OBG Management

Woman dies after robotic hysterectomy: $5M verdict

When a 36-year-old woman underwent robotic hysterectomy, the gynecologist inserted a plastic trocar and sleeve through the patient's umbilicus to access the abdominal cavity at 7:30 am.

The certified registered nurse anesthetist (CRNA) noted a significant abnormality in the patient's vital signs at 8:07 am and administered medication and fluids to treat a suspected blood loss. When the patient's heart rate became extremely elevated at 8:25 am, the CRNA administered another drug, which failed to bring the patient's heart rate down. At 8:37 am, the monitoring machine could not record the patient's blood pressure. The CRNA informed the surgeon of the patient's condition. The supervising anesthesiologist was called; he arrived at 8:45 am and determined that the patient was bleeding internally. He asked the surgeon if he could visualize any bleeding; the surgeon could not.

The patient's condition continued to deteriorate. At 9:05 am, her blood pressure was still undetectable on the monitor. A Code Blue was called at 9:30 am. Exploratory surgery and blood transfusions begun at  9:43 am were not able to counteract the patient's massive blood loss. After cardiac arrest, she was pronounced dead at 11:18 am.

ESTATE'S CLAIM:

The surgeon was negligent in lacerating the left common iliac artery when inserting the trocar, and in not detecting the injury intraoperatively.

The anesthesia staff was  negligent. The CRNA did not inform the surgeon until the situation was dire. A simple procedure could have been performed at any time to check the patient's hematocrit and hemoglobin levels, but that was not done until 9:30 am. If the severity of the patient's condition had been determined earlier, blood transfusions and further treatment could have saved her life.

DEFENDANTS' DEFENSE:

There was no negligence on the part of the surgeon or anesthesia team. The standard of care was met. Arterial laceration is a known risk of the surgery.

VERDICT:

A $5,008,922 Illinois verdict was returned against all defendants except the CRNA.

A woman with MS becomes incontinent after surgery

A 43-year-old woman with multiple sclerosis (MS) underwent a hysterectomy performed by a gynecologic surgeon. During surgery, the patient's ureter was injured, requiring additional surgery. The patient is now permanently incontinent.

PATIENT'S CLAIM:

During surgery, the surgeon constricted the ureter with stitches. A second surgery was needed to remove the stitches and reimplant the ureter. The second surgery left her permanently incontinent. Although incontinence is a known complication of the second surgery, the second surgery would not have been necessary if the surgeon had not injured the ureter during the first surgery. Incontinence was not a result of her MS as she was not incontinent before the second surgery.

DEFENDANTS' DEFENSE:

There was no deviation from the standard of care. There was no stitching around the ureter. The ureter was damaged by kinking, which was addressed during the second surgery. Incontinence was a result of her MS.

VERDICT:

A $700,000 South Carolina verdict was returned.

Bowel injury during robotic procedure: $6.25M settlement

A woman in her late 60s reported minor urinary incontinence to her gynecologist. She underwent robot-assisted laparoscopic hysterectomy with a sling procedure for pelvic prolapse. During the sling procedure, the transverse colon was injured. The patient developed sepsis, requiring multiple attempts at surgical repair, including colostomy. The patient requires a permanent colostomy. She has a malabsorption disorder and needs frequent intravenous treatment for dehydration.

PATIENT'S CLAIM:

The surgeon failed to properly control the robotic device, causing injury to the patient's bowel. The surgeon deviated from the standard of care by failing to convert from the robot-assisted laparoscopic procedure to an open procedure when complications arose. The injury was not properly treated before the surgeon closed the initial surgery, causing the patient to develop sepsis.

PHYSICIAN'S DEFENSE:

The surgeon claimed that the injuries and resulting sepsis were the fault of other physicians and hospital staff. The case settled during trial.

VERDICT:

A $6.25 million New Jersey settlement was reached.

Hydrothermal ablation led to genital burns

A woman SAW AN OBGYN on October 2 to report menorrhagia. She had been treated for uterine fibroids with a Mirena intrauterine device and hydrothermal ablation. Another physician had suggested hysterectomy, which she declined.

When the ObGyn found that the patient had an enlarged uterus, he ordered ultrasonography and an endometrial biopsy. On follow-up, the ObGyn provided options of robotic hysterectomy or operative hysteroscopy with hydrothermal ablation. The patient chose hysteroscopy and the procedure was scheduled for December 28.

During surgery, an improper seal to the cervix around the hydrothermal ablation sheath was detected before heating the fluid. A tenaculum and 2 sponges were placed on the cervix to help form a seal and the fluid was heated for 4 minutes. The procedure was aborted when fluid was seen to be leaking again. Instruments were removed after a cooling period. The patient was discharged from the surgery center the same day with a prescription for oral hydrocodone bitartrate and acetaminophen for pain.

On January 4, the patient reported severe vulvar pain. The ObGyn found thermal burns on both labia with possible cellulitis. He prescribed silver sulfadiazine cream twice daily, levofloxacin 500 mg for 7 days, and warm-water soaks. When the patient called to report continued pain on January 7, the hydrocodone and acetaminophen prescription was renewed. On January 8, the ObGyn found continued evidence of labia and introitus burns with no signs of infection. The patient was told to continue taking the oral pain medication and to apply topical lidocaine gel and silver sulfadiazine cream.

Examinations on January 11, 17, 24, and 31 showed continued evidence of active healing. When new evidence of vulvar ulceration with inflammation and infection appeared, supportive care and antibiotics were given. On February 7, granulation tissue had developed at the introitus with continued healing.

On March 27, she saw a gynecologist for dyspareunia. The skin was healed but a tender band of scar tissue was noted at the burn site. She was referred for physical therapy and given estradiol vaginal cream.

On December 11, the patient reported dyspareunia and depression to the gynecologist, who prescribed medication for depression and referred her to counseling.

PATIENT'S CLAIM:

The ObGyn was negligent in failing to maintain a proper seal around the hydrothermal ablation shield. The patient sustained second-degree burns to her genital area from the hot saline solution that leaked from the uterus. The injury caused lasting dyspareunia and depression.

PHYSICIAN'S DEFENSE:

There was no negligence. Once the ObGyn realized that the seal was incomplete, the procedure was stopped and the fluid cooled before being released. Burns were treated within the standard of care.

VERDICT:

A Texas defense verdict was returned based on a no- evidence partial summary judgment: neither the patient nor the expert witness supplied evidence to support the claims of gross negligence or exemplary damages against the ObGyn.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Woman dies after robotic hysterectomy: $5M verdict

When a 36-year-old woman underwent robotic hysterectomy, the gynecologist inserted a plastic trocar and sleeve through the patient's umbilicus to access the abdominal cavity at 7:30 am.

The certified registered nurse anesthetist (CRNA) noted a significant abnormality in the patient's vital signs at 8:07 am and administered medication and fluids to treat a suspected blood loss. When the patient's heart rate became extremely elevated at 8:25 am, the CRNA administered another drug, which failed to bring the patient's heart rate down. At 8:37 am, the monitoring machine could not record the patient's blood pressure. The CRNA informed the surgeon of the patient's condition. The supervising anesthesiologist was called; he arrived at 8:45 am and determined that the patient was bleeding internally. He asked the surgeon if he could visualize any bleeding; the surgeon could not.

The patient's condition continued to deteriorate. At 9:05 am, her blood pressure was still undetectable on the monitor. A Code Blue was called at 9:30 am. Exploratory surgery and blood transfusions begun at  9:43 am were not able to counteract the patient's massive blood loss. After cardiac arrest, she was pronounced dead at 11:18 am.

ESTATE'S CLAIM:

The surgeon was negligent in lacerating the left common iliac artery when inserting the trocar, and in not detecting the injury intraoperatively.

The anesthesia staff was  negligent. The CRNA did not inform the surgeon until the situation was dire. A simple procedure could have been performed at any time to check the patient's hematocrit and hemoglobin levels, but that was not done until 9:30 am. If the severity of the patient's condition had been determined earlier, blood transfusions and further treatment could have saved her life.

DEFENDANTS' DEFENSE:

There was no negligence on the part of the surgeon or anesthesia team. The standard of care was met. Arterial laceration is a known risk of the surgery.

VERDICT:

A $5,008,922 Illinois verdict was returned against all defendants except the CRNA.

A woman with MS becomes incontinent after surgery

A 43-year-old woman with multiple sclerosis (MS) underwent a hysterectomy performed by a gynecologic surgeon. During surgery, the patient's ureter was injured, requiring additional surgery. The patient is now permanently incontinent.

PATIENT'S CLAIM:

During surgery, the surgeon constricted the ureter with stitches. A second surgery was needed to remove the stitches and reimplant the ureter. The second surgery left her permanently incontinent. Although incontinence is a known complication of the second surgery, the second surgery would not have been necessary if the surgeon had not injured the ureter during the first surgery. Incontinence was not a result of her MS as she was not incontinent before the second surgery.

DEFENDANTS' DEFENSE:

There was no deviation from the standard of care. There was no stitching around the ureter. The ureter was damaged by kinking, which was addressed during the second surgery. Incontinence was a result of her MS.

VERDICT:

A $700,000 South Carolina verdict was returned.

Bowel injury during robotic procedure: $6.25M settlement

A woman in her late 60s reported minor urinary incontinence to her gynecologist. She underwent robot-assisted laparoscopic hysterectomy with a sling procedure for pelvic prolapse. During the sling procedure, the transverse colon was injured. The patient developed sepsis, requiring multiple attempts at surgical repair, including colostomy. The patient requires a permanent colostomy. She has a malabsorption disorder and needs frequent intravenous treatment for dehydration.

PATIENT'S CLAIM:

The surgeon failed to properly control the robotic device, causing injury to the patient's bowel. The surgeon deviated from the standard of care by failing to convert from the robot-assisted laparoscopic procedure to an open procedure when complications arose. The injury was not properly treated before the surgeon closed the initial surgery, causing the patient to develop sepsis.

PHYSICIAN'S DEFENSE:

The surgeon claimed that the injuries and resulting sepsis were the fault of other physicians and hospital staff. The case settled during trial.

VERDICT:

A $6.25 million New Jersey settlement was reached.

Hydrothermal ablation led to genital burns

A woman SAW AN OBGYN on October 2 to report menorrhagia. She had been treated for uterine fibroids with a Mirena intrauterine device and hydrothermal ablation. Another physician had suggested hysterectomy, which she declined.

When the ObGyn found that the patient had an enlarged uterus, he ordered ultrasonography and an endometrial biopsy. On follow-up, the ObGyn provided options of robotic hysterectomy or operative hysteroscopy with hydrothermal ablation. The patient chose hysteroscopy and the procedure was scheduled for December 28.

During surgery, an improper seal to the cervix around the hydrothermal ablation sheath was detected before heating the fluid. A tenaculum and 2 sponges were placed on the cervix to help form a seal and the fluid was heated for 4 minutes. The procedure was aborted when fluid was seen to be leaking again. Instruments were removed after a cooling period. The patient was discharged from the surgery center the same day with a prescription for oral hydrocodone bitartrate and acetaminophen for pain.

On January 4, the patient reported severe vulvar pain. The ObGyn found thermal burns on both labia with possible cellulitis. He prescribed silver sulfadiazine cream twice daily, levofloxacin 500 mg for 7 days, and warm-water soaks. When the patient called to report continued pain on January 7, the hydrocodone and acetaminophen prescription was renewed. On January 8, the ObGyn found continued evidence of labia and introitus burns with no signs of infection. The patient was told to continue taking the oral pain medication and to apply topical lidocaine gel and silver sulfadiazine cream.

Examinations on January 11, 17, 24, and 31 showed continued evidence of active healing. When new evidence of vulvar ulceration with inflammation and infection appeared, supportive care and antibiotics were given. On February 7, granulation tissue had developed at the introitus with continued healing.

On March 27, she saw a gynecologist for dyspareunia. The skin was healed but a tender band of scar tissue was noted at the burn site. She was referred for physical therapy and given estradiol vaginal cream.

On December 11, the patient reported dyspareunia and depression to the gynecologist, who prescribed medication for depression and referred her to counseling.

PATIENT'S CLAIM:

The ObGyn was negligent in failing to maintain a proper seal around the hydrothermal ablation shield. The patient sustained second-degree burns to her genital area from the hot saline solution that leaked from the uterus. The injury caused lasting dyspareunia and depression.

PHYSICIAN'S DEFENSE:

There was no negligence. Once the ObGyn realized that the seal was incomplete, the procedure was stopped and the fluid cooled before being released. Burns were treated within the standard of care.

VERDICT:

A Texas defense verdict was returned based on a no- evidence partial summary judgment: neither the patient nor the expert witness supplied evidence to support the claims of gross negligence or exemplary damages against the ObGyn.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Woman dies after robotic hysterectomy: $5M verdict

When a 36-year-old woman underwent robotic hysterectomy, the gynecologist inserted a plastic trocar and sleeve through the patient's umbilicus to access the abdominal cavity at 7:30 am.

The certified registered nurse anesthetist (CRNA) noted a significant abnormality in the patient's vital signs at 8:07 am and administered medication and fluids to treat a suspected blood loss. When the patient's heart rate became extremely elevated at 8:25 am, the CRNA administered another drug, which failed to bring the patient's heart rate down. At 8:37 am, the monitoring machine could not record the patient's blood pressure. The CRNA informed the surgeon of the patient's condition. The supervising anesthesiologist was called; he arrived at 8:45 am and determined that the patient was bleeding internally. He asked the surgeon if he could visualize any bleeding; the surgeon could not.

The patient's condition continued to deteriorate. At 9:05 am, her blood pressure was still undetectable on the monitor. A Code Blue was called at 9:30 am. Exploratory surgery and blood transfusions begun at  9:43 am were not able to counteract the patient's massive blood loss. After cardiac arrest, she was pronounced dead at 11:18 am.

ESTATE'S CLAIM:

The surgeon was negligent in lacerating the left common iliac artery when inserting the trocar, and in not detecting the injury intraoperatively.

The anesthesia staff was  negligent. The CRNA did not inform the surgeon until the situation was dire. A simple procedure could have been performed at any time to check the patient's hematocrit and hemoglobin levels, but that was not done until 9:30 am. If the severity of the patient's condition had been determined earlier, blood transfusions and further treatment could have saved her life.

DEFENDANTS' DEFENSE:

There was no negligence on the part of the surgeon or anesthesia team. The standard of care was met. Arterial laceration is a known risk of the surgery.

VERDICT:

A $5,008,922 Illinois verdict was returned against all defendants except the CRNA.

A woman with MS becomes incontinent after surgery

A 43-year-old woman with multiple sclerosis (MS) underwent a hysterectomy performed by a gynecologic surgeon. During surgery, the patient's ureter was injured, requiring additional surgery. The patient is now permanently incontinent.

PATIENT'S CLAIM:

During surgery, the surgeon constricted the ureter with stitches. A second surgery was needed to remove the stitches and reimplant the ureter. The second surgery left her permanently incontinent. Although incontinence is a known complication of the second surgery, the second surgery would not have been necessary if the surgeon had not injured the ureter during the first surgery. Incontinence was not a result of her MS as she was not incontinent before the second surgery.

DEFENDANTS' DEFENSE:

There was no deviation from the standard of care. There was no stitching around the ureter. The ureter was damaged by kinking, which was addressed during the second surgery. Incontinence was a result of her MS.

VERDICT:

A $700,000 South Carolina verdict was returned.

Bowel injury during robotic procedure: $6.25M settlement

A woman in her late 60s reported minor urinary incontinence to her gynecologist. She underwent robot-assisted laparoscopic hysterectomy with a sling procedure for pelvic prolapse. During the sling procedure, the transverse colon was injured. The patient developed sepsis, requiring multiple attempts at surgical repair, including colostomy. The patient requires a permanent colostomy. She has a malabsorption disorder and needs frequent intravenous treatment for dehydration.

PATIENT'S CLAIM:

The surgeon failed to properly control the robotic device, causing injury to the patient's bowel. The surgeon deviated from the standard of care by failing to convert from the robot-assisted laparoscopic procedure to an open procedure when complications arose. The injury was not properly treated before the surgeon closed the initial surgery, causing the patient to develop sepsis.

PHYSICIAN'S DEFENSE:

The surgeon claimed that the injuries and resulting sepsis were the fault of other physicians and hospital staff. The case settled during trial.

VERDICT:

A $6.25 million New Jersey settlement was reached.

Hydrothermal ablation led to genital burns

A woman SAW AN OBGYN on October 2 to report menorrhagia. She had been treated for uterine fibroids with a Mirena intrauterine device and hydrothermal ablation. Another physician had suggested hysterectomy, which she declined.

When the ObGyn found that the patient had an enlarged uterus, he ordered ultrasonography and an endometrial biopsy. On follow-up, the ObGyn provided options of robotic hysterectomy or operative hysteroscopy with hydrothermal ablation. The patient chose hysteroscopy and the procedure was scheduled for December 28.

During surgery, an improper seal to the cervix around the hydrothermal ablation sheath was detected before heating the fluid. A tenaculum and 2 sponges were placed on the cervix to help form a seal and the fluid was heated for 4 minutes. The procedure was aborted when fluid was seen to be leaking again. Instruments were removed after a cooling period. The patient was discharged from the surgery center the same day with a prescription for oral hydrocodone bitartrate and acetaminophen for pain.

On January 4, the patient reported severe vulvar pain. The ObGyn found thermal burns on both labia with possible cellulitis. He prescribed silver sulfadiazine cream twice daily, levofloxacin 500 mg for 7 days, and warm-water soaks. When the patient called to report continued pain on January 7, the hydrocodone and acetaminophen prescription was renewed. On January 8, the ObGyn found continued evidence of labia and introitus burns with no signs of infection. The patient was told to continue taking the oral pain medication and to apply topical lidocaine gel and silver sulfadiazine cream.

Examinations on January 11, 17, 24, and 31 showed continued evidence of active healing. When new evidence of vulvar ulceration with inflammation and infection appeared, supportive care and antibiotics were given. On February 7, granulation tissue had developed at the introitus with continued healing.

On March 27, she saw a gynecologist for dyspareunia. The skin was healed but a tender band of scar tissue was noted at the burn site. She was referred for physical therapy and given estradiol vaginal cream.

On December 11, the patient reported dyspareunia and depression to the gynecologist, who prescribed medication for depression and referred her to counseling.

PATIENT'S CLAIM:

The ObGyn was negligent in failing to maintain a proper seal around the hydrothermal ablation shield. The patient sustained second-degree burns to her genital area from the hot saline solution that leaked from the uterus. The injury caused lasting dyspareunia and depression.

PHYSICIAN'S DEFENSE:

There was no negligence. Once the ObGyn realized that the seal was incomplete, the procedure was stopped and the fluid cooled before being released. Burns were treated within the standard of care.

VERDICT:

A Texas defense verdict was returned based on a no- evidence partial summary judgment: neither the patient nor the expert witness supplied evidence to support the claims of gross negligence or exemplary damages against the ObGyn.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Delay in delivery--mother and child die: $1.4M settlement

ESTATE'S CLAIM:

The standard of care for placenta accreta requires delivery between 34 and 36 weeks of gestation. The mother died from a placental abruption and amniotic fluid embolism. Placenta accreta increases the risk of catastrophic hemorrhage. If delivery had occurred on January 14, both the mother and child would be alive.

DEFENDANTS' DEFENSE:

The case settled before trial.

VERDICT:

A $1.425 million Georgia settlement was reached. The settlement amount was limited by a damages cap unique to the defendant hospital.

Placental abruption not detected: $6.2M settlement

At 24 weeks of gestation, a mother presented to the hospital with premature contractions that subsided after her arrival. She was discharged from the hospital. The woman gave birth in her bathtub several hours later. The baby was 10 weeks premature. He suffered profound brain damage and has significant physical defects.

PARENT'S CLAIM:

Neither the ObGyn nor the hospital staff appreciated that the mother was experiencing placental abruption. If diagnosed, treatment could have prevented fetal injury.

DEFENDANTS' DEFENSE:

The case was settled prior to trial.

VERDICT:

A $6.2 million New York settlement was reached.

Child has brachial plexus injury: $2M award

A woman was admitted to the hospital for elective induction of labor. She gained a significant amount of weight while pregnant. During delivery, her family practitioner (FP) determined that vacuum extraction was needed but he was not qualified to use the device. An in-house ObGyn was called in to use the vacuum extractor. The FP delivered the baby's shoulders. The infant was born with a floppy right arm and later diagnosed with rupture injuries to the C-5 and C-6 vertebrae and permanent brachial plexus damage. She has limited range of motion in her right arm and shoulder.

PARENT'S CLAIM:

The FP was relatively inexperienced in labor and delivery. He should not have ordered vacuum extraction because of risk factors including the mother's small stature, her significant weight gain during pregnancy, the use of epidural anesthesia, and induction of labor. Using vacuum extraction increases the risk of shoulder dystocia.

The FP improperly applied excessive downward traction on the fetus causing the infant to sustain a brachial plexus injury.

The FP did not notify the parents of the child's injury immediately after birth; he told them about the injury just before discharge.

DEFENDANTS' DEFENSE:

There is no evidence in the medical records of a shoulder dystocia; "no shoulder dystocia" was charted shortly after delivery. No one in the delivery room testified to a delay in delivering the infant's shoulders. The mother's internal contractions caused the injury. The baby was not injured to the extent claimed.

VERDICT:

The ObGyn who used the vacuum extractor settled before the trial for $300,000. A $2 million Illinois verdict was returned against the FP.

Delay in treating infant in respiratory distress: $7.27M settlement

A child was delivered by a certified nurse midwife at a birthing center. At birth, the baby had a heart rate of 60 bpm and was in respiratory distress but there was no one at the clinic qualified to intubate the infant. Emergency personnel were called but the infant remained in respiratory distress for 8 minutes. The baby experienced birth asphyxia with hypoxic ischemic encephalopathy resulting in severe cerebral palsy.

PARENT'S CLAIM:

The birthing center was poorly staffed and unprepared to treat an emergency situation.

DEFENDANTS' DEFENSE:

The defendants denied all allegations of negligence. The case was settled during trial.

VERDICT:

A $7.27 million Pennsylvania settlement was reached.

Was the spinal block given at wrong level?

A MOTHER WENT TO THE HOSPITAL in labor. Prior to cesarean delivery, she underwent an anesthetic spinal block administered by a CRNA. Initially, the patient reported pain shortly after the injection was performed until the block worked. The baby's delivery was uneventful.

In recovery a few hours later, the patient reported intense and uncontrollable pain in her legs. Magnetic resonance imaging revealed a fluid pocket on her spinal cord at the L1-L2 level. The patient has permanent pain, numbness, and tingling in in both legs.

PATIENT'S CLAIM:

The CRNA failed to insert the spinal block needle in the proper location.

DEFENDANTS' DEFENSE:

The CRNA contended that he complied with the standard of care. He claimed that the patient had an unusual spinal cord anatomy: it was tethered down to the L3-L4 level.

VERDICT:

A $509,152 Kentucky verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Delay in delivery--mother and child die: $1.4M settlement

ESTATE'S CLAIM:

The standard of care for placenta accreta requires delivery between 34 and 36 weeks of gestation. The mother died from a placental abruption and amniotic fluid embolism. Placenta accreta increases the risk of catastrophic hemorrhage. If delivery had occurred on January 14, both the mother and child would be alive.

DEFENDANTS' DEFENSE:

The case settled before trial.

VERDICT:

A $1.425 million Georgia settlement was reached. The settlement amount was limited by a damages cap unique to the defendant hospital.

Placental abruption not detected: $6.2M settlement

At 24 weeks of gestation, a mother presented to the hospital with premature contractions that subsided after her arrival. She was discharged from the hospital. The woman gave birth in her bathtub several hours later. The baby was 10 weeks premature. He suffered profound brain damage and has significant physical defects.

PARENT'S CLAIM:

Neither the ObGyn nor the hospital staff appreciated that the mother was experiencing placental abruption. If diagnosed, treatment could have prevented fetal injury.

DEFENDANTS' DEFENSE:

The case was settled prior to trial.

VERDICT:

A $6.2 million New York settlement was reached.

Child has brachial plexus injury: $2M award

A woman was admitted to the hospital for elective induction of labor. She gained a significant amount of weight while pregnant. During delivery, her family practitioner (FP) determined that vacuum extraction was needed but he was not qualified to use the device. An in-house ObGyn was called in to use the vacuum extractor. The FP delivered the baby's shoulders. The infant was born with a floppy right arm and later diagnosed with rupture injuries to the C-5 and C-6 vertebrae and permanent brachial plexus damage. She has limited range of motion in her right arm and shoulder.

PARENT'S CLAIM:

The FP was relatively inexperienced in labor and delivery. He should not have ordered vacuum extraction because of risk factors including the mother's small stature, her significant weight gain during pregnancy, the use of epidural anesthesia, and induction of labor. Using vacuum extraction increases the risk of shoulder dystocia.

The FP improperly applied excessive downward traction on the fetus causing the infant to sustain a brachial plexus injury.

The FP did not notify the parents of the child's injury immediately after birth; he told them about the injury just before discharge.

DEFENDANTS' DEFENSE:

There is no evidence in the medical records of a shoulder dystocia; "no shoulder dystocia" was charted shortly after delivery. No one in the delivery room testified to a delay in delivering the infant's shoulders. The mother's internal contractions caused the injury. The baby was not injured to the extent claimed.

VERDICT:

The ObGyn who used the vacuum extractor settled before the trial for $300,000. A $2 million Illinois verdict was returned against the FP.

Delay in treating infant in respiratory distress: $7.27M settlement

A child was delivered by a certified nurse midwife at a birthing center. At birth, the baby had a heart rate of 60 bpm and was in respiratory distress but there was no one at the clinic qualified to intubate the infant. Emergency personnel were called but the infant remained in respiratory distress for 8 minutes. The baby experienced birth asphyxia with hypoxic ischemic encephalopathy resulting in severe cerebral palsy.

PARENT'S CLAIM:

The birthing center was poorly staffed and unprepared to treat an emergency situation.

DEFENDANTS' DEFENSE:

The defendants denied all allegations of negligence. The case was settled during trial.

VERDICT:

A $7.27 million Pennsylvania settlement was reached.

Was the spinal block given at wrong level?

A MOTHER WENT TO THE HOSPITAL in labor. Prior to cesarean delivery, she underwent an anesthetic spinal block administered by a CRNA. Initially, the patient reported pain shortly after the injection was performed until the block worked. The baby's delivery was uneventful.

In recovery a few hours later, the patient reported intense and uncontrollable pain in her legs. Magnetic resonance imaging revealed a fluid pocket on her spinal cord at the L1-L2 level. The patient has permanent pain, numbness, and tingling in in both legs.

PATIENT'S CLAIM:

The CRNA failed to insert the spinal block needle in the proper location.

DEFENDANTS' DEFENSE:

The CRNA contended that he complied with the standard of care. He claimed that the patient had an unusual spinal cord anatomy: it was tethered down to the L3-L4 level.

VERDICT:

A $509,152 Kentucky verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Delay in delivery--mother and child die: $1.4M settlement

ESTATE'S CLAIM:

The standard of care for placenta accreta requires delivery between 34 and 36 weeks of gestation. The mother died from a placental abruption and amniotic fluid embolism. Placenta accreta increases the risk of catastrophic hemorrhage. If delivery had occurred on January 14, both the mother and child would be alive.

DEFENDANTS' DEFENSE:

The case settled before trial.

VERDICT:

A $1.425 million Georgia settlement was reached. The settlement amount was limited by a damages cap unique to the defendant hospital.

Placental abruption not detected: $6.2M settlement

At 24 weeks of gestation, a mother presented to the hospital with premature contractions that subsided after her arrival. She was discharged from the hospital. The woman gave birth in her bathtub several hours later. The baby was 10 weeks premature. He suffered profound brain damage and has significant physical defects.

PARENT'S CLAIM:

Neither the ObGyn nor the hospital staff appreciated that the mother was experiencing placental abruption. If diagnosed, treatment could have prevented fetal injury.

DEFENDANTS' DEFENSE:

The case was settled prior to trial.

VERDICT:

A $6.2 million New York settlement was reached.

Child has brachial plexus injury: $2M award

A woman was admitted to the hospital for elective induction of labor. She gained a significant amount of weight while pregnant. During delivery, her family practitioner (FP) determined that vacuum extraction was needed but he was not qualified to use the device. An in-house ObGyn was called in to use the vacuum extractor. The FP delivered the baby's shoulders. The infant was born with a floppy right arm and later diagnosed with rupture injuries to the C-5 and C-6 vertebrae and permanent brachial plexus damage. She has limited range of motion in her right arm and shoulder.

PARENT'S CLAIM:

The FP was relatively inexperienced in labor and delivery. He should not have ordered vacuum extraction because of risk factors including the mother's small stature, her significant weight gain during pregnancy, the use of epidural anesthesia, and induction of labor. Using vacuum extraction increases the risk of shoulder dystocia.

The FP improperly applied excessive downward traction on the fetus causing the infant to sustain a brachial plexus injury.

The FP did not notify the parents of the child's injury immediately after birth; he told them about the injury just before discharge.

DEFENDANTS' DEFENSE:

There is no evidence in the medical records of a shoulder dystocia; "no shoulder dystocia" was charted shortly after delivery. No one in the delivery room testified to a delay in delivering the infant's shoulders. The mother's internal contractions caused the injury. The baby was not injured to the extent claimed.

VERDICT:

The ObGyn who used the vacuum extractor settled before the trial for $300,000. A $2 million Illinois verdict was returned against the FP.

Delay in treating infant in respiratory distress: $7.27M settlement

A child was delivered by a certified nurse midwife at a birthing center. At birth, the baby had a heart rate of 60 bpm and was in respiratory distress but there was no one at the clinic qualified to intubate the infant. Emergency personnel were called but the infant remained in respiratory distress for 8 minutes. The baby experienced birth asphyxia with hypoxic ischemic encephalopathy resulting in severe cerebral palsy.

PARENT'S CLAIM:

The birthing center was poorly staffed and unprepared to treat an emergency situation.

DEFENDANTS' DEFENSE:

The defendants denied all allegations of negligence. The case was settled during trial.

VERDICT:

A $7.27 million Pennsylvania settlement was reached.

Was the spinal block given at wrong level?

A MOTHER WENT TO THE HOSPITAL in labor. Prior to cesarean delivery, she underwent an anesthetic spinal block administered by a CRNA. Initially, the patient reported pain shortly after the injection was performed until the block worked. The baby's delivery was uneventful.

In recovery a few hours later, the patient reported intense and uncontrollable pain in her legs. Magnetic resonance imaging revealed a fluid pocket on her spinal cord at the L1-L2 level. The patient has permanent pain, numbness, and tingling in in both legs.

PATIENT'S CLAIM:

The CRNA failed to insert the spinal block needle in the proper location.

DEFENDANTS' DEFENSE:

The CRNA contended that he complied with the standard of care. He claimed that the patient had an unusual spinal cord anatomy: it was tethered down to the L3-L4 level.

VERDICT:

A $509,152 Kentucky verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

According to the most recent data (2011–2013), 62% of women of childbearing age (15–44 years) use some method of contraception. Of these “contracepting” women, about 25% reported relying on permanent contraception, making it one of the most common methods of contraception used by women in the United States (FIGURE 1).^1,2 Women either can choose to have a permanent contraception procedure performed immediately postpartum, which occurs after approximately 9% of all hospital deliveries in the United States,³ or at a time separate from pregnancy.

The most common methods of permanent contraception include partial salpingectomy at the time of cesarean delivery or within 24 hours after vaginal delivery and laparoscopic occlusive procedures at a time unrelated to the postpartum period.³ Hysteroscopic occlusion of the tubal ostia is a newer option, introduced in 2002; its worldwide use is concentrated in the United States, which accounts for 80% of sales based on revenue.⁴

Historically, for procedures remote from pregnancy, the laparoscopic approach evolved with less sophisticated laparoscopic equipment and limited visualization, which resulted in efficiency and safety being the primary goals of the procedure.⁵ Accordingly, rapid occlusive procedures were commonplace. However, advancement of laparoscopic technology related to insufflation systems, surgical equipment, and video capabilities did not change this practice.

Recent literature has suggested that complete fallopian tube removal provides additional benefits. With increasing knowledge about the origin of ovarian cancer, as well as increasing data to support the hypothesis that complete tubal excision results in increased ovarian cancer protection when compared with occlusive or partial salpingectomies, both the American College of Obstetricians and Gynecologists (ACOG)⁶ and the Society of Gynecologic Oncology (SGO)⁷ recommend discussing bilateral total salpingectomy with patients desiring permanent contraception. Although occlusive procedures decrease a woman’s lifetime risk of ovarian cancer by 24% to 34%,^8,9 total salpingectomy likely reduces this risk by 49% to 65%.^10,11

With this new evidence, McAlpine and colleagues initiated an educational campaign, targeting all ObGyns in British Columbia, which outlined the role of the fallopian tube in ovarian cancer and urged the consideration of total salpingectomy for permanent contraception in place of occlusive or partial salpingectomy procedures. They found that this one-time targeted education increased the use of total salpingectomy for permanent contraception from 0.5% at 2 years before the intervention to 33.3% by 2 years afterwards.¹² On average, laparoscopic bilateral salpingectomy took 10 minutes longer to complete than occlusive procedures. Most importantly, they found no significant differences in complication rates, including hospital readmissions or blood transfusions.

Although our community can be applauded for the rapid uptake of concomitant bilateral salpingectomy at the time of benign hysterectomy,^12,13 offering total salpingectomy for permanent contraception is far from common practice. Similarly, while multiple studies have been published to support the practice of opportunistic salpingectomy at the time of hysterectomy, little has been published about the use of bilateral salpingectomy for permanent contraception until this past year.

In this article, we review some of the first publications to focus specifically on the feasibility and safety profile of performing either immediate postpartum total salpingectomy or interval total salpingectomy in women desiring permanent contraception.

Read about a total salpingectomy at delivery

Total salpingectomy: A viable option for permanent contraception after vaginal or at cesarean delivery

Shinar S, Blecher Y, Alpern S, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185-1189.

Danis RB, Della Badia CR, Richard SD. Postpartum permanent sterilization: could bilateral salpingectomy replace bilateral tubal ligation? J Minim Invasive Gynecol. 2016;23(6):928-932.

Shinar and colleagues presented a retrospective case series that included women undergoing permanent contraception procedures during cesarean delivery at a single tertiary medical center. The authors evaluated outcomes before and after a global hospital policy changed the preferred permanent contraception procedure from partial to total salpingectomy.

Details of the Shinar technique and outcomes

Of the 149 women included, 99 underwent partial salpingectomy via the modified Pomeroy technique and 50 underwent total salpingectomy using an electrothermal bipolar tissue-sealing instrument (Ligasure). The authors found no difference in operative times and similar rates of complications. Composite adverse outcomes, defined as surgery duration greater than 45 minutes, hemoglobin decline greater than 1.2 g/dL, need for blood transfusion, prolonged hospitalization, ICU admission, or re-laparotomy, were comparable and were reported as 30.3% and 36.0% in the partial and total salpingectomy groups, respectively, (P = .57).One major complication occurred in the total salpingectomy cohort; postoperatively the patient had hemodynamic instability and was found to have hemoperitoneum requiring exploratory laparotomy. Significant bleeding from the bilateral mesosalpinges was discovered, presumably directly related to the total salpingectomy.

Related article:
Hysteroscopic tubal occlusion: How new product labeling can be a resource for patient counseling

Details of Danis et al

Intuitively, performing salpingectomy at the time of cesarean delivery does not seem as significant a change in practice as would performing salpingectomy through a small periumbilical incision after vaginal delivery. However, Danis and colleagues did just that; they published a retrospective case series of total salpingectomy performed within 24 hours after a vaginal delivery at an urban, academic institution. They included all women admitted for full-term vaginal deliveries who desired permanent contraception, with no exclusion criteria related to body mass index (BMI). The authors reported on 80 women, including 64 (80%) who underwent partial salpingectomy via the modified Pomeroy or Parkland technique and 16 (20%) who underwent total salpingectomy. Most women had a BMI of less than 30 kg/m²; less than 15% of the women in each group had a BMI greater than 40 kg/m².

The technique for total salpingectomy involved a 2- to 3-cm vertical incision at the level of the umbilicus, elevation of the entire fallopian tube with 2 Babcock clamps, followed by the development of 2 to 3 windows with monopolar electrocautery in the mesosalpinx and subsequent suture ligation with polyglactin 910 (Vicryl, Ethicon).

Major findings included slightly longer operative time in the total salpingectomy compared with the partial salpingectomy group (a finding consistent with other studies^12,14,15) and no difference in complication rates. The average (SD) surgical time in the partial salpingectomy group was 59 (16) minutes, compared with 71 (6) minutes in the total salpingectomy group (P = .003). The authors reported 4 (6.3%) complications in the partial salpingectomy group--ileus, excessive bleeding from mesosalpinx, and incisional site hematoma--and no complications in the total salpingectomy group (P = .58).

Read about interval permanent contraception

Feasibility of interval laparoscopic permanent contraception via bilateral salpingectomy 

Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505-508.

In this retrospective study, authors used billing data to identify women undergoing interval laparoscopic permanent contraception at a single academic medical center. They educated physicians and patients about the potential benefits to ovarian cancer risk with total salpingectomy (similar to the educational initiative done in British Columbia) and discussed the requirement for the extra incision and more time for the surgery. From 2013 to 2015 use of salpingectomy for permanent contraception changed from 45% of the procedures to 85%, a fairly dramatic trend.¹⁸ With these data, the authors compared outcomes between the women receiving tubal occlusive procedures and women receiving bilateral salpingectomy.

Related article:
Risk-reducing salpingectomy at benign hysterectomy: Have surgeons embraced this practice?

Details of surgical time and complications

Tubal occlusion procedures were performed through 2 abdominal ports, and device placement was at the discretion of the provider. Bilateral salpingectomies were performed through 3 abdominal port sites with an electrothermal bipolar tissue-sealing instrument. A total of 149 procedures were identified, 68 tubal occlusions (19% Falope rings, 32% bipolar cautery, and 47% Filshie clips) and 81 bilateral salpingectomies.

The surgical time average (SD) was 6 minutes longer for the salpingectomies (44 [13] minutes vs 38 [15] minutes; P = .018). As would be expected, more experienced residents had shorter surgical times when compared with less experienced residents for both procedures (FIGURE 2).¹⁵ Similar rates of both immediate and short-term surgical complications were noted. One immediate complication was reported in each group, both of which were secondary to anesthesia issues.

Interestingly, short-term complications were lower in the salpingectomy group (4.9%) versus the tubal occlusion group (14.7%), although this difference was barely not statistically significant (P = .051). These complications included 1 incisional site infection requiring oral antibiotics and 3 cases of increased pain in the salpingectomy group and 4 incisional site infections with 6 patients reporting increased pain in the tubal occlusion group.

Read about tube removal and ovarian reserve

Does total removal of the tubes affect ovarian reserve?

Ganer Herman H, Gluck O, Keidar R, et al. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017;doi: 10.1016/j.ajog.2017.04.028.

As acceptability of total salpingectomy for permanent contraception increases, one concern is that complete removal may alter blood supply to the ovary, resulting in decreased ovarian reserve and, subsequently, earlier menopause. Several studies have addressed the potential effect of salpingectomy on ovarian function when performed at the time of hysterectomy, most of which have noted no difference in anti-Müllerian hormone (AMH) levels and sonographic parameters following surgery.¹⁹ However, very little has been published to assess this same question when the salpingectomy is performed for the purpose of permanent contraception.

Ganer Herman and colleagues aimed to assess short-term ovarian reserve by measuring AMH levels preoperatively and 6 to 8 weeks postoperatively in patients undergoing partial or total salpingectomy at the time of elective cesarean delivery.

Related article:
Salpingectomy after vaginal hysterectomy: Technique, tips, and pearls

Details of the study

The study included women aged 18 to 45 who presented for elective cesarean delivery and who requested permanent contraception. Exclusion criteria included previous tubal surgery, emergent cesarean delivery, personal history of breast carcinoma, familial history of ovarian carcinoma, and BRCA carriage.

Women were randomly assigned at a 1:1 ratio to bilateral total salpingectomy or bilateral partial salpingectomy. A complete blood count and AMH level were drawn the night prior to surgery. Intraoperatively, after delivery and hysterotomy closure, partial salpingectomy, via the Parkland technique, or total salpingectomy, using a suture ligation technique, was performed.

Of the 46 women enrolled, follow-up was completed by 16 of 22 women (72%) in the total salpingectomy group and 18 of 24 women (75%) in the partial salpingectomy group. Patients in the total salpingectomy group were slightly older (mean age, 37 vs 34 years; P = .02), but otherwise all demographic and obstetric characteristics were comparable.

No differences were noted in preoperative and postoperative AMH levels between groups, with an average (SD) increase of 0.58 (0.98) ng/mL versus 0.39 (0.41) ng/mL in the total salpingectomy and partial salpingectomy groups, respectively (P = .45), consistent with known postpartum AMH level trends.

Other findings included an average 13-minute increase in operative time in the total salpingectomy cases, similar safety profile of the 2 methods as there were no postoperative complications during the study period, and no differences in postoperative hemoglobin levels.

Conclusion

The studies reviewed in this article are some of the first to evaluate the feasibility and safety of opportunistic, or total, salpingectomy for permanent contraception since the ACOG and SGO recommendations were published. Just as our community has adopted the common practice of opportunistic salpingectomy at the time of hysterectomy, we should continue to advocate for a similar practice when discussing permanent contraception. Additionally, the Westberg study provides good evidence that educational initiatives can influence provider practices, which upholds the data published by McAlpine and colleagues in British Columbia. This information is promising and valuable.

Our universal goal as ObGyns is to provide the best reproductive health care possible based on the most recent evidence available. Continuing to advocate for opportunistic salpingectomy for permanent contraception purposes meets this goal and potentially provides significant noncontraceptive benefits.

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.

According to the most recent data (2011–2013), 62% of women of childbearing age (15–44 years) use some method of contraception. Of these “contracepting” women, about 25% reported relying on permanent contraception, making it one of the most common methods of contraception used by women in the United States (FIGURE 1).^1,2 Women either can choose to have a permanent contraception procedure performed immediately postpartum, which occurs after approximately 9% of all hospital deliveries in the United States,³ or at a time separate from pregnancy.

The most common methods of permanent contraception include partial salpingectomy at the time of cesarean delivery or within 24 hours after vaginal delivery and laparoscopic occlusive procedures at a time unrelated to the postpartum period.³ Hysteroscopic occlusion of the tubal ostia is a newer option, introduced in 2002; its worldwide use is concentrated in the United States, which accounts for 80% of sales based on revenue.⁴

Historically, for procedures remote from pregnancy, the laparoscopic approach evolved with less sophisticated laparoscopic equipment and limited visualization, which resulted in efficiency and safety being the primary goals of the procedure.⁵ Accordingly, rapid occlusive procedures were commonplace. However, advancement of laparoscopic technology related to insufflation systems, surgical equipment, and video capabilities did not change this practice.

Recent literature has suggested that complete fallopian tube removal provides additional benefits. With increasing knowledge about the origin of ovarian cancer, as well as increasing data to support the hypothesis that complete tubal excision results in increased ovarian cancer protection when compared with occlusive or partial salpingectomies, both the American College of Obstetricians and Gynecologists (ACOG)⁶ and the Society of Gynecologic Oncology (SGO)⁷ recommend discussing bilateral total salpingectomy with patients desiring permanent contraception. Although occlusive procedures decrease a woman’s lifetime risk of ovarian cancer by 24% to 34%,^8,9 total salpingectomy likely reduces this risk by 49% to 65%.^10,11

With this new evidence, McAlpine and colleagues initiated an educational campaign, targeting all ObGyns in British Columbia, which outlined the role of the fallopian tube in ovarian cancer and urged the consideration of total salpingectomy for permanent contraception in place of occlusive or partial salpingectomy procedures. They found that this one-time targeted education increased the use of total salpingectomy for permanent contraception from 0.5% at 2 years before the intervention to 33.3% by 2 years afterwards.¹² On average, laparoscopic bilateral salpingectomy took 10 minutes longer to complete than occlusive procedures. Most importantly, they found no significant differences in complication rates, including hospital readmissions or blood transfusions.

Although our community can be applauded for the rapid uptake of concomitant bilateral salpingectomy at the time of benign hysterectomy,^12,13 offering total salpingectomy for permanent contraception is far from common practice. Similarly, while multiple studies have been published to support the practice of opportunistic salpingectomy at the time of hysterectomy, little has been published about the use of bilateral salpingectomy for permanent contraception until this past year.

In this article, we review some of the first publications to focus specifically on the feasibility and safety profile of performing either immediate postpartum total salpingectomy or interval total salpingectomy in women desiring permanent contraception.

Read about a total salpingectomy at delivery

Total salpingectomy: A viable option for permanent contraception after vaginal or at cesarean delivery

Shinar S, Blecher Y, Alpern S, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185-1189.

Danis RB, Della Badia CR, Richard SD. Postpartum permanent sterilization: could bilateral salpingectomy replace bilateral tubal ligation? J Minim Invasive Gynecol. 2016;23(6):928-932.

Shinar and colleagues presented a retrospective case series that included women undergoing permanent contraception procedures during cesarean delivery at a single tertiary medical center. The authors evaluated outcomes before and after a global hospital policy changed the preferred permanent contraception procedure from partial to total salpingectomy.

Details of the Shinar technique and outcomes

Of the 149 women included, 99 underwent partial salpingectomy via the modified Pomeroy technique and 50 underwent total salpingectomy using an electrothermal bipolar tissue-sealing instrument (Ligasure). The authors found no difference in operative times and similar rates of complications. Composite adverse outcomes, defined as surgery duration greater than 45 minutes, hemoglobin decline greater than 1.2 g/dL, need for blood transfusion, prolonged hospitalization, ICU admission, or re-laparotomy, were comparable and were reported as 30.3% and 36.0% in the partial and total salpingectomy groups, respectively, (P = .57).One major complication occurred in the total salpingectomy cohort; postoperatively the patient had hemodynamic instability and was found to have hemoperitoneum requiring exploratory laparotomy. Significant bleeding from the bilateral mesosalpinges was discovered, presumably directly related to the total salpingectomy.

Related article:
Hysteroscopic tubal occlusion: How new product labeling can be a resource for patient counseling

Details of Danis et al

Intuitively, performing salpingectomy at the time of cesarean delivery does not seem as significant a change in practice as would performing salpingectomy through a small periumbilical incision after vaginal delivery. However, Danis and colleagues did just that; they published a retrospective case series of total salpingectomy performed within 24 hours after a vaginal delivery at an urban, academic institution. They included all women admitted for full-term vaginal deliveries who desired permanent contraception, with no exclusion criteria related to body mass index (BMI). The authors reported on 80 women, including 64 (80%) who underwent partial salpingectomy via the modified Pomeroy or Parkland technique and 16 (20%) who underwent total salpingectomy. Most women had a BMI of less than 30 kg/m²; less than 15% of the women in each group had a BMI greater than 40 kg/m².

The technique for total salpingectomy involved a 2- to 3-cm vertical incision at the level of the umbilicus, elevation of the entire fallopian tube with 2 Babcock clamps, followed by the development of 2 to 3 windows with monopolar electrocautery in the mesosalpinx and subsequent suture ligation with polyglactin 910 (Vicryl, Ethicon).

Major findings included slightly longer operative time in the total salpingectomy compared with the partial salpingectomy group (a finding consistent with other studies^12,14,15) and no difference in complication rates. The average (SD) surgical time in the partial salpingectomy group was 59 (16) minutes, compared with 71 (6) minutes in the total salpingectomy group (P = .003). The authors reported 4 (6.3%) complications in the partial salpingectomy group--ileus, excessive bleeding from mesosalpinx, and incisional site hematoma--and no complications in the total salpingectomy group (P = .58).

Read about interval permanent contraception

Feasibility of interval laparoscopic permanent contraception via bilateral salpingectomy 

Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505-508.

In this retrospective study, authors used billing data to identify women undergoing interval laparoscopic permanent contraception at a single academic medical center. They educated physicians and patients about the potential benefits to ovarian cancer risk with total salpingectomy (similar to the educational initiative done in British Columbia) and discussed the requirement for the extra incision and more time for the surgery. From 2013 to 2015 use of salpingectomy for permanent contraception changed from 45% of the procedures to 85%, a fairly dramatic trend.¹⁸ With these data, the authors compared outcomes between the women receiving tubal occlusive procedures and women receiving bilateral salpingectomy.

Related article:
Risk-reducing salpingectomy at benign hysterectomy: Have surgeons embraced this practice?

Details of surgical time and complications

Tubal occlusion procedures were performed through 2 abdominal ports, and device placement was at the discretion of the provider. Bilateral salpingectomies were performed through 3 abdominal port sites with an electrothermal bipolar tissue-sealing instrument. A total of 149 procedures were identified, 68 tubal occlusions (19% Falope rings, 32% bipolar cautery, and 47% Filshie clips) and 81 bilateral salpingectomies.

The surgical time average (SD) was 6 minutes longer for the salpingectomies (44 [13] minutes vs 38 [15] minutes; P = .018). As would be expected, more experienced residents had shorter surgical times when compared with less experienced residents for both procedures (FIGURE 2).¹⁵ Similar rates of both immediate and short-term surgical complications were noted. One immediate complication was reported in each group, both of which were secondary to anesthesia issues.

Interestingly, short-term complications were lower in the salpingectomy group (4.9%) versus the tubal occlusion group (14.7%), although this difference was barely not statistically significant (P = .051). These complications included 1 incisional site infection requiring oral antibiotics and 3 cases of increased pain in the salpingectomy group and 4 incisional site infections with 6 patients reporting increased pain in the tubal occlusion group.

Read about tube removal and ovarian reserve

Does total removal of the tubes affect ovarian reserve?

Ganer Herman H, Gluck O, Keidar R, et al. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017;doi: 10.1016/j.ajog.2017.04.028.

As acceptability of total salpingectomy for permanent contraception increases, one concern is that complete removal may alter blood supply to the ovary, resulting in decreased ovarian reserve and, subsequently, earlier menopause. Several studies have addressed the potential effect of salpingectomy on ovarian function when performed at the time of hysterectomy, most of which have noted no difference in anti-Müllerian hormone (AMH) levels and sonographic parameters following surgery.¹⁹ However, very little has been published to assess this same question when the salpingectomy is performed for the purpose of permanent contraception.

Ganer Herman and colleagues aimed to assess short-term ovarian reserve by measuring AMH levels preoperatively and 6 to 8 weeks postoperatively in patients undergoing partial or total salpingectomy at the time of elective cesarean delivery.

Related article:
Salpingectomy after vaginal hysterectomy: Technique, tips, and pearls

Details of the study

The study included women aged 18 to 45 who presented for elective cesarean delivery and who requested permanent contraception. Exclusion criteria included previous tubal surgery, emergent cesarean delivery, personal history of breast carcinoma, familial history of ovarian carcinoma, and BRCA carriage.

Women were randomly assigned at a 1:1 ratio to bilateral total salpingectomy or bilateral partial salpingectomy. A complete blood count and AMH level were drawn the night prior to surgery. Intraoperatively, after delivery and hysterotomy closure, partial salpingectomy, via the Parkland technique, or total salpingectomy, using a suture ligation technique, was performed.

Of the 46 women enrolled, follow-up was completed by 16 of 22 women (72%) in the total salpingectomy group and 18 of 24 women (75%) in the partial salpingectomy group. Patients in the total salpingectomy group were slightly older (mean age, 37 vs 34 years; P = .02), but otherwise all demographic and obstetric characteristics were comparable.

No differences were noted in preoperative and postoperative AMH levels between groups, with an average (SD) increase of 0.58 (0.98) ng/mL versus 0.39 (0.41) ng/mL in the total salpingectomy and partial salpingectomy groups, respectively (P = .45), consistent with known postpartum AMH level trends.

Other findings included an average 13-minute increase in operative time in the total salpingectomy cases, similar safety profile of the 2 methods as there were no postoperative complications during the study period, and no differences in postoperative hemoglobin levels.

Conclusion

The studies reviewed in this article are some of the first to evaluate the feasibility and safety of opportunistic, or total, salpingectomy for permanent contraception since the ACOG and SGO recommendations were published. Just as our community has adopted the common practice of opportunistic salpingectomy at the time of hysterectomy, we should continue to advocate for a similar practice when discussing permanent contraception. Additionally, the Westberg study provides good evidence that educational initiatives can influence provider practices, which upholds the data published by McAlpine and colleagues in British Columbia. This information is promising and valuable.

Our universal goal as ObGyns is to provide the best reproductive health care possible based on the most recent evidence available. Continuing to advocate for opportunistic salpingectomy for permanent contraception purposes meets this goal and potentially provides significant noncontraceptive benefits.

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.

According to the most recent data (2011–2013), 62% of women of childbearing age (15–44 years) use some method of contraception. Of these “contracepting” women, about 25% reported relying on permanent contraception, making it one of the most common methods of contraception used by women in the United States (FIGURE 1).^1,2 Women either can choose to have a permanent contraception procedure performed immediately postpartum, which occurs after approximately 9% of all hospital deliveries in the United States,³ or at a time separate from pregnancy.

The most common methods of permanent contraception include partial salpingectomy at the time of cesarean delivery or within 24 hours after vaginal delivery and laparoscopic occlusive procedures at a time unrelated to the postpartum period.³ Hysteroscopic occlusion of the tubal ostia is a newer option, introduced in 2002; its worldwide use is concentrated in the United States, which accounts for 80% of sales based on revenue.⁴

Historically, for procedures remote from pregnancy, the laparoscopic approach evolved with less sophisticated laparoscopic equipment and limited visualization, which resulted in efficiency and safety being the primary goals of the procedure.⁵ Accordingly, rapid occlusive procedures were commonplace. However, advancement of laparoscopic technology related to insufflation systems, surgical equipment, and video capabilities did not change this practice.

Recent literature has suggested that complete fallopian tube removal provides additional benefits. With increasing knowledge about the origin of ovarian cancer, as well as increasing data to support the hypothesis that complete tubal excision results in increased ovarian cancer protection when compared with occlusive or partial salpingectomies, both the American College of Obstetricians and Gynecologists (ACOG)⁶ and the Society of Gynecologic Oncology (SGO)⁷ recommend discussing bilateral total salpingectomy with patients desiring permanent contraception. Although occlusive procedures decrease a woman’s lifetime risk of ovarian cancer by 24% to 34%,^8,9 total salpingectomy likely reduces this risk by 49% to 65%.^10,11

With this new evidence, McAlpine and colleagues initiated an educational campaign, targeting all ObGyns in British Columbia, which outlined the role of the fallopian tube in ovarian cancer and urged the consideration of total salpingectomy for permanent contraception in place of occlusive or partial salpingectomy procedures. They found that this one-time targeted education increased the use of total salpingectomy for permanent contraception from 0.5% at 2 years before the intervention to 33.3% by 2 years afterwards.¹² On average, laparoscopic bilateral salpingectomy took 10 minutes longer to complete than occlusive procedures. Most importantly, they found no significant differences in complication rates, including hospital readmissions or blood transfusions.

Although our community can be applauded for the rapid uptake of concomitant bilateral salpingectomy at the time of benign hysterectomy,^12,13 offering total salpingectomy for permanent contraception is far from common practice. Similarly, while multiple studies have been published to support the practice of opportunistic salpingectomy at the time of hysterectomy, little has been published about the use of bilateral salpingectomy for permanent contraception until this past year.

In this article, we review some of the first publications to focus specifically on the feasibility and safety profile of performing either immediate postpartum total salpingectomy or interval total salpingectomy in women desiring permanent contraception.

Read about a total salpingectomy at delivery

Total salpingectomy: A viable option for permanent contraception after vaginal or at cesarean delivery

Shinar S, Blecher Y, Alpern S, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185-1189.

Danis RB, Della Badia CR, Richard SD. Postpartum permanent sterilization: could bilateral salpingectomy replace bilateral tubal ligation? J Minim Invasive Gynecol. 2016;23(6):928-932.

Shinar and colleagues presented a retrospective case series that included women undergoing permanent contraception procedures during cesarean delivery at a single tertiary medical center. The authors evaluated outcomes before and after a global hospital policy changed the preferred permanent contraception procedure from partial to total salpingectomy.

Details of the Shinar technique and outcomes

Of the 149 women included, 99 underwent partial salpingectomy via the modified Pomeroy technique and 50 underwent total salpingectomy using an electrothermal bipolar tissue-sealing instrument (Ligasure). The authors found no difference in operative times and similar rates of complications. Composite adverse outcomes, defined as surgery duration greater than 45 minutes, hemoglobin decline greater than 1.2 g/dL, need for blood transfusion, prolonged hospitalization, ICU admission, or re-laparotomy, were comparable and were reported as 30.3% and 36.0% in the partial and total salpingectomy groups, respectively, (P = .57).One major complication occurred in the total salpingectomy cohort; postoperatively the patient had hemodynamic instability and was found to have hemoperitoneum requiring exploratory laparotomy. Significant bleeding from the bilateral mesosalpinges was discovered, presumably directly related to the total salpingectomy.

Related article:
Hysteroscopic tubal occlusion: How new product labeling can be a resource for patient counseling

Details of Danis et al

Intuitively, performing salpingectomy at the time of cesarean delivery does not seem as significant a change in practice as would performing salpingectomy through a small periumbilical incision after vaginal delivery. However, Danis and colleagues did just that; they published a retrospective case series of total salpingectomy performed within 24 hours after a vaginal delivery at an urban, academic institution. They included all women admitted for full-term vaginal deliveries who desired permanent contraception, with no exclusion criteria related to body mass index (BMI). The authors reported on 80 women, including 64 (80%) who underwent partial salpingectomy via the modified Pomeroy or Parkland technique and 16 (20%) who underwent total salpingectomy. Most women had a BMI of less than 30 kg/m²; less than 15% of the women in each group had a BMI greater than 40 kg/m².

The technique for total salpingectomy involved a 2- to 3-cm vertical incision at the level of the umbilicus, elevation of the entire fallopian tube with 2 Babcock clamps, followed by the development of 2 to 3 windows with monopolar electrocautery in the mesosalpinx and subsequent suture ligation with polyglactin 910 (Vicryl, Ethicon).

Major findings included slightly longer operative time in the total salpingectomy compared with the partial salpingectomy group (a finding consistent with other studies^12,14,15) and no difference in complication rates. The average (SD) surgical time in the partial salpingectomy group was 59 (16) minutes, compared with 71 (6) minutes in the total salpingectomy group (P = .003). The authors reported 4 (6.3%) complications in the partial salpingectomy group--ileus, excessive bleeding from mesosalpinx, and incisional site hematoma--and no complications in the total salpingectomy group (P = .58).

Read about interval permanent contraception

Feasibility of interval laparoscopic permanent contraception via bilateral salpingectomy 

Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505-508.

In this retrospective study, authors used billing data to identify women undergoing interval laparoscopic permanent contraception at a single academic medical center. They educated physicians and patients about the potential benefits to ovarian cancer risk with total salpingectomy (similar to the educational initiative done in British Columbia) and discussed the requirement for the extra incision and more time for the surgery. From 2013 to 2015 use of salpingectomy for permanent contraception changed from 45% of the procedures to 85%, a fairly dramatic trend.¹⁸ With these data, the authors compared outcomes between the women receiving tubal occlusive procedures and women receiving bilateral salpingectomy.

Related article:
Risk-reducing salpingectomy at benign hysterectomy: Have surgeons embraced this practice?

Details of surgical time and complications

Tubal occlusion procedures were performed through 2 abdominal ports, and device placement was at the discretion of the provider. Bilateral salpingectomies were performed through 3 abdominal port sites with an electrothermal bipolar tissue-sealing instrument. A total of 149 procedures were identified, 68 tubal occlusions (19% Falope rings, 32% bipolar cautery, and 47% Filshie clips) and 81 bilateral salpingectomies.

The surgical time average (SD) was 6 minutes longer for the salpingectomies (44 [13] minutes vs 38 [15] minutes; P = .018). As would be expected, more experienced residents had shorter surgical times when compared with less experienced residents for both procedures (FIGURE 2).¹⁵ Similar rates of both immediate and short-term surgical complications were noted. One immediate complication was reported in each group, both of which were secondary to anesthesia issues.

Interestingly, short-term complications were lower in the salpingectomy group (4.9%) versus the tubal occlusion group (14.7%), although this difference was barely not statistically significant (P = .051). These complications included 1 incisional site infection requiring oral antibiotics and 3 cases of increased pain in the salpingectomy group and 4 incisional site infections with 6 patients reporting increased pain in the tubal occlusion group.

Read about tube removal and ovarian reserve

Does total removal of the tubes affect ovarian reserve?

Ganer Herman H, Gluck O, Keidar R, et al. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017;doi: 10.1016/j.ajog.2017.04.028.

As acceptability of total salpingectomy for permanent contraception increases, one concern is that complete removal may alter blood supply to the ovary, resulting in decreased ovarian reserve and, subsequently, earlier menopause. Several studies have addressed the potential effect of salpingectomy on ovarian function when performed at the time of hysterectomy, most of which have noted no difference in anti-Müllerian hormone (AMH) levels and sonographic parameters following surgery.¹⁹ However, very little has been published to assess this same question when the salpingectomy is performed for the purpose of permanent contraception.

Ganer Herman and colleagues aimed to assess short-term ovarian reserve by measuring AMH levels preoperatively and 6 to 8 weeks postoperatively in patients undergoing partial or total salpingectomy at the time of elective cesarean delivery.

Related article:
Salpingectomy after vaginal hysterectomy: Technique, tips, and pearls

Details of the study

The study included women aged 18 to 45 who presented for elective cesarean delivery and who requested permanent contraception. Exclusion criteria included previous tubal surgery, emergent cesarean delivery, personal history of breast carcinoma, familial history of ovarian carcinoma, and BRCA carriage.

Women were randomly assigned at a 1:1 ratio to bilateral total salpingectomy or bilateral partial salpingectomy. A complete blood count and AMH level were drawn the night prior to surgery. Intraoperatively, after delivery and hysterotomy closure, partial salpingectomy, via the Parkland technique, or total salpingectomy, using a suture ligation technique, was performed.

Of the 46 women enrolled, follow-up was completed by 16 of 22 women (72%) in the total salpingectomy group and 18 of 24 women (75%) in the partial salpingectomy group. Patients in the total salpingectomy group were slightly older (mean age, 37 vs 34 years; P = .02), but otherwise all demographic and obstetric characteristics were comparable.

No differences were noted in preoperative and postoperative AMH levels between groups, with an average (SD) increase of 0.58 (0.98) ng/mL versus 0.39 (0.41) ng/mL in the total salpingectomy and partial salpingectomy groups, respectively (P = .45), consistent with known postpartum AMH level trends.

Other findings included an average 13-minute increase in operative time in the total salpingectomy cases, similar safety profile of the 2 methods as there were no postoperative complications during the study period, and no differences in postoperative hemoglobin levels.

Conclusion

The studies reviewed in this article are some of the first to evaluate the feasibility and safety of opportunistic, or total, salpingectomy for permanent contraception since the ACOG and SGO recommendations were published. Just as our community has adopted the common practice of opportunistic salpingectomy at the time of hysterectomy, we should continue to advocate for a similar practice when discussing permanent contraception. Additionally, the Westberg study provides good evidence that educational initiatives can influence provider practices, which upholds the data published by McAlpine and colleagues in British Columbia. This information is promising and valuable.

Our universal goal as ObGyns is to provide the best reproductive health care possible based on the most recent evidence available. Continuing to advocate for opportunistic salpingectomy for permanent contraception purposes meets this goal and potentially provides significant noncontraceptive benefits.

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.

EXPERT COMMENTARY

While numerous studies have investigated the risk of perinatal outcomes with advancing maternal age, the primary objective of a recent study by Lisonkova and colleagues was to examine the association between advancing maternal age and severe maternal morbidities and mortality.

Details of the study

The population-based retrospective cohort study compared age-specific rates of severe maternal morbidities and mortality among 828,269 pregnancies in Washington state between 2003 and 2013. Singleton births to women 15 to 60 years of age were included; out-of-hospital births were excluded. Information was obtained by linking the Birth Events Record Database (which includes information on maternal, pregnancy, and labor and delivery characteristics and birth outcomes), and the Comprehensive Hospital Abstract Reporting System database (which includes diagnostic and procedural codes for all hospitalizations in Washington state).

The primary objective was to examine the association between age and severe maternal morbidities. Maternal morbidities were divided into categories: antepartum hemorrhage, respiratory morbidity, thromboembolism, cerebrovascular morbidity, acute cardiac morbidity, severe postpartum hemorrhage, maternal sepsis, renal failure, obstetric shock, complications of anesthesia and obstetric interventions, and need for life-saving procedures. A composite outcome, comprised of severe maternal morbidities, intensive care unit admission, and maternal mortality, was also created.

Rates of severe morbidities were compared for age groups 15 to 19, 20 to 24, 25 to 29, 30 to 34, 35 to 39, 40 to 44, and ≥45 years to the referent category (25 to 29 years). Additional comparisons were also performed for ages 45 to 49 and ≥50 years for the composite and for morbidities with high incidence. Logistic regression and sensitivity analyses were used to control for demographic and prepregnancy characteristics, underlying medical conditions, assisted conception, and delivery characteristics.

Severe maternal morbidities demonstrated a J-shaped association with age: the lowest rates of morbidity were observed in women 20 to 34 years of age, and steeply increasing rates of morbidity were observed for women aged 40 and older. One notable exception was the rate of sepsis, which was increased in teen mothers compared with all other groups.

The unadjusted rate of the composite outcome of severe maternal morbidity and mortality was 2.1% in teenagers, 1.5% among women 25 to 29 years, 2.3% among those aged 40 to 44, and 3.6% among women aged 45 and older.

Although rates were somewhat attenuated after adjustment for demographic and prepregnancy characteristics, chronic medical conditions, assisted conception, and delivery characteristics, most morbidities remained significantly increased among women aged 39 years and older, including the composite outcome. Among the individual morbidities considered, increased risk was highest for renal failure, amniotic fluid embolism, cardiac morbidity, and shock, with adjusted odds ratios of 2.0 or greater for women older than 39 years.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Study strengths and weaknesses

This study contributes substantially to the existing literature that demonstrates higher rates of pregnancy-associated morbidities in women of increasing maternal age.^1,2 Prior studies in this area focused on perinatal morbidity and mortality and on obstetric outcomes such as cesarean delivery.^3–5 This large-scale study examined the association between advancing maternal age and a variety of serious maternal morbidities. In another study, Callaghan and Berg found a similar pattern among mortalities, with high rates of mortality attributable to hemorrhage, embolism, and cardiomyopathy in women aged 40 years and older.¹

Exclusion of multiple gestations. As in any study, we must consider the methodology, and it is notable that Lisonkova and colleagues’ study excluded multiple gestations. Given the association with advanced maternal age, assisted reproductive technology, and the incidence of multiple gestations, a high rate of multiple gestations would be expected among women of advanced maternal age. (Generally, maternal age of at least 35 years is considered “advanced,” with greater than 40 years “very advanced.”) Since multiple gestations tend to be associated with increases in morbidity, excluding these pregnancies would likely bias the study results toward the null. If multiple gestations had been included, the rates of serious maternal morbidities in older women might be even higher than those demonstrated, potentially strengthening the associations reported here.

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.

EXPERT COMMENTARY

While numerous studies have investigated the risk of perinatal outcomes with advancing maternal age, the primary objective of a recent study by Lisonkova and colleagues was to examine the association between advancing maternal age and severe maternal morbidities and mortality.

Details of the study

The population-based retrospective cohort study compared age-specific rates of severe maternal morbidities and mortality among 828,269 pregnancies in Washington state between 2003 and 2013. Singleton births to women 15 to 60 years of age were included; out-of-hospital births were excluded. Information was obtained by linking the Birth Events Record Database (which includes information on maternal, pregnancy, and labor and delivery characteristics and birth outcomes), and the Comprehensive Hospital Abstract Reporting System database (which includes diagnostic and procedural codes for all hospitalizations in Washington state).

The primary objective was to examine the association between age and severe maternal morbidities. Maternal morbidities were divided into categories: antepartum hemorrhage, respiratory morbidity, thromboembolism, cerebrovascular morbidity, acute cardiac morbidity, severe postpartum hemorrhage, maternal sepsis, renal failure, obstetric shock, complications of anesthesia and obstetric interventions, and need for life-saving procedures. A composite outcome, comprised of severe maternal morbidities, intensive care unit admission, and maternal mortality, was also created.

Rates of severe morbidities were compared for age groups 15 to 19, 20 to 24, 25 to 29, 30 to 34, 35 to 39, 40 to 44, and ≥45 years to the referent category (25 to 29 years). Additional comparisons were also performed for ages 45 to 49 and ≥50 years for the composite and for morbidities with high incidence. Logistic regression and sensitivity analyses were used to control for demographic and prepregnancy characteristics, underlying medical conditions, assisted conception, and delivery characteristics.

Severe maternal morbidities demonstrated a J-shaped association with age: the lowest rates of morbidity were observed in women 20 to 34 years of age, and steeply increasing rates of morbidity were observed for women aged 40 and older. One notable exception was the rate of sepsis, which was increased in teen mothers compared with all other groups.

The unadjusted rate of the composite outcome of severe maternal morbidity and mortality was 2.1% in teenagers, 1.5% among women 25 to 29 years, 2.3% among those aged 40 to 44, and 3.6% among women aged 45 and older.

Although rates were somewhat attenuated after adjustment for demographic and prepregnancy characteristics, chronic medical conditions, assisted conception, and delivery characteristics, most morbidities remained significantly increased among women aged 39 years and older, including the composite outcome. Among the individual morbidities considered, increased risk was highest for renal failure, amniotic fluid embolism, cardiac morbidity, and shock, with adjusted odds ratios of 2.0 or greater for women older than 39 years.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Study strengths and weaknesses

This study contributes substantially to the existing literature that demonstrates higher rates of pregnancy-associated morbidities in women of increasing maternal age.^1,2 Prior studies in this area focused on perinatal morbidity and mortality and on obstetric outcomes such as cesarean delivery.^3–5 This large-scale study examined the association between advancing maternal age and a variety of serious maternal morbidities. In another study, Callaghan and Berg found a similar pattern among mortalities, with high rates of mortality attributable to hemorrhage, embolism, and cardiomyopathy in women aged 40 years and older.¹

Exclusion of multiple gestations. As in any study, we must consider the methodology, and it is notable that Lisonkova and colleagues’ study excluded multiple gestations. Given the association with advanced maternal age, assisted reproductive technology, and the incidence of multiple gestations, a high rate of multiple gestations would be expected among women of advanced maternal age. (Generally, maternal age of at least 35 years is considered “advanced,” with greater than 40 years “very advanced.”) Since multiple gestations tend to be associated with increases in morbidity, excluding these pregnancies would likely bias the study results toward the null. If multiple gestations had been included, the rates of serious maternal morbidities in older women might be even higher than those demonstrated, potentially strengthening the associations reported here.

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.

EXPERT COMMENTARY

While numerous studies have investigated the risk of perinatal outcomes with advancing maternal age, the primary objective of a recent study by Lisonkova and colleagues was to examine the association between advancing maternal age and severe maternal morbidities and mortality.

Details of the study

The population-based retrospective cohort study compared age-specific rates of severe maternal morbidities and mortality among 828,269 pregnancies in Washington state between 2003 and 2013. Singleton births to women 15 to 60 years of age were included; out-of-hospital births were excluded. Information was obtained by linking the Birth Events Record Database (which includes information on maternal, pregnancy, and labor and delivery characteristics and birth outcomes), and the Comprehensive Hospital Abstract Reporting System database (which includes diagnostic and procedural codes for all hospitalizations in Washington state).

The primary objective was to examine the association between age and severe maternal morbidities. Maternal morbidities were divided into categories: antepartum hemorrhage, respiratory morbidity, thromboembolism, cerebrovascular morbidity, acute cardiac morbidity, severe postpartum hemorrhage, maternal sepsis, renal failure, obstetric shock, complications of anesthesia and obstetric interventions, and need for life-saving procedures. A composite outcome, comprised of severe maternal morbidities, intensive care unit admission, and maternal mortality, was also created.

Rates of severe morbidities were compared for age groups 15 to 19, 20 to 24, 25 to 29, 30 to 34, 35 to 39, 40 to 44, and ≥45 years to the referent category (25 to 29 years). Additional comparisons were also performed for ages 45 to 49 and ≥50 years for the composite and for morbidities with high incidence. Logistic regression and sensitivity analyses were used to control for demographic and prepregnancy characteristics, underlying medical conditions, assisted conception, and delivery characteristics.

Severe maternal morbidities demonstrated a J-shaped association with age: the lowest rates of morbidity were observed in women 20 to 34 years of age, and steeply increasing rates of morbidity were observed for women aged 40 and older. One notable exception was the rate of sepsis, which was increased in teen mothers compared with all other groups.

The unadjusted rate of the composite outcome of severe maternal morbidity and mortality was 2.1% in teenagers, 1.5% among women 25 to 29 years, 2.3% among those aged 40 to 44, and 3.6% among women aged 45 and older.

Although rates were somewhat attenuated after adjustment for demographic and prepregnancy characteristics, chronic medical conditions, assisted conception, and delivery characteristics, most morbidities remained significantly increased among women aged 39 years and older, including the composite outcome. Among the individual morbidities considered, increased risk was highest for renal failure, amniotic fluid embolism, cardiac morbidity, and shock, with adjusted odds ratios of 2.0 or greater for women older than 39 years.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Study strengths and weaknesses

This study contributes substantially to the existing literature that demonstrates higher rates of pregnancy-associated morbidities in women of increasing maternal age.^1,2 Prior studies in this area focused on perinatal morbidity and mortality and on obstetric outcomes such as cesarean delivery.^3–5 This large-scale study examined the association between advancing maternal age and a variety of serious maternal morbidities. In another study, Callaghan and Berg found a similar pattern among mortalities, with high rates of mortality attributable to hemorrhage, embolism, and cardiomyopathy in women aged 40 years and older.¹

Exclusion of multiple gestations. As in any study, we must consider the methodology, and it is notable that Lisonkova and colleagues’ study excluded multiple gestations. Given the association with advanced maternal age, assisted reproductive technology, and the incidence of multiple gestations, a high rate of multiple gestations would be expected among women of advanced maternal age. (Generally, maternal age of at least 35 years is considered “advanced,” with greater than 40 years “very advanced.”) Since multiple gestations tend to be associated with increases in morbidity, excluding these pregnancies would likely bias the study results toward the null. If multiple gestations had been included, the rates of serious maternal morbidities in older women might be even higher than those demonstrated, potentially strengthening the associations reported here.

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.

Increasingly, women with psychiatric illness are undergoing pharmacologic treatment during pregnancy. In the United States, an estimated 8% of pregnant women are prescribed antidepressants, and the number of such cases has risen over the past 15 years.¹ Women with a psychiatric diagnosis were once instructed either to discontinue all medication immediately on learning they were pregnant, or to forgo motherhood because their illness might have a negative effect on a child or because avoiding medication during pregnancy might lead to a relapse.

Fortunately, women with depression, anxiety, bipolar disorder, or schizophrenia no longer are being told that they cannot become mothers. For many women, however, stopping medication is not an option. Furthermore, psychiatric illness sometimes is diagnosed initially during pregnancy and requires treatment.

Illustration: Kimberly Martens for OBG Management

Pregnant women and their physicians need accurate information about when to taper off medication, when to start or continue, and which medications are safest. Even for clinicians with a solid knowledge base, counseling a woman who needs or may need psychotropic medication during pregnancy and breastfeeding is a daunting task. Some clinicians still recommend no drug treatment as the safest and best option, given the potential risks to the fetus.

In this review we offer a methodologic approach for decision making about pharmacologic treatment during pregnancy. As the scientific literature is constantly being updated, it is imperative to have the most current information on psychotropics and to know how to individualize that information when counseling a pregnant woman and her family. Using this framework for analyzing the risks and benefits for both mother and fetus, clinicians can avoid the unanswerable question of which medication is the “safest.”

A patient’s mental health care provider is a useful resource for information about a woman’s mental health history and current stability, but he or she may not be expert or comfortable in recommending treatment for a pregnant patient. During pregnancy, a woman’s obstetrician often becomes the “expert” for all treatment decisions.

Analyze risks and benefits of medication versus no medication

The US Food and Drug Administration (FDA) has not approved any psychotropic medication for use during pregnancy. While a clinical study would provide more scientifically rigorous safety data, conducting a double-blinded, placebo-controlled trial in pregnant women with a psychiatric disorder is unethical. Thus, the literature consists mostly of reports on case series, retrospective chart reviews, prospective naturalistic studies, and analyses of large registry databases. Each has benefits and limitations. It is important to understand the limitations when making treatment decisions.

In 1979, the FDA developed a 5-lettersystem (A, B, C, D, X) for classifying the relative safety of medications used during pregnancy.² Many clinicians and pregnant women relied on this system to decide which medications were safe. Unfortunately, the information in the system was inadequate for making informed decisions. For example, although a class B medication might have appeared safer than one in class C, the studies of risk in humans might not have been adequate to permit comparisons. Drug safety classifications were seldom changed, despite the availability of additional data.

In June 2015, the FDA changed the requirements for the Pregnancy and Lactation subsections of the labeling for human prescription drugs and biologic products. Drug manufacturers must now include in each subsection a risk summary, clinical considerations supporting patient care decisions and counseling, and detailed data. These subsections provide information on available human and animal studies, known or potential maternal or fetal adverse reactions, and dose adjustments needed during pregnancy and the postpartum period. In addition, the FDA added a subsection: Females and Males of Reproductive Potential.³

These changes acknowledge there is no list of “safe” medications. The safest medication generally is the one that works for a particular patient at the lowest effective dose. As each woman’s history of illness and effective treatment is different, the best medication may differ as well, even among women with the same illness. Therefore, medication should be individualized to the patient. A risk–benefit analysis comparing psychotropic medication treatment with no medication treatment must be performed for each patient according to her personal history and the best available data.

Read about the risks of untreated illness during pregnancy

What is the risk of untreated illness during pregnancy?

During pregnancy, women are treated for many medical disorders, including psychiatric illness. One general guideline is that, if a pregnant woman does not need a medication—whether it be for an allergy, hypertension, or another disorder—she should not take it. Conversely, if a medication is required for a patient’s well-being, her physician should continue it or switch to a safer one. This general guideline is the same for women with depression, anxiety, or a psychotic disorder.

Managing hypertension during pregnancy is an example of choosing treatment when the risk of the illness to the mother and the infant outweighs the likely small risk associated with taking a medication. Blood pressure is monitored, and, when it reaches a threshold, an antihypertensive is started promptly to avoid morbidity and mortality.

Psychiatric illness carries risks for both mother and fetus as well, but no data show a clear threshold for initiating pharmacologic treatment. Therefore, in prescribing medication the most important steps are to take a complete history and perform a thorough evaluation. Important information includes the number and severity of previous episodes, prior history of hospitalization or suicidal thoughts or attempts, and any history of psychotic or manic status.

Whether to continue or discontinue medication is often decided after inquiring about other times a medication was discontinued. A patient who in the past stayed well for several years after stopping a medication may be able to taper off a medication and conceive during a window of wellness. Some women who have experienced only one episode of illness and have been stable for at least a year may be able to taper off a medication before conceiving (TABLE 1).

In the risk–benefit analysis, assess the need for pharmacologic treatment by considering the risk that untreated illness poses for both mother and fetus, the benefits of treatment for both, and the risk of medication exposure for the fetus.⁴

Mother: Risk of untreated illness versus benefit of treatment

A complete history and a current symptom evaluation are needed to assess the risk that nonpharmacologic treatment poses for the mother. Women with functional impairment, including inability to work, to perform activities of daily living, or to take care of other children, likely require treatment. Studies have found that women who discontinue treatment for a psychiatric illness around the time of conception are likely to experience a recurrence of illness during pregnancy, often in the first trimester, and must restart medication.^5,6 For some diagnoses, particularly bipolar disorder, symptoms during a relapse can be more severe and more difficult to treat, and they carry a risk for both mother and fetus.⁷ A longitudinal study of pregnant women who stopped medication for bipolar disorder found a 71% rate of relapse.⁷ In cases in which there is a history of hospitalization, suicide attempt, or psychosis, discontinuing treatment is not an option; instead, the physician must determine which medication is safest for the particular patient.

Related article:
Does PTSD during pregnancy increase the likelihood of preterm birth?

Fetus: Risk of untreated illness versus benefit of treatment

Mothers with untreated psychiatric illness are at higher risk for poor prenatal care, substance abuse, and inadequate nutrition, all of which increase the risk of negative obstetric and neonatal outcomes.⁸ Evidence indicates that untreated maternal depression increases the risk of preterm delivery and low birth weight.⁹ Children born to mothers with depression have more behavioral problems, more psychiatric illness, more visits to pediatricians, lower IQ scores, and attachment issues.¹⁰ Some of the long-term negative effects of intrauterine stress, which include hypertension, coronary heart disease, and autoimmune disorders, persist into adulthood.¹¹

Fetus: Risk of medication exposure

With any pharmacologic treatment, the timing of fetal exposure affects resultant risks and therefore must be considered in the management plan.

Before conception. Is there any effect on ovulation or fertilization?

Implantation. Does the exposure impair the blastocyst’s ability to implant in the uterine lining?

First trimester. This is the period of organogenesis. Regardless of drug exposure, there is a 2% to 4% baseline risk of a major malformation during any pregnancy. The risk of a particular malformation must be weighed against this baseline risk.

According to limited data, selective serotonin reuptake inhibitors (SSRIs) may increase the risk of early miscarriage.¹² SSRIs also have been implicated in increasing the risk of cardiovascular malformations, although the data are conflicting.^13,14

Antiepileptics such as valproate and carbamazepine are used as mood stabilizers in the treatment of bipolar disorder.¹⁵ Extensive data have shown an association with teratogenicity. Pregnant women who require either of these medications also should be prescribed folic acid 4 or 5 mg/day. Given the high risk of birth defects and cognitive delay, valproate no longer is recommended for women of reproductive potential.¹⁶

Lithium, one of the safest medications used in the treatment of bipolar disorder, is associated with a very small risk of Ebstein anomaly.¹⁷

Lamotrigine is used to treat bipolar depression and appears to have a good safety profile, along with a possible small increased risk of oral clefts.^18,19

Atypical antipsychotics (such as aripiprazole, olanzapine, quetiapine, and risperidone) are often used first-line in the treatment of psychotic disorders and bipolar disorder in women who are not pregnant. Although the safety data on use of these drugs during pregnancy are limited, a recent analysis of pregnant Medicaid enrollees found no increased risk of birth defects after controlling for potential confounding factors.²⁰ Common practice is to avoid these newer agents, given their limited data and the time needed for rare malformations to emerge (adequate numbers require many exposures during pregnancy).

Read additional fetal risks of medication exposure

Second trimester. This is a period of growth and neural development. A 2006 study suggested that SSRI exposure after pregnancy week 20 increases the risk of persistent pulmonary hypertension of the newborn (PPHN).²¹ In 2011, however, the FDA removed the PPHN warning label for SSRIs, citing inconsistent data. Whether the PPHN risk is increased with SSRI use is unclear, but the risk is presumed to be smaller than previously suggested.²² Stopping SSRIs before week 20 puts the mother at risk for relapse during pregnancy and increases her risk of developing postpartum depression. If we follow the recommendation to prescribe medication only for women who need it most, then stopping the medication at any time during pregnancy is not an option.

Third trimester. This is a period of continued growth and lung maturation.

Delivery. Is there a potential for impairment in parturition?

Neonatal adaptation. Newborns are active mainly in adapting to extrauterine life: They regulate their temperature and muscle tone and learn to coordinate sucking, swallowing, and breathing. Does medication exposure impair adaptation, or are signs or symptoms of withdrawal or toxicity present? The evidence that in utero SSRI exposure increases the risk of neonatal adaptation syndrome is consistent, but symptoms are mild and self-limited.²³ Tapering off SSRIs before delivery currently is not recommended, as doing so increases the mother’s risk for postpartum depression and, according to one study, does not prevent symptoms of neonatal adaptation syndrome from developing.²⁴

Behavioral teratogenicity. What are the long-term developmental outcomes for the child? Are there any differences in IQ, speech and language, or psychiatric illness? One study found an increased risk of autism with in utero exposure to sertraline, but the study had many methodologic flaws and its findings have not been replicated.²⁵ Most studies have not found consistent differences in speech, IQ, or behavior between infants exposed and infants not exposed to antidepressants.^26,27 By contrast, in utero exposure to anticonvulsants, particularly valproate, has led to significant developmental problems in children.²⁸ The data on atypical antipsychotics are limited.

Related article:
Do antidepressants really cause autism?
 

None of the medications used to treat depression, bipolar disorder, anxiety, or schizophrenia is considered first-line or safest therapy for the pregnant woman. For any woman who is doing well on a certain medication, but particularly for a pregnant woman, there is no compelling, data-supported reason to switch to another agent. For depression, options include all of the SSRIs, with the possible exception of paroxetine (TABLE 2). In conflicting studies, paroxetine was no different from any other SSRI in not being associated with cardiovascular defects.²⁹

One goal in treatment is to use a medication that previously was effective in the remission of symptoms and to use it at the lowest dose possible. Treating simply to maintain a low dose of drug, however, and not to effect symptom remission, exposes the fetus to both the drug and the illness. Again, the lowest effective dose is the best choice.

Read about treatment during breastfeeding

Treatment during breastfeeding

Women are encouraged to breastfeed for physical and psychological health benefits, for both themselves and their babies. Many medications are compatible with breastfeeding.³⁰ The amount of drug an infant receives through breast milk is considerably less than the amount received during the mother’s pregnancy. Breastfeeding generally is allowed if the calculated infant dose is less than 10% of the weight-adjusted maternal dose.³¹

The amount of drug transferred from maternal plasma into milk is highest for drugs with low protein binding and high lipid solubility.³² Drug clearance in infants must be considered as well. Renal clearance is decreased in newborns and does not reach adult levels until 5 or 6 months of age. In addition, liver metabolism is impaired in neonates and even more so in premature infants.³³ Drugs that require extensive first-pass metabolism may have higher bioavailability, and this factor should be considered.

Some clinicians recommend pumping and discarding breast milk when the drug in it is at its peak level; although the drug is not eliminated, the infant ingests less of it.³⁴ Most women who are anxious about breastfeeding while on medication “pump and dump” until they are more comfortable nursing and the infants are doing well. Except in cases of mother preference, most physicians with expertise in reproductive mental health generally recommend against pumping and discarding milk.

Through breast milk, infants ingest drugs in varying amounts. The amount depends on the qualities of the medication, the timing and duration of breastfeeding, and the characteristics of the infant. Few psychotropic drugs have significant effects on breastfed infants. Even lithium, previously contraindicated, is successfully used, with infant monitoring, during breastfeeding.³⁵ Given breastfeeding’s benefits for both mother and child, many more women on psychotropic medications are choosing to breastfeed.

Related article:
USPSTF Recommendations to Support Breastfeeding

Balance the pros and cons

Deciding to use medication during pregnancy and breastfeeding involves considering the risk of untreated illness versus the benefit of treatment for both mother and fetus, and the risk of medication exposure for the fetus. Mother and fetus are inseparable, and neither can be isolated from the other in treatment decisions. Avoiding psychotropic medication during pregnancy is not always the safest option for mother or fetus. The patient and her clinician and support system must make an informed decision that is based on the best available data and that takes into account the mother’s history of illness and effective treatment. Many women with psychiatric illness no longer have to choose between mental health and starting a family, and their babies will be healthy.

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.

Increasingly, women with psychiatric illness are undergoing pharmacologic treatment during pregnancy. In the United States, an estimated 8% of pregnant women are prescribed antidepressants, and the number of such cases has risen over the past 15 years.¹ Women with a psychiatric diagnosis were once instructed either to discontinue all medication immediately on learning they were pregnant, or to forgo motherhood because their illness might have a negative effect on a child or because avoiding medication during pregnancy might lead to a relapse.

Fortunately, women with depression, anxiety, bipolar disorder, or schizophrenia no longer are being told that they cannot become mothers. For many women, however, stopping medication is not an option. Furthermore, psychiatric illness sometimes is diagnosed initially during pregnancy and requires treatment.

Illustration: Kimberly Martens for OBG Management

Pregnant women and their physicians need accurate information about when to taper off medication, when to start or continue, and which medications are safest. Even for clinicians with a solid knowledge base, counseling a woman who needs or may need psychotropic medication during pregnancy and breastfeeding is a daunting task. Some clinicians still recommend no drug treatment as the safest and best option, given the potential risks to the fetus.

In this review we offer a methodologic approach for decision making about pharmacologic treatment during pregnancy. As the scientific literature is constantly being updated, it is imperative to have the most current information on psychotropics and to know how to individualize that information when counseling a pregnant woman and her family. Using this framework for analyzing the risks and benefits for both mother and fetus, clinicians can avoid the unanswerable question of which medication is the “safest.”

A patient’s mental health care provider is a useful resource for information about a woman’s mental health history and current stability, but he or she may not be expert or comfortable in recommending treatment for a pregnant patient. During pregnancy, a woman’s obstetrician often becomes the “expert” for all treatment decisions.

Analyze risks and benefits of medication versus no medication

The US Food and Drug Administration (FDA) has not approved any psychotropic medication for use during pregnancy. While a clinical study would provide more scientifically rigorous safety data, conducting a double-blinded, placebo-controlled trial in pregnant women with a psychiatric disorder is unethical. Thus, the literature consists mostly of reports on case series, retrospective chart reviews, prospective naturalistic studies, and analyses of large registry databases. Each has benefits and limitations. It is important to understand the limitations when making treatment decisions.

In 1979, the FDA developed a 5-lettersystem (A, B, C, D, X) for classifying the relative safety of medications used during pregnancy.² Many clinicians and pregnant women relied on this system to decide which medications were safe. Unfortunately, the information in the system was inadequate for making informed decisions. For example, although a class B medication might have appeared safer than one in class C, the studies of risk in humans might not have been adequate to permit comparisons. Drug safety classifications were seldom changed, despite the availability of additional data.

In June 2015, the FDA changed the requirements for the Pregnancy and Lactation subsections of the labeling for human prescription drugs and biologic products. Drug manufacturers must now include in each subsection a risk summary, clinical considerations supporting patient care decisions and counseling, and detailed data. These subsections provide information on available human and animal studies, known or potential maternal or fetal adverse reactions, and dose adjustments needed during pregnancy and the postpartum period. In addition, the FDA added a subsection: Females and Males of Reproductive Potential.³

These changes acknowledge there is no list of “safe” medications. The safest medication generally is the one that works for a particular patient at the lowest effective dose. As each woman’s history of illness and effective treatment is different, the best medication may differ as well, even among women with the same illness. Therefore, medication should be individualized to the patient. A risk–benefit analysis comparing psychotropic medication treatment with no medication treatment must be performed for each patient according to her personal history and the best available data.

Read about the risks of untreated illness during pregnancy

What is the risk of untreated illness during pregnancy?

During pregnancy, women are treated for many medical disorders, including psychiatric illness. One general guideline is that, if a pregnant woman does not need a medication—whether it be for an allergy, hypertension, or another disorder—she should not take it. Conversely, if a medication is required for a patient’s well-being, her physician should continue it or switch to a safer one. This general guideline is the same for women with depression, anxiety, or a psychotic disorder.

Managing hypertension during pregnancy is an example of choosing treatment when the risk of the illness to the mother and the infant outweighs the likely small risk associated with taking a medication. Blood pressure is monitored, and, when it reaches a threshold, an antihypertensive is started promptly to avoid morbidity and mortality.

Psychiatric illness carries risks for both mother and fetus as well, but no data show a clear threshold for initiating pharmacologic treatment. Therefore, in prescribing medication the most important steps are to take a complete history and perform a thorough evaluation. Important information includes the number and severity of previous episodes, prior history of hospitalization or suicidal thoughts or attempts, and any history of psychotic or manic status.

Whether to continue or discontinue medication is often decided after inquiring about other times a medication was discontinued. A patient who in the past stayed well for several years after stopping a medication may be able to taper off a medication and conceive during a window of wellness. Some women who have experienced only one episode of illness and have been stable for at least a year may be able to taper off a medication before conceiving (TABLE 1).

In the risk–benefit analysis, assess the need for pharmacologic treatment by considering the risk that untreated illness poses for both mother and fetus, the benefits of treatment for both, and the risk of medication exposure for the fetus.⁴

Mother: Risk of untreated illness versus benefit of treatment

A complete history and a current symptom evaluation are needed to assess the risk that nonpharmacologic treatment poses for the mother. Women with functional impairment, including inability to work, to perform activities of daily living, or to take care of other children, likely require treatment. Studies have found that women who discontinue treatment for a psychiatric illness around the time of conception are likely to experience a recurrence of illness during pregnancy, often in the first trimester, and must restart medication.^5,6 For some diagnoses, particularly bipolar disorder, symptoms during a relapse can be more severe and more difficult to treat, and they carry a risk for both mother and fetus.⁷ A longitudinal study of pregnant women who stopped medication for bipolar disorder found a 71% rate of relapse.⁷ In cases in which there is a history of hospitalization, suicide attempt, or psychosis, discontinuing treatment is not an option; instead, the physician must determine which medication is safest for the particular patient.

Related article:
Does PTSD during pregnancy increase the likelihood of preterm birth?

Fetus: Risk of untreated illness versus benefit of treatment

Mothers with untreated psychiatric illness are at higher risk for poor prenatal care, substance abuse, and inadequate nutrition, all of which increase the risk of negative obstetric and neonatal outcomes.⁸ Evidence indicates that untreated maternal depression increases the risk of preterm delivery and low birth weight.⁹ Children born to mothers with depression have more behavioral problems, more psychiatric illness, more visits to pediatricians, lower IQ scores, and attachment issues.¹⁰ Some of the long-term negative effects of intrauterine stress, which include hypertension, coronary heart disease, and autoimmune disorders, persist into adulthood.¹¹

Fetus: Risk of medication exposure

With any pharmacologic treatment, the timing of fetal exposure affects resultant risks and therefore must be considered in the management plan.

Before conception. Is there any effect on ovulation or fertilization?

Implantation. Does the exposure impair the blastocyst’s ability to implant in the uterine lining?

First trimester. This is the period of organogenesis. Regardless of drug exposure, there is a 2% to 4% baseline risk of a major malformation during any pregnancy. The risk of a particular malformation must be weighed against this baseline risk.

According to limited data, selective serotonin reuptake inhibitors (SSRIs) may increase the risk of early miscarriage.¹² SSRIs also have been implicated in increasing the risk of cardiovascular malformations, although the data are conflicting.^13,14

Antiepileptics such as valproate and carbamazepine are used as mood stabilizers in the treatment of bipolar disorder.¹⁵ Extensive data have shown an association with teratogenicity. Pregnant women who require either of these medications also should be prescribed folic acid 4 or 5 mg/day. Given the high risk of birth defects and cognitive delay, valproate no longer is recommended for women of reproductive potential.¹⁶

Lithium, one of the safest medications used in the treatment of bipolar disorder, is associated with a very small risk of Ebstein anomaly.¹⁷

Lamotrigine is used to treat bipolar depression and appears to have a good safety profile, along with a possible small increased risk of oral clefts.^18,19

Atypical antipsychotics (such as aripiprazole, olanzapine, quetiapine, and risperidone) are often used first-line in the treatment of psychotic disorders and bipolar disorder in women who are not pregnant. Although the safety data on use of these drugs during pregnancy are limited, a recent analysis of pregnant Medicaid enrollees found no increased risk of birth defects after controlling for potential confounding factors.²⁰ Common practice is to avoid these newer agents, given their limited data and the time needed for rare malformations to emerge (adequate numbers require many exposures during pregnancy).

Read additional fetal risks of medication exposure

Second trimester. This is a period of growth and neural development. A 2006 study suggested that SSRI exposure after pregnancy week 20 increases the risk of persistent pulmonary hypertension of the newborn (PPHN).²¹ In 2011, however, the FDA removed the PPHN warning label for SSRIs, citing inconsistent data. Whether the PPHN risk is increased with SSRI use is unclear, but the risk is presumed to be smaller than previously suggested.²² Stopping SSRIs before week 20 puts the mother at risk for relapse during pregnancy and increases her risk of developing postpartum depression. If we follow the recommendation to prescribe medication only for women who need it most, then stopping the medication at any time during pregnancy is not an option.

Third trimester. This is a period of continued growth and lung maturation.

Delivery. Is there a potential for impairment in parturition?

Neonatal adaptation. Newborns are active mainly in adapting to extrauterine life: They regulate their temperature and muscle tone and learn to coordinate sucking, swallowing, and breathing. Does medication exposure impair adaptation, or are signs or symptoms of withdrawal or toxicity present? The evidence that in utero SSRI exposure increases the risk of neonatal adaptation syndrome is consistent, but symptoms are mild and self-limited.²³ Tapering off SSRIs before delivery currently is not recommended, as doing so increases the mother’s risk for postpartum depression and, according to one study, does not prevent symptoms of neonatal adaptation syndrome from developing.²⁴

Behavioral teratogenicity. What are the long-term developmental outcomes for the child? Are there any differences in IQ, speech and language, or psychiatric illness? One study found an increased risk of autism with in utero exposure to sertraline, but the study had many methodologic flaws and its findings have not been replicated.²⁵ Most studies have not found consistent differences in speech, IQ, or behavior between infants exposed and infants not exposed to antidepressants.^26,27 By contrast, in utero exposure to anticonvulsants, particularly valproate, has led to significant developmental problems in children.²⁸ The data on atypical antipsychotics are limited.

Related article:
Do antidepressants really cause autism?
 

None of the medications used to treat depression, bipolar disorder, anxiety, or schizophrenia is considered first-line or safest therapy for the pregnant woman. For any woman who is doing well on a certain medication, but particularly for a pregnant woman, there is no compelling, data-supported reason to switch to another agent. For depression, options include all of the SSRIs, with the possible exception of paroxetine (TABLE 2). In conflicting studies, paroxetine was no different from any other SSRI in not being associated with cardiovascular defects.²⁹

One goal in treatment is to use a medication that previously was effective in the remission of symptoms and to use it at the lowest dose possible. Treating simply to maintain a low dose of drug, however, and not to effect symptom remission, exposes the fetus to both the drug and the illness. Again, the lowest effective dose is the best choice.

Read about treatment during breastfeeding

Treatment during breastfeeding

Women are encouraged to breastfeed for physical and psychological health benefits, for both themselves and their babies. Many medications are compatible with breastfeeding.³⁰ The amount of drug an infant receives through breast milk is considerably less than the amount received during the mother’s pregnancy. Breastfeeding generally is allowed if the calculated infant dose is less than 10% of the weight-adjusted maternal dose.³¹

The amount of drug transferred from maternal plasma into milk is highest for drugs with low protein binding and high lipid solubility.³² Drug clearance in infants must be considered as well. Renal clearance is decreased in newborns and does not reach adult levels until 5 or 6 months of age. In addition, liver metabolism is impaired in neonates and even more so in premature infants.³³ Drugs that require extensive first-pass metabolism may have higher bioavailability, and this factor should be considered.

Some clinicians recommend pumping and discarding breast milk when the drug in it is at its peak level; although the drug is not eliminated, the infant ingests less of it.³⁴ Most women who are anxious about breastfeeding while on medication “pump and dump” until they are more comfortable nursing and the infants are doing well. Except in cases of mother preference, most physicians with expertise in reproductive mental health generally recommend against pumping and discarding milk.

Through breast milk, infants ingest drugs in varying amounts. The amount depends on the qualities of the medication, the timing and duration of breastfeeding, and the characteristics of the infant. Few psychotropic drugs have significant effects on breastfed infants. Even lithium, previously contraindicated, is successfully used, with infant monitoring, during breastfeeding.³⁵ Given breastfeeding’s benefits for both mother and child, many more women on psychotropic medications are choosing to breastfeed.

Related article:
USPSTF Recommendations to Support Breastfeeding

Balance the pros and cons

Deciding to use medication during pregnancy and breastfeeding involves considering the risk of untreated illness versus the benefit of treatment for both mother and fetus, and the risk of medication exposure for the fetus. Mother and fetus are inseparable, and neither can be isolated from the other in treatment decisions. Avoiding psychotropic medication during pregnancy is not always the safest option for mother or fetus. The patient and her clinician and support system must make an informed decision that is based on the best available data and that takes into account the mother’s history of illness and effective treatment. Many women with psychiatric illness no longer have to choose between mental health and starting a family, and their babies will be healthy.

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.

Increasingly, women with psychiatric illness are undergoing pharmacologic treatment during pregnancy. In the United States, an estimated 8% of pregnant women are prescribed antidepressants, and the number of such cases has risen over the past 15 years.¹ Women with a psychiatric diagnosis were once instructed either to discontinue all medication immediately on learning they were pregnant, or to forgo motherhood because their illness might have a negative effect on a child or because avoiding medication during pregnancy might lead to a relapse.

Fortunately, women with depression, anxiety, bipolar disorder, or schizophrenia no longer are being told that they cannot become mothers. For many women, however, stopping medication is not an option. Furthermore, psychiatric illness sometimes is diagnosed initially during pregnancy and requires treatment.

Illustration: Kimberly Martens for OBG Management

Pregnant women and their physicians need accurate information about when to taper off medication, when to start or continue, and which medications are safest. Even for clinicians with a solid knowledge base, counseling a woman who needs or may need psychotropic medication during pregnancy and breastfeeding is a daunting task. Some clinicians still recommend no drug treatment as the safest and best option, given the potential risks to the fetus.

In this review we offer a methodologic approach for decision making about pharmacologic treatment during pregnancy. As the scientific literature is constantly being updated, it is imperative to have the most current information on psychotropics and to know how to individualize that information when counseling a pregnant woman and her family. Using this framework for analyzing the risks and benefits for both mother and fetus, clinicians can avoid the unanswerable question of which medication is the “safest.”

A patient’s mental health care provider is a useful resource for information about a woman’s mental health history and current stability, but he or she may not be expert or comfortable in recommending treatment for a pregnant patient. During pregnancy, a woman’s obstetrician often becomes the “expert” for all treatment decisions.

Analyze risks and benefits of medication versus no medication

The US Food and Drug Administration (FDA) has not approved any psychotropic medication for use during pregnancy. While a clinical study would provide more scientifically rigorous safety data, conducting a double-blinded, placebo-controlled trial in pregnant women with a psychiatric disorder is unethical. Thus, the literature consists mostly of reports on case series, retrospective chart reviews, prospective naturalistic studies, and analyses of large registry databases. Each has benefits and limitations. It is important to understand the limitations when making treatment decisions.

In 1979, the FDA developed a 5-lettersystem (A, B, C, D, X) for classifying the relative safety of medications used during pregnancy.² Many clinicians and pregnant women relied on this system to decide which medications were safe. Unfortunately, the information in the system was inadequate for making informed decisions. For example, although a class B medication might have appeared safer than one in class C, the studies of risk in humans might not have been adequate to permit comparisons. Drug safety classifications were seldom changed, despite the availability of additional data.

In June 2015, the FDA changed the requirements for the Pregnancy and Lactation subsections of the labeling for human prescription drugs and biologic products. Drug manufacturers must now include in each subsection a risk summary, clinical considerations supporting patient care decisions and counseling, and detailed data. These subsections provide information on available human and animal studies, known or potential maternal or fetal adverse reactions, and dose adjustments needed during pregnancy and the postpartum period. In addition, the FDA added a subsection: Females and Males of Reproductive Potential.³

These changes acknowledge there is no list of “safe” medications. The safest medication generally is the one that works for a particular patient at the lowest effective dose. As each woman’s history of illness and effective treatment is different, the best medication may differ as well, even among women with the same illness. Therefore, medication should be individualized to the patient. A risk–benefit analysis comparing psychotropic medication treatment with no medication treatment must be performed for each patient according to her personal history and the best available data.

Read about the risks of untreated illness during pregnancy

What is the risk of untreated illness during pregnancy?

During pregnancy, women are treated for many medical disorders, including psychiatric illness. One general guideline is that, if a pregnant woman does not need a medication—whether it be for an allergy, hypertension, or another disorder—she should not take it. Conversely, if a medication is required for a patient’s well-being, her physician should continue it or switch to a safer one. This general guideline is the same for women with depression, anxiety, or a psychotic disorder.

Managing hypertension during pregnancy is an example of choosing treatment when the risk of the illness to the mother and the infant outweighs the likely small risk associated with taking a medication. Blood pressure is monitored, and, when it reaches a threshold, an antihypertensive is started promptly to avoid morbidity and mortality.

Psychiatric illness carries risks for both mother and fetus as well, but no data show a clear threshold for initiating pharmacologic treatment. Therefore, in prescribing medication the most important steps are to take a complete history and perform a thorough evaluation. Important information includes the number and severity of previous episodes, prior history of hospitalization or suicidal thoughts or attempts, and any history of psychotic or manic status.

Whether to continue or discontinue medication is often decided after inquiring about other times a medication was discontinued. A patient who in the past stayed well for several years after stopping a medication may be able to taper off a medication and conceive during a window of wellness. Some women who have experienced only one episode of illness and have been stable for at least a year may be able to taper off a medication before conceiving (TABLE 1).

In the risk–benefit analysis, assess the need for pharmacologic treatment by considering the risk that untreated illness poses for both mother and fetus, the benefits of treatment for both, and the risk of medication exposure for the fetus.⁴

Mother: Risk of untreated illness versus benefit of treatment

A complete history and a current symptom evaluation are needed to assess the risk that nonpharmacologic treatment poses for the mother. Women with functional impairment, including inability to work, to perform activities of daily living, or to take care of other children, likely require treatment. Studies have found that women who discontinue treatment for a psychiatric illness around the time of conception are likely to experience a recurrence of illness during pregnancy, often in the first trimester, and must restart medication.^5,6 For some diagnoses, particularly bipolar disorder, symptoms during a relapse can be more severe and more difficult to treat, and they carry a risk for both mother and fetus.⁷ A longitudinal study of pregnant women who stopped medication for bipolar disorder found a 71% rate of relapse.⁷ In cases in which there is a history of hospitalization, suicide attempt, or psychosis, discontinuing treatment is not an option; instead, the physician must determine which medication is safest for the particular patient.

Related article:
Does PTSD during pregnancy increase the likelihood of preterm birth?

Fetus: Risk of untreated illness versus benefit of treatment

Mothers with untreated psychiatric illness are at higher risk for poor prenatal care, substance abuse, and inadequate nutrition, all of which increase the risk of negative obstetric and neonatal outcomes.⁸ Evidence indicates that untreated maternal depression increases the risk of preterm delivery and low birth weight.⁹ Children born to mothers with depression have more behavioral problems, more psychiatric illness, more visits to pediatricians, lower IQ scores, and attachment issues.¹⁰ Some of the long-term negative effects of intrauterine stress, which include hypertension, coronary heart disease, and autoimmune disorders, persist into adulthood.¹¹

Fetus: Risk of medication exposure

With any pharmacologic treatment, the timing of fetal exposure affects resultant risks and therefore must be considered in the management plan.

Before conception. Is there any effect on ovulation or fertilization?

Implantation. Does the exposure impair the blastocyst’s ability to implant in the uterine lining?

First trimester. This is the period of organogenesis. Regardless of drug exposure, there is a 2% to 4% baseline risk of a major malformation during any pregnancy. The risk of a particular malformation must be weighed against this baseline risk.

According to limited data, selective serotonin reuptake inhibitors (SSRIs) may increase the risk of early miscarriage.¹² SSRIs also have been implicated in increasing the risk of cardiovascular malformations, although the data are conflicting.^13,14

Antiepileptics such as valproate and carbamazepine are used as mood stabilizers in the treatment of bipolar disorder.¹⁵ Extensive data have shown an association with teratogenicity. Pregnant women who require either of these medications also should be prescribed folic acid 4 or 5 mg/day. Given the high risk of birth defects and cognitive delay, valproate no longer is recommended for women of reproductive potential.¹⁶

Lithium, one of the safest medications used in the treatment of bipolar disorder, is associated with a very small risk of Ebstein anomaly.¹⁷

Lamotrigine is used to treat bipolar depression and appears to have a good safety profile, along with a possible small increased risk of oral clefts.^18,19

Atypical antipsychotics (such as aripiprazole, olanzapine, quetiapine, and risperidone) are often used first-line in the treatment of psychotic disorders and bipolar disorder in women who are not pregnant. Although the safety data on use of these drugs during pregnancy are limited, a recent analysis of pregnant Medicaid enrollees found no increased risk of birth defects after controlling for potential confounding factors.²⁰ Common practice is to avoid these newer agents, given their limited data and the time needed for rare malformations to emerge (adequate numbers require many exposures during pregnancy).

Read additional fetal risks of medication exposure

Second trimester. This is a period of growth and neural development. A 2006 study suggested that SSRI exposure after pregnancy week 20 increases the risk of persistent pulmonary hypertension of the newborn (PPHN).²¹ In 2011, however, the FDA removed the PPHN warning label for SSRIs, citing inconsistent data. Whether the PPHN risk is increased with SSRI use is unclear, but the risk is presumed to be smaller than previously suggested.²² Stopping SSRIs before week 20 puts the mother at risk for relapse during pregnancy and increases her risk of developing postpartum depression. If we follow the recommendation to prescribe medication only for women who need it most, then stopping the medication at any time during pregnancy is not an option.

Third trimester. This is a period of continued growth and lung maturation.

Delivery. Is there a potential for impairment in parturition?

Neonatal adaptation. Newborns are active mainly in adapting to extrauterine life: They regulate their temperature and muscle tone and learn to coordinate sucking, swallowing, and breathing. Does medication exposure impair adaptation, or are signs or symptoms of withdrawal or toxicity present? The evidence that in utero SSRI exposure increases the risk of neonatal adaptation syndrome is consistent, but symptoms are mild and self-limited.²³ Tapering off SSRIs before delivery currently is not recommended, as doing so increases the mother’s risk for postpartum depression and, according to one study, does not prevent symptoms of neonatal adaptation syndrome from developing.²⁴

Behavioral teratogenicity. What are the long-term developmental outcomes for the child? Are there any differences in IQ, speech and language, or psychiatric illness? One study found an increased risk of autism with in utero exposure to sertraline, but the study had many methodologic flaws and its findings have not been replicated.²⁵ Most studies have not found consistent differences in speech, IQ, or behavior between infants exposed and infants not exposed to antidepressants.^26,27 By contrast, in utero exposure to anticonvulsants, particularly valproate, has led to significant developmental problems in children.²⁸ The data on atypical antipsychotics are limited.

Related article:
Do antidepressants really cause autism?
 

None of the medications used to treat depression, bipolar disorder, anxiety, or schizophrenia is considered first-line or safest therapy for the pregnant woman. For any woman who is doing well on a certain medication, but particularly for a pregnant woman, there is no compelling, data-supported reason to switch to another agent. For depression, options include all of the SSRIs, with the possible exception of paroxetine (TABLE 2). In conflicting studies, paroxetine was no different from any other SSRI in not being associated with cardiovascular defects.²⁹

One goal in treatment is to use a medication that previously was effective in the remission of symptoms and to use it at the lowest dose possible. Treating simply to maintain a low dose of drug, however, and not to effect symptom remission, exposes the fetus to both the drug and the illness. Again, the lowest effective dose is the best choice.

Read about treatment during breastfeeding

Treatment during breastfeeding

Women are encouraged to breastfeed for physical and psychological health benefits, for both themselves and their babies. Many medications are compatible with breastfeeding.³⁰ The amount of drug an infant receives through breast milk is considerably less than the amount received during the mother’s pregnancy. Breastfeeding generally is allowed if the calculated infant dose is less than 10% of the weight-adjusted maternal dose.³¹

The amount of drug transferred from maternal plasma into milk is highest for drugs with low protein binding and high lipid solubility.³² Drug clearance in infants must be considered as well. Renal clearance is decreased in newborns and does not reach adult levels until 5 or 6 months of age. In addition, liver metabolism is impaired in neonates and even more so in premature infants.³³ Drugs that require extensive first-pass metabolism may have higher bioavailability, and this factor should be considered.

Some clinicians recommend pumping and discarding breast milk when the drug in it is at its peak level; although the drug is not eliminated, the infant ingests less of it.³⁴ Most women who are anxious about breastfeeding while on medication “pump and dump” until they are more comfortable nursing and the infants are doing well. Except in cases of mother preference, most physicians with expertise in reproductive mental health generally recommend against pumping and discarding milk.

Through breast milk, infants ingest drugs in varying amounts. The amount depends on the qualities of the medication, the timing and duration of breastfeeding, and the characteristics of the infant. Few psychotropic drugs have significant effects on breastfed infants. Even lithium, previously contraindicated, is successfully used, with infant monitoring, during breastfeeding.³⁵ Given breastfeeding’s benefits for both mother and child, many more women on psychotropic medications are choosing to breastfeed.

Related article:
USPSTF Recommendations to Support Breastfeeding

Balance the pros and cons

Deciding to use medication during pregnancy and breastfeeding involves considering the risk of untreated illness versus the benefit of treatment for both mother and fetus, and the risk of medication exposure for the fetus. Mother and fetus are inseparable, and neither can be isolated from the other in treatment decisions. Avoiding psychotropic medication during pregnancy is not always the safest option for mother or fetus. The patient and her clinician and support system must make an informed decision that is based on the best available data and that takes into account the mother’s history of illness and effective treatment. Many women with psychiatric illness no longer have to choose between mental health and starting a family, and their babies will be healthy.

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.

More than 44 million pelvic examinations are performed annually in the United States.¹ In March 2017, the United States Preventive Services Task Force (USPSTF) published an updated recommendation statement regarding the need for routine screening pelvic examinations in asymptomatic adult women (18 years and older) receiving primary care: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of performing screening pelvic examinations in asymptomatic, nonpregnant adult women.”²

That statement, however, was assigned a grade of I, which means that evidence is lacking, of poor quality, or conflicting, and that the balance of benefits and harms cannot be determined. This USPSTF recommendation statement thus will not change practice for ObGyn providers but likely will renew our commitment to provide individualized well-woman care. There was inadequate or poor quality evidence for benefits related to all-cause mortality, disease-specific morbidity, and quality of life, as well as inadequate evidence on harms related to false-positive findings and anxiety stemming from screening pelvic exams.

Read about coding and billing for a standard pelvic exam

The pelvic examination and insurance coverage

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Melanie Witt, RN, MA

Coding and billing for the care provided at a well-woman visit can be uncomplicated if you know the right codes for the right program. The information presented here concerns straightforward preventive care and assumes that the patient also has not presented with a significant problem at the same visit.

First, a patient who is not Medicare-eligible might have insurance coverage for an annual preventive care examination every year. Normally, this service would be billed using the Current Procedural Terminology (CPT) preventive medicine codes, but some insurers require the use of special codes for an annual gynecologic exam. These special codes are:

• S0610, Annual gynecological examination, new patient
• S0612, Annual gynecological examination, established patient
• S0613, Annual gynecological examination; clinical breast examination without pelvic evaluation.

Notably, Aetna, Cigna, and UnitedHealthcare require these codes to signify that a pelvic examination has been performed (except for code S0613), but many Blue Cross Blue Shield programs, for whom these codes were originally created, are now reverting to the CPT preventive medicine codes for all preventive care.

CPT outlines the requirements for use of the preventive medicine codes as: an initial or periodic comprehensive preventive medicine evaluation or reevaluation and management (E/M) service, which includes an age- and gender-appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, and the ordering of laboratory/diagnostic procedures. The codes are divided into new or established patient categories by age range as follows:

The Medicare E/M documentation guidelines do not apply to preventive services, and a head-to-toe examination also is not required. CPT recognizes the American College of Obstetricians and Gynecologists (ACOG) as an authoritative body to make recommendations for the expected preventive service for women, and if such a service is provided and documented, the preventive care codes are to be reported. The payers who use the S codes for a gynecologic exam will require that a pelvic examination has been performed, but such an examination would not be required when using the CPT codes or ACOG's guidelines if the physician and patient agreed that such an exam was not warranted every year. The other components of a preventive service applicable to the female patient's age, however, should be documented in order to report the CPT codes for preventive medicine services.

If a pelvic examination is not performed, say because the patient is young and not sexually active, but an examination of other areas is carried out, the diagnosis code would change from Z01.411, Encounter for gynecological examination (general) (routine) with abnormal findings, or Z01.419, Encounter for gynecological examination (general) (routine) without abnormal findings, to a general health exam: Z00.00, Encounter for general adult medical examination without abnormal findings, or Z00.01, Encounter for general adult medical examination with abnormal findings.  

What about Medicare?

Medicare requirements are somewhat different. First, Medicare covers only a small portion of the preventive care service; that is, it covers a physical examination of the genital organs and breasts and the collection and conveyance of a Pap specimen to the laboratory every 2 years for a low-risk patient. Second, the codes required to get reimbursed for the examination are:

• G0101, Cervical or vaginal cancer screening; pelvic and clinical breast examination
• Q0091, Screening Papanicolaou smear; obtaining, preparing, and conveyance of cervical or vaginal smear to laboratory.

It is not necessary to perform both of these services every 2 years (for instance, the patient may not need a Pap smear every 2 years based on her age and history), but the benefit is available if the service is performed. If the woman is at high risk for developing cervical or vaginal cancer, Medicare will cover this portion of the encounter every year so long as the Medicare-defined criteria for high risk have been documented at the time of the exam.

Related article:
GYN coding changes to note for your maximized reimbursement

Ms. Witt is an independent coding and documentation consultant and former program manager, department of coding and nomenclature, American Congress of Obstetricians and Gynecologists.

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The author reports no financial relationships relevant to this article.

Read the authors’ interpretation of the new USPSTF statement

Interpreting the new USPSTF statement

We understand the USPSTF statement to mean that pelvic exams should not be abandoned, but rather should be individualized to each patient for her specific visit. We agree that for visits focused on counseling and routine screening in asymptomatic, nonpregnant women, pelvic exams likely will not increase the early detection and treatment of disease and more benefit likely would be derived by performing and discussing evidence-based and age-appropriate health services. A classic example would be for initiation or maintenance of oral contraception in an 18-year-old patient for whom an exam could cause unnecessary trauma, pain, or psychological distress leading to future avoidance or barriers to seeking health care. For long-acting reversible contraception placement, however, a pelvic exam clearly would be necessary for insertion of an intrauterine device.

Related article:
Women’s Preventive Services Initiative Guidelines provide consensus for practicing ObGyns

Indications for pelvic examination

Remember that the pelvic examination has 3 distinct parts (and that not all parts need to be routinely conducted)³:

• general inspection of the external genitalia and vulva
• speculum examination and evaluation of the vagina and cervix
• bimanual examination with possible rectovaginal examination in age-appropriate or symptomatic women.

According to the Well-Woman Task Force of the American College of Obstetricians and Gynecologists (ACOG), “For women 21 years and older, external exam may be performed annually and that inclusion of speculum examination, bimanual examination, or both in otherwise healthy women should be a shared, informed decision between patient and provider.”⁴

Indications for performing certain parts of the pelvic exam include⁴:

• routine screening for cervical cancer (Pap test)
• routine screening for gonorrhea, chlamydia infection, and other sexually transmitted infections
• evaluation of abnormal vaginal discharge
• evaluation of abnormal bleeding, pelvic pain, and pelvic floor disorders, such as prolapse, urinary incontinence, and accidental bowel leakage
• evaluation of menopausal symptoms, such as dryness, dyspareunia, and the genitourinary syndrome of menopause
• evaluation of women at increased risk for gynecologic malignancy, such as women with known hereditary breast–ovarian cancer syndromes.

In 2016, ACOG launched the Women’s Preventive Services Initiative (WPSI) in conjunction with the Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services. In this 5-year collaboration, the agencies are endeavoring to review and update the recommendations for women’s preventive health care services, including well-woman visits, human papillomavirus testing, and contraception, among many others.⁵ Once the HRSA adopts these recommendations, women will be able to access comprehensive preventive health services without incurring any out-of-pocket expenses.

The pediatric and adolescent gynecologist perspective

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Roshanak Mansouri Zinn, MD, and Rebekah L. Williams, MD, MS

No literature addresses the utility of screening pelvic examination in the pediatric and adolescent population. According to the American College of Obstetricians and Gynecologists Committee on Adolescent Health Care opinion on the initial reproductive health visit for screening and preventive reproductive health care (reaffirmed in 2016), a screening internal exam is not necessary, but an external genital exam may be indicated and may vary depending on the patient's concerns and prior clinical encounters.¹ The American Academy of Pediatrics promotes annual screening external genital examination for all female patients as part of routine primary care, with internal examinations only as indicated.²

Age-appropriate pelvic examination for girls and nonsexually active adolescents usually is limited to an external genital exam to evaluate the anatomy and note the sexual maturity rating (Tanner stage), an important indicator of normal pubertal development. As in adults, the potential benefits of screening examination in this population include detection of benign gynecologic conditions (including vulvar skin conditions and abnormalities of hymenal or vaginal development). Additionally, early reproductive health visits are an important time for clinicians to build rapport with younger patients and to provide anticipatory education on menstruation, hygiene, and anatomy. These visits can destigmatize and demystify the pelvic examination and help young women seek care more appropriately and more comfortably if problems do arise.

Even when a pelvic exam is indicated, a patient's young age can give providers pause as to what type of exam to perform. Patients with vulvovaginal symptoms, abnormal vaginal bleeding, vaginal discharge, or pelvic or abdominal pain should receive complete evaluation with external genital examination. If external vaginal examination does not allow for complete assessment of the problem, the patient and provider can assess the likelihood of her tolerating an internal exam in the clinic versus undergoing vaginoscopy under sedation. Limited laboratory evaluation and transabdominal pelvic ultrasonography may provide sufficient information for appropriate clinical decision making and management without internal examination. If symptoms persist or do not respond to first-line treatment, an internal exam should be performed.

Patients of any age may experience anxiety or physical discomfort or may even delay or avoid seeking care because of fear of a pelvic exam. However, providers of reproductive health care for children and adolescents can offer early education, reassurance, and a more comfortable experience when pelvic examination is necessary in this population.

References

1. American College of Obstetricians and Gynecologists Committee on Adolescent Health Care. Committee Opinion No. 598: Committee on Adolescent Health Care: the initial reproductive health visit. Obstet Gynecol. 2014;123(5):1143-1147.
2. Braverman PK, Breech L; Committee on Adolescence. American Academy of Pediatrics. Clinical report: gynecologic examination for adolescents in the pediatric office setting. Pediatrics. 2010;126(3):583-590.

 

Dr. Mansouri Zinn is Assistant Professor, Department of Women's Health, University of Texas at Austin.

Dr. Williams is Assistant Professor, Clinical Pediatrics, Section of Adolescent Medicine, Indiana University School of Medicine, Indianapolis.

Developed in collaboration with the North American Society for Pediatric and Adolescent Gynecology

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The authors report no financial relationships relevant to this article.

How will the USPSTF statement affect practice?

In an editorial in the Journal of the American Medical Association commenting on the USPSTF statement, McNicholas and Peipert stated, “Based on the recommendation from the task force, clinicians may ask whether the pelvic examination should be abandoned. The answer is not found in this recommendation statement, but instead in a renewed commitment to shared decision making.”⁶ We wholeheartedly agree with this statement. The health care provider and the patient should make the decision, taking into consideration the patient’s risk factors for gynecologic cancers and other conditions, her personal preferences, and her overall values.

This new USPSTF recommendation statement will not change how we currently practice, and the statement’s grade I rating should not impact insurance coverage for pelvic exams. Additionally, further research is needed to better elucidate the role of the pelvic exam at well-woman visits, with hopes of obtaining more precise guidelines from the USPSTF and ACOG.

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.

More than 44 million pelvic examinations are performed annually in the United States.¹ In March 2017, the United States Preventive Services Task Force (USPSTF) published an updated recommendation statement regarding the need for routine screening pelvic examinations in asymptomatic adult women (18 years and older) receiving primary care: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of performing screening pelvic examinations in asymptomatic, nonpregnant adult women.”²

That statement, however, was assigned a grade of I, which means that evidence is lacking, of poor quality, or conflicting, and that the balance of benefits and harms cannot be determined. This USPSTF recommendation statement thus will not change practice for ObGyn providers but likely will renew our commitment to provide individualized well-woman care. There was inadequate or poor quality evidence for benefits related to all-cause mortality, disease-specific morbidity, and quality of life, as well as inadequate evidence on harms related to false-positive findings and anxiety stemming from screening pelvic exams.

Read about coding and billing for a standard pelvic exam