Surgery

Today, “normal” aging is no longer acceptable. From aesthetics to physical, mental, and sexual health, the maturing population seeks effective minimally invasive and practical methods to halt time and reverse its adverse effects. Nowhere is this more apparent than when dealing with urinary and fecal incontinence, conditions that can be not only embarrassing to patients but also debilitating, with potential crippling adverse affects on quality of life. As the US population ages, the prevalence of incontinence is increasing.

Patients commonly present with questions about their incontinence with preconceived notions on their available treatment options based on Internet searches and advertisements from magazines and television. Thus, as gynecologists, we have a pivotal role in educating women on their conditions and management options in a comprehensive, informative, and reassuring manner. By educating patients on the success rates and limitations of available treatments, patients can make informed decisions and reinforce their sense of autonomy. In this article we present the evidence on current, new, and investigative products available for the treatment of both stress urinary incontinence and overactive bladder, as well as fecal incontinence.

Case 1: Stress urinary incontinence
A 46-year-old woman (G2P2) presents with loss of urine with exercise, dancing, and sneezing that began after the birth of her last baby 5 years ago and is progressively becoming more frequent. She performs Kegel exercises occasionally and denies urinary urgency and/or urge incontinence. She reports a 20-lb weight gain in the past 3 years. Physical examination findings reveal normal pelvic examination with adequate pelvic organ support but weakened pelvic floor muscles during contraction. When you ask her to cough, you observe a small amount of urine loss from the urethral meatus. She has heard of “slings” before, but she is anxious about surgery.

Stress urinary incontinence (SUI) is the involuntary loss of urine with effort, physical exertion, sneezing, or coughing.¹ It is the most common type of incontinence in younger women, with risk factors including increasing age, parity, and obesity.^2,3 SUI treatment options, beginning from least to most invasive, include pelvic floor exercises, biofeedback and/or physical therapy, continence devices, off-label use of medications, urethral bulking agents, and surgical correction with slings. Midurethral tension-free slings are highly efficacious for the treatment of SUI. While a sling is a minimally invasive procedure, patients typically voice concerns regarding surgery and appropriately begin with conservative treatments.

A new FDA-approved OTC option for SUI
First-line conservative therapies offered to patients for SUI include pelvic floor muscle exercises and intravaginal continence devices. Disappointingly, such devices—including pessaries and the incontinence dish—have not been popular among patients for SUI. Authors of a randomized control trial evaluating incontinence pessaries versus behavioral therapy, including pelvic floor muscle training, found that, after 3 months, use of a pes‑ sary was not as effective as behavioral therapy in terms of patient satisfaction and improvement in bothersome urinary incontinence.⁴ In our experience, many patients wearing incontinence rings discontinue their use due to ineffectiveness or discomfort.

Patients now have an FDA-approved, over-the-counter option for SUI symptom management. The Poise Impressa is a disposable, nonabsorbent, flexible intravaginal device for patients with SUI (FIGURE 1). The device is comprised of a silicone core with a soft, nonwoven polypropylene fabric cover. It is inserted similar to a tampon, using an applicator, and provides nonobstructive support to the urethra to prevent stress urinary leakage. To find the proper fit, patients purchase the sizing kit, which includes 3 sizes. Patients are to insert size 1 first and monitor their comfort as well as improvement in leakage. Should size 1not sufficiently relieve leakage, the patient may try sizes 2 and 3 successively, with the goal of finding the most comfortable and effective insert. The insert is approved for up to 8 hours of wear in a 24-hour period, at which time the patient removes the device by pulling the string in a similar manner as removing a tampon.

Efficacy and quality of life data. Over 28 days, 85% of women with severe SUI confirmed on urodynamic testing achieved greater than 70% leakage reduction according to measured pad weights.⁵ Seventy percent of women reported 90% improvement in quality of life using validated questionnaires. In addition, 92% reported feeling dry with an improved perception of incontinence and greater confidence during strenuous activities.⁶ There were no serious adverse events, and the most common mild adverse events were discomfort, pain, and spotting.

As more patients become aware of the device through advertising and word of mouth, we expect patients to seek advice from their gynecologists on the safety and efficacy of the insert. In our experience, most patients report improvement in bothersome symptoms with the device and are overall satisfied. For patients who have discomfort with device placement, a water-based lubricant can be used. Patients using vaginal estrogen may apply the medication at night and wear the device during the day.

Office-based bladder control system in the pipeline
For SUI, options are limited for patients who would rather seek office-based procedures than invasive surgeries. Injections of urethral bulking agents can be performed in an office setting by injecting them transurethrally with a cystoscope slightly distal to the bladder neck. While bulking agents have a role in certain patients with SUI, especially those who are not interested in pursuing more invasive surgeries, only 43% have short-term (less than 6 months) cure and 75% report short-term improvement.⁷

A minimally invasive office-based procedure to treat SUI symptoms is under investigation in clinical trials currently. The Vesair Balloon bladder control system (Solace Therapeutics) is performed with cystoscopic guidance and is being tested at multiple sites throughout the United States (FIGURE 2).

The Vesair Balloon acts like a “shock absorber” to reduce momentary increases in bladder pressure due to external forces or stressors. The balloon is a small device, approximately the size of a quarter, and is implanted through the urethra via a specially designed applicator under cystoscopic guidance in the office setting. Pretreatment with pain medication usually is unnecessary. The VesairBalloon may be retained in situ for up to 12 months, at which time it is removed using a device-specific grasper under direct visualization with a cystoscope in the office.

Preliminary efficacy and safety data. In a single-blinded randomized controlled trial, 63% of women in the Vesair Balloon group had significant improvement in provocative pad weights and quality-of-life questionnaire scores at 3 months, compared with 31% in the control group.⁸ No serious adverse events were observed. Eleven of 63 patients (17%) withdrew from the study—most commonly for bladder irritation and dysuria.

We anxiously await the results of a second single-blinded randomized control trial currently being conducted.

Best surgical options for SUI
Today, the standard surgical procedure for SUI is a midurethral sling. Midurethral slings may be placed through 3 routes: retropubic; transobturator; and single-incision, otherwise known as “mini-slings.” Subjective cure rates of retropubic versus transobturator slings are similar, with lower rates of bladder perforation, major vascular/visceral injury, and operative blood loss in the transobturator group.⁹ However, rates of groin pain are higher in the trans‑ obturator group.

Single-incision slings were developed in an effort to avoid the morbidity and pain with passing traditional sling trocars through the obturator space and skin of the groin. In a randomized controlled trial, the Miniarc single- incision sling (Astora Women’s Health) was found to be noninferior to the Monarc transobturator sling (Astora) at 12 and 36 months.¹⁰ There were no statistically significant differences between subjective and objective cure rates on cough stress tests. Postoperative pain and groin pain were significantly less in patients with the Miniarc sling, compared with the Monarc sling.

It is our opinion that as more data become available, single-incision slings will find their foothold in a subset of patients with SUI.

Case 2: Overactive bladder: Failed medication therapy
A healthy 63-year-old woman presents with a 9-month history of loss of urine with strong urges, urinating 4 times per night, and a feeling of urgency when she needs to urinate. She denies pain with urination, difficulty emptying her bladder fully, and pain with a full bladder. She has restricted her fluid intake to 4 glasses of water per day and has stopped drinking fluids 4 hours before bedtime.

She described her symptoms to her intern‑ ist, who prescribed oxybutynin. She took the medication for 3 months but stopped after she developed severe constipation and dry mouth. She states the medication did not help her urinary symptoms. You discuss with her trials of other medications including topical anticholinergics and mirabegron. She is frustrated with her symptoms and asks if there are any other options besides medications.

Overactive bladder (OAB) is present in up to 16% of the US population, with the percentage estimated to increase by 20% within the next 2 years.^11,12 The drastic increase in prevalence, likely due to the aging population, may result in an increased counseling and management burden placed on general practitioners and gynecologists.

First-line management options for OAB are behavioral modifications and/or medications. Our patient in case 2 failed both first-line therapies. When a patient fails or is intolerant to an anticholinergic medication, we offer mirabegron, a beta-3 agonist (after excluding any contraindications to the medication). Beyond medications, the therapeutic options are rather limited.

Second-line OAB treatment options
In January 2013, the FDA expanded the approved use of onabotulinum toxin A (Botox, Allergan) for the treatment of OAB in those who are intolerant of or have failed treatment with anticholinergic medications. Using a cystoscope, 100 units of onabotulinum toxin A are injected into 20 sites within the bladder wall. Due to the risk of urinary retention in up to 6% of patients, it is recommended to administer onabotulinum toxin A to patients who are willing and capable of performing clean intermittent catheterization.¹³

Efficacy data. In a recent systematic review and meta-analysis, the authors concluded onabotulinum toxin A to be effective in the treatment of idiopathic OAB with a statistically significant reduction compared with baseline in the number of incontinence episodes per day (-2.77 in the treatment group vs -1.01 in the placebo group) and the number of voids per day (-1.61 in the treatment group vs -0.87 in the placebo group).¹⁴ Patients who received onabotulinum toxin A experienced a higher rate of adverse effects, such as urinary tract infections, and were more likely to require clean intermittent catheterization due to incomplete bladder emptying.¹³ Patients can expect symptom improvement for approximately 6 months or longer.¹⁵ Based on the manufacturers’ recommendations, patients are not to be reinjected sooner than 12 weeks from prior onabotulinum toxin A injection.

In women with refractory OAB, available second-line treatments include neuromodulation by sacral nerve or posterior tibial nerve stimulation (PTNS). The latter therapy is an office-based procedure that involves placement of a lead percutaneous to the medial aspect of the ankle near the tibial nerve. It is postulated that stimulation of the tibial nerve results in retrograde stimulation of the S3 sacral nerve plexus, resulting in OAB symptom relief in 54% to 70% of patients.¹⁶

Case 3: Fecal incontinence
A 57-year-old, otherwise healthy, multiparous woman presents with a 3-year history of fecal incontinence. She reports that it is embarrassing and distressing. She avoids certain social activities and is not currently sexually active due to the frequency of bowel leakage episodes.

In an effort to decrease her episodes of incontinence, she takes loperamide hydrochloride (Imodium) regularly with little improvement in the frequency of accidents. She has no history of gastrointestinal, rectal, or gynecologic surgery. She had 2 full-term vaginal deliveries that were uncomplicated. On review of systems, she also discloses occasional urinary incontinence.

Physical examination reveals normal vaginal anatomy with adequate pelvic organ support and no neurologic abnormalities. Rectal examination demonstrates normal tone and no evidence of rectal prolapse. Contractions of the pelvic floor muscles are weak. She is frustrated with her condition and seeks your guidance.

Fecal incontinence affects more than 20 million women in the United States, with only one-third of those with the condition disclosing their symptoms to their physician.¹⁷ Many etiologies for accidental bowel leakage exist, with some of the most common being advancing age and obstetric trauma. Up to one-third of women presenting for evaluation of urinary incontinence have fecal incontinence; therefore, one must be vigilant in screening for this potentially devastating condition.¹⁸

In case 3, the patient has tried medical therapies for fecal incontinence, including stool-bulking agents and motility regulators such as loperamide hydrochloride. Besides offering fiber supplements (or other stool-bulking agents) or physical therapy, nonsurgical options for this patient are limited.

Newly available: A vaginal insert for fecal incontinence
In 2015, the Eclipse System (Pelvalon) became the first FDA-approved vaginal insert for the treatment of fecal incontinence. The manufacturer recently was granted clearance for its second-generation device (FIGURE 3). The device consists of a silicone-coated stainless steel base with a posteriorly facing balloon and a pressure-regulated pump that allows the patient to control her bowel movements. After a patient is fitted with the device in the office setting, she is independently able to insert and remove it as well as deflate the balloon to allow for bowel movements and inflate the balloon to prevent accidental bowel leakage.

In a multicenter trial conducted by Richter and colleagues,¹⁹ 78% of women successfully fitted with the device had a 50% mean reduction of fecal incontinence episodes. Two-week mean incontinence episodes decreased from 11 to 2 after 1 month of continued use of the insert. In addition, there was significant improvement in quality-of-life questionnaire scores.

Of the 110 patients fitted with the device, 32 (29%) withdrew due to unsatisfactory device fit or were unable to remove or insert the device themselves. Common adverse effects included pelvic cramping and discomfort during device fitting. One month after insertion, pelvic pain and cramping continued in up to 10% of patients. No serious adverse events related to the device were observed during the 1-month trial.¹⁹

In the approximate 70% of women successfully fitted with the vaginal insert, the system was highly efficacious in improving subjective and objective outcomes with no unexpected serious adverse events. Currently the device is available at investigative sites across the United States, and the company plans for sales to begin later this year.

Surgical options for fecal incontinence
In patients for whom conservative and medical therapies have failed, surgical treatments may be offered. Surgical options vary from minimally invasive procedures to colostomy. One of the minimally invasive procedures available is the InterStim procedure, or sacral nerve stimulation (SNS). An electrode is inserted percutaneously through the S3 foramen and is connected to an implanted battery under the skin of the buttocks. Low-voltage stimulation is applied to the leads that lie adjacent to the S3 sacral nerve roots.

Patients with SNS experience fewer episodes of fecal incontinence, with over 80% maintaining a reduction in fecal incontinent episodes by greater than 50% up to 5 years after implantation.^20,21

The transobturator postanal sling system (TOPAS, Astora) is a new investigational surgical device. It is inserted in a minimally invasive procedure and is currently undergoing a prospective, multicenter clinical trial (FIGURE 4). It consists of a polypropylene mesh sling placed perianally, with the mesh arms exiting through the obturator foramen bilaterally. It is intended to increase posterior pelvic support at the level of the anorectal junction. Efficacy and safety of the product have yet to be determined.

We need to stay up to date on new treatment options
As the prevalence increases for urinary and fecal incontinence, ObGyns are challenged to remain knowledgeable about the condition, the prognosis, and the success of interventions. Currently, patients have a range of options to manage their urinary and fecal incontinence symptoms, with the number of products and clinical data increasing over time. With the advent of novel products and the widespread availability of information via the Internet, physicians must remain the established source on new innovative treatments and up-to-date clinical data in order to provide competent and comprehensive care.

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

Today, “normal” aging is no longer acceptable. From aesthetics to physical, mental, and sexual health, the maturing population seeks effective minimally invasive and practical methods to halt time and reverse its adverse effects. Nowhere is this more apparent than when dealing with urinary and fecal incontinence, conditions that can be not only embarrassing to patients but also debilitating, with potential crippling adverse affects on quality of life. As the US population ages, the prevalence of incontinence is increasing.

Patients commonly present with questions about their incontinence with preconceived notions on their available treatment options based on Internet searches and advertisements from magazines and television. Thus, as gynecologists, we have a pivotal role in educating women on their conditions and management options in a comprehensive, informative, and reassuring manner. By educating patients on the success rates and limitations of available treatments, patients can make informed decisions and reinforce their sense of autonomy. In this article we present the evidence on current, new, and investigative products available for the treatment of both stress urinary incontinence and overactive bladder, as well as fecal incontinence.

Case 1: Stress urinary incontinence
A 46-year-old woman (G2P2) presents with loss of urine with exercise, dancing, and sneezing that began after the birth of her last baby 5 years ago and is progressively becoming more frequent. She performs Kegel exercises occasionally and denies urinary urgency and/or urge incontinence. She reports a 20-lb weight gain in the past 3 years. Physical examination findings reveal normal pelvic examination with adequate pelvic organ support but weakened pelvic floor muscles during contraction. When you ask her to cough, you observe a small amount of urine loss from the urethral meatus. She has heard of “slings” before, but she is anxious about surgery.

Stress urinary incontinence (SUI) is the involuntary loss of urine with effort, physical exertion, sneezing, or coughing.¹ It is the most common type of incontinence in younger women, with risk factors including increasing age, parity, and obesity.^2,3 SUI treatment options, beginning from least to most invasive, include pelvic floor exercises, biofeedback and/or physical therapy, continence devices, off-label use of medications, urethral bulking agents, and surgical correction with slings. Midurethral tension-free slings are highly efficacious for the treatment of SUI. While a sling is a minimally invasive procedure, patients typically voice concerns regarding surgery and appropriately begin with conservative treatments.

A new FDA-approved OTC option for SUI
First-line conservative therapies offered to patients for SUI include pelvic floor muscle exercises and intravaginal continence devices. Disappointingly, such devices—including pessaries and the incontinence dish—have not been popular among patients for SUI. Authors of a randomized control trial evaluating incontinence pessaries versus behavioral therapy, including pelvic floor muscle training, found that, after 3 months, use of a pes‑ sary was not as effective as behavioral therapy in terms of patient satisfaction and improvement in bothersome urinary incontinence.⁴ In our experience, many patients wearing incontinence rings discontinue their use due to ineffectiveness or discomfort.

Patients now have an FDA-approved, over-the-counter option for SUI symptom management. The Poise Impressa is a disposable, nonabsorbent, flexible intravaginal device for patients with SUI (FIGURE 1). The device is comprised of a silicone core with a soft, nonwoven polypropylene fabric cover. It is inserted similar to a tampon, using an applicator, and provides nonobstructive support to the urethra to prevent stress urinary leakage. To find the proper fit, patients purchase the sizing kit, which includes 3 sizes. Patients are to insert size 1 first and monitor their comfort as well as improvement in leakage. Should size 1not sufficiently relieve leakage, the patient may try sizes 2 and 3 successively, with the goal of finding the most comfortable and effective insert. The insert is approved for up to 8 hours of wear in a 24-hour period, at which time the patient removes the device by pulling the string in a similar manner as removing a tampon.

Efficacy and quality of life data. Over 28 days, 85% of women with severe SUI confirmed on urodynamic testing achieved greater than 70% leakage reduction according to measured pad weights.⁵ Seventy percent of women reported 90% improvement in quality of life using validated questionnaires. In addition, 92% reported feeling dry with an improved perception of incontinence and greater confidence during strenuous activities.⁶ There were no serious adverse events, and the most common mild adverse events were discomfort, pain, and spotting.

As more patients become aware of the device through advertising and word of mouth, we expect patients to seek advice from their gynecologists on the safety and efficacy of the insert. In our experience, most patients report improvement in bothersome symptoms with the device and are overall satisfied. For patients who have discomfort with device placement, a water-based lubricant can be used. Patients using vaginal estrogen may apply the medication at night and wear the device during the day.

Office-based bladder control system in the pipeline
For SUI, options are limited for patients who would rather seek office-based procedures than invasive surgeries. Injections of urethral bulking agents can be performed in an office setting by injecting them transurethrally with a cystoscope slightly distal to the bladder neck. While bulking agents have a role in certain patients with SUI, especially those who are not interested in pursuing more invasive surgeries, only 43% have short-term (less than 6 months) cure and 75% report short-term improvement.⁷

A minimally invasive office-based procedure to treat SUI symptoms is under investigation in clinical trials currently. The Vesair Balloon bladder control system (Solace Therapeutics) is performed with cystoscopic guidance and is being tested at multiple sites throughout the United States (FIGURE 2).

The Vesair Balloon acts like a “shock absorber” to reduce momentary increases in bladder pressure due to external forces or stressors. The balloon is a small device, approximately the size of a quarter, and is implanted through the urethra via a specially designed applicator under cystoscopic guidance in the office setting. Pretreatment with pain medication usually is unnecessary. The VesairBalloon may be retained in situ for up to 12 months, at which time it is removed using a device-specific grasper under direct visualization with a cystoscope in the office.

Preliminary efficacy and safety data. In a single-blinded randomized controlled trial, 63% of women in the Vesair Balloon group had significant improvement in provocative pad weights and quality-of-life questionnaire scores at 3 months, compared with 31% in the control group.⁸ No serious adverse events were observed. Eleven of 63 patients (17%) withdrew from the study—most commonly for bladder irritation and dysuria.

We anxiously await the results of a second single-blinded randomized control trial currently being conducted.

Best surgical options for SUI
Today, the standard surgical procedure for SUI is a midurethral sling. Midurethral slings may be placed through 3 routes: retropubic; transobturator; and single-incision, otherwise known as “mini-slings.” Subjective cure rates of retropubic versus transobturator slings are similar, with lower rates of bladder perforation, major vascular/visceral injury, and operative blood loss in the transobturator group.⁹ However, rates of groin pain are higher in the trans‑ obturator group.

Single-incision slings were developed in an effort to avoid the morbidity and pain with passing traditional sling trocars through the obturator space and skin of the groin. In a randomized controlled trial, the Miniarc single- incision sling (Astora Women’s Health) was found to be noninferior to the Monarc transobturator sling (Astora) at 12 and 36 months.¹⁰ There were no statistically significant differences between subjective and objective cure rates on cough stress tests. Postoperative pain and groin pain were significantly less in patients with the Miniarc sling, compared with the Monarc sling.

It is our opinion that as more data become available, single-incision slings will find their foothold in a subset of patients with SUI.

Case 2: Overactive bladder: Failed medication therapy
A healthy 63-year-old woman presents with a 9-month history of loss of urine with strong urges, urinating 4 times per night, and a feeling of urgency when she needs to urinate. She denies pain with urination, difficulty emptying her bladder fully, and pain with a full bladder. She has restricted her fluid intake to 4 glasses of water per day and has stopped drinking fluids 4 hours before bedtime.

She described her symptoms to her intern‑ ist, who prescribed oxybutynin. She took the medication for 3 months but stopped after she developed severe constipation and dry mouth. She states the medication did not help her urinary symptoms. You discuss with her trials of other medications including topical anticholinergics and mirabegron. She is frustrated with her symptoms and asks if there are any other options besides medications.

Overactive bladder (OAB) is present in up to 16% of the US population, with the percentage estimated to increase by 20% within the next 2 years.^11,12 The drastic increase in prevalence, likely due to the aging population, may result in an increased counseling and management burden placed on general practitioners and gynecologists.

First-line management options for OAB are behavioral modifications and/or medications. Our patient in case 2 failed both first-line therapies. When a patient fails or is intolerant to an anticholinergic medication, we offer mirabegron, a beta-3 agonist (after excluding any contraindications to the medication). Beyond medications, the therapeutic options are rather limited.

Second-line OAB treatment options
In January 2013, the FDA expanded the approved use of onabotulinum toxin A (Botox, Allergan) for the treatment of OAB in those who are intolerant of or have failed treatment with anticholinergic medications. Using a cystoscope, 100 units of onabotulinum toxin A are injected into 20 sites within the bladder wall. Due to the risk of urinary retention in up to 6% of patients, it is recommended to administer onabotulinum toxin A to patients who are willing and capable of performing clean intermittent catheterization.¹³

Efficacy data. In a recent systematic review and meta-analysis, the authors concluded onabotulinum toxin A to be effective in the treatment of idiopathic OAB with a statistically significant reduction compared with baseline in the number of incontinence episodes per day (-2.77 in the treatment group vs -1.01 in the placebo group) and the number of voids per day (-1.61 in the treatment group vs -0.87 in the placebo group).¹⁴ Patients who received onabotulinum toxin A experienced a higher rate of adverse effects, such as urinary tract infections, and were more likely to require clean intermittent catheterization due to incomplete bladder emptying.¹³ Patients can expect symptom improvement for approximately 6 months or longer.¹⁵ Based on the manufacturers’ recommendations, patients are not to be reinjected sooner than 12 weeks from prior onabotulinum toxin A injection.

In women with refractory OAB, available second-line treatments include neuromodulation by sacral nerve or posterior tibial nerve stimulation (PTNS). The latter therapy is an office-based procedure that involves placement of a lead percutaneous to the medial aspect of the ankle near the tibial nerve. It is postulated that stimulation of the tibial nerve results in retrograde stimulation of the S3 sacral nerve plexus, resulting in OAB symptom relief in 54% to 70% of patients.¹⁶

Case 3: Fecal incontinence
A 57-year-old, otherwise healthy, multiparous woman presents with a 3-year history of fecal incontinence. She reports that it is embarrassing and distressing. She avoids certain social activities and is not currently sexually active due to the frequency of bowel leakage episodes.

In an effort to decrease her episodes of incontinence, she takes loperamide hydrochloride (Imodium) regularly with little improvement in the frequency of accidents. She has no history of gastrointestinal, rectal, or gynecologic surgery. She had 2 full-term vaginal deliveries that were uncomplicated. On review of systems, she also discloses occasional urinary incontinence.

Physical examination reveals normal vaginal anatomy with adequate pelvic organ support and no neurologic abnormalities. Rectal examination demonstrates normal tone and no evidence of rectal prolapse. Contractions of the pelvic floor muscles are weak. She is frustrated with her condition and seeks your guidance.

Fecal incontinence affects more than 20 million women in the United States, with only one-third of those with the condition disclosing their symptoms to their physician.¹⁷ Many etiologies for accidental bowel leakage exist, with some of the most common being advancing age and obstetric trauma. Up to one-third of women presenting for evaluation of urinary incontinence have fecal incontinence; therefore, one must be vigilant in screening for this potentially devastating condition.¹⁸

In case 3, the patient has tried medical therapies for fecal incontinence, including stool-bulking agents and motility regulators such as loperamide hydrochloride. Besides offering fiber supplements (or other stool-bulking agents) or physical therapy, nonsurgical options for this patient are limited.

Newly available: A vaginal insert for fecal incontinence
In 2015, the Eclipse System (Pelvalon) became the first FDA-approved vaginal insert for the treatment of fecal incontinence. The manufacturer recently was granted clearance for its second-generation device (FIGURE 3). The device consists of a silicone-coated stainless steel base with a posteriorly facing balloon and a pressure-regulated pump that allows the patient to control her bowel movements. After a patient is fitted with the device in the office setting, she is independently able to insert and remove it as well as deflate the balloon to allow for bowel movements and inflate the balloon to prevent accidental bowel leakage.

In a multicenter trial conducted by Richter and colleagues,¹⁹ 78% of women successfully fitted with the device had a 50% mean reduction of fecal incontinence episodes. Two-week mean incontinence episodes decreased from 11 to 2 after 1 month of continued use of the insert. In addition, there was significant improvement in quality-of-life questionnaire scores.

Of the 110 patients fitted with the device, 32 (29%) withdrew due to unsatisfactory device fit or were unable to remove or insert the device themselves. Common adverse effects included pelvic cramping and discomfort during device fitting. One month after insertion, pelvic pain and cramping continued in up to 10% of patients. No serious adverse events related to the device were observed during the 1-month trial.¹⁹

In the approximate 70% of women successfully fitted with the vaginal insert, the system was highly efficacious in improving subjective and objective outcomes with no unexpected serious adverse events. Currently the device is available at investigative sites across the United States, and the company plans for sales to begin later this year.

Surgical options for fecal incontinence
In patients for whom conservative and medical therapies have failed, surgical treatments may be offered. Surgical options vary from minimally invasive procedures to colostomy. One of the minimally invasive procedures available is the InterStim procedure, or sacral nerve stimulation (SNS). An electrode is inserted percutaneously through the S3 foramen and is connected to an implanted battery under the skin of the buttocks. Low-voltage stimulation is applied to the leads that lie adjacent to the S3 sacral nerve roots.

Patients with SNS experience fewer episodes of fecal incontinence, with over 80% maintaining a reduction in fecal incontinent episodes by greater than 50% up to 5 years after implantation.^20,21

The transobturator postanal sling system (TOPAS, Astora) is a new investigational surgical device. It is inserted in a minimally invasive procedure and is currently undergoing a prospective, multicenter clinical trial (FIGURE 4). It consists of a polypropylene mesh sling placed perianally, with the mesh arms exiting through the obturator foramen bilaterally. It is intended to increase posterior pelvic support at the level of the anorectal junction. Efficacy and safety of the product have yet to be determined.

We need to stay up to date on new treatment options
As the prevalence increases for urinary and fecal incontinence, ObGyns are challenged to remain knowledgeable about the condition, the prognosis, and the success of interventions. Currently, patients have a range of options to manage their urinary and fecal incontinence symptoms, with the number of products and clinical data increasing over time. With the advent of novel products and the widespread availability of information via the Internet, physicians must remain the established source on new innovative treatments and up-to-date clinical data in order to provide competent and comprehensive care.

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

Today, “normal” aging is no longer acceptable. From aesthetics to physical, mental, and sexual health, the maturing population seeks effective minimally invasive and practical methods to halt time and reverse its adverse effects. Nowhere is this more apparent than when dealing with urinary and fecal incontinence, conditions that can be not only embarrassing to patients but also debilitating, with potential crippling adverse affects on quality of life. As the US population ages, the prevalence of incontinence is increasing.

Patients commonly present with questions about their incontinence with preconceived notions on their available treatment options based on Internet searches and advertisements from magazines and television. Thus, as gynecologists, we have a pivotal role in educating women on their conditions and management options in a comprehensive, informative, and reassuring manner. By educating patients on the success rates and limitations of available treatments, patients can make informed decisions and reinforce their sense of autonomy. In this article we present the evidence on current, new, and investigative products available for the treatment of both stress urinary incontinence and overactive bladder, as well as fecal incontinence.

Case 1: Stress urinary incontinence
A 46-year-old woman (G2P2) presents with loss of urine with exercise, dancing, and sneezing that began after the birth of her last baby 5 years ago and is progressively becoming more frequent. She performs Kegel exercises occasionally and denies urinary urgency and/or urge incontinence. She reports a 20-lb weight gain in the past 3 years. Physical examination findings reveal normal pelvic examination with adequate pelvic organ support but weakened pelvic floor muscles during contraction. When you ask her to cough, you observe a small amount of urine loss from the urethral meatus. She has heard of “slings” before, but she is anxious about surgery.

Stress urinary incontinence (SUI) is the involuntary loss of urine with effort, physical exertion, sneezing, or coughing.¹ It is the most common type of incontinence in younger women, with risk factors including increasing age, parity, and obesity.^2,3 SUI treatment options, beginning from least to most invasive, include pelvic floor exercises, biofeedback and/or physical therapy, continence devices, off-label use of medications, urethral bulking agents, and surgical correction with slings. Midurethral tension-free slings are highly efficacious for the treatment of SUI. While a sling is a minimally invasive procedure, patients typically voice concerns regarding surgery and appropriately begin with conservative treatments.

A new FDA-approved OTC option for SUI
First-line conservative therapies offered to patients for SUI include pelvic floor muscle exercises and intravaginal continence devices. Disappointingly, such devices—including pessaries and the incontinence dish—have not been popular among patients for SUI. Authors of a randomized control trial evaluating incontinence pessaries versus behavioral therapy, including pelvic floor muscle training, found that, after 3 months, use of a pes‑ sary was not as effective as behavioral therapy in terms of patient satisfaction and improvement in bothersome urinary incontinence.⁴ In our experience, many patients wearing incontinence rings discontinue their use due to ineffectiveness or discomfort.

Patients now have an FDA-approved, over-the-counter option for SUI symptom management. The Poise Impressa is a disposable, nonabsorbent, flexible intravaginal device for patients with SUI (FIGURE 1). The device is comprised of a silicone core with a soft, nonwoven polypropylene fabric cover. It is inserted similar to a tampon, using an applicator, and provides nonobstructive support to the urethra to prevent stress urinary leakage. To find the proper fit, patients purchase the sizing kit, which includes 3 sizes. Patients are to insert size 1 first and monitor their comfort as well as improvement in leakage. Should size 1not sufficiently relieve leakage, the patient may try sizes 2 and 3 successively, with the goal of finding the most comfortable and effective insert. The insert is approved for up to 8 hours of wear in a 24-hour period, at which time the patient removes the device by pulling the string in a similar manner as removing a tampon.

Efficacy and quality of life data. Over 28 days, 85% of women with severe SUI confirmed on urodynamic testing achieved greater than 70% leakage reduction according to measured pad weights.⁵ Seventy percent of women reported 90% improvement in quality of life using validated questionnaires. In addition, 92% reported feeling dry with an improved perception of incontinence and greater confidence during strenuous activities.⁶ There were no serious adverse events, and the most common mild adverse events were discomfort, pain, and spotting.

As more patients become aware of the device through advertising and word of mouth, we expect patients to seek advice from their gynecologists on the safety and efficacy of the insert. In our experience, most patients report improvement in bothersome symptoms with the device and are overall satisfied. For patients who have discomfort with device placement, a water-based lubricant can be used. Patients using vaginal estrogen may apply the medication at night and wear the device during the day.

Office-based bladder control system in the pipeline
For SUI, options are limited for patients who would rather seek office-based procedures than invasive surgeries. Injections of urethral bulking agents can be performed in an office setting by injecting them transurethrally with a cystoscope slightly distal to the bladder neck. While bulking agents have a role in certain patients with SUI, especially those who are not interested in pursuing more invasive surgeries, only 43% have short-term (less than 6 months) cure and 75% report short-term improvement.⁷

A minimally invasive office-based procedure to treat SUI symptoms is under investigation in clinical trials currently. The Vesair Balloon bladder control system (Solace Therapeutics) is performed with cystoscopic guidance and is being tested at multiple sites throughout the United States (FIGURE 2).

The Vesair Balloon acts like a “shock absorber” to reduce momentary increases in bladder pressure due to external forces or stressors. The balloon is a small device, approximately the size of a quarter, and is implanted through the urethra via a specially designed applicator under cystoscopic guidance in the office setting. Pretreatment with pain medication usually is unnecessary. The VesairBalloon may be retained in situ for up to 12 months, at which time it is removed using a device-specific grasper under direct visualization with a cystoscope in the office.

Preliminary efficacy and safety data. In a single-blinded randomized controlled trial, 63% of women in the Vesair Balloon group had significant improvement in provocative pad weights and quality-of-life questionnaire scores at 3 months, compared with 31% in the control group.⁸ No serious adverse events were observed. Eleven of 63 patients (17%) withdrew from the study—most commonly for bladder irritation and dysuria.

We anxiously await the results of a second single-blinded randomized control trial currently being conducted.

Best surgical options for SUI
Today, the standard surgical procedure for SUI is a midurethral sling. Midurethral slings may be placed through 3 routes: retropubic; transobturator; and single-incision, otherwise known as “mini-slings.” Subjective cure rates of retropubic versus transobturator slings are similar, with lower rates of bladder perforation, major vascular/visceral injury, and operative blood loss in the transobturator group.⁹ However, rates of groin pain are higher in the trans‑ obturator group.

Single-incision slings were developed in an effort to avoid the morbidity and pain with passing traditional sling trocars through the obturator space and skin of the groin. In a randomized controlled trial, the Miniarc single- incision sling (Astora Women’s Health) was found to be noninferior to the Monarc transobturator sling (Astora) at 12 and 36 months.¹⁰ There were no statistically significant differences between subjective and objective cure rates on cough stress tests. Postoperative pain and groin pain were significantly less in patients with the Miniarc sling, compared with the Monarc sling.

It is our opinion that as more data become available, single-incision slings will find their foothold in a subset of patients with SUI.

Case 2: Overactive bladder: Failed medication therapy
A healthy 63-year-old woman presents with a 9-month history of loss of urine with strong urges, urinating 4 times per night, and a feeling of urgency when she needs to urinate. She denies pain with urination, difficulty emptying her bladder fully, and pain with a full bladder. She has restricted her fluid intake to 4 glasses of water per day and has stopped drinking fluids 4 hours before bedtime.

She described her symptoms to her intern‑ ist, who prescribed oxybutynin. She took the medication for 3 months but stopped after she developed severe constipation and dry mouth. She states the medication did not help her urinary symptoms. You discuss with her trials of other medications including topical anticholinergics and mirabegron. She is frustrated with her symptoms and asks if there are any other options besides medications.

Overactive bladder (OAB) is present in up to 16% of the US population, with the percentage estimated to increase by 20% within the next 2 years.^11,12 The drastic increase in prevalence, likely due to the aging population, may result in an increased counseling and management burden placed on general practitioners and gynecologists.

First-line management options for OAB are behavioral modifications and/or medications. Our patient in case 2 failed both first-line therapies. When a patient fails or is intolerant to an anticholinergic medication, we offer mirabegron, a beta-3 agonist (after excluding any contraindications to the medication). Beyond medications, the therapeutic options are rather limited.

Second-line OAB treatment options
In January 2013, the FDA expanded the approved use of onabotulinum toxin A (Botox, Allergan) for the treatment of OAB in those who are intolerant of or have failed treatment with anticholinergic medications. Using a cystoscope, 100 units of onabotulinum toxin A are injected into 20 sites within the bladder wall. Due to the risk of urinary retention in up to 6% of patients, it is recommended to administer onabotulinum toxin A to patients who are willing and capable of performing clean intermittent catheterization.¹³

Efficacy data. In a recent systematic review and meta-analysis, the authors concluded onabotulinum toxin A to be effective in the treatment of idiopathic OAB with a statistically significant reduction compared with baseline in the number of incontinence episodes per day (-2.77 in the treatment group vs -1.01 in the placebo group) and the number of voids per day (-1.61 in the treatment group vs -0.87 in the placebo group).¹⁴ Patients who received onabotulinum toxin A experienced a higher rate of adverse effects, such as urinary tract infections, and were more likely to require clean intermittent catheterization due to incomplete bladder emptying.¹³ Patients can expect symptom improvement for approximately 6 months or longer.¹⁵ Based on the manufacturers’ recommendations, patients are not to be reinjected sooner than 12 weeks from prior onabotulinum toxin A injection.

In women with refractory OAB, available second-line treatments include neuromodulation by sacral nerve or posterior tibial nerve stimulation (PTNS). The latter therapy is an office-based procedure that involves placement of a lead percutaneous to the medial aspect of the ankle near the tibial nerve. It is postulated that stimulation of the tibial nerve results in retrograde stimulation of the S3 sacral nerve plexus, resulting in OAB symptom relief in 54% to 70% of patients.¹⁶

Case 3: Fecal incontinence
A 57-year-old, otherwise healthy, multiparous woman presents with a 3-year history of fecal incontinence. She reports that it is embarrassing and distressing. She avoids certain social activities and is not currently sexually active due to the frequency of bowel leakage episodes.

In an effort to decrease her episodes of incontinence, she takes loperamide hydrochloride (Imodium) regularly with little improvement in the frequency of accidents. She has no history of gastrointestinal, rectal, or gynecologic surgery. She had 2 full-term vaginal deliveries that were uncomplicated. On review of systems, she also discloses occasional urinary incontinence.

Physical examination reveals normal vaginal anatomy with adequate pelvic organ support and no neurologic abnormalities. Rectal examination demonstrates normal tone and no evidence of rectal prolapse. Contractions of the pelvic floor muscles are weak. She is frustrated with her condition and seeks your guidance.

Fecal incontinence affects more than 20 million women in the United States, with only one-third of those with the condition disclosing their symptoms to their physician.¹⁷ Many etiologies for accidental bowel leakage exist, with some of the most common being advancing age and obstetric trauma. Up to one-third of women presenting for evaluation of urinary incontinence have fecal incontinence; therefore, one must be vigilant in screening for this potentially devastating condition.¹⁸

In case 3, the patient has tried medical therapies for fecal incontinence, including stool-bulking agents and motility regulators such as loperamide hydrochloride. Besides offering fiber supplements (or other stool-bulking agents) or physical therapy, nonsurgical options for this patient are limited.

Newly available: A vaginal insert for fecal incontinence
In 2015, the Eclipse System (Pelvalon) became the first FDA-approved vaginal insert for the treatment of fecal incontinence. The manufacturer recently was granted clearance for its second-generation device (FIGURE 3). The device consists of a silicone-coated stainless steel base with a posteriorly facing balloon and a pressure-regulated pump that allows the patient to control her bowel movements. After a patient is fitted with the device in the office setting, she is independently able to insert and remove it as well as deflate the balloon to allow for bowel movements and inflate the balloon to prevent accidental bowel leakage.

In a multicenter trial conducted by Richter and colleagues,¹⁹ 78% of women successfully fitted with the device had a 50% mean reduction of fecal incontinence episodes. Two-week mean incontinence episodes decreased from 11 to 2 after 1 month of continued use of the insert. In addition, there was significant improvement in quality-of-life questionnaire scores.

Of the 110 patients fitted with the device, 32 (29%) withdrew due to unsatisfactory device fit or were unable to remove or insert the device themselves. Common adverse effects included pelvic cramping and discomfort during device fitting. One month after insertion, pelvic pain and cramping continued in up to 10% of patients. No serious adverse events related to the device were observed during the 1-month trial.¹⁹

In the approximate 70% of women successfully fitted with the vaginal insert, the system was highly efficacious in improving subjective and objective outcomes with no unexpected serious adverse events. Currently the device is available at investigative sites across the United States, and the company plans for sales to begin later this year.

Surgical options for fecal incontinence
In patients for whom conservative and medical therapies have failed, surgical treatments may be offered. Surgical options vary from minimally invasive procedures to colostomy. One of the minimally invasive procedures available is the InterStim procedure, or sacral nerve stimulation (SNS). An electrode is inserted percutaneously through the S3 foramen and is connected to an implanted battery under the skin of the buttocks. Low-voltage stimulation is applied to the leads that lie adjacent to the S3 sacral nerve roots.

Patients with SNS experience fewer episodes of fecal incontinence, with over 80% maintaining a reduction in fecal incontinent episodes by greater than 50% up to 5 years after implantation.^20,21

The transobturator postanal sling system (TOPAS, Astora) is a new investigational surgical device. It is inserted in a minimally invasive procedure and is currently undergoing a prospective, multicenter clinical trial (FIGURE 4). It consists of a polypropylene mesh sling placed perianally, with the mesh arms exiting through the obturator foramen bilaterally. It is intended to increase posterior pelvic support at the level of the anorectal junction. Efficacy and safety of the product have yet to be determined.

We need to stay up to date on new treatment options
As the prevalence increases for urinary and fecal incontinence, ObGyns are challenged to remain knowledgeable about the condition, the prognosis, and the success of interventions. Currently, patients have a range of options to manage their urinary and fecal incontinence symptoms, with the number of products and clinical data increasing over time. With the advent of novel products and the widespread availability of information via the Internet, physicians must remain the established source on new innovative treatments and up-to-date clinical data in order to provide competent and comprehensive care.

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

Stroke during delivery: $35.4M verdict
During delivery, a 25-year-old woman had a hemorrhagic stroke that left her unable to care for herself or her child.

Patient’s claim The patient’s neurologist failed to advise the ObGyn that the patient had a history of brain aneurysm and a venous varix, which increased the risk for stroke during labor and delivery. The patient had shared her history with the ObGyn, and she requested that her neurologist contact the ObGyn.

Neurologist’s defense There was no negligence. The entire medical file had been delivered to the ObGyn. Any negligence was on the part of the ObGyn for failure to educate herself as to the patient’s condition.

Verdict A $35.4 million Massachusetts verdict was returned against the neurologist, including $12.9 million for past and future pain and suffering, $4 million for past medical care, $11 million for future medical care, $4.5 million for the husband’s loss of consortium, $1.5 million for lost wages, and $1.5 million for the child’s loss of consortium.
 

IUGR detected but not immediately treated: $15.5M settlement
During a prenatal visit at 38 weeks’ gestation, a mother’s ObGyn saw signs of intrauterine growth restriction (IUGR) but did not order ultrasono- graphy to confirm the diagnosis or induce labor. When born 15 days later, the baby had a low birth weight and low Apgar scores. The child has permanent brain injury due to hypoxia.

Parents’ claim The ObGyn should have confirmed the presence of IUGR and appropriately managed the mother’s prenatal care. The child’s injuries could have been prevented if an earlier delivery had occurred.

Physician’s defense The case was settled during the trial.

Verdict A $15.5 million Illinois settlement was reached.
 

Ureter injured during total abdominal hysterectomy
A 40-year-old woman with uterine fibroids, excessive bleeding, and pelvic pain underwent total abdominal hysterectomy performed by her ObGyn.

Postoperatively, the patient reported abdominal pain, but she was discharged from the hospital. Two days later, she returned to the emergency department reporting continued and increasing abdominal pain and urine leakage. The ObGyn referred her to a urologist who diagnosed stricture of the left ureter with a ureterovaginal fistula. A nephrostomy procedure was performed. Three months later, left ureter reimplantation surgery was completed.

Patient’s claim The ObGyn was negligent in injuring the ureter during hysterectomy, in not identifying the injury during surgery, and in not diagnosing and treating the injury in a timely manner, despite the patient’s reports of increasing pain.

Physician’s defense The case was settled during the trial.

Verdict A $350,000 Virginia settlement was reached.
 

Breech presentation but cesarean not performed
When her water broke, a mother was admitted to the hospital. The ObGyn ordered induction of labor but deferred vaginal examination to avoid infection. After labor was induced, a nurse noticed the presence of meconium. She performed a vaginal examination and found that the baby was in breech position; she did not immediately contact the ObGyn. After several hours of labor, the baby was born limp and not breathing with a heart rate of 50 bpm. The baby was resuscitated but sustained severe brain damage.

Parents’ claim The mother should have been examined before induction of labor. When it was determined that the baby was in breech position, a cesarean delivery should have been ordered. Communication between the nurse and ObGyn was poor.

Defendants' defense There was no negligence; labor was managed according to the standard of care.

Verdict A New Jersey defense verdict was returned.
 

Stroke during delivery: $35.4M verdict
During delivery, a 25-year-old woman had a hemorrhagic stroke that left her unable to care for herself or her child.

Patient’s claim The patient’s neurologist failed to advise the ObGyn that the patient had a history of brain aneurysm and a venous varix, which increased the risk for stroke during labor and delivery. The patient had shared her history with the ObGyn, and she requested that her neurologist contact the ObGyn.

Neurologist’s defense There was no negligence. The entire medical file had been delivered to the ObGyn. Any negligence was on the part of the ObGyn for failure to educate herself as to the patient’s condition.

Verdict A $35.4 million Massachusetts verdict was returned against the neurologist, including $12.9 million for past and future pain and suffering, $4 million for past medical care, $11 million for future medical care, $4.5 million for the husband’s loss of consortium, $1.5 million for lost wages, and $1.5 million for the child’s loss of consortium.
 

IUGR detected but not immediately treated: $15.5M settlement
During a prenatal visit at 38 weeks’ gestation, a mother’s ObGyn saw signs of intrauterine growth restriction (IUGR) but did not order ultrasono- graphy to confirm the diagnosis or induce labor. When born 15 days later, the baby had a low birth weight and low Apgar scores. The child has permanent brain injury due to hypoxia.

Parents’ claim The ObGyn should have confirmed the presence of IUGR and appropriately managed the mother’s prenatal care. The child’s injuries could have been prevented if an earlier delivery had occurred.

Physician’s defense The case was settled during the trial.

Verdict A $15.5 million Illinois settlement was reached.
 

Ureter injured during total abdominal hysterectomy
A 40-year-old woman with uterine fibroids, excessive bleeding, and pelvic pain underwent total abdominal hysterectomy performed by her ObGyn.

Postoperatively, the patient reported abdominal pain, but she was discharged from the hospital. Two days later, she returned to the emergency department reporting continued and increasing abdominal pain and urine leakage. The ObGyn referred her to a urologist who diagnosed stricture of the left ureter with a ureterovaginal fistula. A nephrostomy procedure was performed. Three months later, left ureter reimplantation surgery was completed.

Patient’s claim The ObGyn was negligent in injuring the ureter during hysterectomy, in not identifying the injury during surgery, and in not diagnosing and treating the injury in a timely manner, despite the patient’s reports of increasing pain.

Physician’s defense The case was settled during the trial.

Verdict A $350,000 Virginia settlement was reached.
 

Breech presentation but cesarean not performed
When her water broke, a mother was admitted to the hospital. The ObGyn ordered induction of labor but deferred vaginal examination to avoid infection. After labor was induced, a nurse noticed the presence of meconium. She performed a vaginal examination and found that the baby was in breech position; she did not immediately contact the ObGyn. After several hours of labor, the baby was born limp and not breathing with a heart rate of 50 bpm. The baby was resuscitated but sustained severe brain damage.

Parents’ claim The mother should have been examined before induction of labor. When it was determined that the baby was in breech position, a cesarean delivery should have been ordered. Communication between the nurse and ObGyn was poor.

Defendants' defense There was no negligence; labor was managed according to the standard of care.

Verdict A New Jersey defense verdict was returned.
 

Stroke during delivery: $35.4M verdict
During delivery, a 25-year-old woman had a hemorrhagic stroke that left her unable to care for herself or her child.

Patient’s claim The patient’s neurologist failed to advise the ObGyn that the patient had a history of brain aneurysm and a venous varix, which increased the risk for stroke during labor and delivery. The patient had shared her history with the ObGyn, and she requested that her neurologist contact the ObGyn.

Neurologist’s defense There was no negligence. The entire medical file had been delivered to the ObGyn. Any negligence was on the part of the ObGyn for failure to educate herself as to the patient’s condition.

Verdict A $35.4 million Massachusetts verdict was returned against the neurologist, including $12.9 million for past and future pain and suffering, $4 million for past medical care, $11 million for future medical care, $4.5 million for the husband’s loss of consortium, $1.5 million for lost wages, and $1.5 million for the child’s loss of consortium.
 

IUGR detected but not immediately treated: $15.5M settlement
During a prenatal visit at 38 weeks’ gestation, a mother’s ObGyn saw signs of intrauterine growth restriction (IUGR) but did not order ultrasono- graphy to confirm the diagnosis or induce labor. When born 15 days later, the baby had a low birth weight and low Apgar scores. The child has permanent brain injury due to hypoxia.

Parents’ claim The ObGyn should have confirmed the presence of IUGR and appropriately managed the mother’s prenatal care. The child’s injuries could have been prevented if an earlier delivery had occurred.

Physician’s defense The case was settled during the trial.

Verdict A $15.5 million Illinois settlement was reached.
 

Ureter injured during total abdominal hysterectomy
A 40-year-old woman with uterine fibroids, excessive bleeding, and pelvic pain underwent total abdominal hysterectomy performed by her ObGyn.

Postoperatively, the patient reported abdominal pain, but she was discharged from the hospital. Two days later, she returned to the emergency department reporting continued and increasing abdominal pain and urine leakage. The ObGyn referred her to a urologist who diagnosed stricture of the left ureter with a ureterovaginal fistula. A nephrostomy procedure was performed. Three months later, left ureter reimplantation surgery was completed.

Patient’s claim The ObGyn was negligent in injuring the ureter during hysterectomy, in not identifying the injury during surgery, and in not diagnosing and treating the injury in a timely manner, despite the patient’s reports of increasing pain.

Physician’s defense The case was settled during the trial.

Verdict A $350,000 Virginia settlement was reached.
 

Breech presentation but cesarean not performed
When her water broke, a mother was admitted to the hospital. The ObGyn ordered induction of labor but deferred vaginal examination to avoid infection. After labor was induced, a nurse noticed the presence of meconium. She performed a vaginal examination and found that the baby was in breech position; she did not immediately contact the ObGyn. After several hours of labor, the baby was born limp and not breathing with a heart rate of 50 bpm. The baby was resuscitated but sustained severe brain damage.

Parents’ claim The mother should have been examined before induction of labor. When it was determined that the baby was in breech position, a cesarean delivery should have been ordered. Communication between the nurse and ObGyn was poor.

Defendants' defense There was no negligence; labor was managed according to the standard of care.

Verdict A New Jersey defense verdict was returned.
 

Appendicitis is the most common surgical emergency in children. It is seen at all ages; however, it is less common in infants and toddlers younger than 4 years of age and peaks at an incidence of 25/100,000 in children 12- to 18-years-old. Fortunately, appendicitis is rarely fatal but can be associated with significant morbidity, especially in young children in whom the diagnosis is often delayed and perforation is more common. Reducing morbidity requires early diagnosis and optimizing management such that perforation and associated peritonitis are prevented.

The classical signs and symptoms of appendicitis are periumbilical pain migrating to the right lower quadrant, nausea, and low-grade fever. Presentation may vary if the location of the appendix is atypical, but primarily is age associated. In young children, abdominal distension, hip pain with or without limp, and fever are commonplace. In older children, right lower quadrant abdominal pain that intensifies with coughing or movement is frequent. Localized tenderness also appears to be age related; right lower quadrant tenderness and rebound are more often found in older children and adolescents, whereas younger children have more diffuse signs.

When I started my career, abdominal x-rays would be performed in search of a fecalith. However, such studies were of low sensitivity, and clinical acumen had a primary role in the decision to take the child to the operating room. In the current era, ultrasound and CT scan provide reasonable sensitivity and specificity. Ultrasound criteria include a diameter greater than 6 mm, concentric rings (target sign), an appendicolith, high echogenicity, obstruction of the lumen, and fluid surrounding the appendix.

As the pathogenesis of appendicitis represents occlusion of the appendiceal lumen, followed by overgrowth or translocation of bowel flora resulting in inflammation of the wall of the appendix, anaerobes and gram-negative gut flora represent the most important pathogens. In advanced cases, necrosis and gangrene of the appendix result with progression to rupture and peritonitis.

The traditional management was early surgical intervention to reduce the risk of perforation and peritonitis with acceptance of high rates of negative abdominal explorations as an acceptable consequence. Today, the approach to management of appendicitis is undergoing reevaluation. Early antimicrobial treatment has become routine in the management of nonperforated, perforated, or abscessed appendicitis. However, the question being asked is, “Do all children with uncomplicated appendicitis need appendectomy, or is antibiotic management sufficient?”

P. Salminen et al. reported on the results of a randomized clinical trial in 530 patients aged 18-60 years, comparing antimicrobial treatment alone with early appendectomy. Among 273 patients in the surgical group, all but 1 underwent successful appendectomy, resulting in a success rate of 99.6% (95% CI, 98.0%-100.0%). In the antibiotic group, 186 of 256 patients (70%) treated with antibiotics did not require surgery; 70 (27%) underwent appendectomy within 1 year of initial presentation for appendicitis (JAMA. 2015 Jun 16;313[23]:2340-8). There were no intraabdominal abscesses or other major complications associated with delayed appendectomy in patients randomized to antibiotic treatment. The authors concluded that among patients with CT-proven, uncomplicated appendicitis, antibiotic treatment did not meet the prespecified criterion for noninferiority, compared with appendectomy. However, most patients randomized to antibiotics for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period.

J.A. Horst et al. reviewed published reports of medical management of appendicitis in children (Ann Emerg Med. 2015 Aug;66[2]:119-22). They concluded that medical management of uncomplicated appendicitis in a select low-risk pediatric population is safe and does not result in significant morbidity. The arguments against a nonoperative approach include the risk of recurrent appendicitis, including the anxiety associated with any recurrences of abdominal pain, the risk of antibiotic-related complications, the potential for increased duration of hospitalization, and the relatively low morbidity of appendectomy in children. Factors associated with failed antibiotic management included fecaliths, fluid collections, or an appendiceal diameter greater than 1.1 cm on CT scan. The investigators concluded such children are poor candidates for nonsurgical management.

The bottom line is that antimicrobial therapy, in the absence of surgery, can be effective. Certainly in remote settings where surgery is not readily available, antimicrobial therapy with fluid and electrolyte management and close observation can be used in children with uncomplicated appendicitis with few failures and relatively few children requiring subsequent appendectomy. In more complicated cases with evidence of fecalith, or appendiceal abscess or phlegm, initial antimicrobial therapy reduces the acute inflammation and urgent need for surgery, but persistent inflammation of the appendix is often observed and appendectomy, either acutely or after improvement following antimicrobial therapy, appears indicated. Many different antimicrobial regimens have proven effective; ceftriaxone and metronidazole are associated with low rates of complications, offer an opportunity for once-daily therapy, and are cost effective, compared with other once-daily regimens.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center.

Appendicitis is the most common surgical emergency in children. It is seen at all ages; however, it is less common in infants and toddlers younger than 4 years of age and peaks at an incidence of 25/100,000 in children 12- to 18-years-old. Fortunately, appendicitis is rarely fatal but can be associated with significant morbidity, especially in young children in whom the diagnosis is often delayed and perforation is more common. Reducing morbidity requires early diagnosis and optimizing management such that perforation and associated peritonitis are prevented.

The classical signs and symptoms of appendicitis are periumbilical pain migrating to the right lower quadrant, nausea, and low-grade fever. Presentation may vary if the location of the appendix is atypical, but primarily is age associated. In young children, abdominal distension, hip pain with or without limp, and fever are commonplace. In older children, right lower quadrant abdominal pain that intensifies with coughing or movement is frequent. Localized tenderness also appears to be age related; right lower quadrant tenderness and rebound are more often found in older children and adolescents, whereas younger children have more diffuse signs.

When I started my career, abdominal x-rays would be performed in search of a fecalith. However, such studies were of low sensitivity, and clinical acumen had a primary role in the decision to take the child to the operating room. In the current era, ultrasound and CT scan provide reasonable sensitivity and specificity. Ultrasound criteria include a diameter greater than 6 mm, concentric rings (target sign), an appendicolith, high echogenicity, obstruction of the lumen, and fluid surrounding the appendix.

As the pathogenesis of appendicitis represents occlusion of the appendiceal lumen, followed by overgrowth or translocation of bowel flora resulting in inflammation of the wall of the appendix, anaerobes and gram-negative gut flora represent the most important pathogens. In advanced cases, necrosis and gangrene of the appendix result with progression to rupture and peritonitis.

The traditional management was early surgical intervention to reduce the risk of perforation and peritonitis with acceptance of high rates of negative abdominal explorations as an acceptable consequence. Today, the approach to management of appendicitis is undergoing reevaluation. Early antimicrobial treatment has become routine in the management of nonperforated, perforated, or abscessed appendicitis. However, the question being asked is, “Do all children with uncomplicated appendicitis need appendectomy, or is antibiotic management sufficient?”

P. Salminen et al. reported on the results of a randomized clinical trial in 530 patients aged 18-60 years, comparing antimicrobial treatment alone with early appendectomy. Among 273 patients in the surgical group, all but 1 underwent successful appendectomy, resulting in a success rate of 99.6% (95% CI, 98.0%-100.0%). In the antibiotic group, 186 of 256 patients (70%) treated with antibiotics did not require surgery; 70 (27%) underwent appendectomy within 1 year of initial presentation for appendicitis (JAMA. 2015 Jun 16;313[23]:2340-8). There were no intraabdominal abscesses or other major complications associated with delayed appendectomy in patients randomized to antibiotic treatment. The authors concluded that among patients with CT-proven, uncomplicated appendicitis, antibiotic treatment did not meet the prespecified criterion for noninferiority, compared with appendectomy. However, most patients randomized to antibiotics for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period.

J.A. Horst et al. reviewed published reports of medical management of appendicitis in children (Ann Emerg Med. 2015 Aug;66[2]:119-22). They concluded that medical management of uncomplicated appendicitis in a select low-risk pediatric population is safe and does not result in significant morbidity. The arguments against a nonoperative approach include the risk of recurrent appendicitis, including the anxiety associated with any recurrences of abdominal pain, the risk of antibiotic-related complications, the potential for increased duration of hospitalization, and the relatively low morbidity of appendectomy in children. Factors associated with failed antibiotic management included fecaliths, fluid collections, or an appendiceal diameter greater than 1.1 cm on CT scan. The investigators concluded such children are poor candidates for nonsurgical management.

The bottom line is that antimicrobial therapy, in the absence of surgery, can be effective. Certainly in remote settings where surgery is not readily available, antimicrobial therapy with fluid and electrolyte management and close observation can be used in children with uncomplicated appendicitis with few failures and relatively few children requiring subsequent appendectomy. In more complicated cases with evidence of fecalith, or appendiceal abscess or phlegm, initial antimicrobial therapy reduces the acute inflammation and urgent need for surgery, but persistent inflammation of the appendix is often observed and appendectomy, either acutely or after improvement following antimicrobial therapy, appears indicated. Many different antimicrobial regimens have proven effective; ceftriaxone and metronidazole are associated with low rates of complications, offer an opportunity for once-daily therapy, and are cost effective, compared with other once-daily regimens.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center.

Appendicitis is the most common surgical emergency in children. It is seen at all ages; however, it is less common in infants and toddlers younger than 4 years of age and peaks at an incidence of 25/100,000 in children 12- to 18-years-old. Fortunately, appendicitis is rarely fatal but can be associated with significant morbidity, especially in young children in whom the diagnosis is often delayed and perforation is more common. Reducing morbidity requires early diagnosis and optimizing management such that perforation and associated peritonitis are prevented.

The classical signs and symptoms of appendicitis are periumbilical pain migrating to the right lower quadrant, nausea, and low-grade fever. Presentation may vary if the location of the appendix is atypical, but primarily is age associated. In young children, abdominal distension, hip pain with or without limp, and fever are commonplace. In older children, right lower quadrant abdominal pain that intensifies with coughing or movement is frequent. Localized tenderness also appears to be age related; right lower quadrant tenderness and rebound are more often found in older children and adolescents, whereas younger children have more diffuse signs.

When I started my career, abdominal x-rays would be performed in search of a fecalith. However, such studies were of low sensitivity, and clinical acumen had a primary role in the decision to take the child to the operating room. In the current era, ultrasound and CT scan provide reasonable sensitivity and specificity. Ultrasound criteria include a diameter greater than 6 mm, concentric rings (target sign), an appendicolith, high echogenicity, obstruction of the lumen, and fluid surrounding the appendix.

As the pathogenesis of appendicitis represents occlusion of the appendiceal lumen, followed by overgrowth or translocation of bowel flora resulting in inflammation of the wall of the appendix, anaerobes and gram-negative gut flora represent the most important pathogens. In advanced cases, necrosis and gangrene of the appendix result with progression to rupture and peritonitis.

The traditional management was early surgical intervention to reduce the risk of perforation and peritonitis with acceptance of high rates of negative abdominal explorations as an acceptable consequence. Today, the approach to management of appendicitis is undergoing reevaluation. Early antimicrobial treatment has become routine in the management of nonperforated, perforated, or abscessed appendicitis. However, the question being asked is, “Do all children with uncomplicated appendicitis need appendectomy, or is antibiotic management sufficient?”

P. Salminen et al. reported on the results of a randomized clinical trial in 530 patients aged 18-60 years, comparing antimicrobial treatment alone with early appendectomy. Among 273 patients in the surgical group, all but 1 underwent successful appendectomy, resulting in a success rate of 99.6% (95% CI, 98.0%-100.0%). In the antibiotic group, 186 of 256 patients (70%) treated with antibiotics did not require surgery; 70 (27%) underwent appendectomy within 1 year of initial presentation for appendicitis (JAMA. 2015 Jun 16;313[23]:2340-8). There were no intraabdominal abscesses or other major complications associated with delayed appendectomy in patients randomized to antibiotic treatment. The authors concluded that among patients with CT-proven, uncomplicated appendicitis, antibiotic treatment did not meet the prespecified criterion for noninferiority, compared with appendectomy. However, most patients randomized to antibiotics for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period.

J.A. Horst et al. reviewed published reports of medical management of appendicitis in children (Ann Emerg Med. 2015 Aug;66[2]:119-22). They concluded that medical management of uncomplicated appendicitis in a select low-risk pediatric population is safe and does not result in significant morbidity. The arguments against a nonoperative approach include the risk of recurrent appendicitis, including the anxiety associated with any recurrences of abdominal pain, the risk of antibiotic-related complications, the potential for increased duration of hospitalization, and the relatively low morbidity of appendectomy in children. Factors associated with failed antibiotic management included fecaliths, fluid collections, or an appendiceal diameter greater than 1.1 cm on CT scan. The investigators concluded such children are poor candidates for nonsurgical management.

The bottom line is that antimicrobial therapy, in the absence of surgery, can be effective. Certainly in remote settings where surgery is not readily available, antimicrobial therapy with fluid and electrolyte management and close observation can be used in children with uncomplicated appendicitis with few failures and relatively few children requiring subsequent appendectomy. In more complicated cases with evidence of fecalith, or appendiceal abscess or phlegm, initial antimicrobial therapy reduces the acute inflammation and urgent need for surgery, but persistent inflammation of the appendix is often observed and appendectomy, either acutely or after improvement following antimicrobial therapy, appears indicated. Many different antimicrobial regimens have proven effective; ceftriaxone and metronidazole are associated with low rates of complications, offer an opportunity for once-daily therapy, and are cost effective, compared with other once-daily regimens.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center.

Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.

In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.

Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.

Physician’s defense The case was settled during the trial.

Verdict A $7.5 million Illinois settlement was reached

Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.

Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.

Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.

Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.

Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.

Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.

Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.

Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.

Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.

Verdict A $3.75 million New Jersey settlement was reached with the medical center.
 

Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.

Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.

Hospital’s defense The case was settled during the trial.

Verdict A $700,000 Illinois settlement was reached with the hospital.

Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.

In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.

Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.

Physician’s defense The case was settled during the trial.

Verdict A $7.5 million Illinois settlement was reached

Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.

Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.

Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.

Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.

Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.

Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.

Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.

Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.

Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.

Verdict A $3.75 million New Jersey settlement was reached with the medical center.
 

Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.

Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.

Hospital’s defense The case was settled during the trial.

Verdict A $700,000 Illinois settlement was reached with the hospital.

Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.

In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.

Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.

Physician’s defense The case was settled during the trial.

Verdict A $7.5 million Illinois settlement was reached

Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.

Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.

Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.

Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.

Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.

Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.

Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.

Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.

Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.

Verdict A $3.75 million New Jersey settlement was reached with the medical center.
 

Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.

Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.

Hospital’s defense The case was settled during the trial.

Verdict A $700,000 Illinois settlement was reached with the hospital.