Henry M. Lerner, MD

In Part 1 of this article in the December 2020 issue of OBG Management, I discussed the reasons that pessaries are an effective treatment option for many women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI) and provided details on the types of pessaries available.

In this article, I highlight the steps in fitting a pessary, pessary aftercare, and potential complications associated with pessary use. In addition, I discuss the effectiveness of pessary treatment for POP and SUI as well as for preterm labor prevention and defecatory disorders.

The pessary fitting process

For a given patient, the best size pessary is the smallest one that will not fall out. The only “rule” for fitting a pessary is that a woman’s internal vaginal caliber should be wider than her introitus.

When fitting a pessary, goals include that the selected pessary:

• should be comfortable for the patient to wear
• is not easily expelled
• does not interfere with urination or defecation
• does not cause vaginal irritation.

The presence or absence of a cervix or uterus does not affect pessary choice.

Most experts agree that the process for fitting the right size pessary is one of trial and error. As with fitting a contraceptive diaphragm, the clinician should perform a manual examination to estimate the integrity and width of the perineum and the depth of the vagina to roughly approximate the pessary size that might best fit. Using a set of “fitting pessaries,” a pessary of the estimated size should be placed into the vagina and the fit evaluated as to whether the device is too big, too small, or appropriate. If the pessary is easily expelled, larger sizes should be tried until the pessary remains in place or the patient is uncomfortable. Once the pessary is in place, the clinician should be able to run his or her finger around the entire pessary; if this is not possible, the pessary is too tight. In addition, the pessary should remain more than one finger breadth above the introitus when the patient is standing or bearing down.

Since many patients who require a pessary are elderly, their perineal skin and vaginal mucosa may be atrophic and fragile. Inserting a pessary can be uncomfortable and can cause abrasions or tears. Successfully fitting a pessary may require extra care under these circumstances. The following steps may help alleviate these difficulties:

• Explain the fitting process to the patient in detail.
• Employ lubrication liberally.
• Enlarge the introitus by applying gentle digital pressure on the posterior fourchette.
• Apply 2% lidocaine ointment several minutes prior to pessary fitting to help decrease patient discomfort.
• Treat the patient for several weeks with vaginal estrogen cream before attempting to fit a pessary if severe vulvovaginal atrophy is present.

Once the type and size of the pessary are selected and a pessary is inserted, evaluate the patient with the pessary in place. Assess for the following:

Discomfort. Ask the patient if she feels discomfort with the pessary in position. A patient with a properly fitting pessary should not feel that it is in place. If she does feel discomfort initially, the discomfort will only increase with time and the issue should be addressed at that time.

Expulsion. Test to make certain that the pessary is not easily expelled from the vagina. Have the patient walk, cough, squat, and even jump if possible.

Urination. Have the patient urinate with the pessary in place. This tests for her ability to void while wearing the pessary and shows whether the contraction of pelvic muscles during voiding results in expulsion of the pessary. (Experience shows that it is best to do this with a plastic “hat” over the toilet so that if the pessary is expelled, it does not drop into the bowl.)

Re-examination. After these provocative tests, examine the patient again to ensure that the pessary has not slid out of place.

Depending on whether or not your office stocks pessaries, at this point the patient is either given the correct type and size of pessary or it is ordered for her. If the former, the patient should try placing it herself; if she is unable to, the clinician should place it for her. In either event, its position should be checked. If the pessary has to be ordered, the patient must schedule an appointment to return for pessary insertion.

Whether the pessary is supplied by the office or ordered, instruct the patient on how to insert and remove the pessary, how frequently to remove it for cleansing (see below), and signs to watch for, such as vaginal bleeding, inability to void or defecate, or pelvic pain.

It is advisable to schedule a subsequent visit for 2 to 3 weeks after initial pessary placement to assess how the patient is doing and to address any issues that have developed.

Continue to: Special circumstances...

It is safe for a patient with a pessary in place to undergo magnetic resonance imaging.¹ Patients should be informed, however, that full body scans, such as at airports, will detect pessaries. Patients may need to obtain a physician’s note to document that the pessary is a medical device.

Finally, several factors may prevent successful pessary fitting. These include prior pelvic surgery, obesity, short vaginal length (less than 6–7 cm), and a vaginal introitus width of greater than 4 finger breadths.

Necessary pessary aftercare

Once a pessary is in place and the patient is comfortable with it, the only maintenance necessary is the pessary’s intermittent removal for cleansing and for evaluation of the vaginal mucosa for erosion and ulcerations. How frequently this should be done varies based on the type of pessary, the amount of discharge that a woman produces, whether or not an odor develops after prolonged wearing of the pessary, and whether or not the patient’s vaginal mucosa has been abraded.

The question of timing for pessary cleaning

Although there are many opinions about how often pessaries should be removed and cleaned, no data in the literature support any specific interval. Pessaries that are easily removed by women themselves can be cleaned as frequently as desired, often on a weekly basis. The patient simply removes the pessary, washes it with soap and water, and reinserts it. For pessaries that are difficult to remove (such as the Gellhorn, cube, or donut) or for women who are physically unable to remove their own ring pessary, the clinician should remove and clean the pessary in the office every 3 to 6 months. It has been shown that there is no difference in complications from pessary use with either of these intervals.²

Prior to any vaginal surgical procedure, patients must be instructed to remove their pessary 10 to 14 days beforehand so that the surgeon can see the full extent of prolapse when making decisions about reconstruction and so that any vaginal mucosal erosions or abrasions have time to heal.

Office visits for follow-up care

The pessary “cleaning visit” has several goals, including to:

• see if the pessary is meeting the patient’s needs in terms of resolving symptoms of prolapse and/or restoring urinary continence
• discuss with the patient any problems she may be having, such as pelvic discomfort or pressure, difficulty voiding or defecating, excessive vaginal discharge, or vaginal odor
• check for vaginal mucosal erosion or ulceration; such vaginal lesions often can be prevented by the prophylactic use of either estrogen vaginal cream twice weekly or the continuous use of an estradiol vaginal ring in addition to the pessary
• evaluate the condition of the pessary itself and clean it with soap and water.

Continue to: Potential complications of pessary use...

The most common complications experienced by pessary users are:

Odor or excessive discharge. Bacterial vaginosis (BV) occurs more frequently in women who use pessaries. The symptoms of BV can be minimized—but unfortunately not totally eliminated—by the prophylactic use of antiseptic vaginal creams or gels, such as metronidazole, clindamycin, Trimo-San (oxyquinoline sulfate and sodium lauryl sulfate), and others. Inserting the gel vaginally once a week can significantly reduce discharge and odor.³

Vaginal mucosal erosion and ulceration. These are treated by removing the pessary for 2 weeks during which time estrogen cream is applied daily or an estradiol vaginal ring is put in place. If no resolution occurs after 2 weeks, the nonhealing vaginal mucosa should be biopsied.

Pressure on the rectum or bladder. If the pessary causes significant discomfort or interferes with voiding function, then either a different size or a different type pessary should be tried

Patients may discontinue pessary use for a variety of reasons. Among these are:

• discomfort
• inadequate improvement of POP or incontinence symptoms
• expulsion of the pessary during daily activities
• the patient’s desire for surgery instead
• worsening of urine leakage
• difficulty inserting or removing the pessary
• damage to the vaginal mucosa
• pain during removal of the pessary in the office.

Pessary effectiveness for POP and SUI symptoms

As might be expected with a device that is available in so many forms and is used to treat varied types of POP and SUI, the data concerning the success rates of pessary use vary considerably. These rates depend on the definition of success, that is, complete or partial control of prolapse and/or incontinence; which devices are being evaluated; and the nature and severity of the POP and/or SUI being treated.

That being said, a review of the literature reveals that the rates of prolapse symptom relief vary from 48% to 92% (TABLE 1).^4-13

As for success in relieving symptoms of incontinence, studies show improvements in from 40% to 77% of patients (TABLE 2).^6,8,14-17

In addition, some studies show a 50% improvement in bowel symptoms (urgency, obstruction, and anal incontinence) with the use of a pessary.^9,18

How pessaries compare with surgery

While surgery has the advantage of being a one-time fix with a very high rate of initial success in correcting both POP and incontinence, surgery also has potential drawbacks:

• It is an invasive procedure with the discomfort and risk of complications any surgery entails.
• There is a relatively high rate of prolapse recurrence.
• It exposes the patient to the possibility of mesh erosion if mesh is employed either for POP support or incontinence treatment.

Pessaries, on the other hand, are inexpensive, nonsurgical, removable, and allow for immediate correction of symptoms. Moreover, if the pessary is tried and is found to be unsatisfactory, surgery always can be performed subsequently.

Drawbacks of pessary treatment compared with surgery include the:

• ongoing need to wear an artificial internal device
• need for intermittent pessary removal and cleansing
• inability to have sexual intercourse with certain kinds of pessaries in place
• possible accumulation of vaginal discharge and odor.

Sexual activity and pessaries

Studies by Fernando, Meriwether, and Kuhn concur that for a substantial number of pessary users who are sexually active, both frequency and satisfaction with sexual intercourse are increased.^8,19,20 Kuhn further showed that desire, orgasm, and lubrication improved with the use of pessaries.²⁰ While some types of pessaries do require removal for intercourse, Clemons reported that issues involving sexual activity are not associated with pessary discontinuation.²¹

Using a pessary to predict a surgical outcome

Because a pessary elevates the pelvic organs, supports the vaginal walls, and lifts the bladder and urethra into a position that simulates the results of surgical repair, trial placement of a pessary can be used as a fairly accurate predictive tool to model what pelvic support and continence status will be after a proposed surgical procedure.^22,23 This is especially important because a significant number of patients with POP will have their occult stress incontinence unmasked following a reparative procedure.²⁴ A brief pessary trial prior to surgery, therefore, can be a useful tool for both patient and surgeon.

Continue to: Pessaries for prevention of preterm labor...

Pessaries for prevention of preterm labor

Almost 1 in 10 births in the United States occurs before 37 completed weeks of gestation.²⁵ Obstetricians have long thought that in women at risk for preterm delivery, the use of a pessary might help reduce the pressure of the growing uterus on the cervix and thus help prevent premature cervical dilation. It also has been thought that use of a pessary would be a safer and less invasive alternative to cervical cerclage. Many studies have evaluated the use of pessaries for the prevention of preterm labor with a mixture of positive (TABLE 3)^26-29 and negative results (TABLE 4).^30-33

From these data, it is reasonable to conclude that:

• The final answer concerning the effectiveness or lack thereof of pessary use in preventing preterm delivery is not yet in.
• Any advantage there might be to using pessaries to prevent preterm delivery cannot be too significant if multiple studies show as many negative outcomes as positive ones.

Pessary effectiveness in defecatory disorders

Vaginal birth has the potential to create multiple anatomic injuries in the anus, lower pelvis, and perineum that can affect defecation and bowel control. Tears of the anal sphincter, whether obvious or occult, may heal incompletely or be repaired inadequately.³⁴ Nerve innervation of the perianal and perineal areas can be interrupted or damaged by stretching, tearing, or prolonged compression. Of healthy parous adult women, 7% to 16% admit incontinence of gas or feces.^35,36

In addition, when a rectocele is present, stool in the lower rectum may cause bulging of the anterior rectal wall into the vagina, preventing stool from passing out of the anus. This sometimes requires women to digitally press their posterior vaginal walls during defecation to evacuate stool successfully. The question thus arises as to whether or not pessary placement and subsequent relief of rectoceles might facilitate bowel movements and decrease or eliminate defecatory dysfunction.

As with the issue of pessary use for prevention of preterm delivery, the answer is mixed. For instance, while Brazell¹⁸ showed that there was an overall improvement in bowel symptoms in pessary users, a study by Komesu¹⁰ did not demonstrate improvement.

There is, however, a relatively new device specifically designed to control defecatory problems: the vaginal bowel control system (Eclipse; Pelvalon). The silicon device is placed intravaginally as one does a pessary. After insertion, it is inflated via a valve and syringe. It works by putting pressure on and reversibly closing the lower rectum, thus blocking the uncontrolled passage of stool and gas. It can be worn continuously or intermittently, but it does need to be deflated for normal bowel movements. One trial of this device demonstrated a 50% reduction in incontinence episodes with a patient satisfaction rate of 84% at 3 months.³⁷ This device may well prove to be a valuable nonsurgical approach to the treatment of fecal incontinence. Unfortunately, the device is relatively expensive and usually is not covered by insurance as third-party payers do not consider it to be a pessary (which generally is covered).

Practice management particulars

Useful information on Current Procedural Terminology codes for pessaries, diagnostic codes, and the cost of various pessaries is provided in TABLE 5,³⁸TABLE 6,³⁹ and TABLE 7.^40-42

A contemporary device used since antiquity

Pessaries, considered “old-fashioned” by many gynecologists, are actually a very cost-effective and useful tool for the correction of POP and SUI. It behooves all who provide medical care to women to be familiar with them, to know when they might be useful, and to know how to fit and prescribe them. ●

In Part 1 of this article in the December 2020 issue of OBG Management, I discussed the reasons that pessaries are an effective treatment option for many women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI) and provided details on the types of pessaries available.

In this article, I highlight the steps in fitting a pessary, pessary aftercare, and potential complications associated with pessary use. In addition, I discuss the effectiveness of pessary treatment for POP and SUI as well as for preterm labor prevention and defecatory disorders.

The pessary fitting process

For a given patient, the best size pessary is the smallest one that will not fall out. The only “rule” for fitting a pessary is that a woman’s internal vaginal caliber should be wider than her introitus.

When fitting a pessary, goals include that the selected pessary:

• should be comfortable for the patient to wear
• is not easily expelled
• does not interfere with urination or defecation
• does not cause vaginal irritation.

The presence or absence of a cervix or uterus does not affect pessary choice.

Most experts agree that the process for fitting the right size pessary is one of trial and error. As with fitting a contraceptive diaphragm, the clinician should perform a manual examination to estimate the integrity and width of the perineum and the depth of the vagina to roughly approximate the pessary size that might best fit. Using a set of “fitting pessaries,” a pessary of the estimated size should be placed into the vagina and the fit evaluated as to whether the device is too big, too small, or appropriate. If the pessary is easily expelled, larger sizes should be tried until the pessary remains in place or the patient is uncomfortable. Once the pessary is in place, the clinician should be able to run his or her finger around the entire pessary; if this is not possible, the pessary is too tight. In addition, the pessary should remain more than one finger breadth above the introitus when the patient is standing or bearing down.

Since many patients who require a pessary are elderly, their perineal skin and vaginal mucosa may be atrophic and fragile. Inserting a pessary can be uncomfortable and can cause abrasions or tears. Successfully fitting a pessary may require extra care under these circumstances. The following steps may help alleviate these difficulties:

• Explain the fitting process to the patient in detail.
• Employ lubrication liberally.
• Enlarge the introitus by applying gentle digital pressure on the posterior fourchette.
• Apply 2% lidocaine ointment several minutes prior to pessary fitting to help decrease patient discomfort.
• Treat the patient for several weeks with vaginal estrogen cream before attempting to fit a pessary if severe vulvovaginal atrophy is present.

Once the type and size of the pessary are selected and a pessary is inserted, evaluate the patient with the pessary in place. Assess for the following:

Discomfort. Ask the patient if she feels discomfort with the pessary in position. A patient with a properly fitting pessary should not feel that it is in place. If she does feel discomfort initially, the discomfort will only increase with time and the issue should be addressed at that time.

Expulsion. Test to make certain that the pessary is not easily expelled from the vagina. Have the patient walk, cough, squat, and even jump if possible.

Urination. Have the patient urinate with the pessary in place. This tests for her ability to void while wearing the pessary and shows whether the contraction of pelvic muscles during voiding results in expulsion of the pessary. (Experience shows that it is best to do this with a plastic “hat” over the toilet so that if the pessary is expelled, it does not drop into the bowl.)

Re-examination. After these provocative tests, examine the patient again to ensure that the pessary has not slid out of place.

Depending on whether or not your office stocks pessaries, at this point the patient is either given the correct type and size of pessary or it is ordered for her. If the former, the patient should try placing it herself; if she is unable to, the clinician should place it for her. In either event, its position should be checked. If the pessary has to be ordered, the patient must schedule an appointment to return for pessary insertion.

Whether the pessary is supplied by the office or ordered, instruct the patient on how to insert and remove the pessary, how frequently to remove it for cleansing (see below), and signs to watch for, such as vaginal bleeding, inability to void or defecate, or pelvic pain.

It is advisable to schedule a subsequent visit for 2 to 3 weeks after initial pessary placement to assess how the patient is doing and to address any issues that have developed.

Continue to: Special circumstances...

It is safe for a patient with a pessary in place to undergo magnetic resonance imaging.¹ Patients should be informed, however, that full body scans, such as at airports, will detect pessaries. Patients may need to obtain a physician’s note to document that the pessary is a medical device.

Finally, several factors may prevent successful pessary fitting. These include prior pelvic surgery, obesity, short vaginal length (less than 6–7 cm), and a vaginal introitus width of greater than 4 finger breadths.

Necessary pessary aftercare

Once a pessary is in place and the patient is comfortable with it, the only maintenance necessary is the pessary’s intermittent removal for cleansing and for evaluation of the vaginal mucosa for erosion and ulcerations. How frequently this should be done varies based on the type of pessary, the amount of discharge that a woman produces, whether or not an odor develops after prolonged wearing of the pessary, and whether or not the patient’s vaginal mucosa has been abraded.

The question of timing for pessary cleaning

Although there are many opinions about how often pessaries should be removed and cleaned, no data in the literature support any specific interval. Pessaries that are easily removed by women themselves can be cleaned as frequently as desired, often on a weekly basis. The patient simply removes the pessary, washes it with soap and water, and reinserts it. For pessaries that are difficult to remove (such as the Gellhorn, cube, or donut) or for women who are physically unable to remove their own ring pessary, the clinician should remove and clean the pessary in the office every 3 to 6 months. It has been shown that there is no difference in complications from pessary use with either of these intervals.²

Prior to any vaginal surgical procedure, patients must be instructed to remove their pessary 10 to 14 days beforehand so that the surgeon can see the full extent of prolapse when making decisions about reconstruction and so that any vaginal mucosal erosions or abrasions have time to heal.

Office visits for follow-up care

The pessary “cleaning visit” has several goals, including to:

• see if the pessary is meeting the patient’s needs in terms of resolving symptoms of prolapse and/or restoring urinary continence
• discuss with the patient any problems she may be having, such as pelvic discomfort or pressure, difficulty voiding or defecating, excessive vaginal discharge, or vaginal odor
• check for vaginal mucosal erosion or ulceration; such vaginal lesions often can be prevented by the prophylactic use of either estrogen vaginal cream twice weekly or the continuous use of an estradiol vaginal ring in addition to the pessary
• evaluate the condition of the pessary itself and clean it with soap and water.

Continue to: Potential complications of pessary use...

The most common complications experienced by pessary users are:

Odor or excessive discharge. Bacterial vaginosis (BV) occurs more frequently in women who use pessaries. The symptoms of BV can be minimized—but unfortunately not totally eliminated—by the prophylactic use of antiseptic vaginal creams or gels, such as metronidazole, clindamycin, Trimo-San (oxyquinoline sulfate and sodium lauryl sulfate), and others. Inserting the gel vaginally once a week can significantly reduce discharge and odor.³

Vaginal mucosal erosion and ulceration. These are treated by removing the pessary for 2 weeks during which time estrogen cream is applied daily or an estradiol vaginal ring is put in place. If no resolution occurs after 2 weeks, the nonhealing vaginal mucosa should be biopsied.

Pressure on the rectum or bladder. If the pessary causes significant discomfort or interferes with voiding function, then either a different size or a different type pessary should be tried

Patients may discontinue pessary use for a variety of reasons. Among these are:

• discomfort
• inadequate improvement of POP or incontinence symptoms
• expulsion of the pessary during daily activities
• the patient’s desire for surgery instead
• worsening of urine leakage
• difficulty inserting or removing the pessary
• damage to the vaginal mucosa
• pain during removal of the pessary in the office.

Pessary effectiveness for POP and SUI symptoms

As might be expected with a device that is available in so many forms and is used to treat varied types of POP and SUI, the data concerning the success rates of pessary use vary considerably. These rates depend on the definition of success, that is, complete or partial control of prolapse and/or incontinence; which devices are being evaluated; and the nature and severity of the POP and/or SUI being treated.

That being said, a review of the literature reveals that the rates of prolapse symptom relief vary from 48% to 92% (TABLE 1).^4-13

As for success in relieving symptoms of incontinence, studies show improvements in from 40% to 77% of patients (TABLE 2).^6,8,14-17

In addition, some studies show a 50% improvement in bowel symptoms (urgency, obstruction, and anal incontinence) with the use of a pessary.^9,18

How pessaries compare with surgery

While surgery has the advantage of being a one-time fix with a very high rate of initial success in correcting both POP and incontinence, surgery also has potential drawbacks:

• It is an invasive procedure with the discomfort and risk of complications any surgery entails.
• There is a relatively high rate of prolapse recurrence.
• It exposes the patient to the possibility of mesh erosion if mesh is employed either for POP support or incontinence treatment.

Pessaries, on the other hand, are inexpensive, nonsurgical, removable, and allow for immediate correction of symptoms. Moreover, if the pessary is tried and is found to be unsatisfactory, surgery always can be performed subsequently.

Drawbacks of pessary treatment compared with surgery include the:

• ongoing need to wear an artificial internal device
• need for intermittent pessary removal and cleansing
• inability to have sexual intercourse with certain kinds of pessaries in place
• possible accumulation of vaginal discharge and odor.

Sexual activity and pessaries

Studies by Fernando, Meriwether, and Kuhn concur that for a substantial number of pessary users who are sexually active, both frequency and satisfaction with sexual intercourse are increased.^8,19,20 Kuhn further showed that desire, orgasm, and lubrication improved with the use of pessaries.²⁰ While some types of pessaries do require removal for intercourse, Clemons reported that issues involving sexual activity are not associated with pessary discontinuation.²¹

Using a pessary to predict a surgical outcome

Because a pessary elevates the pelvic organs, supports the vaginal walls, and lifts the bladder and urethra into a position that simulates the results of surgical repair, trial placement of a pessary can be used as a fairly accurate predictive tool to model what pelvic support and continence status will be after a proposed surgical procedure.^22,23 This is especially important because a significant number of patients with POP will have their occult stress incontinence unmasked following a reparative procedure.²⁴ A brief pessary trial prior to surgery, therefore, can be a useful tool for both patient and surgeon.

Continue to: Pessaries for prevention of preterm labor...

Pessaries for prevention of preterm labor

Almost 1 in 10 births in the United States occurs before 37 completed weeks of gestation.²⁵ Obstetricians have long thought that in women at risk for preterm delivery, the use of a pessary might help reduce the pressure of the growing uterus on the cervix and thus help prevent premature cervical dilation. It also has been thought that use of a pessary would be a safer and less invasive alternative to cervical cerclage. Many studies have evaluated the use of pessaries for the prevention of preterm labor with a mixture of positive (TABLE 3)^26-29 and negative results (TABLE 4).^30-33

From these data, it is reasonable to conclude that:

• The final answer concerning the effectiveness or lack thereof of pessary use in preventing preterm delivery is not yet in.
• Any advantage there might be to using pessaries to prevent preterm delivery cannot be too significant if multiple studies show as many negative outcomes as positive ones.

Pessary effectiveness in defecatory disorders

Vaginal birth has the potential to create multiple anatomic injuries in the anus, lower pelvis, and perineum that can affect defecation and bowel control. Tears of the anal sphincter, whether obvious or occult, may heal incompletely or be repaired inadequately.³⁴ Nerve innervation of the perianal and perineal areas can be interrupted or damaged by stretching, tearing, or prolonged compression. Of healthy parous adult women, 7% to 16% admit incontinence of gas or feces.^35,36

In addition, when a rectocele is present, stool in the lower rectum may cause bulging of the anterior rectal wall into the vagina, preventing stool from passing out of the anus. This sometimes requires women to digitally press their posterior vaginal walls during defecation to evacuate stool successfully. The question thus arises as to whether or not pessary placement and subsequent relief of rectoceles might facilitate bowel movements and decrease or eliminate defecatory dysfunction.

As with the issue of pessary use for prevention of preterm delivery, the answer is mixed. For instance, while Brazell¹⁸ showed that there was an overall improvement in bowel symptoms in pessary users, a study by Komesu¹⁰ did not demonstrate improvement.

There is, however, a relatively new device specifically designed to control defecatory problems: the vaginal bowel control system (Eclipse; Pelvalon). The silicon device is placed intravaginally as one does a pessary. After insertion, it is inflated via a valve and syringe. It works by putting pressure on and reversibly closing the lower rectum, thus blocking the uncontrolled passage of stool and gas. It can be worn continuously or intermittently, but it does need to be deflated for normal bowel movements. One trial of this device demonstrated a 50% reduction in incontinence episodes with a patient satisfaction rate of 84% at 3 months.³⁷ This device may well prove to be a valuable nonsurgical approach to the treatment of fecal incontinence. Unfortunately, the device is relatively expensive and usually is not covered by insurance as third-party payers do not consider it to be a pessary (which generally is covered).

Practice management particulars

Useful information on Current Procedural Terminology codes for pessaries, diagnostic codes, and the cost of various pessaries is provided in TABLE 5,³⁸TABLE 6,³⁹ and TABLE 7.^40-42

A contemporary device used since antiquity

Pessaries, considered “old-fashioned” by many gynecologists, are actually a very cost-effective and useful tool for the correction of POP and SUI. It behooves all who provide medical care to women to be familiar with them, to know when they might be useful, and to know how to fit and prescribe them. ●

In Part 1 of this article in the December 2020 issue of OBG Management, I discussed the reasons that pessaries are an effective treatment option for many women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI) and provided details on the types of pessaries available.

In this article, I highlight the steps in fitting a pessary, pessary aftercare, and potential complications associated with pessary use. In addition, I discuss the effectiveness of pessary treatment for POP and SUI as well as for preterm labor prevention and defecatory disorders.

The pessary fitting process

For a given patient, the best size pessary is the smallest one that will not fall out. The only “rule” for fitting a pessary is that a woman’s internal vaginal caliber should be wider than her introitus.

When fitting a pessary, goals include that the selected pessary:

• should be comfortable for the patient to wear
• is not easily expelled
• does not interfere with urination or defecation
• does not cause vaginal irritation.

The presence or absence of a cervix or uterus does not affect pessary choice.

Most experts agree that the process for fitting the right size pessary is one of trial and error. As with fitting a contraceptive diaphragm, the clinician should perform a manual examination to estimate the integrity and width of the perineum and the depth of the vagina to roughly approximate the pessary size that might best fit. Using a set of “fitting pessaries,” a pessary of the estimated size should be placed into the vagina and the fit evaluated as to whether the device is too big, too small, or appropriate. If the pessary is easily expelled, larger sizes should be tried until the pessary remains in place or the patient is uncomfortable. Once the pessary is in place, the clinician should be able to run his or her finger around the entire pessary; if this is not possible, the pessary is too tight. In addition, the pessary should remain more than one finger breadth above the introitus when the patient is standing or bearing down.

Since many patients who require a pessary are elderly, their perineal skin and vaginal mucosa may be atrophic and fragile. Inserting a pessary can be uncomfortable and can cause abrasions or tears. Successfully fitting a pessary may require extra care under these circumstances. The following steps may help alleviate these difficulties:

• Explain the fitting process to the patient in detail.
• Employ lubrication liberally.
• Enlarge the introitus by applying gentle digital pressure on the posterior fourchette.
• Apply 2% lidocaine ointment several minutes prior to pessary fitting to help decrease patient discomfort.
• Treat the patient for several weeks with vaginal estrogen cream before attempting to fit a pessary if severe vulvovaginal atrophy is present.

Once the type and size of the pessary are selected and a pessary is inserted, evaluate the patient with the pessary in place. Assess for the following:

Discomfort. Ask the patient if she feels discomfort with the pessary in position. A patient with a properly fitting pessary should not feel that it is in place. If she does feel discomfort initially, the discomfort will only increase with time and the issue should be addressed at that time.

Expulsion. Test to make certain that the pessary is not easily expelled from the vagina. Have the patient walk, cough, squat, and even jump if possible.

Urination. Have the patient urinate with the pessary in place. This tests for her ability to void while wearing the pessary and shows whether the contraction of pelvic muscles during voiding results in expulsion of the pessary. (Experience shows that it is best to do this with a plastic “hat” over the toilet so that if the pessary is expelled, it does not drop into the bowl.)

Re-examination. After these provocative tests, examine the patient again to ensure that the pessary has not slid out of place.

Depending on whether or not your office stocks pessaries, at this point the patient is either given the correct type and size of pessary or it is ordered for her. If the former, the patient should try placing it herself; if she is unable to, the clinician should place it for her. In either event, its position should be checked. If the pessary has to be ordered, the patient must schedule an appointment to return for pessary insertion.

Whether the pessary is supplied by the office or ordered, instruct the patient on how to insert and remove the pessary, how frequently to remove it for cleansing (see below), and signs to watch for, such as vaginal bleeding, inability to void or defecate, or pelvic pain.

It is advisable to schedule a subsequent visit for 2 to 3 weeks after initial pessary placement to assess how the patient is doing and to address any issues that have developed.

Continue to: Special circumstances...

It is safe for a patient with a pessary in place to undergo magnetic resonance imaging.¹ Patients should be informed, however, that full body scans, such as at airports, will detect pessaries. Patients may need to obtain a physician’s note to document that the pessary is a medical device.

Finally, several factors may prevent successful pessary fitting. These include prior pelvic surgery, obesity, short vaginal length (less than 6–7 cm), and a vaginal introitus width of greater than 4 finger breadths.

Necessary pessary aftercare

Once a pessary is in place and the patient is comfortable with it, the only maintenance necessary is the pessary’s intermittent removal for cleansing and for evaluation of the vaginal mucosa for erosion and ulcerations. How frequently this should be done varies based on the type of pessary, the amount of discharge that a woman produces, whether or not an odor develops after prolonged wearing of the pessary, and whether or not the patient’s vaginal mucosa has been abraded.

The question of timing for pessary cleaning

Although there are many opinions about how often pessaries should be removed and cleaned, no data in the literature support any specific interval. Pessaries that are easily removed by women themselves can be cleaned as frequently as desired, often on a weekly basis. The patient simply removes the pessary, washes it with soap and water, and reinserts it. For pessaries that are difficult to remove (such as the Gellhorn, cube, or donut) or for women who are physically unable to remove their own ring pessary, the clinician should remove and clean the pessary in the office every 3 to 6 months. It has been shown that there is no difference in complications from pessary use with either of these intervals.²

Prior to any vaginal surgical procedure, patients must be instructed to remove their pessary 10 to 14 days beforehand so that the surgeon can see the full extent of prolapse when making decisions about reconstruction and so that any vaginal mucosal erosions or abrasions have time to heal.

Office visits for follow-up care

The pessary “cleaning visit” has several goals, including to:

• see if the pessary is meeting the patient’s needs in terms of resolving symptoms of prolapse and/or restoring urinary continence
• discuss with the patient any problems she may be having, such as pelvic discomfort or pressure, difficulty voiding or defecating, excessive vaginal discharge, or vaginal odor
• check for vaginal mucosal erosion or ulceration; such vaginal lesions often can be prevented by the prophylactic use of either estrogen vaginal cream twice weekly or the continuous use of an estradiol vaginal ring in addition to the pessary
• evaluate the condition of the pessary itself and clean it with soap and water.

Continue to: Potential complications of pessary use...

The most common complications experienced by pessary users are:

Odor or excessive discharge. Bacterial vaginosis (BV) occurs more frequently in women who use pessaries. The symptoms of BV can be minimized—but unfortunately not totally eliminated—by the prophylactic use of antiseptic vaginal creams or gels, such as metronidazole, clindamycin, Trimo-San (oxyquinoline sulfate and sodium lauryl sulfate), and others. Inserting the gel vaginally once a week can significantly reduce discharge and odor.³

Vaginal mucosal erosion and ulceration. These are treated by removing the pessary for 2 weeks during which time estrogen cream is applied daily or an estradiol vaginal ring is put in place. If no resolution occurs after 2 weeks, the nonhealing vaginal mucosa should be biopsied.

Pressure on the rectum or bladder. If the pessary causes significant discomfort or interferes with voiding function, then either a different size or a different type pessary should be tried

Patients may discontinue pessary use for a variety of reasons. Among these are:

• discomfort
• inadequate improvement of POP or incontinence symptoms
• expulsion of the pessary during daily activities
• the patient’s desire for surgery instead
• worsening of urine leakage
• difficulty inserting or removing the pessary
• damage to the vaginal mucosa
• pain during removal of the pessary in the office.

Pessary effectiveness for POP and SUI symptoms

As might be expected with a device that is available in so many forms and is used to treat varied types of POP and SUI, the data concerning the success rates of pessary use vary considerably. These rates depend on the definition of success, that is, complete or partial control of prolapse and/or incontinence; which devices are being evaluated; and the nature and severity of the POP and/or SUI being treated.

That being said, a review of the literature reveals that the rates of prolapse symptom relief vary from 48% to 92% (TABLE 1).^4-13

As for success in relieving symptoms of incontinence, studies show improvements in from 40% to 77% of patients (TABLE 2).^6,8,14-17

In addition, some studies show a 50% improvement in bowel symptoms (urgency, obstruction, and anal incontinence) with the use of a pessary.^9,18

How pessaries compare with surgery

While surgery has the advantage of being a one-time fix with a very high rate of initial success in correcting both POP and incontinence, surgery also has potential drawbacks:

• It is an invasive procedure with the discomfort and risk of complications any surgery entails.
• There is a relatively high rate of prolapse recurrence.
• It exposes the patient to the possibility of mesh erosion if mesh is employed either for POP support or incontinence treatment.

Pessaries, on the other hand, are inexpensive, nonsurgical, removable, and allow for immediate correction of symptoms. Moreover, if the pessary is tried and is found to be unsatisfactory, surgery always can be performed subsequently.

Drawbacks of pessary treatment compared with surgery include the:

• ongoing need to wear an artificial internal device
• need for intermittent pessary removal and cleansing
• inability to have sexual intercourse with certain kinds of pessaries in place
• possible accumulation of vaginal discharge and odor.

Sexual activity and pessaries

Studies by Fernando, Meriwether, and Kuhn concur that for a substantial number of pessary users who are sexually active, both frequency and satisfaction with sexual intercourse are increased.^8,19,20 Kuhn further showed that desire, orgasm, and lubrication improved with the use of pessaries.²⁰ While some types of pessaries do require removal for intercourse, Clemons reported that issues involving sexual activity are not associated with pessary discontinuation.²¹

Using a pessary to predict a surgical outcome

Because a pessary elevates the pelvic organs, supports the vaginal walls, and lifts the bladder and urethra into a position that simulates the results of surgical repair, trial placement of a pessary can be used as a fairly accurate predictive tool to model what pelvic support and continence status will be after a proposed surgical procedure.^22,23 This is especially important because a significant number of patients with POP will have their occult stress incontinence unmasked following a reparative procedure.²⁴ A brief pessary trial prior to surgery, therefore, can be a useful tool for both patient and surgeon.

Continue to: Pessaries for prevention of preterm labor...

Pessaries for prevention of preterm labor

Almost 1 in 10 births in the United States occurs before 37 completed weeks of gestation.²⁵ Obstetricians have long thought that in women at risk for preterm delivery, the use of a pessary might help reduce the pressure of the growing uterus on the cervix and thus help prevent premature cervical dilation. It also has been thought that use of a pessary would be a safer and less invasive alternative to cervical cerclage. Many studies have evaluated the use of pessaries for the prevention of preterm labor with a mixture of positive (TABLE 3)^26-29 and negative results (TABLE 4).^30-33

From these data, it is reasonable to conclude that:

• The final answer concerning the effectiveness or lack thereof of pessary use in preventing preterm delivery is not yet in.
• Any advantage there might be to using pessaries to prevent preterm delivery cannot be too significant if multiple studies show as many negative outcomes as positive ones.

Pessary effectiveness in defecatory disorders

Vaginal birth has the potential to create multiple anatomic injuries in the anus, lower pelvis, and perineum that can affect defecation and bowel control. Tears of the anal sphincter, whether obvious or occult, may heal incompletely or be repaired inadequately.³⁴ Nerve innervation of the perianal and perineal areas can be interrupted or damaged by stretching, tearing, or prolonged compression. Of healthy parous adult women, 7% to 16% admit incontinence of gas or feces.^35,36

In addition, when a rectocele is present, stool in the lower rectum may cause bulging of the anterior rectal wall into the vagina, preventing stool from passing out of the anus. This sometimes requires women to digitally press their posterior vaginal walls during defecation to evacuate stool successfully. The question thus arises as to whether or not pessary placement and subsequent relief of rectoceles might facilitate bowel movements and decrease or eliminate defecatory dysfunction.

As with the issue of pessary use for prevention of preterm delivery, the answer is mixed. For instance, while Brazell¹⁸ showed that there was an overall improvement in bowel symptoms in pessary users, a study by Komesu¹⁰ did not demonstrate improvement.

There is, however, a relatively new device specifically designed to control defecatory problems: the vaginal bowel control system (Eclipse; Pelvalon). The silicon device is placed intravaginally as one does a pessary. After insertion, it is inflated via a valve and syringe. It works by putting pressure on and reversibly closing the lower rectum, thus blocking the uncontrolled passage of stool and gas. It can be worn continuously or intermittently, but it does need to be deflated for normal bowel movements. One trial of this device demonstrated a 50% reduction in incontinence episodes with a patient satisfaction rate of 84% at 3 months.³⁷ This device may well prove to be a valuable nonsurgical approach to the treatment of fecal incontinence. Unfortunately, the device is relatively expensive and usually is not covered by insurance as third-party payers do not consider it to be a pessary (which generally is covered).

Practice management particulars

Useful information on Current Procedural Terminology codes for pessaries, diagnostic codes, and the cost of various pessaries is provided in TABLE 5,³⁸TABLE 6,³⁹ and TABLE 7.^40-42

A contemporary device used since antiquity

Pessaries, considered “old-fashioned” by many gynecologists, are actually a very cost-effective and useful tool for the correction of POP and SUI. It behooves all who provide medical care to women to be familiar with them, to know when they might be useful, and to know how to fit and prescribe them. ●

Over the last 30 years, surgical correction of the common condition pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has become so routine and straightforward that many gynecologists and urogynecologists choose surgery as their first choice for treating these conditions, withholding it only from the riskiest patients or from those who, for a variety of reasons, do not choose surgery. Moreover, as generalist gynecologists increasingly refer patients with POP or incontinence to their urogynecologist colleagues, they increasingly lack the skills, or have not been trained, to use conservative treatment strategies for these disorders. Thus, pessaries—devices constructed of inert plastic, silicone, or latex and placed inside the vagina to support prolapsed pelvic structures—frequently are not part of the general gynecologist’s armamentarium.

When properly selected, however, pessaries used for indicated purposes and correctly fitted are an excellent, inexpensive, low-risk, and noninvasive tool that can provide immediate relief not only of POP but also of SUI and defecatory difficulties. As an alternative to surgery, pessaries are especially valuable, because the other major nonsurgical modality for treatment of POP and incontinence—pelvic floor muscle training—often is not covered by insurance (making it expensive for patients), takes many weekly sessions to complete (which can make access challenging), and frequently is not readily available.¹

POP is very common. An estimated 15% to 30% of women in North America have some degree of prolapse, and more than 500,000 surgeries for this condition are performed in the United States each year.² Risk factors for POP include:

• vaginal childbirth, especially higher parity
• advancing age
• high body mass index (BMI)
• prior hysterectomy
• raised intra-abdominal pressure, such as from obesity, chronic cough, or heavy lifting.

In addition to the discomfort caused by the herniation of pelvic and vaginal structures, POP also is associated with urinary incontinence (73%), urinary urgency and frequency (86%), and fecal incontinence (31%).³

Moreover, according to the US Census Bureau, the number of American women aged 65 or older will double to more than 40 million by 2030.⁴ This will greatly increase the population of women at risk for POP who may be candidates for pessary use. It therefore behooves gynecologists to become familiar with the correct usage, fitting, and maintenance of this effective, nonsurgical mode of treatment for POP.

In this article, I discuss why pessaries are a good option for many patients with POP, review the types of pessaries available, and offer guidance on how to choose the right pessary for an individual patient’s needs. In addition, the box at the end of this article provides an interesting timeline of pessary history dating back to antiquity.

Next month in Part 2 of this article, I cover how to fit a pessary; device aftercare; potential complications of use; and effectiveness of pessaries for POP, SUI, preterm labor prevention, and defecatory disorders.

Continue to: Potential candidates for pessary use...

Potential candidates for pessary use

Almost all women with POP—and in many cases accompanying SUI—are potential candidates for a pessary. In fact, many urogynecologists believe that a trial of pessary usage should be the first treatment modality offered for POP.⁵ Women who cannot use a pessary include those with an extremely short vagina (<6 cm) and those who have severely eroded vaginal mucosa. In the latter situation, the mucosa can be treated with estrogen cream for several weeks and, once the tissue has healed, a pessary can be fitted.

Given that surgical repair is generally a straightforward, one-time procedure that obviates the need for long-term use of an artificial device worn internally, why might a patient or her physician opt for a pessary instead?

Some of the many reasons include:

• Many patients prefer to avoid surgery.
• Many patients are not appropriate candidates for surgery because they have significant comorbid risk factors or high BMI.
• Patients may have recurrent prolapse or incontinence and wish to avoid repeat surgery.
• Patients with SUI may have heard of the occurrence of mesh erosion and wish to avoid that possibility.
• Women who live in low-resource environments or countries where elective surgical care is relatively unavailable may not have the option of surgery.

A clinician might also recommend pessary use:

• as a diagnostic tool to attempt to assess the potential results of vaginal repair surgery
• to estimate the potential effectiveness of a midurethral sling procedure; several investigators have found this to be approximately as accurate as urodynamic testing^6,7
• as prophylaxis for pregnant women with either a history of preterm cervical dilation or a short cervix detected on ultrasonography
• for pregnant women with POP that is worsening and becoming increasingly uncomfortable
• for women with POP who wish to have more children
• for short-term use while a patient is delaying or awaiting POP surgery or to allow time for other medical issues to resolve
• for patients who wish only intermittent, temporary support while exercising or engaging in sports.

Patient acceptance may be contingent on counseling

Numerous studies show that women who choose pessaries to treat POP are generally older than women who elect surgery. Still, patient acceptance of a trial of pessary use depends much on the counseling and information she receives. Properly informed, many patients with POP will opt for a trial of pessary placement. One study showed that, of women with untreated POP, 36% preferred pessary placement to surgery.⁸ Other investigators reported that when women with symptomatic POP had the benefits of a pessary versus surgery explained to them, nearly two-thirds opted for a pessary as their mode of treatment.⁹

Exceptions to pessary use

Fortunately, there are relatively few contraindications to pessary use. These are vaginal or pelvic infection and an exposed foreign body in the vagina, such as eroded vaginal mesh. In addition, patients at risk for nonadherence with follow-up care are poor candidates, as it could lead to missing such problems as mucosal erosion, ulceration, or even (extremely rarely) fistula formation. Pessaries may be inappropriate for sexually active women who on their own are unable to remove and reinsert pessary types that do not allow for intercourse while in place (see below).

Continue to: Types of pessaries...

Types of pessaries

The numerous kinds of pessaries available fall into 3 general categories: support, space filling, and lever, and devices within each group have modifications and variations. As with most areas of prescribing and treatment in medicine, it is best to become very familiar with just a few kinds of pessaries, know their indications, and use them when appropriate.

Most pessaries are constructed of inert silicone which, unlike earlier rubber pessaries, does not absorb odor or discharge. They are easy to clean, long lasting, and are autoclavable and hypoallergenic.

Support pessaries

Support pessaries look like contraceptive diaphragms. They are easy to place and remove, are comfortable, and do an excellent job correcting moderate POP. They also can control or eliminate symptoms of SUI by the pressure they exert on the urethra and their alteration of the urethrovesicular angle.

Ring pessaries. The most commonly used type of pessary, the ring pessary,¹⁰ comes in 4 variations:

• a simple open ring
• a ring with a web of material, called a “support shield,” that fills the ring
• an open ring with a firm 2-cm “incontinence knob” attached that is positioned over the urethra
• a ring with support shield and incontinence knob.

When in position, the deepest edge of a ring pessary fits behind the cervix (or in the vaginal apex for women who have had a hysterectomy) while the front of the ring slips into place behind the pubic symphysis, just like a diaphragm. When a ring with an incontinence knob is used, the ring is rotated until the knob is directly over the urethra.

Sexual intercourse is possible with any of the ring pessaries in place. Of the various types of pessaries, the ring pessary is the easiest to insert and remove. Some women tie a piece of dental floss to the edge of the ring to make its removal even easier.

The ring pessary is available in sizes 0 (44.5 mm) to 13 (127 mm). For most women a size 3, 4, or 5 ring pessary fits well.

The Marland pessary is similar to the ring pessary with the addition of a wedge-shaped piece of material approximately 3 cm in height that arises from half of the ring. It rarely is used in the United States because most American gynecologists are unfamiliar with it, and there is little evidence that it is more effective than the ring pessary.¹¹

The Shaatz pessary is a rigid round pessary, smaller in diameter than the standard ring pessary, and similar to the Gellhorn pessary (discussed below) but without a stem. It is placed the same way one places a ring pessary but with its concave surface up against the cervix or, if there is no cervix, against the upper anterior vaginal wall. Its main benefit is that it provides firmer support than the ring pessary. This pessary is not widely used in the United States.

The Gehrung pessary looks like a flat strip of material that has been bent into the shape of a “U.” It is designed to correct severe cystoceles and rectoceles. For insertion, the edges at the open end of the pessary are squeezed together and the pessary is inserted with the closed part of the “U” facing the anterior vaginal wall. The upper edge is advanced until it rests in the anterior fornix of the vagina (or in the vaginal apex in women who have had a hysterectomy). Although it is more efficacious than some other pessaries for control of vaginal wall prolapse, its unfamiliarity to clinicians and its unusual shape result in it being used rarely.

Continue to: Space-filling pessaries...

Space-filling pessaries

Space-filling pessaries are used when more severe degrees of prolapse are present than can be managed by the ring or other support pessaries. This is especially the case when the vagina is so capacious or the introitus so lax that a standard ring pessary cannot be kept in place, resulting in frequent expulsions.

Space-filling pessaries are 3 dimensional and work by filling the vagina with a relatively large object that prevents the cervix/vaginal apex from dropping down and the vaginal walls from prolapsing. They have a special role for women who:

• are posthysterectomy and have an enterocele and/or vaginal apex prolapse
• have significant rectoceles for which support pessaries are not effective
• have a wide vaginal hiatus and thus are prone to expel support pessaries.

Space-filling pessaries do have some drawbacks compared with support pessaries. For example, they do not help in controlling SUI, and they are difficult for patients to remove on their own for cleaning. In addition, sexual intercourse is impossible with a space-filling pessary in place.

The Gellhorn pessary is the most common of the space-filling pessaries, and it is the one gynecologists and urogynecologists most often use for severe prolapse. It has a concave disc that fits up against the cervix or vaginal apex and a solid stem that points down the vagina. The stem itself is supported by the perineal body. It offers excellent support for severe uterine and vaginal wall prolapse, as long as the perineal body is intact. The stem stabilizes the disc portion of the pessary and prevents pessary expulsion. Gellhorn pessaries are available with long or short stems.

The Gellhorn is inserted into the vagina by folding the stem 90 degrees until it is in the same plane as the disc. With lubricated fingers, the patient’s perineal body is depressed and the disc of the pessary is folded and slid in. The disc is then placed up against the cervix or vaginal apex with the stem pointing down the vagina and tucked just inside the posterior edge of the introitus.

Removing the Gellhorn pessary can be problematic and is difficult for patients to do on their own. Clinicians often must use a ring forceps to grasp the stem of the pessary in order to bring it into the lower vagina, where the stem is folded up against the disc and the entire pessary removed. As with all space-filling pessaries, the Gellhorn must be taken out prior to intercourse.

The Gellhorn pessary is available in sizes that range from a disc diameter of 1.5 to 3.75 inches. Those measuring 2.5, 2.75, or 3 inches are used most commonly.

The cube pessary is a soft, dice-shaped piece of silicone with an indentation in each of its 6 sides. It is used for severe prolapse.

Squeezing the cube allows for easier insertion into the vagina; once it is at the top of the vagina, the cube expands back to its normal shape. The indentations on each side of the cube attach to the vaginal walls with moderate suction, which helps to keep the pessary in place. Because of the suction, the cube pessary can be used in cases of severe prolapse when other pessaries will not stay in place; a drawback is that the suction created by the indented sides can cause vaginal mucosal erosion.¹⁰ Ideally, the cube pessary should be removed every night for cleansing as discharge and accompanying odor can accumulate. The string attached to the cube pessary aids in its removal.

The cube pessary is available in sizes 0 to 7, with edge lengths that range from 1 to 2.25 inches.

The donut pessary, as its name suggests, has the form of a large donut. It can be compressed slightly to help with insertion. Because it occupies a large space within the vagina, it is used (like the cube pessary) for treatment of severe prolapse. The size and shape of the donut pessary, however, can make it difficult for patients to insert and take out on their own.

The donut pessary is available in sizes 0 (51 mm) to 8 (95 mm).

The inflatable pessary has the same basic shape as the donut pessary and serves the same purpose: It acts as a large semisoft object that fills the vagina to support the vaginal walls and cervix (or vaginal apex) in cases of severe prolapse. The inflatable pessary differs in that it has a valve on a stem through which air can be inserted and removed. This allows the uninflated pessary to be placed relatively easily into the vagina and then pumped full of air to the dimensions necessary to prevent vaginal, cervical, uterine, or apex prolapse. Air likewise can be removed to facilitate pessary removal.

One drawback of the inflatable pessary is that it is made of latex and thus cannot be used by anyone with a latex allergy. Also, as latex retains discharge and odors, this pessary should be removed and washed daily.

The inflatable pessary is available in sizes that range from 2 to 2.75 inches in 0.25-inch increments.

Continue to: Space-filling pessaries...

In addition to the more commonly used support and space-filling pessaries, there is a third kind that is rarely used in current practice: the lever pessaries. These pessaries—the Hodge, the Smith, and the Risser—are rectangles made of inert plastic that are folded into 3 planes to facilitate positioning in the vagina. The narrower of the 2 shorter ends of the folded rectangle is placed behind the cervix or at the vaginal apex while the other short end is placed behind the symphysis pubis.

Although sometimes used to correct POP in nonpregnant women, the lever pessary’s main purpose is to antivert a retroflexed uterus and to support the cervix and uterus in cases of prolapse during pregnancy or impending cervical incompetence.

The 3 lever pessaries differ in terms of whether the narrow ends of the pessary are straight or curved and wider or narrower.

How to choose the right pessary for your patient

If a patient’s POP or urinary incontinence symptoms would best be treated with a pessary, the next step is to select the pessary type and size best suited for that patient’s needs and the size that should be prescribed. While there is controversy among experts as to whether or not certain pessaries are better than others for different indications,¹² most gynecologists and urogynecologists who use pessaries on a regular basis agree on the following:

1. Support pessaries will meet the needs of most women with moderate POP and/or SUI. These include the ring pessary with or without the support shield and with or without an incontinence knob. A support pessary is the go-to pessary in most cases. Most women find it comfortable to wear, it is easy to put in and take out, and sexual intercourse is possible with the pessary in place.

2. The specific degree of a patient’s prolapse and/or incontinence dictates whether or not to prescribe the support shield feature or the incontinence knob with a ring pessary. The shield helps support a prolapsed cervix and uterus when they are present.^5,13 The knob is a useful feature if incontinence is a prominent symptom.

3. The Gellhorn pessary is usually the first choice for more severe prolapse. As long as there is some degree of posterior perineal support, this pessary does an excellent job of correcting even severe prolapse whether of a cervix and uterus or of vaginal walls and apex. It does require the patient to have some practice and dexterity for inserting and removing it on her own; individuals not comfortable or physically able to do so will need to have the pessary removed and cleaned by a clinician on a regular basis in the office. (Part 2 of this article will discuss pessary cleansing intervals).

4. Space-filling pessaries (such as the cube and donut) are useful when there is a severe degree of prolapse and insufficient perineal support to maintain a Gellhorn pessary. In practice, they are generally used less frequently—which is unfortunate, as they are a potentially useful solution for older women with severe prolapse who might not be candidates for surgical repair. As mentioned, both the cube and donut pessaries require more frequent removal for cleaning.

5. In unusual cases, the use of 2 pessaries simultaneously may resolve a difficult problem, such as when a pessary is the only option for treatment, the prolapse is severe, or it is impossible to find a pessary that resists being expelled from the vagina.¹⁴ A space-filling pessary in the most cephalad aspect of the vagina used in conjunction with a ring pessary with support shield below it can sometimes resolve even the worst cases of prolapse.

Continue to: Stay tuned...

Stay tuned

Part 2 of this article next month will provide more information on pessaries, including fitting, aftercare, potential complications, and effectiveness in various disorders. ●

Over the last 30 years, surgical correction of the common condition pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has become so routine and straightforward that many gynecologists and urogynecologists choose surgery as their first choice for treating these conditions, withholding it only from the riskiest patients or from those who, for a variety of reasons, do not choose surgery. Moreover, as generalist gynecologists increasingly refer patients with POP or incontinence to their urogynecologist colleagues, they increasingly lack the skills, or have not been trained, to use conservative treatment strategies for these disorders. Thus, pessaries—devices constructed of inert plastic, silicone, or latex and placed inside the vagina to support prolapsed pelvic structures—frequently are not part of the general gynecologist’s armamentarium.

When properly selected, however, pessaries used for indicated purposes and correctly fitted are an excellent, inexpensive, low-risk, and noninvasive tool that can provide immediate relief not only of POP but also of SUI and defecatory difficulties. As an alternative to surgery, pessaries are especially valuable, because the other major nonsurgical modality for treatment of POP and incontinence—pelvic floor muscle training—often is not covered by insurance (making it expensive for patients), takes many weekly sessions to complete (which can make access challenging), and frequently is not readily available.¹

POP is very common. An estimated 15% to 30% of women in North America have some degree of prolapse, and more than 500,000 surgeries for this condition are performed in the United States each year.² Risk factors for POP include:

• vaginal childbirth, especially higher parity
• advancing age
• high body mass index (BMI)
• prior hysterectomy
• raised intra-abdominal pressure, such as from obesity, chronic cough, or heavy lifting.

In addition to the discomfort caused by the herniation of pelvic and vaginal structures, POP also is associated with urinary incontinence (73%), urinary urgency and frequency (86%), and fecal incontinence (31%).³

Moreover, according to the US Census Bureau, the number of American women aged 65 or older will double to more than 40 million by 2030.⁴ This will greatly increase the population of women at risk for POP who may be candidates for pessary use. It therefore behooves gynecologists to become familiar with the correct usage, fitting, and maintenance of this effective, nonsurgical mode of treatment for POP.

In this article, I discuss why pessaries are a good option for many patients with POP, review the types of pessaries available, and offer guidance on how to choose the right pessary for an individual patient’s needs. In addition, the box at the end of this article provides an interesting timeline of pessary history dating back to antiquity.

Next month in Part 2 of this article, I cover how to fit a pessary; device aftercare; potential complications of use; and effectiveness of pessaries for POP, SUI, preterm labor prevention, and defecatory disorders.

Continue to: Potential candidates for pessary use...

Potential candidates for pessary use

Almost all women with POP—and in many cases accompanying SUI—are potential candidates for a pessary. In fact, many urogynecologists believe that a trial of pessary usage should be the first treatment modality offered for POP.⁵ Women who cannot use a pessary include those with an extremely short vagina (<6 cm) and those who have severely eroded vaginal mucosa. In the latter situation, the mucosa can be treated with estrogen cream for several weeks and, once the tissue has healed, a pessary can be fitted.

Given that surgical repair is generally a straightforward, one-time procedure that obviates the need for long-term use of an artificial device worn internally, why might a patient or her physician opt for a pessary instead?

Some of the many reasons include:

• Many patients prefer to avoid surgery.
• Many patients are not appropriate candidates for surgery because they have significant comorbid risk factors or high BMI.
• Patients may have recurrent prolapse or incontinence and wish to avoid repeat surgery.
• Patients with SUI may have heard of the occurrence of mesh erosion and wish to avoid that possibility.
• Women who live in low-resource environments or countries where elective surgical care is relatively unavailable may not have the option of surgery.

A clinician might also recommend pessary use:

• as a diagnostic tool to attempt to assess the potential results of vaginal repair surgery
• to estimate the potential effectiveness of a midurethral sling procedure; several investigators have found this to be approximately as accurate as urodynamic testing^6,7
• as prophylaxis for pregnant women with either a history of preterm cervical dilation or a short cervix detected on ultrasonography
• for pregnant women with POP that is worsening and becoming increasingly uncomfortable
• for women with POP who wish to have more children
• for short-term use while a patient is delaying or awaiting POP surgery or to allow time for other medical issues to resolve
• for patients who wish only intermittent, temporary support while exercising or engaging in sports.

Patient acceptance may be contingent on counseling

Numerous studies show that women who choose pessaries to treat POP are generally older than women who elect surgery. Still, patient acceptance of a trial of pessary use depends much on the counseling and information she receives. Properly informed, many patients with POP will opt for a trial of pessary placement. One study showed that, of women with untreated POP, 36% preferred pessary placement to surgery.⁸ Other investigators reported that when women with symptomatic POP had the benefits of a pessary versus surgery explained to them, nearly two-thirds opted for a pessary as their mode of treatment.⁹

Exceptions to pessary use

Fortunately, there are relatively few contraindications to pessary use. These are vaginal or pelvic infection and an exposed foreign body in the vagina, such as eroded vaginal mesh. In addition, patients at risk for nonadherence with follow-up care are poor candidates, as it could lead to missing such problems as mucosal erosion, ulceration, or even (extremely rarely) fistula formation. Pessaries may be inappropriate for sexually active women who on their own are unable to remove and reinsert pessary types that do not allow for intercourse while in place (see below).

Continue to: Types of pessaries...

Types of pessaries

The numerous kinds of pessaries available fall into 3 general categories: support, space filling, and lever, and devices within each group have modifications and variations. As with most areas of prescribing and treatment in medicine, it is best to become very familiar with just a few kinds of pessaries, know their indications, and use them when appropriate.

Most pessaries are constructed of inert silicone which, unlike earlier rubber pessaries, does not absorb odor or discharge. They are easy to clean, long lasting, and are autoclavable and hypoallergenic.

Support pessaries

Support pessaries look like contraceptive diaphragms. They are easy to place and remove, are comfortable, and do an excellent job correcting moderate POP. They also can control or eliminate symptoms of SUI by the pressure they exert on the urethra and their alteration of the urethrovesicular angle.

Ring pessaries. The most commonly used type of pessary, the ring pessary,¹⁰ comes in 4 variations:

• a simple open ring
• a ring with a web of material, called a “support shield,” that fills the ring
• an open ring with a firm 2-cm “incontinence knob” attached that is positioned over the urethra
• a ring with support shield and incontinence knob.

When in position, the deepest edge of a ring pessary fits behind the cervix (or in the vaginal apex for women who have had a hysterectomy) while the front of the ring slips into place behind the pubic symphysis, just like a diaphragm. When a ring with an incontinence knob is used, the ring is rotated until the knob is directly over the urethra.

Sexual intercourse is possible with any of the ring pessaries in place. Of the various types of pessaries, the ring pessary is the easiest to insert and remove. Some women tie a piece of dental floss to the edge of the ring to make its removal even easier.

The ring pessary is available in sizes 0 (44.5 mm) to 13 (127 mm). For most women a size 3, 4, or 5 ring pessary fits well.

The Marland pessary is similar to the ring pessary with the addition of a wedge-shaped piece of material approximately 3 cm in height that arises from half of the ring. It rarely is used in the United States because most American gynecologists are unfamiliar with it, and there is little evidence that it is more effective than the ring pessary.¹¹

The Shaatz pessary is a rigid round pessary, smaller in diameter than the standard ring pessary, and similar to the Gellhorn pessary (discussed below) but without a stem. It is placed the same way one places a ring pessary but with its concave surface up against the cervix or, if there is no cervix, against the upper anterior vaginal wall. Its main benefit is that it provides firmer support than the ring pessary. This pessary is not widely used in the United States.

The Gehrung pessary looks like a flat strip of material that has been bent into the shape of a “U.” It is designed to correct severe cystoceles and rectoceles. For insertion, the edges at the open end of the pessary are squeezed together and the pessary is inserted with the closed part of the “U” facing the anterior vaginal wall. The upper edge is advanced until it rests in the anterior fornix of the vagina (or in the vaginal apex in women who have had a hysterectomy). Although it is more efficacious than some other pessaries for control of vaginal wall prolapse, its unfamiliarity to clinicians and its unusual shape result in it being used rarely.

Continue to: Space-filling pessaries...

Space-filling pessaries

Space-filling pessaries are used when more severe degrees of prolapse are present than can be managed by the ring or other support pessaries. This is especially the case when the vagina is so capacious or the introitus so lax that a standard ring pessary cannot be kept in place, resulting in frequent expulsions.

Space-filling pessaries are 3 dimensional and work by filling the vagina with a relatively large object that prevents the cervix/vaginal apex from dropping down and the vaginal walls from prolapsing. They have a special role for women who:

• are posthysterectomy and have an enterocele and/or vaginal apex prolapse
• have significant rectoceles for which support pessaries are not effective
• have a wide vaginal hiatus and thus are prone to expel support pessaries.

Space-filling pessaries do have some drawbacks compared with support pessaries. For example, they do not help in controlling SUI, and they are difficult for patients to remove on their own for cleaning. In addition, sexual intercourse is impossible with a space-filling pessary in place.

The Gellhorn pessary is the most common of the space-filling pessaries, and it is the one gynecologists and urogynecologists most often use for severe prolapse. It has a concave disc that fits up against the cervix or vaginal apex and a solid stem that points down the vagina. The stem itself is supported by the perineal body. It offers excellent support for severe uterine and vaginal wall prolapse, as long as the perineal body is intact. The stem stabilizes the disc portion of the pessary and prevents pessary expulsion. Gellhorn pessaries are available with long or short stems.

The Gellhorn is inserted into the vagina by folding the stem 90 degrees until it is in the same plane as the disc. With lubricated fingers, the patient’s perineal body is depressed and the disc of the pessary is folded and slid in. The disc is then placed up against the cervix or vaginal apex with the stem pointing down the vagina and tucked just inside the posterior edge of the introitus.

Removing the Gellhorn pessary can be problematic and is difficult for patients to do on their own. Clinicians often must use a ring forceps to grasp the stem of the pessary in order to bring it into the lower vagina, where the stem is folded up against the disc and the entire pessary removed. As with all space-filling pessaries, the Gellhorn must be taken out prior to intercourse.

The Gellhorn pessary is available in sizes that range from a disc diameter of 1.5 to 3.75 inches. Those measuring 2.5, 2.75, or 3 inches are used most commonly.

The cube pessary is a soft, dice-shaped piece of silicone with an indentation in each of its 6 sides. It is used for severe prolapse.

Squeezing the cube allows for easier insertion into the vagina; once it is at the top of the vagina, the cube expands back to its normal shape. The indentations on each side of the cube attach to the vaginal walls with moderate suction, which helps to keep the pessary in place. Because of the suction, the cube pessary can be used in cases of severe prolapse when other pessaries will not stay in place; a drawback is that the suction created by the indented sides can cause vaginal mucosal erosion.¹⁰ Ideally, the cube pessary should be removed every night for cleansing as discharge and accompanying odor can accumulate. The string attached to the cube pessary aids in its removal.

The cube pessary is available in sizes 0 to 7, with edge lengths that range from 1 to 2.25 inches.

The donut pessary, as its name suggests, has the form of a large donut. It can be compressed slightly to help with insertion. Because it occupies a large space within the vagina, it is used (like the cube pessary) for treatment of severe prolapse. The size and shape of the donut pessary, however, can make it difficult for patients to insert and take out on their own.

The donut pessary is available in sizes 0 (51 mm) to 8 (95 mm).

The inflatable pessary has the same basic shape as the donut pessary and serves the same purpose: It acts as a large semisoft object that fills the vagina to support the vaginal walls and cervix (or vaginal apex) in cases of severe prolapse. The inflatable pessary differs in that it has a valve on a stem through which air can be inserted and removed. This allows the uninflated pessary to be placed relatively easily into the vagina and then pumped full of air to the dimensions necessary to prevent vaginal, cervical, uterine, or apex prolapse. Air likewise can be removed to facilitate pessary removal.

One drawback of the inflatable pessary is that it is made of latex and thus cannot be used by anyone with a latex allergy. Also, as latex retains discharge and odors, this pessary should be removed and washed daily.

The inflatable pessary is available in sizes that range from 2 to 2.75 inches in 0.25-inch increments.

Continue to: Space-filling pessaries...

In addition to the more commonly used support and space-filling pessaries, there is a third kind that is rarely used in current practice: the lever pessaries. These pessaries—the Hodge, the Smith, and the Risser—are rectangles made of inert plastic that are folded into 3 planes to facilitate positioning in the vagina. The narrower of the 2 shorter ends of the folded rectangle is placed behind the cervix or at the vaginal apex while the other short end is placed behind the symphysis pubis.

Although sometimes used to correct POP in nonpregnant women, the lever pessary’s main purpose is to antivert a retroflexed uterus and to support the cervix and uterus in cases of prolapse during pregnancy or impending cervical incompetence.

The 3 lever pessaries differ in terms of whether the narrow ends of the pessary are straight or curved and wider or narrower.

How to choose the right pessary for your patient

If a patient’s POP or urinary incontinence symptoms would best be treated with a pessary, the next step is to select the pessary type and size best suited for that patient’s needs and the size that should be prescribed. While there is controversy among experts as to whether or not certain pessaries are better than others for different indications,¹² most gynecologists and urogynecologists who use pessaries on a regular basis agree on the following:

1. Support pessaries will meet the needs of most women with moderate POP and/or SUI. These include the ring pessary with or without the support shield and with or without an incontinence knob. A support pessary is the go-to pessary in most cases. Most women find it comfortable to wear, it is easy to put in and take out, and sexual intercourse is possible with the pessary in place.

2. The specific degree of a patient’s prolapse and/or incontinence dictates whether or not to prescribe the support shield feature or the incontinence knob with a ring pessary. The shield helps support a prolapsed cervix and uterus when they are present.^5,13 The knob is a useful feature if incontinence is a prominent symptom.

3. The Gellhorn pessary is usually the first choice for more severe prolapse. As long as there is some degree of posterior perineal support, this pessary does an excellent job of correcting even severe prolapse whether of a cervix and uterus or of vaginal walls and apex. It does require the patient to have some practice and dexterity for inserting and removing it on her own; individuals not comfortable or physically able to do so will need to have the pessary removed and cleaned by a clinician on a regular basis in the office. (Part 2 of this article will discuss pessary cleansing intervals).

4. Space-filling pessaries (such as the cube and donut) are useful when there is a severe degree of prolapse and insufficient perineal support to maintain a Gellhorn pessary. In practice, they are generally used less frequently—which is unfortunate, as they are a potentially useful solution for older women with severe prolapse who might not be candidates for surgical repair. As mentioned, both the cube and donut pessaries require more frequent removal for cleaning.

5. In unusual cases, the use of 2 pessaries simultaneously may resolve a difficult problem, such as when a pessary is the only option for treatment, the prolapse is severe, or it is impossible to find a pessary that resists being expelled from the vagina.¹⁴ A space-filling pessary in the most cephalad aspect of the vagina used in conjunction with a ring pessary with support shield below it can sometimes resolve even the worst cases of prolapse.

Continue to: Stay tuned...

Stay tuned

Part 2 of this article next month will provide more information on pessaries, including fitting, aftercare, potential complications, and effectiveness in various disorders. ●

Over the last 30 years, surgical correction of the common condition pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has become so routine and straightforward that many gynecologists and urogynecologists choose surgery as their first choice for treating these conditions, withholding it only from the riskiest patients or from those who, for a variety of reasons, do not choose surgery. Moreover, as generalist gynecologists increasingly refer patients with POP or incontinence to their urogynecologist colleagues, they increasingly lack the skills, or have not been trained, to use conservative treatment strategies for these disorders. Thus, pessaries—devices constructed of inert plastic, silicone, or latex and placed inside the vagina to support prolapsed pelvic structures—frequently are not part of the general gynecologist’s armamentarium.

When properly selected, however, pessaries used for indicated purposes and correctly fitted are an excellent, inexpensive, low-risk, and noninvasive tool that can provide immediate relief not only of POP but also of SUI and defecatory difficulties. As an alternative to surgery, pessaries are especially valuable, because the other major nonsurgical modality for treatment of POP and incontinence—pelvic floor muscle training—often is not covered by insurance (making it expensive for patients), takes many weekly sessions to complete (which can make access challenging), and frequently is not readily available.¹

POP is very common. An estimated 15% to 30% of women in North America have some degree of prolapse, and more than 500,000 surgeries for this condition are performed in the United States each year.² Risk factors for POP include:

• vaginal childbirth, especially higher parity
• advancing age
• high body mass index (BMI)
• prior hysterectomy
• raised intra-abdominal pressure, such as from obesity, chronic cough, or heavy lifting.

In addition to the discomfort caused by the herniation of pelvic and vaginal structures, POP also is associated with urinary incontinence (73%), urinary urgency and frequency (86%), and fecal incontinence (31%).³

Moreover, according to the US Census Bureau, the number of American women aged 65 or older will double to more than 40 million by 2030.⁴ This will greatly increase the population of women at risk for POP who may be candidates for pessary use. It therefore behooves gynecologists to become familiar with the correct usage, fitting, and maintenance of this effective, nonsurgical mode of treatment for POP.

In this article, I discuss why pessaries are a good option for many patients with POP, review the types of pessaries available, and offer guidance on how to choose the right pessary for an individual patient’s needs. In addition, the box at the end of this article provides an interesting timeline of pessary history dating back to antiquity.

Next month in Part 2 of this article, I cover how to fit a pessary; device aftercare; potential complications of use; and effectiveness of pessaries for POP, SUI, preterm labor prevention, and defecatory disorders.

Continue to: Potential candidates for pessary use...

Potential candidates for pessary use

Almost all women with POP—and in many cases accompanying SUI—are potential candidates for a pessary. In fact, many urogynecologists believe that a trial of pessary usage should be the first treatment modality offered for POP.⁵ Women who cannot use a pessary include those with an extremely short vagina (<6 cm) and those who have severely eroded vaginal mucosa. In the latter situation, the mucosa can be treated with estrogen cream for several weeks and, once the tissue has healed, a pessary can be fitted.

Given that surgical repair is generally a straightforward, one-time procedure that obviates the need for long-term use of an artificial device worn internally, why might a patient or her physician opt for a pessary instead?

Some of the many reasons include:

• Many patients prefer to avoid surgery.
• Many patients are not appropriate candidates for surgery because they have significant comorbid risk factors or high BMI.
• Patients may have recurrent prolapse or incontinence and wish to avoid repeat surgery.
• Patients with SUI may have heard of the occurrence of mesh erosion and wish to avoid that possibility.
• Women who live in low-resource environments or countries where elective surgical care is relatively unavailable may not have the option of surgery.

A clinician might also recommend pessary use:

• as a diagnostic tool to attempt to assess the potential results of vaginal repair surgery
• to estimate the potential effectiveness of a midurethral sling procedure; several investigators have found this to be approximately as accurate as urodynamic testing^6,7
• as prophylaxis for pregnant women with either a history of preterm cervical dilation or a short cervix detected on ultrasonography
• for pregnant women with POP that is worsening and becoming increasingly uncomfortable
• for women with POP who wish to have more children
• for short-term use while a patient is delaying or awaiting POP surgery or to allow time for other medical issues to resolve
• for patients who wish only intermittent, temporary support while exercising or engaging in sports.

Patient acceptance may be contingent on counseling

Numerous studies show that women who choose pessaries to treat POP are generally older than women who elect surgery. Still, patient acceptance of a trial of pessary use depends much on the counseling and information she receives. Properly informed, many patients with POP will opt for a trial of pessary placement. One study showed that, of women with untreated POP, 36% preferred pessary placement to surgery.⁸ Other investigators reported that when women with symptomatic POP had the benefits of a pessary versus surgery explained to them, nearly two-thirds opted for a pessary as their mode of treatment.⁹

Exceptions to pessary use

Fortunately, there are relatively few contraindications to pessary use. These are vaginal or pelvic infection and an exposed foreign body in the vagina, such as eroded vaginal mesh. In addition, patients at risk for nonadherence with follow-up care are poor candidates, as it could lead to missing such problems as mucosal erosion, ulceration, or even (extremely rarely) fistula formation. Pessaries may be inappropriate for sexually active women who on their own are unable to remove and reinsert pessary types that do not allow for intercourse while in place (see below).

Continue to: Types of pessaries...

Types of pessaries

The numerous kinds of pessaries available fall into 3 general categories: support, space filling, and lever, and devices within each group have modifications and variations. As with most areas of prescribing and treatment in medicine, it is best to become very familiar with just a few kinds of pessaries, know their indications, and use them when appropriate.

Most pessaries are constructed of inert silicone which, unlike earlier rubber pessaries, does not absorb odor or discharge. They are easy to clean, long lasting, and are autoclavable and hypoallergenic.

Support pessaries

Support pessaries look like contraceptive diaphragms. They are easy to place and remove, are comfortable, and do an excellent job correcting moderate POP. They also can control or eliminate symptoms of SUI by the pressure they exert on the urethra and their alteration of the urethrovesicular angle.

Ring pessaries. The most commonly used type of pessary, the ring pessary,¹⁰ comes in 4 variations:

• a simple open ring
• a ring with a web of material, called a “support shield,” that fills the ring
• an open ring with a firm 2-cm “incontinence knob” attached that is positioned over the urethra
• a ring with support shield and incontinence knob.

When in position, the deepest edge of a ring pessary fits behind the cervix (or in the vaginal apex for women who have had a hysterectomy) while the front of the ring slips into place behind the pubic symphysis, just like a diaphragm. When a ring with an incontinence knob is used, the ring is rotated until the knob is directly over the urethra.

Sexual intercourse is possible with any of the ring pessaries in place. Of the various types of pessaries, the ring pessary is the easiest to insert and remove. Some women tie a piece of dental floss to the edge of the ring to make its removal even easier.

The ring pessary is available in sizes 0 (44.5 mm) to 13 (127 mm). For most women a size 3, 4, or 5 ring pessary fits well.

The Marland pessary is similar to the ring pessary with the addition of a wedge-shaped piece of material approximately 3 cm in height that arises from half of the ring. It rarely is used in the United States because most American gynecologists are unfamiliar with it, and there is little evidence that it is more effective than the ring pessary.¹¹

The Shaatz pessary is a rigid round pessary, smaller in diameter than the standard ring pessary, and similar to the Gellhorn pessary (discussed below) but without a stem. It is placed the same way one places a ring pessary but with its concave surface up against the cervix or, if there is no cervix, against the upper anterior vaginal wall. Its main benefit is that it provides firmer support than the ring pessary. This pessary is not widely used in the United States.

The Gehrung pessary looks like a flat strip of material that has been bent into the shape of a “U.” It is designed to correct severe cystoceles and rectoceles. For insertion, the edges at the open end of the pessary are squeezed together and the pessary is inserted with the closed part of the “U” facing the anterior vaginal wall. The upper edge is advanced until it rests in the anterior fornix of the vagina (or in the vaginal apex in women who have had a hysterectomy). Although it is more efficacious than some other pessaries for control of vaginal wall prolapse, its unfamiliarity to clinicians and its unusual shape result in it being used rarely.

Continue to: Space-filling pessaries...

Space-filling pessaries

Space-filling pessaries are used when more severe degrees of prolapse are present than can be managed by the ring or other support pessaries. This is especially the case when the vagina is so capacious or the introitus so lax that a standard ring pessary cannot be kept in place, resulting in frequent expulsions.

Space-filling pessaries are 3 dimensional and work by filling the vagina with a relatively large object that prevents the cervix/vaginal apex from dropping down and the vaginal walls from prolapsing. They have a special role for women who:

• are posthysterectomy and have an enterocele and/or vaginal apex prolapse
• have significant rectoceles for which support pessaries are not effective
• have a wide vaginal hiatus and thus are prone to expel support pessaries.

Space-filling pessaries do have some drawbacks compared with support pessaries. For example, they do not help in controlling SUI, and they are difficult for patients to remove on their own for cleaning. In addition, sexual intercourse is impossible with a space-filling pessary in place.

The Gellhorn pessary is the most common of the space-filling pessaries, and it is the one gynecologists and urogynecologists most often use for severe prolapse. It has a concave disc that fits up against the cervix or vaginal apex and a solid stem that points down the vagina. The stem itself is supported by the perineal body. It offers excellent support for severe uterine and vaginal wall prolapse, as long as the perineal body is intact. The stem stabilizes the disc portion of the pessary and prevents pessary expulsion. Gellhorn pessaries are available with long or short stems.

The Gellhorn is inserted into the vagina by folding the stem 90 degrees until it is in the same plane as the disc. With lubricated fingers, the patient’s perineal body is depressed and the disc of the pessary is folded and slid in. The disc is then placed up against the cervix or vaginal apex with the stem pointing down the vagina and tucked just inside the posterior edge of the introitus.

Removing the Gellhorn pessary can be problematic and is difficult for patients to do on their own. Clinicians often must use a ring forceps to grasp the stem of the pessary in order to bring it into the lower vagina, where the stem is folded up against the disc and the entire pessary removed. As with all space-filling pessaries, the Gellhorn must be taken out prior to intercourse.

The Gellhorn pessary is available in sizes that range from a disc diameter of 1.5 to 3.75 inches. Those measuring 2.5, 2.75, or 3 inches are used most commonly.

The cube pessary is a soft, dice-shaped piece of silicone with an indentation in each of its 6 sides. It is used for severe prolapse.

Squeezing the cube allows for easier insertion into the vagina; once it is at the top of the vagina, the cube expands back to its normal shape. The indentations on each side of the cube attach to the vaginal walls with moderate suction, which helps to keep the pessary in place. Because of the suction, the cube pessary can be used in cases of severe prolapse when other pessaries will not stay in place; a drawback is that the suction created by the indented sides can cause vaginal mucosal erosion.¹⁰ Ideally, the cube pessary should be removed every night for cleansing as discharge and accompanying odor can accumulate. The string attached to the cube pessary aids in its removal.

The cube pessary is available in sizes 0 to 7, with edge lengths that range from 1 to 2.25 inches.

The donut pessary, as its name suggests, has the form of a large donut. It can be compressed slightly to help with insertion. Because it occupies a large space within the vagina, it is used (like the cube pessary) for treatment of severe prolapse. The size and shape of the donut pessary, however, can make it difficult for patients to insert and take out on their own.

The donut pessary is available in sizes 0 (51 mm) to 8 (95 mm).

The inflatable pessary has the same basic shape as the donut pessary and serves the same purpose: It acts as a large semisoft object that fills the vagina to support the vaginal walls and cervix (or vaginal apex) in cases of severe prolapse. The inflatable pessary differs in that it has a valve on a stem through which air can be inserted and removed. This allows the uninflated pessary to be placed relatively easily into the vagina and then pumped full of air to the dimensions necessary to prevent vaginal, cervical, uterine, or apex prolapse. Air likewise can be removed to facilitate pessary removal.

One drawback of the inflatable pessary is that it is made of latex and thus cannot be used by anyone with a latex allergy. Also, as latex retains discharge and odors, this pessary should be removed and washed daily.

The inflatable pessary is available in sizes that range from 2 to 2.75 inches in 0.25-inch increments.

Continue to: Space-filling pessaries...

In addition to the more commonly used support and space-filling pessaries, there is a third kind that is rarely used in current practice: the lever pessaries. These pessaries—the Hodge, the Smith, and the Risser—are rectangles made of inert plastic that are folded into 3 planes to facilitate positioning in the vagina. The narrower of the 2 shorter ends of the folded rectangle is placed behind the cervix or at the vaginal apex while the other short end is placed behind the symphysis pubis.

Although sometimes used to correct POP in nonpregnant women, the lever pessary’s main purpose is to antivert a retroflexed uterus and to support the cervix and uterus in cases of prolapse during pregnancy or impending cervical incompetence.

The 3 lever pessaries differ in terms of whether the narrow ends of the pessary are straight or curved and wider or narrower.

How to choose the right pessary for your patient

If a patient’s POP or urinary incontinence symptoms would best be treated with a pessary, the next step is to select the pessary type and size best suited for that patient’s needs and the size that should be prescribed. While there is controversy among experts as to whether or not certain pessaries are better than others for different indications,¹² most gynecologists and urogynecologists who use pessaries on a regular basis agree on the following:

1. Support pessaries will meet the needs of most women with moderate POP and/or SUI. These include the ring pessary with or without the support shield and with or without an incontinence knob. A support pessary is the go-to pessary in most cases. Most women find it comfortable to wear, it is easy to put in and take out, and sexual intercourse is possible with the pessary in place.

2. The specific degree of a patient’s prolapse and/or incontinence dictates whether or not to prescribe the support shield feature or the incontinence knob with a ring pessary. The shield helps support a prolapsed cervix and uterus when they are present.^5,13 The knob is a useful feature if incontinence is a prominent symptom.

3. The Gellhorn pessary is usually the first choice for more severe prolapse. As long as there is some degree of posterior perineal support, this pessary does an excellent job of correcting even severe prolapse whether of a cervix and uterus or of vaginal walls and apex. It does require the patient to have some practice and dexterity for inserting and removing it on her own; individuals not comfortable or physically able to do so will need to have the pessary removed and cleaned by a clinician on a regular basis in the office. (Part 2 of this article will discuss pessary cleansing intervals).

4. Space-filling pessaries (such as the cube and donut) are useful when there is a severe degree of prolapse and insufficient perineal support to maintain a Gellhorn pessary. In practice, they are generally used less frequently—which is unfortunate, as they are a potentially useful solution for older women with severe prolapse who might not be candidates for surgical repair. As mentioned, both the cube and donut pessaries require more frequent removal for cleaning.

5. In unusual cases, the use of 2 pessaries simultaneously may resolve a difficult problem, such as when a pessary is the only option for treatment, the prolapse is severe, or it is impossible to find a pessary that resists being expelled from the vagina.¹⁴ A space-filling pessary in the most cephalad aspect of the vagina used in conjunction with a ring pessary with support shield below it can sometimes resolve even the worst cases of prolapse.

Continue to: Stay tuned...

Stay tuned

Part 2 of this article next month will provide more information on pessaries, including fitting, aftercare, potential complications, and effectiveness in various disorders. ●

Obstetricians are often blamed for causing neonatal brachial plexus palsy (NBPP). For that reason, understanding the true pathophysiology and causation of this birth-related entity is of extreme importance.

In Part 1 of this two-part series, I summarized findings from the new report on NBPP from the American College of Obstetricians and Gynecologists (ACOG), focusing on whether the phenomenon of shoulder dystocia and NBPP can be predicted or prevented.¹ Here, in Part 2, I focus on ACOG’s conclusions concerning pathophysiology and causation of NBPP, as well as the College’s recommendations for applying that knowledge to practice.

Some infants are more susceptible than others to the forces of labor and delivery
Babies emerge from the uterus and maternal pelvis by a combination of uterine ­contractions and maternal pushing (endogenous forces) aided by the traction forces applied by the birth attendant (exogenous forces). Research over the past 2 decades has shown that endogenous forces play a significant—if not dominant—role in the causation of NBPP.

Stretching and potential injury to the brachial plexus occur when the long axis of the fetus is pushed down the birth canal while either the maternal symphysis pubis or sacral promontory catches and holds either the anterior or posterior shoulder of the fetus, respectively. This conjunction of events generates a stretching force on the tissues that connect the fetal trunk and head—the neck—under which lies the brachial plexus. The same anatomic relationships and labor forces also vigorously compress the fetal neck against the maternal symphysis pubis or sacral promontory and may cause compression injury. Any traction applied by the clinician accentuates these stretching and pressure forces acting on the nerves of the brachial plexus.

How the neonate responds to these forces depends on the tensile strength of its tissues, the metabolic condition of the fetus after a potentially long labor (as measured by acid-base status), the degree of protective muscle tone around the fetal shoulder and neck, and other fluctuating conditions. In other words, because of the many variables involved, some fetuses are more or less susceptible to injury than others.

Maternal forces alone can cause NBPP
The ACOG report¹ makes an important statement:

Some plaintiff attorneys and their expert witnesses have tried to make the case that, although endogenous forces can cause temporary brachial plexus injuries, they cannot cause permanent brachial plexus injuries. However, as the ACOG report goes on to state:

The report acknowledges that the clinician can increase brachial plexus stretch by applying downward lateral traction to the neonate’s head during delivery efforts. However, contrary to claims often made by the plaintiff bar, in the presence of shoulder dystocia, even properly applied axial traction will necessarily increase the stretching of the brachial plexus. The report also notes that traction applied in the plane of the fetal cervicothoracic spine typically is along a vector estimated to be 25° to 45° below the horizontal plane of a woman in lithotomy position, not in an exact straight line with the maternal trunk. This degree of delivery force below the horizon is defined as normal “axial traction.”

Exogenous forces have yet to be definitively measured
Multiple attempts have been made to quantify the amount of force applied by clinicians in various delivery scenarios. However, in the published studies in which this force has been “measured,” the accuracy of the findings has not been validated. The three studies in which delivery force was directly measured in a clinical setting “provide a limited assessment of exogenous forces” and “do not address the angle at which forces were applied.”^3–5 All other studies used artificial models.

As a result, few conclusions from such studies are directly applicable to the clinical arena. Moreover, in other studies using simulated birth scenarios, there was no feedback to participating clinicians as to whether the force they applied would have been sufficient to deliver the “fetus.” It was therefore difficult for participants in such studies to “determine how the situation corresponds with the force they would apply clinically.”¹

Cadaver studies have been inadequate to assess the in situ response of the brachial plexus
Many plaintiff claims regarding the cause of brachial plexus injury use cadaver studies as evidence. However, most such studies were conducted between 98 and 140 years ago. In these older studies, quantitative evaluation was rare. And in the few more recent studies, there are several reasons why the data obtained are problematic:

• the nerves being studied were dissected free from supporting tissues
• nerve tissue deteriorates quickly post­mortem
• some studies used adult tissues; there may be significant differences between adult and newborn nerve tissue that obscure comparison.

The ACOG report concludes the section on cadaver studies by stating:

Physical models also fall short
The problem with the use of physical models in evaluating NBPP centers on the need to find materials that have the same or similar properties as the tissues of interest. These sorts of bioengineering limitations generally do not allow for findings that have direct clinical applicability.

Of interest, however, is the finding of at least two groups of investigators that less traction is required when simulating delivery of a model infant when rotational maneuvers (Rubin’s) are employed rather than after McRoberts repositioning. 

Computer models have yielded data on the relative effects of endogenous and exogenous forces
Sophisticated computer analysis has been used to investigate both endogenous and ­exogenous delivery forces. Results of such studies have shown that maternal endo­genous forces exert twice as much pressure on the base of the fetal neck against the maternal symphysis pubis as do deliverer-­induced ­exogenous forces.

Is there a threshold of force?
Data that include measurement of the force applied to the brachial plexus nerves of a live infant during a real delivery are almost nonexistent. One group—on the basis of a single case of transient NBPP and potentially flawed pressure measurements—has suggested that the threshold for NBPP in the human is 100 Newtons.³ However, other studies have shown that physician-applied forces in routine deliveries commonly exceed this hypothesized cutoff—yet the rate of NBPP remains low. In measuring delivery forces it must be remembered that significant variation exists between individual neonates, both in terms of mechanical properties and anatomy. Because of this ­variation—and the nonlinear behavior of nerve tissues—the specific force needed to cause a nerve injury or rupture in a given neonate has not been established.

Chapter 3 of the ACOG report closes with a statement:

NBPP and shoulder dystocia
Shoulder dystocia is defined as a delivery that requires additional obstetric maneuvers after gentle downward traction on the fetal head fails to deliver the fetal shoulders. The ACOG report makes the important point that shoulder dystocia is not formally diagnosed until a trial of downward axial traction has been unsuccessful in delivering the anterior shoulder. This point is a refutation of the frequent plaintiff claim that, once a shoulder dystocia is thought to be present, no traction whatsoever should be applied by the clinician at any time during the remainder of the delivery.

Shoulder dystocia incidence is rising
The reported incidence of shoulder dystocia has increased over the past several decades. It is unclear whether this increase is related to maternal obesity, fetal macrosomia, or more widespread reporting. However, paradoxes exist in the relationship among risk factors, shoulder dystocia, and brachial plexus injury:

• although there is an increased incidence of shoulder dystocia with increased birth weight, the mean birth weight of neonates with recognized shoulder dystocia is not significantly higher than the mean birth weight of all term infants
• strategies to reduce NBPP by ­preventing shoulder dystocia—including early induction of labor and prophylactic use of McRoberts maneuver and suprapubic pressure—have not been effective in reducing the incidence of NBPP.

The ACOG report makes the statement: “Maternal and fetal factors associated with shoulder dystocia do not allow for reliable prediction of persistent NBPP.”¹

What is optimal management of shoulder dystocia?
The last obstetric part of the ACOG report takes as its focus the management of shoulder dystocia. It discusses the importance of communication among members of the delivery team and with the mother whose neonate is experiencing a shoulder dystocia. The report states:

This statement contrasts with claims frequently made by plaintiff medical expert witnesses that the woman experiencing a shoulder dystocia should absolutely cease from pushing.

In a section on team training, the report describes the delivery team’s priorities:

Studies evaluating process standardization, the use of checklists, teamwork training, crew resource management, and evidence-based medicine have shown that these tools improve neonatal and maternal outcomes.

Simulation training also has been shown to help reduce transient NBPP (see the box below for more on simulation programs for shoulder dystocia). Whether it also can lower the rate of permanent NBPP is unclear.¹

In the new ACOG report on neonatal brachial plexus injury, simulation training is discussed as one solution to the dilemma of how clinicians can gain experience in managing obstetric events that occur infrequently.¹ Simulation training also has the potential to improve teamwork, communication, and the situational awareness of the health-care team as a whole. Several studies over the past few years have shown that, in some units, the implementation of simulation training actually has decreased the number of cases of neonatal brachial plexus palsy (NBPP), compared with no simulation training.

For example, Draycott and colleagues explored the rate of neonatal injury associated with shoulder dystocia before and after implementation of a mandatory 1-day simulation training program at Southmead Hospital in Bristol, United Kingdom.² The program consisted of practice on a shoulder dystocia training mannequin and covered risk factors, recognition of shoulder dystocia, maneuvers, and documentation. The training used a stepwise approach, beginning with a call for help and continuing through McRoberts’ positioning, suprapubic pressure, and internal maneuvers such as delivery of the posterior arm (Figure).

There were 15,908 births in the pretraining period and 13,117 in the posttraining period, with shoulder dystocia rates comparable between the two periods. Not only did clinical management of shoulder dystocia improve after training, but there was a significant reduction in neonatal injury at birth after shoulder dystocia (30 injuries of 324 shoulder dystocia cases [9.3%] before training vs six injuries of 262 shoulder dystocia cases [2.3%] afterward).²

In another study of obstetric brachial plexus injury before and after implementation of simulation training for shoulder dystocia, Inglis and colleagues found a decline in the rate of such injury from 30% to 10.67% (P<.01).³ Shoulder dystocia training remained associated with reduced obstetric brachial plexus injury after logistic-regression analysis.³

Shoulder dystocia training is now recommended by the Joint Commission on Accreditation of Healthcare Organizations in the United States. However, in its report, ACOG concludes—despite studies from Draycott and colleagues and others—that, owing to “limited data,” “there remains no evidence that introduction of simulation can reduce the frequency of persistent NBPP.”¹

References

1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
2. Draycott TJ, Crofts FJ, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14–20.
3. Inglis SR, Feier N, Chetiyaar JB, et al. Effects of shoulder dystocia training on the incidence of brachial plexus palsy. Am J Obstet Gynecol. 2011;204(4):322.e1–e6.

Delivery of the posterior arm
The report reaffirms the previous statement from the ACOG practice bulletin on shoulder dystocia, which asserts that no specific sequence of maneuvers for resolving shoulder dystocia has been shown to be superior to any other.⁶ It does note, however, that recent studies seem to demonstrate a benefit when delivery of the posterior arm is prioritized over the usual first-line maneuvers of McRoberts positioning and the application of suprapubic pressure. If confirmed, such findings may alter the standard of care for shoulder dystocia resolution and result in a change in ACOG recommendations.

Documentation may be enhanced by use of a checklist
The ACOG report stresses the importance of accurate, contemporaneous documentation of the management of shoulder dystocia, observing that checklists and documentation reminders help ensure the completeness and relevance of notes after shoulder dystocia deliveries and NBPP. ACOG has produced such a checklist, which can be found in the appendix of the report itself.1

How long before central neurologic injury occurs?
Another issue covered in the report is how long a clinician has to resolve a shoulder dystocia before central neurologic damage occurs. Studies have shown that permanent neurologic injury can occur as soon as 2 minutes after shoulder impaction, although the risk of acidosis or severe hypoxic-ischemic encephalopathy remains low until impaction has lasted at least 5 minutes.

Other issues covered in the report
The last chapters of the ACOG report focus on orthopedic aspects of brachial plexus injury, including diagnosis, treatment, and prognosis.

The report concludes with a glossary and three appendices:

• Royal College of Obstetricians and Gynecologists Green Top Guidebook #42 on shoulder dystocia
• ACOG Practice Bulletin #40 on shoulder dystocia
• ACOG Patient Safety Checklist #6 on the documentation of shoulder dystocia.

Why the ACOG report is foundational
The ACOG report on NBPP is an important and much-needed document. It includes a comprehensive review of the literature on brachial plexus injury and shoulder dystocia, written by nationally recognized experts in the field. Most important, it makes definitive statements that counteract false and dubious claims often made by the plaintiff bar in brachial plexus injury cases and provides evidence to back those statements.

The report:

• disproves the claim that “excessive” physician traction is the only etiology of brachial plexus injuries
• demonstrates that no differentiation can be made between the etiology of permanent versus temporary brachial plexus injuries
• describes how brachial plexus injuries can occur in the absence of physician traction or even of shoulder dystocia
• provides a summary of scientific information about brachial plexus injuries that will benefit obstetric clinicians
• provides a wealth of literature documentation that will enable physician defendants to counteract many of the claims plaintiffs and their expert witnesses make in brachial plexus injury cases.

The report is—and will remain—a foundational document in obstetrics for many years to come.

Share your thoughts on this article! Send your Letter to the Editor to [email protected].

Obstetricians are often blamed for causing neonatal brachial plexus palsy (NBPP). For that reason, understanding the true pathophysiology and causation of this birth-related entity is of extreme importance.

In Part 1 of this two-part series, I summarized findings from the new report on NBPP from the American College of Obstetricians and Gynecologists (ACOG), focusing on whether the phenomenon of shoulder dystocia and NBPP can be predicted or prevented.¹ Here, in Part 2, I focus on ACOG’s conclusions concerning pathophysiology and causation of NBPP, as well as the College’s recommendations for applying that knowledge to practice.

Some infants are more susceptible than others to the forces of labor and delivery
Babies emerge from the uterus and maternal pelvis by a combination of uterine ­contractions and maternal pushing (endogenous forces) aided by the traction forces applied by the birth attendant (exogenous forces). Research over the past 2 decades has shown that endogenous forces play a significant—if not dominant—role in the causation of NBPP.

Stretching and potential injury to the brachial plexus occur when the long axis of the fetus is pushed down the birth canal while either the maternal symphysis pubis or sacral promontory catches and holds either the anterior or posterior shoulder of the fetus, respectively. This conjunction of events generates a stretching force on the tissues that connect the fetal trunk and head—the neck—under which lies the brachial plexus. The same anatomic relationships and labor forces also vigorously compress the fetal neck against the maternal symphysis pubis or sacral promontory and may cause compression injury. Any traction applied by the clinician accentuates these stretching and pressure forces acting on the nerves of the brachial plexus.

How the neonate responds to these forces depends on the tensile strength of its tissues, the metabolic condition of the fetus after a potentially long labor (as measured by acid-base status), the degree of protective muscle tone around the fetal shoulder and neck, and other fluctuating conditions. In other words, because of the many variables involved, some fetuses are more or less susceptible to injury than others.

Maternal forces alone can cause NBPP
The ACOG report¹ makes an important statement:

Some plaintiff attorneys and their expert witnesses have tried to make the case that, although endogenous forces can cause temporary brachial plexus injuries, they cannot cause permanent brachial plexus injuries. However, as the ACOG report goes on to state:

The report acknowledges that the clinician can increase brachial plexus stretch by applying downward lateral traction to the neonate’s head during delivery efforts. However, contrary to claims often made by the plaintiff bar, in the presence of shoulder dystocia, even properly applied axial traction will necessarily increase the stretching of the brachial plexus. The report also notes that traction applied in the plane of the fetal cervicothoracic spine typically is along a vector estimated to be 25° to 45° below the horizontal plane of a woman in lithotomy position, not in an exact straight line with the maternal trunk. This degree of delivery force below the horizon is defined as normal “axial traction.”

Exogenous forces have yet to be definitively measured
Multiple attempts have been made to quantify the amount of force applied by clinicians in various delivery scenarios. However, in the published studies in which this force has been “measured,” the accuracy of the findings has not been validated. The three studies in which delivery force was directly measured in a clinical setting “provide a limited assessment of exogenous forces” and “do not address the angle at which forces were applied.”^3–5 All other studies used artificial models.

As a result, few conclusions from such studies are directly applicable to the clinical arena. Moreover, in other studies using simulated birth scenarios, there was no feedback to participating clinicians as to whether the force they applied would have been sufficient to deliver the “fetus.” It was therefore difficult for participants in such studies to “determine how the situation corresponds with the force they would apply clinically.”¹

Cadaver studies have been inadequate to assess the in situ response of the brachial plexus
Many plaintiff claims regarding the cause of brachial plexus injury use cadaver studies as evidence. However, most such studies were conducted between 98 and 140 years ago. In these older studies, quantitative evaluation was rare. And in the few more recent studies, there are several reasons why the data obtained are problematic:

• the nerves being studied were dissected free from supporting tissues
• nerve tissue deteriorates quickly post­mortem
• some studies used adult tissues; there may be significant differences between adult and newborn nerve tissue that obscure comparison.

The ACOG report concludes the section on cadaver studies by stating:

Physical models also fall short
The problem with the use of physical models in evaluating NBPP centers on the need to find materials that have the same or similar properties as the tissues of interest. These sorts of bioengineering limitations generally do not allow for findings that have direct clinical applicability.

Of interest, however, is the finding of at least two groups of investigators that less traction is required when simulating delivery of a model infant when rotational maneuvers (Rubin’s) are employed rather than after McRoberts repositioning. 

Computer models have yielded data on the relative effects of endogenous and exogenous forces
Sophisticated computer analysis has been used to investigate both endogenous and ­exogenous delivery forces. Results of such studies have shown that maternal endo­genous forces exert twice as much pressure on the base of the fetal neck against the maternal symphysis pubis as do deliverer-­induced ­exogenous forces.

Is there a threshold of force?
Data that include measurement of the force applied to the brachial plexus nerves of a live infant during a real delivery are almost nonexistent. One group—on the basis of a single case of transient NBPP and potentially flawed pressure measurements—has suggested that the threshold for NBPP in the human is 100 Newtons.³ However, other studies have shown that physician-applied forces in routine deliveries commonly exceed this hypothesized cutoff—yet the rate of NBPP remains low. In measuring delivery forces it must be remembered that significant variation exists between individual neonates, both in terms of mechanical properties and anatomy. Because of this ­variation—and the nonlinear behavior of nerve tissues—the specific force needed to cause a nerve injury or rupture in a given neonate has not been established.

Chapter 3 of the ACOG report closes with a statement:

NBPP and shoulder dystocia
Shoulder dystocia is defined as a delivery that requires additional obstetric maneuvers after gentle downward traction on the fetal head fails to deliver the fetal shoulders. The ACOG report makes the important point that shoulder dystocia is not formally diagnosed until a trial of downward axial traction has been unsuccessful in delivering the anterior shoulder. This point is a refutation of the frequent plaintiff claim that, once a shoulder dystocia is thought to be present, no traction whatsoever should be applied by the clinician at any time during the remainder of the delivery.

Shoulder dystocia incidence is rising
The reported incidence of shoulder dystocia has increased over the past several decades. It is unclear whether this increase is related to maternal obesity, fetal macrosomia, or more widespread reporting. However, paradoxes exist in the relationship among risk factors, shoulder dystocia, and brachial plexus injury:

• although there is an increased incidence of shoulder dystocia with increased birth weight, the mean birth weight of neonates with recognized shoulder dystocia is not significantly higher than the mean birth weight of all term infants
• strategies to reduce NBPP by ­preventing shoulder dystocia—including early induction of labor and prophylactic use of McRoberts maneuver and suprapubic pressure—have not been effective in reducing the incidence of NBPP.

The ACOG report makes the statement: “Maternal and fetal factors associated with shoulder dystocia do not allow for reliable prediction of persistent NBPP.”¹

What is optimal management of shoulder dystocia?
The last obstetric part of the ACOG report takes as its focus the management of shoulder dystocia. It discusses the importance of communication among members of the delivery team and with the mother whose neonate is experiencing a shoulder dystocia. The report states:

This statement contrasts with claims frequently made by plaintiff medical expert witnesses that the woman experiencing a shoulder dystocia should absolutely cease from pushing.

In a section on team training, the report describes the delivery team’s priorities:

Studies evaluating process standardization, the use of checklists, teamwork training, crew resource management, and evidence-based medicine have shown that these tools improve neonatal and maternal outcomes.

Simulation training also has been shown to help reduce transient NBPP (see the box below for more on simulation programs for shoulder dystocia). Whether it also can lower the rate of permanent NBPP is unclear.¹

In the new ACOG report on neonatal brachial plexus injury, simulation training is discussed as one solution to the dilemma of how clinicians can gain experience in managing obstetric events that occur infrequently.¹ Simulation training also has the potential to improve teamwork, communication, and the situational awareness of the health-care team as a whole. Several studies over the past few years have shown that, in some units, the implementation of simulation training actually has decreased the number of cases of neonatal brachial plexus palsy (NBPP), compared with no simulation training.

For example, Draycott and colleagues explored the rate of neonatal injury associated with shoulder dystocia before and after implementation of a mandatory 1-day simulation training program at Southmead Hospital in Bristol, United Kingdom.² The program consisted of practice on a shoulder dystocia training mannequin and covered risk factors, recognition of shoulder dystocia, maneuvers, and documentation. The training used a stepwise approach, beginning with a call for help and continuing through McRoberts’ positioning, suprapubic pressure, and internal maneuvers such as delivery of the posterior arm (Figure).

There were 15,908 births in the pretraining period and 13,117 in the posttraining period, with shoulder dystocia rates comparable between the two periods. Not only did clinical management of shoulder dystocia improve after training, but there was a significant reduction in neonatal injury at birth after shoulder dystocia (30 injuries of 324 shoulder dystocia cases [9.3%] before training vs six injuries of 262 shoulder dystocia cases [2.3%] afterward).²

In another study of obstetric brachial plexus injury before and after implementation of simulation training for shoulder dystocia, Inglis and colleagues found a decline in the rate of such injury from 30% to 10.67% (P<.01).³ Shoulder dystocia training remained associated with reduced obstetric brachial plexus injury after logistic-regression analysis.³

Shoulder dystocia training is now recommended by the Joint Commission on Accreditation of Healthcare Organizations in the United States. However, in its report, ACOG concludes—despite studies from Draycott and colleagues and others—that, owing to “limited data,” “there remains no evidence that introduction of simulation can reduce the frequency of persistent NBPP.”¹

References

1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
2. Draycott TJ, Crofts FJ, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14–20.
3. Inglis SR, Feier N, Chetiyaar JB, et al. Effects of shoulder dystocia training on the incidence of brachial plexus palsy. Am J Obstet Gynecol. 2011;204(4):322.e1–e6.

Delivery of the posterior arm
The report reaffirms the previous statement from the ACOG practice bulletin on shoulder dystocia, which asserts that no specific sequence of maneuvers for resolving shoulder dystocia has been shown to be superior to any other.⁶ It does note, however, that recent studies seem to demonstrate a benefit when delivery of the posterior arm is prioritized over the usual first-line maneuvers of McRoberts positioning and the application of suprapubic pressure. If confirmed, such findings may alter the standard of care for shoulder dystocia resolution and result in a change in ACOG recommendations.

Documentation may be enhanced by use of a checklist
The ACOG report stresses the importance of accurate, contemporaneous documentation of the management of shoulder dystocia, observing that checklists and documentation reminders help ensure the completeness and relevance of notes after shoulder dystocia deliveries and NBPP. ACOG has produced such a checklist, which can be found in the appendix of the report itself.1

How long before central neurologic injury occurs?
Another issue covered in the report is how long a clinician has to resolve a shoulder dystocia before central neurologic damage occurs. Studies have shown that permanent neurologic injury can occur as soon as 2 minutes after shoulder impaction, although the risk of acidosis or severe hypoxic-ischemic encephalopathy remains low until impaction has lasted at least 5 minutes.

Other issues covered in the report
The last chapters of the ACOG report focus on orthopedic aspects of brachial plexus injury, including diagnosis, treatment, and prognosis.

The report concludes with a glossary and three appendices:

• Royal College of Obstetricians and Gynecologists Green Top Guidebook #42 on shoulder dystocia
• ACOG Practice Bulletin #40 on shoulder dystocia
• ACOG Patient Safety Checklist #6 on the documentation of shoulder dystocia.

Why the ACOG report is foundational
The ACOG report on NBPP is an important and much-needed document. It includes a comprehensive review of the literature on brachial plexus injury and shoulder dystocia, written by nationally recognized experts in the field. Most important, it makes definitive statements that counteract false and dubious claims often made by the plaintiff bar in brachial plexus injury cases and provides evidence to back those statements.

The report:

• disproves the claim that “excessive” physician traction is the only etiology of brachial plexus injuries
• demonstrates that no differentiation can be made between the etiology of permanent versus temporary brachial plexus injuries
• describes how brachial plexus injuries can occur in the absence of physician traction or even of shoulder dystocia
• provides a summary of scientific information about brachial plexus injuries that will benefit obstetric clinicians
• provides a wealth of literature documentation that will enable physician defendants to counteract many of the claims plaintiffs and their expert witnesses make in brachial plexus injury cases.

The report is—and will remain—a foundational document in obstetrics for many years to come.

Share your thoughts on this article! Send your Letter to the Editor to [email protected].

Obstetricians are often blamed for causing neonatal brachial plexus palsy (NBPP). For that reason, understanding the true pathophysiology and causation of this birth-related entity is of extreme importance.

In Part 1 of this two-part series, I summarized findings from the new report on NBPP from the American College of Obstetricians and Gynecologists (ACOG), focusing on whether the phenomenon of shoulder dystocia and NBPP can be predicted or prevented.¹ Here, in Part 2, I focus on ACOG’s conclusions concerning pathophysiology and causation of NBPP, as well as the College’s recommendations for applying that knowledge to practice.

Some infants are more susceptible than others to the forces of labor and delivery
Babies emerge from the uterus and maternal pelvis by a combination of uterine ­contractions and maternal pushing (endogenous forces) aided by the traction forces applied by the birth attendant (exogenous forces). Research over the past 2 decades has shown that endogenous forces play a significant—if not dominant—role in the causation of NBPP.

Stretching and potential injury to the brachial plexus occur when the long axis of the fetus is pushed down the birth canal while either the maternal symphysis pubis or sacral promontory catches and holds either the anterior or posterior shoulder of the fetus, respectively. This conjunction of events generates a stretching force on the tissues that connect the fetal trunk and head—the neck—under which lies the brachial plexus. The same anatomic relationships and labor forces also vigorously compress the fetal neck against the maternal symphysis pubis or sacral promontory and may cause compression injury. Any traction applied by the clinician accentuates these stretching and pressure forces acting on the nerves of the brachial plexus.

How the neonate responds to these forces depends on the tensile strength of its tissues, the metabolic condition of the fetus after a potentially long labor (as measured by acid-base status), the degree of protective muscle tone around the fetal shoulder and neck, and other fluctuating conditions. In other words, because of the many variables involved, some fetuses are more or less susceptible to injury than others.

Maternal forces alone can cause NBPP
The ACOG report¹ makes an important statement:

Some plaintiff attorneys and their expert witnesses have tried to make the case that, although endogenous forces can cause temporary brachial plexus injuries, they cannot cause permanent brachial plexus injuries. However, as the ACOG report goes on to state:

The report acknowledges that the clinician can increase brachial plexus stretch by applying downward lateral traction to the neonate’s head during delivery efforts. However, contrary to claims often made by the plaintiff bar, in the presence of shoulder dystocia, even properly applied axial traction will necessarily increase the stretching of the brachial plexus. The report also notes that traction applied in the plane of the fetal cervicothoracic spine typically is along a vector estimated to be 25° to 45° below the horizontal plane of a woman in lithotomy position, not in an exact straight line with the maternal trunk. This degree of delivery force below the horizon is defined as normal “axial traction.”

Exogenous forces have yet to be definitively measured
Multiple attempts have been made to quantify the amount of force applied by clinicians in various delivery scenarios. However, in the published studies in which this force has been “measured,” the accuracy of the findings has not been validated. The three studies in which delivery force was directly measured in a clinical setting “provide a limited assessment of exogenous forces” and “do not address the angle at which forces were applied.”^3–5 All other studies used artificial models.

As a result, few conclusions from such studies are directly applicable to the clinical arena. Moreover, in other studies using simulated birth scenarios, there was no feedback to participating clinicians as to whether the force they applied would have been sufficient to deliver the “fetus.” It was therefore difficult for participants in such studies to “determine how the situation corresponds with the force they would apply clinically.”¹

Cadaver studies have been inadequate to assess the in situ response of the brachial plexus
Many plaintiff claims regarding the cause of brachial plexus injury use cadaver studies as evidence. However, most such studies were conducted between 98 and 140 years ago. In these older studies, quantitative evaluation was rare. And in the few more recent studies, there are several reasons why the data obtained are problematic:

• the nerves being studied were dissected free from supporting tissues
• nerve tissue deteriorates quickly post­mortem
• some studies used adult tissues; there may be significant differences between adult and newborn nerve tissue that obscure comparison.

The ACOG report concludes the section on cadaver studies by stating:

Physical models also fall short
The problem with the use of physical models in evaluating NBPP centers on the need to find materials that have the same or similar properties as the tissues of interest. These sorts of bioengineering limitations generally do not allow for findings that have direct clinical applicability.

Of interest, however, is the finding of at least two groups of investigators that less traction is required when simulating delivery of a model infant when rotational maneuvers (Rubin’s) are employed rather than after McRoberts repositioning. 

Computer models have yielded data on the relative effects of endogenous and exogenous forces
Sophisticated computer analysis has been used to investigate both endogenous and ­exogenous delivery forces. Results of such studies have shown that maternal endo­genous forces exert twice as much pressure on the base of the fetal neck against the maternal symphysis pubis as do deliverer-­induced ­exogenous forces.

Is there a threshold of force?
Data that include measurement of the force applied to the brachial plexus nerves of a live infant during a real delivery are almost nonexistent. One group—on the basis of a single case of transient NBPP and potentially flawed pressure measurements—has suggested that the threshold for NBPP in the human is 100 Newtons.³ However, other studies have shown that physician-applied forces in routine deliveries commonly exceed this hypothesized cutoff—yet the rate of NBPP remains low. In measuring delivery forces it must be remembered that significant variation exists between individual neonates, both in terms of mechanical properties and anatomy. Because of this ­variation—and the nonlinear behavior of nerve tissues—the specific force needed to cause a nerve injury or rupture in a given neonate has not been established.

Chapter 3 of the ACOG report closes with a statement:

NBPP and shoulder dystocia
Shoulder dystocia is defined as a delivery that requires additional obstetric maneuvers after gentle downward traction on the fetal head fails to deliver the fetal shoulders. The ACOG report makes the important point that shoulder dystocia is not formally diagnosed until a trial of downward axial traction has been unsuccessful in delivering the anterior shoulder. This point is a refutation of the frequent plaintiff claim that, once a shoulder dystocia is thought to be present, no traction whatsoever should be applied by the clinician at any time during the remainder of the delivery.

Shoulder dystocia incidence is rising
The reported incidence of shoulder dystocia has increased over the past several decades. It is unclear whether this increase is related to maternal obesity, fetal macrosomia, or more widespread reporting. However, paradoxes exist in the relationship among risk factors, shoulder dystocia, and brachial plexus injury:

• although there is an increased incidence of shoulder dystocia with increased birth weight, the mean birth weight of neonates with recognized shoulder dystocia is not significantly higher than the mean birth weight of all term infants
• strategies to reduce NBPP by ­preventing shoulder dystocia—including early induction of labor and prophylactic use of McRoberts maneuver and suprapubic pressure—have not been effective in reducing the incidence of NBPP.

The ACOG report makes the statement: “Maternal and fetal factors associated with shoulder dystocia do not allow for reliable prediction of persistent NBPP.”¹

What is optimal management of shoulder dystocia?
The last obstetric part of the ACOG report takes as its focus the management of shoulder dystocia. It discusses the importance of communication among members of the delivery team and with the mother whose neonate is experiencing a shoulder dystocia. The report states:

This statement contrasts with claims frequently made by plaintiff medical expert witnesses that the woman experiencing a shoulder dystocia should absolutely cease from pushing.

In a section on team training, the report describes the delivery team’s priorities:

Studies evaluating process standardization, the use of checklists, teamwork training, crew resource management, and evidence-based medicine have shown that these tools improve neonatal and maternal outcomes.

Simulation training also has been shown to help reduce transient NBPP (see the box below for more on simulation programs for shoulder dystocia). Whether it also can lower the rate of permanent NBPP is unclear.¹

In the new ACOG report on neonatal brachial plexus injury, simulation training is discussed as one solution to the dilemma of how clinicians can gain experience in managing obstetric events that occur infrequently.¹ Simulation training also has the potential to improve teamwork, communication, and the situational awareness of the health-care team as a whole. Several studies over the past few years have shown that, in some units, the implementation of simulation training actually has decreased the number of cases of neonatal brachial plexus palsy (NBPP), compared with no simulation training.

For example, Draycott and colleagues explored the rate of neonatal injury associated with shoulder dystocia before and after implementation of a mandatory 1-day simulation training program at Southmead Hospital in Bristol, United Kingdom.² The program consisted of practice on a shoulder dystocia training mannequin and covered risk factors, recognition of shoulder dystocia, maneuvers, and documentation. The training used a stepwise approach, beginning with a call for help and continuing through McRoberts’ positioning, suprapubic pressure, and internal maneuvers such as delivery of the posterior arm (Figure).

There were 15,908 births in the pretraining period and 13,117 in the posttraining period, with shoulder dystocia rates comparable between the two periods. Not only did clinical management of shoulder dystocia improve after training, but there was a significant reduction in neonatal injury at birth after shoulder dystocia (30 injuries of 324 shoulder dystocia cases [9.3%] before training vs six injuries of 262 shoulder dystocia cases [2.3%] afterward).²

In another study of obstetric brachial plexus injury before and after implementation of simulation training for shoulder dystocia, Inglis and colleagues found a decline in the rate of such injury from 30% to 10.67% (P<.01).³ Shoulder dystocia training remained associated with reduced obstetric brachial plexus injury after logistic-regression analysis.³

Shoulder dystocia training is now recommended by the Joint Commission on Accreditation of Healthcare Organizations in the United States. However, in its report, ACOG concludes—despite studies from Draycott and colleagues and others—that, owing to “limited data,” “there remains no evidence that introduction of simulation can reduce the frequency of persistent NBPP.”¹

References

1. American College of Obstetricians and Gynecologists. Executive summary: neonatal brachial plexus palsy. Report of the American College of Obstetricians and Gynecologists’ Task Force on neonatal brachial plexus palsy. Obstet Gynecol. 2014;123(4):902–904.
2. Draycott TJ, Crofts FJ, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14–20.
3. Inglis SR, Feier N, Chetiyaar JB, et al. Effects of shoulder dystocia training on the incidence of brachial plexus palsy. Am J Obstet Gynecol. 2011;204(4):322.e1–e6.

Delivery of the posterior arm
The report reaffirms the previous statement from the ACOG practice bulletin on shoulder dystocia, which asserts that no specific sequence of maneuvers for resolving shoulder dystocia has been shown to be superior to any other.⁶ It does note, however, that recent studies seem to demonstrate a benefit when delivery of the posterior arm is prioritized over the usual first-line maneuvers of McRoberts positioning and the application of suprapubic pressure. If confirmed, such findings may alter the standard of care for shoulder dystocia resolution and result in a change in ACOG recommendations.

Documentation may be enhanced by use of a checklist
The ACOG report stresses the importance of accurate, contemporaneous documentation of the management of shoulder dystocia, observing that checklists and documentation reminders help ensure the completeness and relevance of notes after shoulder dystocia deliveries and NBPP. ACOG has produced such a checklist, which can be found in the appendix of the report itself.1

How long before central neurologic injury occurs?
Another issue covered in the report is how long a clinician has to resolve a shoulder dystocia before central neurologic damage occurs. Studies have shown that permanent neurologic injury can occur as soon as 2 minutes after shoulder impaction, although the risk of acidosis or severe hypoxic-ischemic encephalopathy remains low until impaction has lasted at least 5 minutes.

Other issues covered in the report
The last chapters of the ACOG report focus on orthopedic aspects of brachial plexus injury, including diagnosis, treatment, and prognosis.

The report concludes with a glossary and three appendices:

• Royal College of Obstetricians and Gynecologists Green Top Guidebook #42 on shoulder dystocia
• ACOG Practice Bulletin #40 on shoulder dystocia
• ACOG Patient Safety Checklist #6 on the documentation of shoulder dystocia.

Why the ACOG report is foundational
The ACOG report on NBPP is an important and much-needed document. It includes a comprehensive review of the literature on brachial plexus injury and shoulder dystocia, written by nationally recognized experts in the field. Most important, it makes definitive statements that counteract false and dubious claims often made by the plaintiff bar in brachial plexus injury cases and provides evidence to back those statements.

The report:

• disproves the claim that “excessive” physician traction is the only etiology of brachial plexus injuries
• demonstrates that no differentiation can be made between the etiology of permanent versus temporary brachial plexus injuries
• describes how brachial plexus injuries can occur in the absence of physician traction or even of shoulder dystocia
• provides a summary of scientific information about brachial plexus injuries that will benefit obstetric clinicians
• provides a wealth of literature documentation that will enable physician defendants to counteract many of the claims plaintiffs and their expert witnesses make in brachial plexus injury cases.

The report is—and will remain—a foundational document in obstetrics for many years to come.

Share your thoughts on this article! Send your Letter to the Editor to [email protected].

Neonatal brachial plexus palsy (NBPP) after a delivery involving shoulder dystocia is not only a clinical disaster—it constitutes the second largest category of litigation in obstetrics.¹

Lawsuits that center on NBPP often feature plaintiff expert witnesses who claim that the only way a permanent brachial plexus injury can occur is by a clinician applying “excessive” traction on the fetal head during delivery. The same experts often claim that the mother had multiple risk factors for shoulder dystocia and should never have been allowed a trial of labor in the first place.

The jury is left suspecting that the NBPP was a disaster waiting to happen, with warning signs that were ignored by the clinician. Jurors also may be convinced that, when the dystocia occurred, the defendant handled it badly, causing a severe, lifelong injury to the beautiful child whose images they are shown in the courtroom.

But this scenario is far from accurate.

ACOG publishes new guidance on NBPPThe American College of Obstetricians and Gynecologists (ACOG) periodically issues practice bulletins on the subject of shoulder dystocia, the most recent one written in 2002 and reaffirmed in 2013.2 These bulletins are, of necessity, relatively brief summaries of current thinking about the causes, pathophysiology, treatment, and preventability of shoulder dystocia and associated brachial plexus injuries.

In 2011, James Breeden, MD, then president-elect of ACOG, called for formation of a task force on NBPP. The task force’s report, Neonatal Brachial Plexus Palsy,³ was published earlier this year and represents ACOG’s official position on the important—but still controversial—subjects of shoulder dystocia and NBPP. This report should serve not only to help clinicians better understand and manage these entities but also as a foundational document in the prolific and complex medicolegal suits involving them.

Given the length of this report, however, a concise summary of the key takeaways is in order.

NBPP and shoulder dystocia are not always linked

Early in the report, ACOG presents three very important statements, all of which challenge claims that are frequently made by plaintiffs in brachial plexus injury cases:

1. NBPP can occur without concomitant, clinically recognizable shoulder dystocia, although it often is associated with shoulder dystocia.
2. In the presence of shoulder dystocia, all ancillary maneuvers necessarily increase strain on the brachial plexus, no matter how expertly the maneuvers are performed.
3. Recent multidisciplinary research now indicates that the existence of NBPP after birth does not prove that exogenous forces are the sole cause of this injury.

These findings raise a number of questions, including:

• Can NBPP be predicted and prevented?
• What is the pathophysiologic mechanism for NBPP with and without shoulder dystocia?
• Are there specific interventions that may reduce the frequency of NBPP?

In Part 1 of this article, I summarize ACOG data on whether and how NBPP might be predicted. Part 2, to follow in October 2014, will discuss the pathophysiologic mechanism for NBPP and discuss potential interventions.

The data on NBPP without shoulder dystocia
The results of 12 reports published between 1990 and 2011 describe NBPP (temporary and persistent) that occurred without concomitant shoulder dystocia. These reports indicate that 46% of NBPP cases occurred without documented shoulder dystocia (0.9 ­cases/1,000 births).

Persistent NBPP. Two of these reports provide data on persistent NBPP without shoulder dystocia. Even when injury to the brachial plexus was documented as lasting more than 1 year, 26% of cases occurred in the absence of documented shoulder dystocia.

NBPP sometimes can occur during ­cesarean delivery. Four studies evaluated more than 240,000 births and found a rate of NBPP with cesarean delivery ranging from 0.3 to 1.5 cases per 1,000 live births.

All of these studies are described in the ACOG report.

When NBPP is related to shoulder dystocia
Shoulder dystocia may occur when there is a lack of fit of the transverse diameter of the fetal shoulders through the different pelvic diameters the shoulders encounter as they descend through the pelvis during the course of labor and delivery. This lack of fit can be related to excessive size of the fetal shoulders, inadequacy of pelvic dimensions to allow passage of a given fetus, or both. Abnormalities of fetal anatomy, fetal presentation, and soft tissue obstruction are rarely the cause of shoulder dystocia.

The difference between anterior shoulder obstruction behind the symphysis pubis and posterior shoulder obstruction from arrest at the level of the sacral promontory also is discussed in the ACOG report. In both cases, it is this obstruction of the affected shoulder while the long axis of the body continues to be pushed downward that widens the angle between the neck and impacted shoulder and stretches the brachial plexus.

The ACOG report acknowledges that may cases of NBPP do occur in conjunction with shoulder dystocia and that the same biomechanical factors that predispose a fetus to develop NBPP are associated with shoulder dystocia as well. However, the report takes pains to point out that the frequent conjunction of these two entities—NBPP and shoulder dystocia—may lead to an “erroneous retrospective inference of causation.”

Risk and predictive factors

The ACOG report states: “Various risk factors have been described in association with NBPP. Overall, however, these risk factors have not been shown to be statistically ­reliable or clinically useful predictors for...NBPP.”

For example, fetal macrosomia, defined as a birth weight of 4,000 g or more, has been reported as a risk factor for NBPP either alone or in conjunction with maternal diabetes. Although NBPP does occur more frequently as birth weight increases, seven studies over the past 20 years have shown that most cases of NBPP occur in infants of mothers without diabetes and in infants who weigh less than 4,000 g.

Other studies have shown that, if cesarean delivery were performed in cases of suspected macrosomia, it would have only a limited effect on reducing the incidence of NBPP. Specifically, in women with diabetes who have an estimated fetal weight of more than 4,500 g, the positive predictive value for NBPP is only 5%. Without maternal diabetes, that figure is less than 2%.

Estimating fetal weight by ultrasound does not significantly enhance our ability to predict NBPP. Ultrasound estimates of birth weight usually fall within 15% to 20% of actual birth weight, and the sensitivity of ultrasound in detecting birth weights more than 4,500 g is only 40%.

Therefore, ultrasound estimates of birth weight are of limited utility for contemporaneous clinical management. Furthermore, no data exist to support the claim that estimated fetal weight can be used prophylactically to reduce the incidence of NBPP.

Recurrent shoulder dystocia may be predictive of future NBPP
Whether studied alone or with NBPP, risk factors for shoulder dystocia are not reliable predictors of its occurrence. This is not the case, however, for recurrent shoulder dystocia, where the risk of neonatal brachial plexus palsy can be as high as 4.5%, compared with 1% to 2% for a first episode of shoulder dystocia.

C5 and C6 roots merge to form the upper trunk, C7 root forms the middle trunk, and C8 and T1 roots merge to form the lower trunk.

The frequency of NBPP is “rare,” according to the ACOG report, which cites a rate of 1.5 cases for every 1,000 births. Favorable outcomes with complete recovery are estimated to range from 50% to 80%.3

Brachial plexus injuries are classically defined as Erb’s palsy—involving C5 and C6 nerve roots—or Klumpke’s palsy, in which there is damage to the C8 and T1 nerve roots.

Erb’s palsy is recognizable by the characteristic “waiter’s tip” position of the hand, which is caused by muscle imbalance in the shoulder and upper arm. Most NBPP injuries are Erb’s palsy, which affect 1.2 infants in every 1,000 births.

Klumpke’s palsy results in weakness of the hand and medial forearm muscles. It affects 0.05 infants in every 1,000 births. The remaining cases involve a combination of the two types of palsy.

These injuries can be temporary, resolving by 12 months after birth, or permanent. The rate of persistence of NBPP at 12 months ranges from 3% to 33%.

Can clinician maneuvers increase the likelihood of NBPP?

The ACOG report addresses the direction and angle of clinician traction at delivery. The report confirms what clinicians generally have been taught: The application of fundal pressure during a delivery in which shoulder dystocia is recognized can exacerbate shoulder impaction and can lead to an increased risk of NBPP.

Traction applied by the clinician and lateral bending of the fetal neck often are implicated as causative factors of NBPP. However, ACOG presents evidence that NBPP can occur entirely unrelated to clinician traction. The report cites studies involving both transient and persistent NBPP in fetuses delivered vaginally without evident shoulder dystocia. The same types of injury are sometimes seen in fetuses delivered by cesarean, as has been mentioned.

The report goes on to state:

Recommendations for practice

At the close of its second chapter (“Risk and predictive factors”), the ACOG report offers the same official recommendations that appear in its current practice bulletin on shoulder dystocia. It notes that there are three clinical situations in which it may be ­prudent to alter usual obstetric management, with an aim of reducing the risk of shoulder dystocia and NBPP:

• when fetal macrosomia is suspected, with fetal weight estimated to exceed 5,000 g in a woman without diabetes or 4,500 g in a woman with diabetes
• when the mother has a history of recognized shoulder dystocia, especially when neonatal injury was severe
• when midpelvic operative vaginal delivery is contemplated with a fetus estimated to weigh more than 4,000 g.

It is interesting to note that these recommendations are made, according to the report, “notwithstanding the unreliability of specific risk factors to predict NBPP or clinically apparent shoulder dystocia in a specific case.” The report further adds:

More to come

For ACOG’s conclusions on the pathophysiology and causation of NBPP, with a view toward formulating specific protective interventions, see Part 2 of this article, which will appear in the October 2014 issue of OBG Management.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Neonatal brachial plexus palsy (NBPP) after a delivery involving shoulder dystocia is not only a clinical disaster—it constitutes the second largest category of litigation in obstetrics.¹

Lawsuits that center on NBPP often feature plaintiff expert witnesses who claim that the only way a permanent brachial plexus injury can occur is by a clinician applying “excessive” traction on the fetal head during delivery. The same experts often claim that the mother had multiple risk factors for shoulder dystocia and should never have been allowed a trial of labor in the first place.

The jury is left suspecting that the NBPP was a disaster waiting to happen, with warning signs that were ignored by the clinician. Jurors also may be convinced that, when the dystocia occurred, the defendant handled it badly, causing a severe, lifelong injury to the beautiful child whose images they are shown in the courtroom.

But this scenario is far from accurate.

ACOG publishes new guidance on NBPPThe American College of Obstetricians and Gynecologists (ACOG) periodically issues practice bulletins on the subject of shoulder dystocia, the most recent one written in 2002 and reaffirmed in 2013.2 These bulletins are, of necessity, relatively brief summaries of current thinking about the causes, pathophysiology, treatment, and preventability of shoulder dystocia and associated brachial plexus injuries.

In 2011, James Breeden, MD, then president-elect of ACOG, called for formation of a task force on NBPP. The task force’s report, Neonatal Brachial Plexus Palsy,³ was published earlier this year and represents ACOG’s official position on the important—but still controversial—subjects of shoulder dystocia and NBPP. This report should serve not only to help clinicians better understand and manage these entities but also as a foundational document in the prolific and complex medicolegal suits involving them.

Given the length of this report, however, a concise summary of the key takeaways is in order.

NBPP and shoulder dystocia are not always linked

Early in the report, ACOG presents three very important statements, all of which challenge claims that are frequently made by plaintiffs in brachial plexus injury cases:

1. NBPP can occur without concomitant, clinically recognizable shoulder dystocia, although it often is associated with shoulder dystocia.
2. In the presence of shoulder dystocia, all ancillary maneuvers necessarily increase strain on the brachial plexus, no matter how expertly the maneuvers are performed.
3. Recent multidisciplinary research now indicates that the existence of NBPP after birth does not prove that exogenous forces are the sole cause of this injury.

These findings raise a number of questions, including:

• Can NBPP be predicted and prevented?
• What is the pathophysiologic mechanism for NBPP with and without shoulder dystocia?
• Are there specific interventions that may reduce the frequency of NBPP?

In Part 1 of this article, I summarize ACOG data on whether and how NBPP might be predicted. Part 2, to follow in October 2014, will discuss the pathophysiologic mechanism for NBPP and discuss potential interventions.

The data on NBPP without shoulder dystocia
The results of 12 reports published between 1990 and 2011 describe NBPP (temporary and persistent) that occurred without concomitant shoulder dystocia. These reports indicate that 46% of NBPP cases occurred without documented shoulder dystocia (0.9 ­cases/1,000 births).

Persistent NBPP. Two of these reports provide data on persistent NBPP without shoulder dystocia. Even when injury to the brachial plexus was documented as lasting more than 1 year, 26% of cases occurred in the absence of documented shoulder dystocia.

NBPP sometimes can occur during ­cesarean delivery. Four studies evaluated more than 240,000 births and found a rate of NBPP with cesarean delivery ranging from 0.3 to 1.5 cases per 1,000 live births.

All of these studies are described in the ACOG report.

When NBPP is related to shoulder dystocia
Shoulder dystocia may occur when there is a lack of fit of the transverse diameter of the fetal shoulders through the different pelvic diameters the shoulders encounter as they descend through the pelvis during the course of labor and delivery. This lack of fit can be related to excessive size of the fetal shoulders, inadequacy of pelvic dimensions to allow passage of a given fetus, or both. Abnormalities of fetal anatomy, fetal presentation, and soft tissue obstruction are rarely the cause of shoulder dystocia.

The difference between anterior shoulder obstruction behind the symphysis pubis and posterior shoulder obstruction from arrest at the level of the sacral promontory also is discussed in the ACOG report. In both cases, it is this obstruction of the affected shoulder while the long axis of the body continues to be pushed downward that widens the angle between the neck and impacted shoulder and stretches the brachial plexus.

The ACOG report acknowledges that may cases of NBPP do occur in conjunction with shoulder dystocia and that the same biomechanical factors that predispose a fetus to develop NBPP are associated with shoulder dystocia as well. However, the report takes pains to point out that the frequent conjunction of these two entities—NBPP and shoulder dystocia—may lead to an “erroneous retrospective inference of causation.”

Risk and predictive factors

The ACOG report states: “Various risk factors have been described in association with NBPP. Overall, however, these risk factors have not been shown to be statistically ­reliable or clinically useful predictors for...NBPP.”

For example, fetal macrosomia, defined as a birth weight of 4,000 g or more, has been reported as a risk factor for NBPP either alone or in conjunction with maternal diabetes. Although NBPP does occur more frequently as birth weight increases, seven studies over the past 20 years have shown that most cases of NBPP occur in infants of mothers without diabetes and in infants who weigh less than 4,000 g.

Other studies have shown that, if cesarean delivery were performed in cases of suspected macrosomia, it would have only a limited effect on reducing the incidence of NBPP. Specifically, in women with diabetes who have an estimated fetal weight of more than 4,500 g, the positive predictive value for NBPP is only 5%. Without maternal diabetes, that figure is less than 2%.

Estimating fetal weight by ultrasound does not significantly enhance our ability to predict NBPP. Ultrasound estimates of birth weight usually fall within 15% to 20% of actual birth weight, and the sensitivity of ultrasound in detecting birth weights more than 4,500 g is only 40%.

Therefore, ultrasound estimates of birth weight are of limited utility for contemporaneous clinical management. Furthermore, no data exist to support the claim that estimated fetal weight can be used prophylactically to reduce the incidence of NBPP.

Recurrent shoulder dystocia may be predictive of future NBPP
Whether studied alone or with NBPP, risk factors for shoulder dystocia are not reliable predictors of its occurrence. This is not the case, however, for recurrent shoulder dystocia, where the risk of neonatal brachial plexus palsy can be as high as 4.5%, compared with 1% to 2% for a first episode of shoulder dystocia.

C5 and C6 roots merge to form the upper trunk, C7 root forms the middle trunk, and C8 and T1 roots merge to form the lower trunk.

The frequency of NBPP is “rare,” according to the ACOG report, which cites a rate of 1.5 cases for every 1,000 births. Favorable outcomes with complete recovery are estimated to range from 50% to 80%.3

Brachial plexus injuries are classically defined as Erb’s palsy—involving C5 and C6 nerve roots—or Klumpke’s palsy, in which there is damage to the C8 and T1 nerve roots.

Erb’s palsy is recognizable by the characteristic “waiter’s tip” position of the hand, which is caused by muscle imbalance in the shoulder and upper arm. Most NBPP injuries are Erb’s palsy, which affect 1.2 infants in every 1,000 births.

Klumpke’s palsy results in weakness of the hand and medial forearm muscles. It affects 0.05 infants in every 1,000 births. The remaining cases involve a combination of the two types of palsy.

These injuries can be temporary, resolving by 12 months after birth, or permanent. The rate of persistence of NBPP at 12 months ranges from 3% to 33%.

Can clinician maneuvers increase the likelihood of NBPP?

The ACOG report addresses the direction and angle of clinician traction at delivery. The report confirms what clinicians generally have been taught: The application of fundal pressure during a delivery in which shoulder dystocia is recognized can exacerbate shoulder impaction and can lead to an increased risk of NBPP.

Traction applied by the clinician and lateral bending of the fetal neck often are implicated as causative factors of NBPP. However, ACOG presents evidence that NBPP can occur entirely unrelated to clinician traction. The report cites studies involving both transient and persistent NBPP in fetuses delivered vaginally without evident shoulder dystocia. The same types of injury are sometimes seen in fetuses delivered by cesarean, as has been mentioned.

The report goes on to state:

Recommendations for practice

At the close of its second chapter (“Risk and predictive factors”), the ACOG report offers the same official recommendations that appear in its current practice bulletin on shoulder dystocia. It notes that there are three clinical situations in which it may be ­prudent to alter usual obstetric management, with an aim of reducing the risk of shoulder dystocia and NBPP:

• when fetal macrosomia is suspected, with fetal weight estimated to exceed 5,000 g in a woman without diabetes or 4,500 g in a woman with diabetes
• when the mother has a history of recognized shoulder dystocia, especially when neonatal injury was severe
• when midpelvic operative vaginal delivery is contemplated with a fetus estimated to weigh more than 4,000 g.

It is interesting to note that these recommendations are made, according to the report, “notwithstanding the unreliability of specific risk factors to predict NBPP or clinically apparent shoulder dystocia in a specific case.” The report further adds:

More to come

For ACOG’s conclusions on the pathophysiology and causation of NBPP, with a view toward formulating specific protective interventions, see Part 2 of this article, which will appear in the October 2014 issue of OBG Management.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Neonatal brachial plexus palsy (NBPP) after a delivery involving shoulder dystocia is not only a clinical disaster—it constitutes the second largest category of litigation in obstetrics.¹

Lawsuits that center on NBPP often feature plaintiff expert witnesses who claim that the only way a permanent brachial plexus injury can occur is by a clinician applying “excessive” traction on the fetal head during delivery. The same experts often claim that the mother had multiple risk factors for shoulder dystocia and should never have been allowed a trial of labor in the first place.

The jury is left suspecting that the NBPP was a disaster waiting to happen, with warning signs that were ignored by the clinician. Jurors also may be convinced that, when the dystocia occurred, the defendant handled it badly, causing a severe, lifelong injury to the beautiful child whose images they are shown in the courtroom.

But this scenario is far from accurate.

ACOG publishes new guidance on NBPPThe American College of Obstetricians and Gynecologists (ACOG) periodically issues practice bulletins on the subject of shoulder dystocia, the most recent one written in 2002 and reaffirmed in 2013.2 These bulletins are, of necessity, relatively brief summaries of current thinking about the causes, pathophysiology, treatment, and preventability of shoulder dystocia and associated brachial plexus injuries.

In 2011, James Breeden, MD, then president-elect of ACOG, called for formation of a task force on NBPP. The task force’s report, Neonatal Brachial Plexus Palsy,³ was published earlier this year and represents ACOG’s official position on the important—but still controversial—subjects of shoulder dystocia and NBPP. This report should serve not only to help clinicians better understand and manage these entities but also as a foundational document in the prolific and complex medicolegal suits involving them.

Given the length of this report, however, a concise summary of the key takeaways is in order.

NBPP and shoulder dystocia are not always linked

Early in the report, ACOG presents three very important statements, all of which challenge claims that are frequently made by plaintiffs in brachial plexus injury cases:

1. NBPP can occur without concomitant, clinically recognizable shoulder dystocia, although it often is associated with shoulder dystocia.
2. In the presence of shoulder dystocia, all ancillary maneuvers necessarily increase strain on the brachial plexus, no matter how expertly the maneuvers are performed.
3. Recent multidisciplinary research now indicates that the existence of NBPP after birth does not prove that exogenous forces are the sole cause of this injury.

These findings raise a number of questions, including:

• Can NBPP be predicted and prevented?
• What is the pathophysiologic mechanism for NBPP with and without shoulder dystocia?
• Are there specific interventions that may reduce the frequency of NBPP?

In Part 1 of this article, I summarize ACOG data on whether and how NBPP might be predicted. Part 2, to follow in October 2014, will discuss the pathophysiologic mechanism for NBPP and discuss potential interventions.

The data on NBPP without shoulder dystocia
The results of 12 reports published between 1990 and 2011 describe NBPP (temporary and persistent) that occurred without concomitant shoulder dystocia. These reports indicate that 46% of NBPP cases occurred without documented shoulder dystocia (0.9 ­cases/1,000 births).

Persistent NBPP. Two of these reports provide data on persistent NBPP without shoulder dystocia. Even when injury to the brachial plexus was documented as lasting more than 1 year, 26% of cases occurred in the absence of documented shoulder dystocia.

NBPP sometimes can occur during ­cesarean delivery. Four studies evaluated more than 240,000 births and found a rate of NBPP with cesarean delivery ranging from 0.3 to 1.5 cases per 1,000 live births.

All of these studies are described in the ACOG report.

When NBPP is related to shoulder dystocia
Shoulder dystocia may occur when there is a lack of fit of the transverse diameter of the fetal shoulders through the different pelvic diameters the shoulders encounter as they descend through the pelvis during the course of labor and delivery. This lack of fit can be related to excessive size of the fetal shoulders, inadequacy of pelvic dimensions to allow passage of a given fetus, or both. Abnormalities of fetal anatomy, fetal presentation, and soft tissue obstruction are rarely the cause of shoulder dystocia.

The difference between anterior shoulder obstruction behind the symphysis pubis and posterior shoulder obstruction from arrest at the level of the sacral promontory also is discussed in the ACOG report. In both cases, it is this obstruction of the affected shoulder while the long axis of the body continues to be pushed downward that widens the angle between the neck and impacted shoulder and stretches the brachial plexus.

The ACOG report acknowledges that may cases of NBPP do occur in conjunction with shoulder dystocia and that the same biomechanical factors that predispose a fetus to develop NBPP are associated with shoulder dystocia as well. However, the report takes pains to point out that the frequent conjunction of these two entities—NBPP and shoulder dystocia—may lead to an “erroneous retrospective inference of causation.”

Risk and predictive factors

The ACOG report states: “Various risk factors have been described in association with NBPP. Overall, however, these risk factors have not been shown to be statistically ­reliable or clinically useful predictors for...NBPP.”

For example, fetal macrosomia, defined as a birth weight of 4,000 g or more, has been reported as a risk factor for NBPP either alone or in conjunction with maternal diabetes. Although NBPP does occur more frequently as birth weight increases, seven studies over the past 20 years have shown that most cases of NBPP occur in infants of mothers without diabetes and in infants who weigh less than 4,000 g.

Other studies have shown that, if cesarean delivery were performed in cases of suspected macrosomia, it would have only a limited effect on reducing the incidence of NBPP. Specifically, in women with diabetes who have an estimated fetal weight of more than 4,500 g, the positive predictive value for NBPP is only 5%. Without maternal diabetes, that figure is less than 2%.

Estimating fetal weight by ultrasound does not significantly enhance our ability to predict NBPP. Ultrasound estimates of birth weight usually fall within 15% to 20% of actual birth weight, and the sensitivity of ultrasound in detecting birth weights more than 4,500 g is only 40%.

Therefore, ultrasound estimates of birth weight are of limited utility for contemporaneous clinical management. Furthermore, no data exist to support the claim that estimated fetal weight can be used prophylactically to reduce the incidence of NBPP.

Recurrent shoulder dystocia may be predictive of future NBPP
Whether studied alone or with NBPP, risk factors for shoulder dystocia are not reliable predictors of its occurrence. This is not the case, however, for recurrent shoulder dystocia, where the risk of neonatal brachial plexus palsy can be as high as 4.5%, compared with 1% to 2% for a first episode of shoulder dystocia.

C5 and C6 roots merge to form the upper trunk, C7 root forms the middle trunk, and C8 and T1 roots merge to form the lower trunk.

The frequency of NBPP is “rare,” according to the ACOG report, which cites a rate of 1.5 cases for every 1,000 births. Favorable outcomes with complete recovery are estimated to range from 50% to 80%.3

Brachial plexus injuries are classically defined as Erb’s palsy—involving C5 and C6 nerve roots—or Klumpke’s palsy, in which there is damage to the C8 and T1 nerve roots.

Erb’s palsy is recognizable by the characteristic “waiter’s tip” position of the hand, which is caused by muscle imbalance in the shoulder and upper arm. Most NBPP injuries are Erb’s palsy, which affect 1.2 infants in every 1,000 births.

Klumpke’s palsy results in weakness of the hand and medial forearm muscles. It affects 0.05 infants in every 1,000 births. The remaining cases involve a combination of the two types of palsy.

These injuries can be temporary, resolving by 12 months after birth, or permanent. The rate of persistence of NBPP at 12 months ranges from 3% to 33%.

Can clinician maneuvers increase the likelihood of NBPP?

The ACOG report addresses the direction and angle of clinician traction at delivery. The report confirms what clinicians generally have been taught: The application of fundal pressure during a delivery in which shoulder dystocia is recognized can exacerbate shoulder impaction and can lead to an increased risk of NBPP.

Traction applied by the clinician and lateral bending of the fetal neck often are implicated as causative factors of NBPP. However, ACOG presents evidence that NBPP can occur entirely unrelated to clinician traction. The report cites studies involving both transient and persistent NBPP in fetuses delivered vaginally without evident shoulder dystocia. The same types of injury are sometimes seen in fetuses delivered by cesarean, as has been mentioned.

The report goes on to state:

Recommendations for practice

At the close of its second chapter (“Risk and predictive factors”), the ACOG report offers the same official recommendations that appear in its current practice bulletin on shoulder dystocia. It notes that there are three clinical situations in which it may be ­prudent to alter usual obstetric management, with an aim of reducing the risk of shoulder dystocia and NBPP:

• when fetal macrosomia is suspected, with fetal weight estimated to exceed 5,000 g in a woman without diabetes or 4,500 g in a woman with diabetes
• when the mother has a history of recognized shoulder dystocia, especially when neonatal injury was severe
• when midpelvic operative vaginal delivery is contemplated with a fetus estimated to weigh more than 4,000 g.

It is interesting to note that these recommendations are made, according to the report, “notwithstanding the unreliability of specific risk factors to predict NBPP or clinically apparent shoulder dystocia in a specific case.” The report further adds:

More to come

For ACOG’s conclusions on the pathophysiology and causation of NBPP, with a view toward formulating specific protective interventions, see Part 2 of this article, which will appear in the October 2014 issue of OBG Management.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.