and controlled fashion may decrease the risk of OASIS.⁹ See the TABLE, “Four maneuvers to control and slow the birth of the fetal head.”^10–14

Related article:
Stop performing median episiotomy!

Wound complications following the repair of a 3rd- or 4th-degree laceration are reported to occur in approximately 5% to 10% of cases.¹⁵ The most common wound complications are dehiscence, infection, abscess formation, pain, sexual dysfunction, and anal incontinence. Minor wound complications, including superficial epithelial separation, can be managed expectantly. However, major wound complications need intensive treatment.

In one study of 21 women who had a major wound complication following the repair of a 4th-degree laceration, 53% had dehiscence plus infection, 33% had dehiscence alone, and 14% had infection alone.¹⁶ Major wound complications present at a mean of 5 days after delivery, with a wide range from 1 to 17 days following delivery.¹⁷ In a study of 144 cases of wound breakdown following a perineal laceration repair, the major risk factors for wound breakdown were episiotomy (aOR, 11.1), smoking (aOR, 6.4), midwife repair of laceration (aOR, 4.7), use of chromic suture (aOR, 3.9), and operative vaginal delivery (aOR, 3.4).¹⁸ In one study of 66 women with a wound complication following the repair of a 3rd- or 4th-degree laceration, clinical risk factors for a wound complication were cigarette smoking (OR, 4.04), 4th-degree laceration (OR, 1.89), and operative vaginal delivery (OR, 1.76).¹⁹ The use of intrapartum antibiotics appears to be protective (OR, 0.29) against wound complications following a major perineal laceration.¹⁹

Approach to the patient with a dehisced and infected perineal wound

Historically, wound dehiscence fol­­­lowing surgical repair of a perineal injury was managed by allowing the wound to slowly close. This approach adversely impacts the quality of life of the affected woman because it may take weeks for the wound to heal. One small random­ized trial¹⁷ and multiple case series^20–24 report that an active multistep management algorithm permits early closure of the majority of these wounds, thereby accelerating the patient’s full recovery. Delayed primary (within 72 hours postpartum) or early secondary reconstruction (within 14 days of delivery) has been demonstrated to be safe with acceptable long-term functional out­-­comes.²⁵ The modern approach to the treatment of a patient with an infected wound dehiscence following a severe perineal injury involves 3 steps.

Related article:
It’s time to restrict the use of episiotomy

Step 1. Restore tissue to health

The dehisced wound is cultured and, if infection is present, treatment is initiated with intravenous antibiotics appropriate for an infection with colorectal flora. One antibiotic option includes a cephalosporin (cefotetan 2 g IV every 6 hours) plus metronidazole (500 mg IV every 8 hours).

In the operating room, the wound should be thoroughly assessed, cleansed, and debrided. This step includes irrigation of the wound with a warm fluid, mechanical debridement, and sharp dissection of necrotic tissue. If the wound is infected, removal of stitches that are visible in the open wound is recommended.

Often more than one session of debridement may be needed to obtain wound edges that are free from exudate and show granulation at the wound margins. Between debridement sessions, wet-to-dry dressings are utilized. Two to 10 days of wound care may be needed before an attempt is made to close the wound. The wound is suitable for repair when there is no infected tissue and granulation tissue is present. Some surgeons prefer a mechanical bowel preparation regimen just before surgically closing the open wound. This may prevent early bowel movements and provide for tissue healing after surgery.²⁶ The same preparations recommended for colonoscopy can be considered prior to surgical repair.

Step 2. Surgically close the wound

The wound is surgically closed in the operating room. If in Step 1 the assessment of the wound shows major trauma, assistance from a urogynecologist may be warranted. Surgical management of a perineal wound dehiscence requires a clear understanding of perineal anatomy and the structures contained between the vagina and the anorectum.

Six key structures may be involved in perineal injury: the anorectal mucosa, internal anal sphincter, external anal sphincter, vaginal wall and perineal skin, bulbocavernosus muscle, and transverse perineal muscles. It is important to definitively identify the individual structures that need to be repaired. Careful dissection is then carried out to mobilize these structures for repair. Additional debridement may be necessary to remove excess granulation tissue.

Anorectal mucosa repair. With repair of a 4th-degree perineal wound dehiscence, the apex of the defect in the anorectal mucosa is identified. The defect is repaired beginning at the apex using closely spaced interrupted sutures or a running suture of 3-0 or 4-0 polyglactin 910. Adequate tissue bites that will resist tearing should be taken. If interrupted sutures are used, tying the knots within the anorectal canal prevents them from being located within the healing wound.

Internal anal sphincter repair. After the anorectal mucosa is closed, attention is turned to reapproximation of the internal anal sphincter. The ends of a torn internal anal sphincter are often located lateral to the anorectal mucosa and appear as shiny gray-white fibrous tissue. The surgeon’s gloved index finger can be placed within the anorectal canal to aid in identification of the internal anal sphincter, as it tends to have a rubbery feel. Additionally, while the surgeon’s gloved index finger is in the anorectal canal, the surgeon’s gloved thumb can be used to retract the anorectal mucosa slightly medial and inferior so that adequate bites of the internal anal sphincter can be taken on each side.

Alternatively, Allis clamps canbe placed on the ends of the retracted internal anal sphincter to facilitate repair. Suture selection for repair of the internal anal sphincter can include 3-0 polyglactin 910 or 3-0 monofilament, delayed-absorbable suture such as polydioxanone sulfate (PDS). Some surgeons prefer delayed-absorbable suture (PDS) for this layer given the internal anal sphincter is constantly contracting and relaxing as it samples stool.²⁶ This layer also can be closed with either interrupted sutures or a running suture.

External anal sphincter repair. After the anorectal mucosa and internal anal sphincter defects are reapproximated, attention is turned to the external anal sphincter. Like the internal anal sphincter, the ends of the external anal sphincter are often retracted laterally and must be definitively identified and mobilized in order to ensure an adequate tension-free repair. It is important to include the fascial sheath in the repair of the external anal sphincter.²⁷ Allis clamps can be used to grasp the ends of the torn muscle after they are identified.

We recommend 0 or 2-0 PDS for repair of the external sphincter. Repair can be performed using either an end-to-end or overlapping technique. An end-to-end repair traditionally involves reapproximating the ends of the torn muscle and its overlying fascial sheath using interrupted sutures placed at four quadrants (12:00, 3:00, 6:00, 9:00).

In contrast, in an overlapping repair, the ends of the muscle are brought together with mattress sutures. Suture is passed top down through the medial aspect of the more superior muscle flap and top down through the inferior muscle flap more laterally. The same suture is then passed bottom up through the inferior muscle flap more laterally and finally bottom up through the medial aspect of the more superior muscle flap. Two to four mattress sutures are usually placed. After all sutures are placed, they are tied securely.

An overlapping repair results in a greater amount of tissue contact between the two torn muscle ends. However, adequate mobility of the external anal sphincter is necessary to perform this type of repair.

Vaginal wall and perineal body repair. After the anal sphincters have been repaired, the vaginal wall and remainder of the perineal body are reconstructed using the same techniques involved in a 2nd-degree laceration repair. Care must be taken to retrieve and reapproximate the torn ends of the bulbocavernosus muscles, which are also often retracted laterally and superiorly. After the bulbocavernosus and transverse perineal muscles are brought together in the midline, the posterior vaginal wall should be perpendicular to the perineum.

An alternative to surgical closure of a 2nd-degree dehiscence is the use of vacuum-assisted wound closure. Disadvantages of this approach include difficulty in maintaining a vacuum seal in the perineal region and the risk of wound contamination with feces. In one case report, 3 weeks of vacuum-assisted wound closure resulted in healing of a 10-cm wound dehiscence that occurred 5 days following a forceps-assisted vaginal delivery with a mediolateral episiotomy.²⁸

Step 3. Ensure complete healing of the wound

Superb postoperative wound care helps to ensure a quick return to full recovery. Wound care should include regularly scheduled sitz baths (at least 3 times daily) followed by drying the perineum. It is preferable to provide a liquid diet that avoids frequent bowel movements in the initial 3 postoperative days. Stool softeners and fiber supplementation are recommended when a full diet is resumed. Some surgeons have found mineral oil (1 to 2 tablespoons daily) effective in producing soft stools that are easy to pass.²⁶ Ensuring soft stool consistency is important to help prevent repair breakdown that may occur with passage of hard stools, fecal impaction, and/or straining during defecation.

We recommend follow-up 1 to 2 weeks after surgery to assess wound healing. No vaginal intercourseis permitted until complete healing is achieved.

Use a surgical checklist

All obstetricians and midwives strive to reduce the risk of OASIS at vaginal birth. When OASIS occurs, it is often useful to use a surgical checklist to ensure the execution of all steps in the management of the repair and recovery process.²⁹ It is heartbreaking to see an OASIS repair breakdown in the week following a vaginal delivery. But by following the 3 steps outlined here, the secondary repair is likely to be successful and will quickly return most patients to full health.

Related article:
Develop and use a checklist for 3rd- and 4th-degree perineal lacerations

The authors report no financial relationships relevant to this article.

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.

“UPDATE ON CONTRACEPTION”

Mitchell D. Creinin, MD; Natasha R. Schimmoeller, MD, MPH, MA (August 2016)

Interesting anatomic variation and management for IUD placement

I recently saw a patient for insertion of an intrauterine device (IUD). On examination with a speculum, I could not find the patient’s cervix. On bimanual exam, I found the cervix to be extremely anterior. I again placed a speculum and, even knowing where to look, could not bring the cervix into view. I did a second bimanual exam and noticed that I could move the cervix into a more axial plane if I exerted suprapubic pressure. The patient’s uterus was retroverted and her cervix was behind her symphysis. When I placed the speculum again, I asked the patient to apply suprapubic pressure, as I just had. With this procedure I then found her cervix easily, grasped it with a tenaculum, and inserted the IUD, which went well.

Jeffrey Joseph, MD
Wakefield, Rhode Island

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.

“UPDATE ON CONTRACEPTION”

Mitchell D. Creinin, MD; Natasha R. Schimmoeller, MD, MPH, MA (August 2016)

Interesting anatomic variation and management for IUD placement

I recently saw a patient for insertion of an intrauterine device (IUD). On examination with a speculum, I could not find the patient’s cervix. On bimanual exam, I found the cervix to be extremely anterior. I again placed a speculum and, even knowing where to look, could not bring the cervix into view. I did a second bimanual exam and noticed that I could move the cervix into a more axial plane if I exerted suprapubic pressure. The patient’s uterus was retroverted and her cervix was behind her symphysis. When I placed the speculum again, I asked the patient to apply suprapubic pressure, as I just had. With this procedure I then found her cervix easily, grasped it with a tenaculum, and inserted the IUD, which went well.

Jeffrey Joseph, MD
Wakefield, Rhode Island

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.

“UPDATE ON CONTRACEPTION”

Mitchell D. Creinin, MD; Natasha R. Schimmoeller, MD, MPH, MA (August 2016)

Interesting anatomic variation and management for IUD placement

I recently saw a patient for insertion of an intrauterine device (IUD). On examination with a speculum, I could not find the patient’s cervix. On bimanual exam, I found the cervix to be extremely anterior. I again placed a speculum and, even knowing where to look, could not bring the cervix into view. I did a second bimanual exam and noticed that I could move the cervix into a more axial plane if I exerted suprapubic pressure. The patient’s uterus was retroverted and her cervix was behind her symphysis. When I placed the speculum again, I asked the patient to apply suprapubic pressure, as I just had. With this procedure I then found her cervix easily, grasped it with a tenaculum, and inserted the IUD, which went well.

Jeffrey Joseph, MD
Wakefield, Rhode Island

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.

“STOP USING RECTAL MISOPROSTOL FOR THE TREATMENT OF POSTPARTUM HEMORRHAGE CAUSED BY UTERINE ATONY”

ROBERT L. BARBIERI, MD (JULY 2016)

More on rectal misoprostol for postpartum hemorrhage

We applaud Dr. Barbieri’s July Editorial urging providers to stop administering misoprostol rectally for the treatment of postpartum hemorrhage (PPH) given the well-documented evidence and pharmacokinetics that recommend the sublingual route. Confusion among providers may derive from the fact that not all international guidelines, including the American College of Obstetricians and Gynecologists clinical guidelines on the management of PPH, have been updated to reflect the latest evidence.¹ Guidelines from the World Health Organization and the International Federation of Gynecology and Obstetrics reflect the latest evidence and clearly recommend the evidence-based regimen of 800 μg misoprostol sublingually for treatment of PPH,² which has been shown to be comparable to 40 IU oxytocin intravenously in women who ­receive oxytocin for PPH prophylaxis.³

Although oxytocin remains the first-line treatment for PPH, evidence suggests that sublingual misoprostol should be considered a viable first alternative if oxytocin is not available or fails. There is little evidence on the benefit of methergine or carboprost over misoprostol for PPH treatment, and inclusion of these drugs in treatment guidelines and practice is based on extrapolations from studies on PPH prevention.⁴ As Dr. Barbieri noted, pyrexia from misoprostol has been cited in the literature; however, contrary to contraindications for methergine, for example, this rare event does not pose serious risks to women, is self-limiting, and appears to be most acute among certain populations.⁵

It is paramount that safe, effective, and evidence-based PPH treatments be available and known to providers both in the United States and globally in order to provide women with timely treatment. Greater discussion and research is warranted about the hierarchy of use for these drugs and the possible impact of routine use of uterotonics before and during delivery, given that overexposure to uterotonics may in fact be making PPH harder to treat.⁶

Gillian Burkhardt, MD, and Rasha Dabash, MPH
New York, New York

Dr. Barbieri responds

I thank Drs. Burkhardt and Dabash for sharing their expert perspective with our readers. They advocate for the use of sublingual misoprostol for the treatment of PPH “if oxytocin is not available or fails.” I agree that at a home birth, if oxytocin is not available, sublingual misoprostol would be of great benefit. I remain concerned that misoprostol has little clinical utility for the treatment of PPH in the hospital setting in which oxytocin, methergine, and carboprost are available alternatives. Misoprostol causes fever in many women, and women who develop a postpartum fever due to misoprostol will receive unnecessary antibiotic treatment. I recommend that our readers stop using misoprostol for the treatment of PPH in the hospital setting.

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.

“STOP USING RECTAL MISOPROSTOL FOR THE TREATMENT OF POSTPARTUM HEMORRHAGE CAUSED BY UTERINE ATONY”

ROBERT L. BARBIERI, MD (JULY 2016)

More on rectal misoprostol for postpartum hemorrhage

We applaud Dr. Barbieri’s July Editorial urging providers to stop administering misoprostol rectally for the treatment of postpartum hemorrhage (PPH) given the well-documented evidence and pharmacokinetics that recommend the sublingual route. Confusion among providers may derive from the fact that not all international guidelines, including the American College of Obstetricians and Gynecologists clinical guidelines on the management of PPH, have been updated to reflect the latest evidence.¹ Guidelines from the World Health Organization and the International Federation of Gynecology and Obstetrics reflect the latest evidence and clearly recommend the evidence-based regimen of 800 μg misoprostol sublingually for treatment of PPH,² which has been shown to be comparable to 40 IU oxytocin intravenously in women who ­receive oxytocin for PPH prophylaxis.³

Although oxytocin remains the first-line treatment for PPH, evidence suggests that sublingual misoprostol should be considered a viable first alternative if oxytocin is not available or fails. There is little evidence on the benefit of methergine or carboprost over misoprostol for PPH treatment, and inclusion of these drugs in treatment guidelines and practice is based on extrapolations from studies on PPH prevention.⁴ As Dr. Barbieri noted, pyrexia from misoprostol has been cited in the literature; however, contrary to contraindications for methergine, for example, this rare event does not pose serious risks to women, is self-limiting, and appears to be most acute among certain populations.⁵

It is paramount that safe, effective, and evidence-based PPH treatments be available and known to providers both in the United States and globally in order to provide women with timely treatment. Greater discussion and research is warranted about the hierarchy of use for these drugs and the possible impact of routine use of uterotonics before and during delivery, given that overexposure to uterotonics may in fact be making PPH harder to treat.⁶

Gillian Burkhardt, MD, and Rasha Dabash, MPH
New York, New York

Dr. Barbieri responds

I thank Drs. Burkhardt and Dabash for sharing their expert perspective with our readers. They advocate for the use of sublingual misoprostol for the treatment of PPH “if oxytocin is not available or fails.” I agree that at a home birth, if oxytocin is not available, sublingual misoprostol would be of great benefit. I remain concerned that misoprostol has little clinical utility for the treatment of PPH in the hospital setting in which oxytocin, methergine, and carboprost are available alternatives. Misoprostol causes fever in many women, and women who develop a postpartum fever due to misoprostol will receive unnecessary antibiotic treatment. I recommend that our readers stop using misoprostol for the treatment of PPH in the hospital setting.

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.

“STOP USING RECTAL MISOPROSTOL FOR THE TREATMENT OF POSTPARTUM HEMORRHAGE CAUSED BY UTERINE ATONY”

ROBERT L. BARBIERI, MD (JULY 2016)

More on rectal misoprostol for postpartum hemorrhage

We applaud Dr. Barbieri’s July Editorial urging providers to stop administering misoprostol rectally for the treatment of postpartum hemorrhage (PPH) given the well-documented evidence and pharmacokinetics that recommend the sublingual route. Confusion among providers may derive from the fact that not all international guidelines, including the American College of Obstetricians and Gynecologists clinical guidelines on the management of PPH, have been updated to reflect the latest evidence.¹ Guidelines from the World Health Organization and the International Federation of Gynecology and Obstetrics reflect the latest evidence and clearly recommend the evidence-based regimen of 800 μg misoprostol sublingually for treatment of PPH,² which has been shown to be comparable to 40 IU oxytocin intravenously in women who ­receive oxytocin for PPH prophylaxis.³

Although oxytocin remains the first-line treatment for PPH, evidence suggests that sublingual misoprostol should be considered a viable first alternative if oxytocin is not available or fails. There is little evidence on the benefit of methergine or carboprost over misoprostol for PPH treatment, and inclusion of these drugs in treatment guidelines and practice is based on extrapolations from studies on PPH prevention.⁴ As Dr. Barbieri noted, pyrexia from misoprostol has been cited in the literature; however, contrary to contraindications for methergine, for example, this rare event does not pose serious risks to women, is self-limiting, and appears to be most acute among certain populations.⁵

It is paramount that safe, effective, and evidence-based PPH treatments be available and known to providers both in the United States and globally in order to provide women with timely treatment. Greater discussion and research is warranted about the hierarchy of use for these drugs and the possible impact of routine use of uterotonics before and during delivery, given that overexposure to uterotonics may in fact be making PPH harder to treat.⁶

Gillian Burkhardt, MD, and Rasha Dabash, MPH
New York, New York

Dr. Barbieri responds

I thank Drs. Burkhardt and Dabash for sharing their expert perspective with our readers. They advocate for the use of sublingual misoprostol for the treatment of PPH “if oxytocin is not available or fails.” I agree that at a home birth, if oxytocin is not available, sublingual misoprostol would be of great benefit. I remain concerned that misoprostol has little clinical utility for the treatment of PPH in the hospital setting in which oxytocin, methergine, and carboprost are available alternatives. Misoprostol causes fever in many women, and women who develop a postpartum fever due to misoprostol will receive unnecessary antibiotic treatment. I recommend that our readers stop using misoprostol for the treatment of PPH in the hospital setting.

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.

MASSAGE AND MOISTURING OIL

Just Pure Essentials suggests that JUST…Love be used to moisturize the face and body and for facial cleansing and shaving. It has been recommended by women’s health professionals as a lubricant and moisturizer to relieve vaginal dryness, says the manufacturer.

Just Pure Essentials products are 100% vegan; chemical and preservative free; and without alcohols, additives, or phytoestrogens. The base of each product is coconut medium-chain triglyceride (MCT) oil pressed from nongenetically modified coconut oil by a steam distillation process. The oil is blended with other organic oils and botanical ingredients, including green tea see oil, French plum oil, argan, and marshmallow leaf. It does not contain dyes, perfumes, or artificial flavors. Just Pure Essentials says its formulas do not dry up and turn sticky.

FOR MORE INFORMATION, VISIT: www.justpureessentials.com

pjur med says that PREMIUM glide is specially formulated for dry or highly sensitive genital mucous membranes and is made of non–pore-blocking, high-quality silicones. SENSITIVE glide is specifically developed for those with very sensitive genital mucous membranes, according to the manufacturer. Both products are available in 3.4 fl oz bottles. pjur med suggests its products are suitable for every skin type and maintains that they are dermatologically tested and paraben-, glycerin-, and preservative-free. In addition, pjur med says its formulas have been kept as neutral as possible and the ingredients have been put together in a way that microbial growth cannot occur.

FOR MORE INFORMATION, VISIT: www.pjurmed.com

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.

MASSAGE AND MOISTURING OIL

Just Pure Essentials suggests that JUST…Love be used to moisturize the face and body and for facial cleansing and shaving. It has been recommended by women’s health professionals as a lubricant and moisturizer to relieve vaginal dryness, says the manufacturer.

Just Pure Essentials products are 100% vegan; chemical and preservative free; and without alcohols, additives, or phytoestrogens. The base of each product is coconut medium-chain triglyceride (MCT) oil pressed from nongenetically modified coconut oil by a steam distillation process. The oil is blended with other organic oils and botanical ingredients, including green tea see oil, French plum oil, argan, and marshmallow leaf. It does not contain dyes, perfumes, or artificial flavors. Just Pure Essentials says its formulas do not dry up and turn sticky.

FOR MORE INFORMATION, VISIT: www.justpureessentials.com

pjur med says that PREMIUM glide is specially formulated for dry or highly sensitive genital mucous membranes and is made of non–pore-blocking, high-quality silicones. SENSITIVE glide is specifically developed for those with very sensitive genital mucous membranes, according to the manufacturer. Both products are available in 3.4 fl oz bottles. pjur med suggests its products are suitable for every skin type and maintains that they are dermatologically tested and paraben-, glycerin-, and preservative-free. In addition, pjur med says its formulas have been kept as neutral as possible and the ingredients have been put together in a way that microbial growth cannot occur.

FOR MORE INFORMATION, VISIT: www.pjurmed.com

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.

MASSAGE AND MOISTURING OIL

Just Pure Essentials suggests that JUST…Love be used to moisturize the face and body and for facial cleansing and shaving. It has been recommended by women’s health professionals as a lubricant and moisturizer to relieve vaginal dryness, says the manufacturer.

Just Pure Essentials products are 100% vegan; chemical and preservative free; and without alcohols, additives, or phytoestrogens. The base of each product is coconut medium-chain triglyceride (MCT) oil pressed from nongenetically modified coconut oil by a steam distillation process. The oil is blended with other organic oils and botanical ingredients, including green tea see oil, French plum oil, argan, and marshmallow leaf. It does not contain dyes, perfumes, or artificial flavors. Just Pure Essentials says its formulas do not dry up and turn sticky.

FOR MORE INFORMATION, VISIT: www.justpureessentials.com

pjur med says that PREMIUM glide is specially formulated for dry or highly sensitive genital mucous membranes and is made of non–pore-blocking, high-quality silicones. SENSITIVE glide is specifically developed for those with very sensitive genital mucous membranes, according to the manufacturer. Both products are available in 3.4 fl oz bottles. pjur med suggests its products are suitable for every skin type and maintains that they are dermatologically tested and paraben-, glycerin-, and preservative-free. In addition, pjur med says its formulas have been kept as neutral as possible and the ingredients have been put together in a way that microbial growth cannot occur.

FOR MORE INFORMATION, VISIT: www.pjurmed.com

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.

• Visit NAMS

• Visit NAMS

• Visit NAMS

The 2016 AAGL Global Congress kicked off in Orlando, Florida, with a jam-packed day of postgraduate courses on Monday, November 14. On Tuesday, Scientific Program Chair Kevin J. E. Stepp, MD, introduced the keynote speaker, and the 45th annual meeting of the AAGL was off and running. Many of the meeting's major events and individual sessions were captured through social media, and a few of those posts are captured here. We look forward to seeing you at next year’s meeting, where we hope you’ll be social with us once again!

View the story & AAGL: Conference Social Highlights on Storify

The 2016 AAGL Global Congress kicked off in Orlando, Florida, with a jam-packed day of postgraduate courses on Monday, November 14. On Tuesday, Scientific Program Chair Kevin J. E. Stepp, MD, introduced the keynote speaker, and the 45th annual meeting of the AAGL was off and running. Many of the meeting's major events and individual sessions were captured through social media, and a few of those posts are captured here. We look forward to seeing you at next year’s meeting, where we hope you’ll be social with us once again!

View the story & AAGL: Conference Social Highlights on Storify

The 2016 AAGL Global Congress kicked off in Orlando, Florida, with a jam-packed day of postgraduate courses on Monday, November 14. On Tuesday, Scientific Program Chair Kevin J. E. Stepp, MD, introduced the keynote speaker, and the 45th annual meeting of the AAGL was off and running. Many of the meeting's major events and individual sessions were captured through social media, and a few of those posts are captured here. We look forward to seeing you at next year’s meeting, where we hope you’ll be social with us once again!

View the story & AAGL: Conference Social Highlights on Storify