OBG Management

Did unsafe oxytocin dose cause uterine rupture? $3.5M settlement

When a mother presented to the hospital in labor, the on-call ObGyn ordered oxytocin with the dosage to be increased by 2 mU/min until she was receiving 30 mU/min or until an adequate contraction pattern was achieved and maintained. Over the next few hours, the labor and delivery nurse increased the dosage of the infusion several times.

As the patient began to push, a trickle of bright red blood was seen coming from her vagina and the baby's heart tones were temporarily lost. When the fetal heart tones were restored, his heart rate was approximately 50 bpm. After vaginal delivery was attempted using vacuum extraction and forceps, an emergency cesarean delivery was performed, leading to the finding that the mother's uterus had ruptured.

The baby suffered a permanent brain injury due to hypoxic-ischemic encephalopathy.

PATIENT'S CLAIM: The mother sued the hospital and on-call ObGyn. She alleged that the health care providers breached the standard of care by negligently increasing and maintaining the oxytocin at unsafe levels, which caused the mother's uterus to be overworked and eventually rupture. The rupture led to the child's hypoxia. An expert ObGyn noted that the patient's contractions were adequate by the time the oxytocin dose reached 14 mU/min, but the dosage continued to be increased.

DEFENDANTS' DEFENSE: The case was settled during the trial.

VERDICT: A $3.5 million Kansas settlement was reached.

When did the bowel injury occur?

One day after undergoing a hysterectomy, a woman went to the emergency department (ED) because she was feeling ill. She received a diagnosis of a pulmonary embolism for which she was given anticoagulant medications. The patient's symptoms persisted. Computed tomography (CT) imaging showed a bowel injury, and, 17 days after the initial surgery, an emergency laparotomy was performed.

PATIENT'S CLAIM: The patient sued the surgeon and the hospital. The hospital settled before the trial and the case continued against the surgeon.

The patient's early symptoms after surgery were evidence of a bowel injury, but imaging was not undertaken for several days. If the imaging had been undertaken earlier, the bowel injury would have been detected before it caused a rectovaginal fistula. An expert pathologist testified that the microscopic findings he detected postlaparotomy could only exist if a bowel perforation had been there for a significant period of time before the fistula developed. The patient's experts argued that the injury was not a "free perforation," but had been contained by her body, preventing the spread of the infection.

DEFENDANTS' DEFENSE: The surgeon maintained that the injury did not occur during the hysterectomy but developed in the days just before it was discovered. Over time, a collection of infected fluid at the vaginal cuff eroded into the bowel above it, creating an entryway for stool to pass through. Continuous leakage from the bowel for 17 days (the length of time between development of symptoms and discovery of the bowel injury) would have likely resulted in the patient's death.

VERDICT: A Missouri defense verdict was returned.

Did improper delivery techniques caused brachial plexus injury? $950,000 settlement

In April, a woman began receiving prenatal care for her 7th pregnancy. Her history of maternal obesity and diabetes mellitus, physical examinations, and tests suggested that she was at increased risk for having a macrosomic baby and encountering shoulder dystocia during vaginal delivery.

At 37 weeks' gestation, the mother was admitted to the hospital for induction of labor. Shoulder dystocia was encountered during delivery. At birth, the baby weighed 9 lb 10 oz and her right arm was limp. She was found to have a right brachial plexus injury involving C5‒C8 nerve roots and muscles. Two nerve root avulsions were evident on MRI and visualized by the surgeon during an extensive nerve graft operation. Arm function and range of motion improved after surgery, but the child has not recovered normal use of her arm.

PARENTS' CLAIM: Under the standard of care, the ObGyn was required to obtain informed consent, including a discussion of the risks of vaginal delivery (shoulder dystocia and brachial plexus injury), and the option of cesarean delivery. The patient claimed that the ObGyn neither obtained informed consent nor discussed these risks with her.

The labor and delivery nurse reported that the ObGyn told her, before delivery, that he was expecting a large baby and, perhaps, shoulder dystocia.

The ObGyn deviated from the standard of care by applying more than gentle traction to the fetal head while the shoulder was still impacted. The injury to the baby's right brachial plexus resulted from excessive lateral traction used by the ObGyn. The injury would not have occurred if a cesarean delivery had been performed. The mechanism of maternal forces injuring a brachial plexus nerve has never been visualized by any physician and is an unproven hypothesis.

PHYSICIAN'S DEFENSE: The ObGyn reported using standard maneuvers to deliver the baby. He applied traction on the fetal head 3 times: once after McRoberts maneuver, once after suprapubic pressure, and once after delivery of the posterior arm. He dictated into his notes that "We had to be careful to avoid excessive tractive forces." He claimed that shoulder dystocia is an unpredictable and unpreventable obstetric emergency, and that the injury was caused by the maternal forces of labor.

VERDICT: A $950,000 Virginia settlement was reached.

Wrongful death claim

On March 13, a 76-year-old woman went to her primary care physician's office because of a vaginal discharge. A nurse practitioner (NP) diagnosed a urinary tract infection (UTI) and prescribed cefixime (Suprax). Four days later, the patient began to experience severe diarrhea and blamed the medication. At a follow-up visit on March 20, the NP switched the patient to sulfamethoxazole-trimethoprim (Bactrim).

The following day, the patient was found unresponsive on her bathroom floor and was taken to the ED. It was determined that she had Clostridium difficile colitis (C difficile) and was admitted to the hospital. She developed acute renal failure, metabolic acidosis, hypovolemia, hypotension, and tachycardia. When she went into cardiac arrest, attempts to resuscitate her failed. She died on March 22.

ESTATE'S CLAIM: The estate sued the NP, claiming that the patient's symptoms did not meet the criteria for a UTI. If appropriate tests had been performed, the correct diagnosis would have been made and she could have received potentially life-saving treatment.

DEFENDANTS' DEFENSE: The NP claimed there was no negligence. Her diagnosis and treatment of the patient's condition were appropriate in all respects. The development of C difficile is a risk of any antibiotic.

VERDICT: An Indiana defense verdict was returned.

Nuchal cord: Undisclosed settlement

During delivery, the labor and delivery nurses lost the fetal heart-rate (FHR) monitor tracing, resulting in their being unaware of increasing signs of fetal intolerance to labor. The nurses continued to administer oxytocin to induce labor.

At birth, a nuchal cord was identified. The baby was born without signs of life but was successfully resuscitated by hospital staff.

The baby was found to have sustained severe brain damage as a result of profound fetal hypoxia. The child will require 24-hour nursing and supportive care for as long as she lives.

PARENTS' CLAIM: The nurses and ObGyn breached the standard of care resulting in her child's severe brain damage. The hospital nurses failed to continuously monitor the FHR. Profound brain damage was preventable in this case.

DEFENDANTS' DEFENSE: The nurses continuously monitored by listening to sounds coming out of the bedside monitor even though no taping of FHR was occurring on the central monitors or FHR monitor strip. A nuchal cord is an unforeseeable medical emergency; nothing different could have been done to change the outcome.

VERDICT: An undisclosed Texas settlement was reached.

Surgical needle left near bladder

The patient underwent a hysterectomy on July 9. Because of an injury sustained during the operation, bladder repair surgery was performed on July 19. After that surgery, she reported bleeding and urinary incontinence. Results of a computed tomography (CT) scan showed that the bladder repair was not successful, a vesicovaginal fistula had developed, and a 13-mm C-shaped needle was found near her bladder. A third operation to remove the needle from her abdomen took place on August 16.

PATIENT'S CLAIM: The needle left behind after the second surgery caused a fistula to develop. The patient suffered mental and emotional distress from knowing the needle was in her abdomen. Foreign objects left in a patient during surgery are strong evidence of negligence.

DEFENDANTS' DEFENSE: The primary defense claim was the absence of causation--any negligence did not cause the injury. Defense experts testified that the needle was on top of the bladder and did move anywhere to cause damage. The patient developed a vesicovaginal fistula due to complications from the bladder repair operation and not from the needle. In addition, there was testimony that the third surgery was unnecessary because the needle would eventually flush out of the abdomen without causing damage.

VERDICT: A Michigan defense verdict was returned.

Claims cancer diagnosis was delayed

On October 1, 2008, a woman saw her family physician (FP) for routine care. Blood work results showed an elevated white blood cell (WBC) count. The patient claimed that the FP did not inform her of these test results.

One year later, the patient went to an urgent care facility where blood work was performed; the results showed a high WBC count. After a work-up, the patient was given a presumptive diagnosis of mantel cell lymphoma. By December 9, she had undergone the first round of chemotherapy. Subsequent tests revealed that the presumptive diagnosis was incorrect; she actually had low-grade lymphoproliferative disorder.

In lieu of this new diagnosis, the medical team offered the patient the option of discontinuing chemotherapy. She decided, however, to continue the treatment. Chemotherapy was followed by 2 years of rituximab/hyaluronidase human maintenance therapy.

PATIENT'S CLAIM: The patient presented her case to a medical review board. The course of treatment (chemotherapy plus maintenance therapy) left her with permanent heart damage and an elevated risk of developing secondary cancer.

The patient claimed that none of this would have happened if her FP had informed her of the October 2008 test results and recommended appropriate follow-up studies. The results of those studies would have given her the correct diagnosis and allowed her to receive prompt, proper treatment. The medical review board responded unanimously that the FP's conduct constituted a breach of the standard of care, but concluded that the breach was not a factor in the patient's damages.

The patient filed suit against the FP. An expert in internal medicine commented that, based on the 2008 WBC count, the tests should have been repeated and the patient should have been referred to a hematologist/oncologist. Failure to do so increased the patient's risk of developing cancer in the future.

DEFENDANTS' DEFENSE: The FP denied any breach of standard of care. According to her notes, she had shared test results with the patient on November 26 and recommended following up with repeat blood work. The FP blamed the patient for failing to follow-up as recommended.

VERDICT: An Indiana defense 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 [email protected]. Please include your name and the city and state in which you practice.

Did unsafe oxytocin dose cause uterine rupture? $3.5M settlement

When a mother presented to the hospital in labor, the on-call ObGyn ordered oxytocin with the dosage to be increased by 2 mU/min until she was receiving 30 mU/min or until an adequate contraction pattern was achieved and maintained. Over the next few hours, the labor and delivery nurse increased the dosage of the infusion several times.

As the patient began to push, a trickle of bright red blood was seen coming from her vagina and the baby's heart tones were temporarily lost. When the fetal heart tones were restored, his heart rate was approximately 50 bpm. After vaginal delivery was attempted using vacuum extraction and forceps, an emergency cesarean delivery was performed, leading to the finding that the mother's uterus had ruptured.

The baby suffered a permanent brain injury due to hypoxic-ischemic encephalopathy.

PATIENT'S CLAIM: The mother sued the hospital and on-call ObGyn. She alleged that the health care providers breached the standard of care by negligently increasing and maintaining the oxytocin at unsafe levels, which caused the mother's uterus to be overworked and eventually rupture. The rupture led to the child's hypoxia. An expert ObGyn noted that the patient's contractions were adequate by the time the oxytocin dose reached 14 mU/min, but the dosage continued to be increased.

DEFENDANTS' DEFENSE: The case was settled during the trial.

VERDICT: A $3.5 million Kansas settlement was reached.

When did the bowel injury occur?

One day after undergoing a hysterectomy, a woman went to the emergency department (ED) because she was feeling ill. She received a diagnosis of a pulmonary embolism for which she was given anticoagulant medications. The patient's symptoms persisted. Computed tomography (CT) imaging showed a bowel injury, and, 17 days after the initial surgery, an emergency laparotomy was performed.

PATIENT'S CLAIM: The patient sued the surgeon and the hospital. The hospital settled before the trial and the case continued against the surgeon.

The patient's early symptoms after surgery were evidence of a bowel injury, but imaging was not undertaken for several days. If the imaging had been undertaken earlier, the bowel injury would have been detected before it caused a rectovaginal fistula. An expert pathologist testified that the microscopic findings he detected postlaparotomy could only exist if a bowel perforation had been there for a significant period of time before the fistula developed. The patient's experts argued that the injury was not a "free perforation," but had been contained by her body, preventing the spread of the infection.

DEFENDANTS' DEFENSE: The surgeon maintained that the injury did not occur during the hysterectomy but developed in the days just before it was discovered. Over time, a collection of infected fluid at the vaginal cuff eroded into the bowel above it, creating an entryway for stool to pass through. Continuous leakage from the bowel for 17 days (the length of time between development of symptoms and discovery of the bowel injury) would have likely resulted in the patient's death.

VERDICT: A Missouri defense verdict was returned.

Did improper delivery techniques caused brachial plexus injury? $950,000 settlement

In April, a woman began receiving prenatal care for her 7th pregnancy. Her history of maternal obesity and diabetes mellitus, physical examinations, and tests suggested that she was at increased risk for having a macrosomic baby and encountering shoulder dystocia during vaginal delivery.

At 37 weeks' gestation, the mother was admitted to the hospital for induction of labor. Shoulder dystocia was encountered during delivery. At birth, the baby weighed 9 lb 10 oz and her right arm was limp. She was found to have a right brachial plexus injury involving C5‒C8 nerve roots and muscles. Two nerve root avulsions were evident on MRI and visualized by the surgeon during an extensive nerve graft operation. Arm function and range of motion improved after surgery, but the child has not recovered normal use of her arm.

PARENTS' CLAIM: Under the standard of care, the ObGyn was required to obtain informed consent, including a discussion of the risks of vaginal delivery (shoulder dystocia and brachial plexus injury), and the option of cesarean delivery. The patient claimed that the ObGyn neither obtained informed consent nor discussed these risks with her.

The labor and delivery nurse reported that the ObGyn told her, before delivery, that he was expecting a large baby and, perhaps, shoulder dystocia.

The ObGyn deviated from the standard of care by applying more than gentle traction to the fetal head while the shoulder was still impacted. The injury to the baby's right brachial plexus resulted from excessive lateral traction used by the ObGyn. The injury would not have occurred if a cesarean delivery had been performed. The mechanism of maternal forces injuring a brachial plexus nerve has never been visualized by any physician and is an unproven hypothesis.

PHYSICIAN'S DEFENSE: The ObGyn reported using standard maneuvers to deliver the baby. He applied traction on the fetal head 3 times: once after McRoberts maneuver, once after suprapubic pressure, and once after delivery of the posterior arm. He dictated into his notes that "We had to be careful to avoid excessive tractive forces." He claimed that shoulder dystocia is an unpredictable and unpreventable obstetric emergency, and that the injury was caused by the maternal forces of labor.

VERDICT: A $950,000 Virginia settlement was reached.

Wrongful death claim

On March 13, a 76-year-old woman went to her primary care physician's office because of a vaginal discharge. A nurse practitioner (NP) diagnosed a urinary tract infection (UTI) and prescribed cefixime (Suprax). Four days later, the patient began to experience severe diarrhea and blamed the medication. At a follow-up visit on March 20, the NP switched the patient to sulfamethoxazole-trimethoprim (Bactrim).

The following day, the patient was found unresponsive on her bathroom floor and was taken to the ED. It was determined that she had Clostridium difficile colitis (C difficile) and was admitted to the hospital. She developed acute renal failure, metabolic acidosis, hypovolemia, hypotension, and tachycardia. When she went into cardiac arrest, attempts to resuscitate her failed. She died on March 22.

ESTATE'S CLAIM: The estate sued the NP, claiming that the patient's symptoms did not meet the criteria for a UTI. If appropriate tests had been performed, the correct diagnosis would have been made and she could have received potentially life-saving treatment.

DEFENDANTS' DEFENSE: The NP claimed there was no negligence. Her diagnosis and treatment of the patient's condition were appropriate in all respects. The development of C difficile is a risk of any antibiotic.

VERDICT: An Indiana defense verdict was returned.

Nuchal cord: Undisclosed settlement

During delivery, the labor and delivery nurses lost the fetal heart-rate (FHR) monitor tracing, resulting in their being unaware of increasing signs of fetal intolerance to labor. The nurses continued to administer oxytocin to induce labor.

At birth, a nuchal cord was identified. The baby was born without signs of life but was successfully resuscitated by hospital staff.

The baby was found to have sustained severe brain damage as a result of profound fetal hypoxia. The child will require 24-hour nursing and supportive care for as long as she lives.

PARENTS' CLAIM: The nurses and ObGyn breached the standard of care resulting in her child's severe brain damage. The hospital nurses failed to continuously monitor the FHR. Profound brain damage was preventable in this case.

DEFENDANTS' DEFENSE: The nurses continuously monitored by listening to sounds coming out of the bedside monitor even though no taping of FHR was occurring on the central monitors or FHR monitor strip. A nuchal cord is an unforeseeable medical emergency; nothing different could have been done to change the outcome.

VERDICT: An undisclosed Texas settlement was reached.

Surgical needle left near bladder

The patient underwent a hysterectomy on July 9. Because of an injury sustained during the operation, bladder repair surgery was performed on July 19. After that surgery, she reported bleeding and urinary incontinence. Results of a computed tomography (CT) scan showed that the bladder repair was not successful, a vesicovaginal fistula had developed, and a 13-mm C-shaped needle was found near her bladder. A third operation to remove the needle from her abdomen took place on August 16.

PATIENT'S CLAIM: The needle left behind after the second surgery caused a fistula to develop. The patient suffered mental and emotional distress from knowing the needle was in her abdomen. Foreign objects left in a patient during surgery are strong evidence of negligence.

DEFENDANTS' DEFENSE: The primary defense claim was the absence of causation--any negligence did not cause the injury. Defense experts testified that the needle was on top of the bladder and did move anywhere to cause damage. The patient developed a vesicovaginal fistula due to complications from the bladder repair operation and not from the needle. In addition, there was testimony that the third surgery was unnecessary because the needle would eventually flush out of the abdomen without causing damage.

VERDICT: A Michigan defense verdict was returned.

Claims cancer diagnosis was delayed

On October 1, 2008, a woman saw her family physician (FP) for routine care. Blood work results showed an elevated white blood cell (WBC) count. The patient claimed that the FP did not inform her of these test results.

One year later, the patient went to an urgent care facility where blood work was performed; the results showed a high WBC count. After a work-up, the patient was given a presumptive diagnosis of mantel cell lymphoma. By December 9, she had undergone the first round of chemotherapy. Subsequent tests revealed that the presumptive diagnosis was incorrect; she actually had low-grade lymphoproliferative disorder.

In lieu of this new diagnosis, the medical team offered the patient the option of discontinuing chemotherapy. She decided, however, to continue the treatment. Chemotherapy was followed by 2 years of rituximab/hyaluronidase human maintenance therapy.

PATIENT'S CLAIM: The patient presented her case to a medical review board. The course of treatment (chemotherapy plus maintenance therapy) left her with permanent heart damage and an elevated risk of developing secondary cancer.

The patient claimed that none of this would have happened if her FP had informed her of the October 2008 test results and recommended appropriate follow-up studies. The results of those studies would have given her the correct diagnosis and allowed her to receive prompt, proper treatment. The medical review board responded unanimously that the FP's conduct constituted a breach of the standard of care, but concluded that the breach was not a factor in the patient's damages.

The patient filed suit against the FP. An expert in internal medicine commented that, based on the 2008 WBC count, the tests should have been repeated and the patient should have been referred to a hematologist/oncologist. Failure to do so increased the patient's risk of developing cancer in the future.

DEFENDANTS' DEFENSE: The FP denied any breach of standard of care. According to her notes, she had shared test results with the patient on November 26 and recommended following up with repeat blood work. The FP blamed the patient for failing to follow-up as recommended.

VERDICT: An Indiana defense 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 [email protected]. Please include your name and the city and state in which you practice.

Did unsafe oxytocin dose cause uterine rupture? $3.5M settlement

When a mother presented to the hospital in labor, the on-call ObGyn ordered oxytocin with the dosage to be increased by 2 mU/min until she was receiving 30 mU/min or until an adequate contraction pattern was achieved and maintained. Over the next few hours, the labor and delivery nurse increased the dosage of the infusion several times.

As the patient began to push, a trickle of bright red blood was seen coming from her vagina and the baby's heart tones were temporarily lost. When the fetal heart tones were restored, his heart rate was approximately 50 bpm. After vaginal delivery was attempted using vacuum extraction and forceps, an emergency cesarean delivery was performed, leading to the finding that the mother's uterus had ruptured.

The baby suffered a permanent brain injury due to hypoxic-ischemic encephalopathy.

PATIENT'S CLAIM: The mother sued the hospital and on-call ObGyn. She alleged that the health care providers breached the standard of care by negligently increasing and maintaining the oxytocin at unsafe levels, which caused the mother's uterus to be overworked and eventually rupture. The rupture led to the child's hypoxia. An expert ObGyn noted that the patient's contractions were adequate by the time the oxytocin dose reached 14 mU/min, but the dosage continued to be increased.

DEFENDANTS' DEFENSE: The case was settled during the trial.

VERDICT: A $3.5 million Kansas settlement was reached.

When did the bowel injury occur?

One day after undergoing a hysterectomy, a woman went to the emergency department (ED) because she was feeling ill. She received a diagnosis of a pulmonary embolism for which she was given anticoagulant medications. The patient's symptoms persisted. Computed tomography (CT) imaging showed a bowel injury, and, 17 days after the initial surgery, an emergency laparotomy was performed.

PATIENT'S CLAIM: The patient sued the surgeon and the hospital. The hospital settled before the trial and the case continued against the surgeon.

The patient's early symptoms after surgery were evidence of a bowel injury, but imaging was not undertaken for several days. If the imaging had been undertaken earlier, the bowel injury would have been detected before it caused a rectovaginal fistula. An expert pathologist testified that the microscopic findings he detected postlaparotomy could only exist if a bowel perforation had been there for a significant period of time before the fistula developed. The patient's experts argued that the injury was not a "free perforation," but had been contained by her body, preventing the spread of the infection.

DEFENDANTS' DEFENSE: The surgeon maintained that the injury did not occur during the hysterectomy but developed in the days just before it was discovered. Over time, a collection of infected fluid at the vaginal cuff eroded into the bowel above it, creating an entryway for stool to pass through. Continuous leakage from the bowel for 17 days (the length of time between development of symptoms and discovery of the bowel injury) would have likely resulted in the patient's death.

VERDICT: A Missouri defense verdict was returned.

Did improper delivery techniques caused brachial plexus injury? $950,000 settlement

In April, a woman began receiving prenatal care for her 7th pregnancy. Her history of maternal obesity and diabetes mellitus, physical examinations, and tests suggested that she was at increased risk for having a macrosomic baby and encountering shoulder dystocia during vaginal delivery.

At 37 weeks' gestation, the mother was admitted to the hospital for induction of labor. Shoulder dystocia was encountered during delivery. At birth, the baby weighed 9 lb 10 oz and her right arm was limp. She was found to have a right brachial plexus injury involving C5‒C8 nerve roots and muscles. Two nerve root avulsions were evident on MRI and visualized by the surgeon during an extensive nerve graft operation. Arm function and range of motion improved after surgery, but the child has not recovered normal use of her arm.

PARENTS' CLAIM: Under the standard of care, the ObGyn was required to obtain informed consent, including a discussion of the risks of vaginal delivery (shoulder dystocia and brachial plexus injury), and the option of cesarean delivery. The patient claimed that the ObGyn neither obtained informed consent nor discussed these risks with her.

The labor and delivery nurse reported that the ObGyn told her, before delivery, that he was expecting a large baby and, perhaps, shoulder dystocia.

The ObGyn deviated from the standard of care by applying more than gentle traction to the fetal head while the shoulder was still impacted. The injury to the baby's right brachial plexus resulted from excessive lateral traction used by the ObGyn. The injury would not have occurred if a cesarean delivery had been performed. The mechanism of maternal forces injuring a brachial plexus nerve has never been visualized by any physician and is an unproven hypothesis.

PHYSICIAN'S DEFENSE: The ObGyn reported using standard maneuvers to deliver the baby. He applied traction on the fetal head 3 times: once after McRoberts maneuver, once after suprapubic pressure, and once after delivery of the posterior arm. He dictated into his notes that "We had to be careful to avoid excessive tractive forces." He claimed that shoulder dystocia is an unpredictable and unpreventable obstetric emergency, and that the injury was caused by the maternal forces of labor.

VERDICT: A $950,000 Virginia settlement was reached.

Wrongful death claim

On March 13, a 76-year-old woman went to her primary care physician's office because of a vaginal discharge. A nurse practitioner (NP) diagnosed a urinary tract infection (UTI) and prescribed cefixime (Suprax). Four days later, the patient began to experience severe diarrhea and blamed the medication. At a follow-up visit on March 20, the NP switched the patient to sulfamethoxazole-trimethoprim (Bactrim).

The following day, the patient was found unresponsive on her bathroom floor and was taken to the ED. It was determined that she had Clostridium difficile colitis (C difficile) and was admitted to the hospital. She developed acute renal failure, metabolic acidosis, hypovolemia, hypotension, and tachycardia. When she went into cardiac arrest, attempts to resuscitate her failed. She died on March 22.

ESTATE'S CLAIM: The estate sued the NP, claiming that the patient's symptoms did not meet the criteria for a UTI. If appropriate tests had been performed, the correct diagnosis would have been made and she could have received potentially life-saving treatment.

DEFENDANTS' DEFENSE: The NP claimed there was no negligence. Her diagnosis and treatment of the patient's condition were appropriate in all respects. The development of C difficile is a risk of any antibiotic.

VERDICT: An Indiana defense verdict was returned.

Nuchal cord: Undisclosed settlement

During delivery, the labor and delivery nurses lost the fetal heart-rate (FHR) monitor tracing, resulting in their being unaware of increasing signs of fetal intolerance to labor. The nurses continued to administer oxytocin to induce labor.

At birth, a nuchal cord was identified. The baby was born without signs of life but was successfully resuscitated by hospital staff.

The baby was found to have sustained severe brain damage as a result of profound fetal hypoxia. The child will require 24-hour nursing and supportive care for as long as she lives.

PARENTS' CLAIM: The nurses and ObGyn breached the standard of care resulting in her child's severe brain damage. The hospital nurses failed to continuously monitor the FHR. Profound brain damage was preventable in this case.

DEFENDANTS' DEFENSE: The nurses continuously monitored by listening to sounds coming out of the bedside monitor even though no taping of FHR was occurring on the central monitors or FHR monitor strip. A nuchal cord is an unforeseeable medical emergency; nothing different could have been done to change the outcome.

VERDICT: An undisclosed Texas settlement was reached.

Surgical needle left near bladder

The patient underwent a hysterectomy on July 9. Because of an injury sustained during the operation, bladder repair surgery was performed on July 19. After that surgery, she reported bleeding and urinary incontinence. Results of a computed tomography (CT) scan showed that the bladder repair was not successful, a vesicovaginal fistula had developed, and a 13-mm C-shaped needle was found near her bladder. A third operation to remove the needle from her abdomen took place on August 16.

PATIENT'S CLAIM: The needle left behind after the second surgery caused a fistula to develop. The patient suffered mental and emotional distress from knowing the needle was in her abdomen. Foreign objects left in a patient during surgery are strong evidence of negligence.

DEFENDANTS' DEFENSE: The primary defense claim was the absence of causation--any negligence did not cause the injury. Defense experts testified that the needle was on top of the bladder and did move anywhere to cause damage. The patient developed a vesicovaginal fistula due to complications from the bladder repair operation and not from the needle. In addition, there was testimony that the third surgery was unnecessary because the needle would eventually flush out of the abdomen without causing damage.

VERDICT: A Michigan defense verdict was returned.

Claims cancer diagnosis was delayed

On October 1, 2008, a woman saw her family physician (FP) for routine care. Blood work results showed an elevated white blood cell (WBC) count. The patient claimed that the FP did not inform her of these test results.

One year later, the patient went to an urgent care facility where blood work was performed; the results showed a high WBC count. After a work-up, the patient was given a presumptive diagnosis of mantel cell lymphoma. By December 9, she had undergone the first round of chemotherapy. Subsequent tests revealed that the presumptive diagnosis was incorrect; she actually had low-grade lymphoproliferative disorder.

In lieu of this new diagnosis, the medical team offered the patient the option of discontinuing chemotherapy. She decided, however, to continue the treatment. Chemotherapy was followed by 2 years of rituximab/hyaluronidase human maintenance therapy.

PATIENT'S CLAIM: The patient presented her case to a medical review board. The course of treatment (chemotherapy plus maintenance therapy) left her with permanent heart damage and an elevated risk of developing secondary cancer.

The patient claimed that none of this would have happened if her FP had informed her of the October 2008 test results and recommended appropriate follow-up studies. The results of those studies would have given her the correct diagnosis and allowed her to receive prompt, proper treatment. The medical review board responded unanimously that the FP's conduct constituted a breach of the standard of care, but concluded that the breach was not a factor in the patient's damages.

The patient filed suit against the FP. An expert in internal medicine commented that, based on the 2008 WBC count, the tests should have been repeated and the patient should have been referred to a hematologist/oncologist. Failure to do so increased the patient's risk of developing cancer in the future.

DEFENDANTS' DEFENSE: The FP denied any breach of standard of care. According to her notes, she had shared test results with the patient on November 26 and recommended following up with repeat blood work. The FP blamed the patient for failing to follow-up as recommended.

VERDICT: An Indiana defense 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 [email protected]. Please include your name and the city and state in which you practice.

Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

Liletta, a levonorgestrel 52 mg contraceptive intrauterine system (IUS) (Allergan), is currently approved by the US Food and Drug Administration for up to 4 years of use. A multicenter trial is continuing to measure Liletta’s efficacy and safety for a total of 8 years of use.¹

Meanwhile, investigators led by Stephanie B. Teal, MD, from the University of Colorado, Aurora, have evaluated the 5-year data for Liletta. Researchers included David K. Turok, MD, from the University of Utah, Salt Lake City; Jeffrey T. Jensen, MD, from the Oregon Health & Science University, Portland; Beatrice A. Chen, MD, from the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Thomas D. Kimble, MD, from Eastern Virginia Medical School, Norfolk; and Mitchell D. Creinin, MD, from the University of California-Davis, Sacramento. Results were reported in a poster presentation at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists held in Austin, Texas, from April 27–30, 2018.¹

Study details

A total of 1,714 women aged 16−45 years were enrolled in the multicenter study for 5 years after successful IUS placement. This included 146 women aged 36−45 years who received the IUS for safety evaluation only, and 1,568 women aged 16−35 years who were evaluated for both safety and efficacy.¹

Results of the study

The 16−35-year-old participants included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these participants, 9 pregnancies occurred, including 4 in nulliparous women and 1 in an obese woman. In this age group, 1 pregnancy occurred after perforation and 1 following expulsion. Six (67%) of the pregnancies were ectopic.¹

The Pearl Index in the first year was .15 (95% confidence interval [CI], .02−.55). Cumulative life-table pregnancy rates at the end of years 3 and 5 were .59 (95% CI, .28−1.25) and .92 (95% CI, .46–1.82), respectively.¹

Of the total participants, perforation occurred in 2 (0.1%) women, both within the first year. Expulsion occurred in 63 participants (3.7%), most (50 [80.6%]) during the first year. Eleven patients (0.6%) were found to have a pelvic infection. Thirty-nine women (2.3%) discontinued use of Liletta due to bleeding complaints, primarily (n = 29 [74.3%]) in the first year.¹

Conclusion

The researchers concluded that Liletta is highly effective and has an excellent safety profile over 5 years of use. Most adverse effects, including expulsion and discontinuation for bleeding, occurred during the first year.¹

Nitrous oxide, a colorless, odorless gas, has long been used for labor analgesia in many countries, including the United Kingdom, Canada, throughout Europe, Australia, and New Zealand. Recently, interest in its use in the United States has increased, since the US Food and Drug Administration (FDA) approval in 2012 of simple devices for administration of nitrous oxide in a variety of locations. Being able to offer an alternative technique, other than parenteral opioids, for women who may not wish to or who cannot have regional analgesia, and for women who have delivered and need analgesia for postdelivery repair, conveys significant benefits. Risks to its use are very low, although the quality of pain relief is inferior to that offered by regional analgesic techniques. Our experience with its use since 2014 at Brigham and Women’s Hospital in Boston, Massachusetts, corroborates that reported in the literature and leads us to continue offering inhaled nitrous oxide and advocating that others do as well.^1–7 When using nitrous oxide in your labor and delivery unit, or if considering its use, keep the following points in mind.

A successful inhaled nitrous oxide program requires proper patient selection

Inhaled nitrous oxide is not an epidural (TABLE).⁸ The pain relief is clearly inferior to that of an epidural. Inhaled nitrous oxide will not replace epidurals or even have any effect on the epidural rate at a particular institution.⁶ However, the use of inhaled nitrous oxide for labor analgesia has a long track record of safety (albeit with moderate efficacy for selected patients) for many years in many countries around the world. Inhaled nitrous oxide is a valuable addition to the options we can offer patients:

• who are poor responders to opioid medication or who have high opioid tolerance
• with certain disorders of coagulation
• with chronic pain or anxiety
• who for other reasons need to consider alternatives or adjuncts to neuraxial analgesia.

Although it is important to be realistic regarding the expectations of analgesia quality offered by this agent,⁷ compared with other agents we have tried, it has less adverse effects, is economically reasonable, and has no proven impact on neonatal outcomes.

No significant complications with inhaled nitrous oxide have been reported

Systematic reviews did not report any significant complications to either mother or newborn.^1,2 Our personal experiences corroborate this, as no complications have been associated with its frequent use at Brigham and Women’s Hospital. Reported adverse effects are mild. The incidence of nausea is 13%, dizziness is 3% to 5%, and drowsiness is 4%; these rates are hard to detect over the baseline rates of those side effects associated with labor and delivery alone.¹ Many other centers have now adopted the use of this agent, with several hundred locations now offering inhaled nitrous oxide for labor analgesia in the United States.

Practical use of inhaled nitrous oxide is relatively simple

Several vendors offer portable, user-friendly, cost-effective equipment that is appropriate for labor and delivery use. All devices are structured in demand-valve modality, meaning that the patient must initiate a breath in order to open a valve that allows gas to flow. Cessation of the inspiratory effort closes the valve, thus preventing the free flow of gas into the ambient atmosphere of the room. The devices generally include a tank with nitrous oxide as well as a source of oxygen. Most devices designed for labor and delivery provide a fixed mixture of 50% nitrous oxide and 50% oxygen, with fail-safe mechanisms to allow increased oxygen delivery in the event of failure or depletion of the nitrous supply. All modern, FDA–approved devices include effective scavenging systems, such that expired gases are vented outside (generally via room suction), which prevents occupational exposure to low levels of nitrous oxide.

Inhaled nitrous oxide for labor pain must be patient controlled

An essential feature of the use of inhaled nitrous oxide for labor analgesia is that it must be considered a patient-controlled system. Patients have an option to use either a mask or a mouthpiece, according to their preferences and comfort. The patient must hold the mask or mouthpiece herself; it is neither appropriate nor safe for anyone else, such as a nurse, family member, or labor support personnel, to assist with this task.

Some coordination with the nurse is essential for optimal timing of administration. Onset of a therapeutic level of pain relief is generally 30 to 60 seconds after inhalation has begun, with rapid resolution after cessation of the inhalation. The patient should thus initiate the inspiration of the gas at the earliest signs of onset of a contraction, so as to achieve maximal analgesia at the peak of the contraction. Waiting until the peak of the contraction to initiate inhalation of the nitrous oxide will not provide effective analgesia, yet will result in sedation after the contraction has ended.

Read about patient satisfaction with inhaled nitrous oxide.

No oversight by an anesthesiologist is required

The Centers for Medicare and Medicaid Services (CMS) produced a clarification statement for definitions of “anesthesia services” (42 CFR 482.52)⁹ that may be offered by a hospital, based on American Society of Anesthesiologists (ASA) definitions. CMS, consistent with ASA guidelines, does not define moderate or conscious sedation as “anesthesia,” thus direct oversight by an anesthesiologist is not required. Furthermore, the definition of “minimal sedation,” which is where 50% concentration delivery of inhaled nitrous oxide would be categorized, also does not meet this requirement by CMS.

Illustration: Kimberly Martens for OBG Management

Women who use inhaled nitrous oxide for labor pain typically are satisfied with its use

The use of analog pain scale measurements may not be appropriate in a setting where dissociation from pain might be the primary beneficial effect. Measurements of maternal satisfaction with their analgesic experience support this. The experiences at Vanderbilt University and Brigham and Women’s Hospital show that, while pain relief is limited, like reported in systematic reviews, maternal satisfaction scores for labor analgesia are not different among women who receive inhaled nitrous oxide analgesia, neuraxial analgesia, and those who transition from nitrous to neuraxial analgesia. In fact, published evidence supports extraordinarily high satisfaction in women who plan to use inhaled nitrous oxide, and actually successfully do so, despite only limited degrees of pain relief.^10,11 Work to identify the characteristics of women who report success with inhaled nitrous oxide use needs to be performed so that patients can be better selected and informed when making analgesic choices.

Animal research on inhaled nitrous oxide may not translate well to human neonates

A very recent task force convened by the European Society of Anaesthesiology (ESA) addressed some of the potential concerns about inhaled nitrous oxide analgesia.¹² Per their report:

“the potential teratogenic effect of N2O observed in experimental models cannot be extrapolated to humans. There is a lack of evidence for an association between N2O and reproductive toxicity. The incidence of health hazards and abortion was not shown to be higher in women exposed to, or spouses of men exposed to N2O than those who were not so exposed. Moreover, the incidence of congenital malformations was not higher among women who received N2O for anaesthesia during the first trimester of pregnancy nor during anaesthesia management for cervical cerclage, nor for surgery in the first two trimesters of pregnancy.”

There is a theoretical concern of an increase in neuronal apoptosis in neonates, demonstrated in laboratory animals in anesthetic concentrations, but the human relevance of this is not clear, since the data on animal developmental neurotoxicity is generally combined with data wherein potent inhalational anesthetic agents were also used, not nitrous oxide alone.¹³ The analgesic doses and time of exposure of inhaled nitrous oxide administered for labor analgesia are well below those required for these changes, as subanesthetic doses are associated with minimal changes, if any, in laboratory animals.

No labor analgesic is without the potential for fetal effects, and alternative labor analgesics such as systemic opioids in higher doses also may have potential adverse effects on the fetus, such as fetal heart rate effects or early tone, alertness, and breastfeeding difficulties. The low solubility and short half-life of inhaled nitrous oxide contribute to low absorption by tissues, thus contributing to the safety of this agent. Nitrous oxide via inhalation for sedation during elective cesarean has been reported to show no adverse effects on neonatal Apgar scores.¹⁴

Modern equipment keeps occupational exposure to nitrous oxide safe

One retrospective review of women exposed to high concentrations of inhaled nitrous oxide reported reduced fertility.¹⁵ However, the only effects on fertility were seen when nitrous was used without scavenging equipment, and in high concentrations. Moreover, that study examined dental offices, where nitrous was free flowing during procedures—quite a different setting than the intermittent inhalation, demand-valve modality as is used during labor—and when using appropriate modern, FDA-approved equipment, and scavenging devices. Per the recent ESA task force¹²:

“Members of the task force agreed that, despite theoretical concerns and laboratory data, there is no evidence indicating that the use of N2O in a clinically relevant setting would increase health risk in patients or providers exposed to this drug. With the ubiquitous availability of scavenging systems in the modern operating room, the health concern for medical staff has decreased dramatically. Properly operating scavenging systems reduce N2O concentrations by more than 70%, thereby efficiently keeping ambient N2O levels well below official limits.”

The ESA task force concludes: “An extensive amount of clinical evidence indicates that N2O can be used safely for procedural pain management, for labour pain, and for anxiolysis and sedation in dentistry.”¹²

Two important reminders

Inhaled nitrous oxide has been a central component of the labor pain relief menu in most of the rest of the world for decades, and the safety record is impeccable. This agent has now had extensive and growing experience in American maternity units. Remember 2 critical points: 1) patient selection is key, 2) analgesia is not like that provided by regional anesthetic techniques such as an epidural.

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

Nitrous oxide, a colorless, odorless gas, has long been used for labor analgesia in many countries, including the United Kingdom, Canada, throughout Europe, Australia, and New Zealand. Recently, interest in its use in the United States has increased, since the US Food and Drug Administration (FDA) approval in 2012 of simple devices for administration of nitrous oxide in a variety of locations. Being able to offer an alternative technique, other than parenteral opioids, for women who may not wish to or who cannot have regional analgesia, and for women who have delivered and need analgesia for postdelivery repair, conveys significant benefits. Risks to its use are very low, although the quality of pain relief is inferior to that offered by regional analgesic techniques. Our experience with its use since 2014 at Brigham and Women’s Hospital in Boston, Massachusetts, corroborates that reported in the literature and leads us to continue offering inhaled nitrous oxide and advocating that others do as well.^1–7 When using nitrous oxide in your labor and delivery unit, or if considering its use, keep the following points in mind.

A successful inhaled nitrous oxide program requires proper patient selection

Inhaled nitrous oxide is not an epidural (TABLE).⁸ The pain relief is clearly inferior to that of an epidural. Inhaled nitrous oxide will not replace epidurals or even have any effect on the epidural rate at a particular institution.⁶ However, the use of inhaled nitrous oxide for labor analgesia has a long track record of safety (albeit with moderate efficacy for selected patients) for many years in many countries around the world. Inhaled nitrous oxide is a valuable addition to the options we can offer patients:

• who are poor responders to opioid medication or who have high opioid tolerance
• with certain disorders of coagulation
• with chronic pain or anxiety
• who for other reasons need to consider alternatives or adjuncts to neuraxial analgesia.

Although it is important to be realistic regarding the expectations of analgesia quality offered by this agent,⁷ compared with other agents we have tried, it has less adverse effects, is economically reasonable, and has no proven impact on neonatal outcomes.

No significant complications with inhaled nitrous oxide have been reported

Systematic reviews did not report any significant complications to either mother or newborn.^1,2 Our personal experiences corroborate this, as no complications have been associated with its frequent use at Brigham and Women’s Hospital. Reported adverse effects are mild. The incidence of nausea is 13%, dizziness is 3% to 5%, and drowsiness is 4%; these rates are hard to detect over the baseline rates of those side effects associated with labor and delivery alone.¹ Many other centers have now adopted the use of this agent, with several hundred locations now offering inhaled nitrous oxide for labor analgesia in the United States.

Practical use of inhaled nitrous oxide is relatively simple

Several vendors offer portable, user-friendly, cost-effective equipment that is appropriate for labor and delivery use. All devices are structured in demand-valve modality, meaning that the patient must initiate a breath in order to open a valve that allows gas to flow. Cessation of the inspiratory effort closes the valve, thus preventing the free flow of gas into the ambient atmosphere of the room. The devices generally include a tank with nitrous oxide as well as a source of oxygen. Most devices designed for labor and delivery provide a fixed mixture of 50% nitrous oxide and 50% oxygen, with fail-safe mechanisms to allow increased oxygen delivery in the event of failure or depletion of the nitrous supply. All modern, FDA–approved devices include effective scavenging systems, such that expired gases are vented outside (generally via room suction), which prevents occupational exposure to low levels of nitrous oxide.

Inhaled nitrous oxide for labor pain must be patient controlled

An essential feature of the use of inhaled nitrous oxide for labor analgesia is that it must be considered a patient-controlled system. Patients have an option to use either a mask or a mouthpiece, according to their preferences and comfort. The patient must hold the mask or mouthpiece herself; it is neither appropriate nor safe for anyone else, such as a nurse, family member, or labor support personnel, to assist with this task.

Some coordination with the nurse is essential for optimal timing of administration. Onset of a therapeutic level of pain relief is generally 30 to 60 seconds after inhalation has begun, with rapid resolution after cessation of the inhalation. The patient should thus initiate the inspiration of the gas at the earliest signs of onset of a contraction, so as to achieve maximal analgesia at the peak of the contraction. Waiting until the peak of the contraction to initiate inhalation of the nitrous oxide will not provide effective analgesia, yet will result in sedation after the contraction has ended.

Read about patient satisfaction with inhaled nitrous oxide.

No oversight by an anesthesiologist is required

The Centers for Medicare and Medicaid Services (CMS) produced a clarification statement for definitions of “anesthesia services” (42 CFR 482.52)⁹ that may be offered by a hospital, based on American Society of Anesthesiologists (ASA) definitions. CMS, consistent with ASA guidelines, does not define moderate or conscious sedation as “anesthesia,” thus direct oversight by an anesthesiologist is not required. Furthermore, the definition of “minimal sedation,” which is where 50% concentration delivery of inhaled nitrous oxide would be categorized, also does not meet this requirement by CMS.

Illustration: Kimberly Martens for OBG Management

Women who use inhaled nitrous oxide for labor pain typically are satisfied with its use

The use of analog pain scale measurements may not be appropriate in a setting where dissociation from pain might be the primary beneficial effect. Measurements of maternal satisfaction with their analgesic experience support this. The experiences at Vanderbilt University and Brigham and Women’s Hospital show that, while pain relief is limited, like reported in systematic reviews, maternal satisfaction scores for labor analgesia are not different among women who receive inhaled nitrous oxide analgesia, neuraxial analgesia, and those who transition from nitrous to neuraxial analgesia. In fact, published evidence supports extraordinarily high satisfaction in women who plan to use inhaled nitrous oxide, and actually successfully do so, despite only limited degrees of pain relief.^10,11 Work to identify the characteristics of women who report success with inhaled nitrous oxide use needs to be performed so that patients can be better selected and informed when making analgesic choices.

Animal research on inhaled nitrous oxide may not translate well to human neonates

A very recent task force convened by the European Society of Anaesthesiology (ESA) addressed some of the potential concerns about inhaled nitrous oxide analgesia.¹² Per their report:

“the potential teratogenic effect of N2O observed in experimental models cannot be extrapolated to humans. There is a lack of evidence for an association between N2O and reproductive toxicity. The incidence of health hazards and abortion was not shown to be higher in women exposed to, or spouses of men exposed to N2O than those who were not so exposed. Moreover, the incidence of congenital malformations was not higher among women who received N2O for anaesthesia during the first trimester of pregnancy nor during anaesthesia management for cervical cerclage, nor for surgery in the first two trimesters of pregnancy.”

There is a theoretical concern of an increase in neuronal apoptosis in neonates, demonstrated in laboratory animals in anesthetic concentrations, but the human relevance of this is not clear, since the data on animal developmental neurotoxicity is generally combined with data wherein potent inhalational anesthetic agents were also used, not nitrous oxide alone.¹³ The analgesic doses and time of exposure of inhaled nitrous oxide administered for labor analgesia are well below those required for these changes, as subanesthetic doses are associated with minimal changes, if any, in laboratory animals.

No labor analgesic is without the potential for fetal effects, and alternative labor analgesics such as systemic opioids in higher doses also may have potential adverse effects on the fetus, such as fetal heart rate effects or early tone, alertness, and breastfeeding difficulties. The low solubility and short half-life of inhaled nitrous oxide contribute to low absorption by tissues, thus contributing to the safety of this agent. Nitrous oxide via inhalation for sedation during elective cesarean has been reported to show no adverse effects on neonatal Apgar scores.¹⁴

Modern equipment keeps occupational exposure to nitrous oxide safe

One retrospective review of women exposed to high concentrations of inhaled nitrous oxide reported reduced fertility.¹⁵ However, the only effects on fertility were seen when nitrous was used without scavenging equipment, and in high concentrations. Moreover, that study examined dental offices, where nitrous was free flowing during procedures—quite a different setting than the intermittent inhalation, demand-valve modality as is used during labor—and when using appropriate modern, FDA-approved equipment, and scavenging devices. Per the recent ESA task force¹²:

“Members of the task force agreed that, despite theoretical concerns and laboratory data, there is no evidence indicating that the use of N2O in a clinically relevant setting would increase health risk in patients or providers exposed to this drug. With the ubiquitous availability of scavenging systems in the modern operating room, the health concern for medical staff has decreased dramatically. Properly operating scavenging systems reduce N2O concentrations by more than 70%, thereby efficiently keeping ambient N2O levels well below official limits.”

The ESA task force concludes: “An extensive amount of clinical evidence indicates that N2O can be used safely for procedural pain management, for labour pain, and for anxiolysis and sedation in dentistry.”¹²

Two important reminders

Inhaled nitrous oxide has been a central component of the labor pain relief menu in most of the rest of the world for decades, and the safety record is impeccable. This agent has now had extensive and growing experience in American maternity units. Remember 2 critical points: 1) patient selection is key, 2) analgesia is not like that provided by regional anesthetic techniques such as an epidural.

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

Nitrous oxide, a colorless, odorless gas, has long been used for labor analgesia in many countries, including the United Kingdom, Canada, throughout Europe, Australia, and New Zealand. Recently, interest in its use in the United States has increased, since the US Food and Drug Administration (FDA) approval in 2012 of simple devices for administration of nitrous oxide in a variety of locations. Being able to offer an alternative technique, other than parenteral opioids, for women who may not wish to or who cannot have regional analgesia, and for women who have delivered and need analgesia for postdelivery repair, conveys significant benefits. Risks to its use are very low, although the quality of pain relief is inferior to that offered by regional analgesic techniques. Our experience with its use since 2014 at Brigham and Women’s Hospital in Boston, Massachusetts, corroborates that reported in the literature and leads us to continue offering inhaled nitrous oxide and advocating that others do as well.^1–7 When using nitrous oxide in your labor and delivery unit, or if considering its use, keep the following points in mind.

A successful inhaled nitrous oxide program requires proper patient selection

Inhaled nitrous oxide is not an epidural (TABLE).⁸ The pain relief is clearly inferior to that of an epidural. Inhaled nitrous oxide will not replace epidurals or even have any effect on the epidural rate at a particular institution.⁶ However, the use of inhaled nitrous oxide for labor analgesia has a long track record of safety (albeit with moderate efficacy for selected patients) for many years in many countries around the world. Inhaled nitrous oxide is a valuable addition to the options we can offer patients:

• who are poor responders to opioid medication or who have high opioid tolerance
• with certain disorders of coagulation
• with chronic pain or anxiety
• who for other reasons need to consider alternatives or adjuncts to neuraxial analgesia.

Although it is important to be realistic regarding the expectations of analgesia quality offered by this agent,⁷ compared with other agents we have tried, it has less adverse effects, is economically reasonable, and has no proven impact on neonatal outcomes.

No significant complications with inhaled nitrous oxide have been reported

Systematic reviews did not report any significant complications to either mother or newborn.^1,2 Our personal experiences corroborate this, as no complications have been associated with its frequent use at Brigham and Women’s Hospital. Reported adverse effects are mild. The incidence of nausea is 13%, dizziness is 3% to 5%, and drowsiness is 4%; these rates are hard to detect over the baseline rates of those side effects associated with labor and delivery alone.¹ Many other centers have now adopted the use of this agent, with several hundred locations now offering inhaled nitrous oxide for labor analgesia in the United States.

Practical use of inhaled nitrous oxide is relatively simple

Several vendors offer portable, user-friendly, cost-effective equipment that is appropriate for labor and delivery use. All devices are structured in demand-valve modality, meaning that the patient must initiate a breath in order to open a valve that allows gas to flow. Cessation of the inspiratory effort closes the valve, thus preventing the free flow of gas into the ambient atmosphere of the room. The devices generally include a tank with nitrous oxide as well as a source of oxygen. Most devices designed for labor and delivery provide a fixed mixture of 50% nitrous oxide and 50% oxygen, with fail-safe mechanisms to allow increased oxygen delivery in the event of failure or depletion of the nitrous supply. All modern, FDA–approved devices include effective scavenging systems, such that expired gases are vented outside (generally via room suction), which prevents occupational exposure to low levels of nitrous oxide.

Inhaled nitrous oxide for labor pain must be patient controlled

An essential feature of the use of inhaled nitrous oxide for labor analgesia is that it must be considered a patient-controlled system. Patients have an option to use either a mask or a mouthpiece, according to their preferences and comfort. The patient must hold the mask or mouthpiece herself; it is neither appropriate nor safe for anyone else, such as a nurse, family member, or labor support personnel, to assist with this task.

Some coordination with the nurse is essential for optimal timing of administration. Onset of a therapeutic level of pain relief is generally 30 to 60 seconds after inhalation has begun, with rapid resolution after cessation of the inhalation. The patient should thus initiate the inspiration of the gas at the earliest signs of onset of a contraction, so as to achieve maximal analgesia at the peak of the contraction. Waiting until the peak of the contraction to initiate inhalation of the nitrous oxide will not provide effective analgesia, yet will result in sedation after the contraction has ended.

Read about patient satisfaction with inhaled nitrous oxide.

No oversight by an anesthesiologist is required

The Centers for Medicare and Medicaid Services (CMS) produced a clarification statement for definitions of “anesthesia services” (42 CFR 482.52)⁹ that may be offered by a hospital, based on American Society of Anesthesiologists (ASA) definitions. CMS, consistent with ASA guidelines, does not define moderate or conscious sedation as “anesthesia,” thus direct oversight by an anesthesiologist is not required. Furthermore, the definition of “minimal sedation,” which is where 50% concentration delivery of inhaled nitrous oxide would be categorized, also does not meet this requirement by CMS.

Illustration: Kimberly Martens for OBG Management

Women who use inhaled nitrous oxide for labor pain typically are satisfied with its use

The use of analog pain scale measurements may not be appropriate in a setting where dissociation from pain might be the primary beneficial effect. Measurements of maternal satisfaction with their analgesic experience support this. The experiences at Vanderbilt University and Brigham and Women’s Hospital show that, while pain relief is limited, like reported in systematic reviews, maternal satisfaction scores for labor analgesia are not different among women who receive inhaled nitrous oxide analgesia, neuraxial analgesia, and those who transition from nitrous to neuraxial analgesia. In fact, published evidence supports extraordinarily high satisfaction in women who plan to use inhaled nitrous oxide, and actually successfully do so, despite only limited degrees of pain relief.^10,11 Work to identify the characteristics of women who report success with inhaled nitrous oxide use needs to be performed so that patients can be better selected and informed when making analgesic choices.

Animal research on inhaled nitrous oxide may not translate well to human neonates

A very recent task force convened by the European Society of Anaesthesiology (ESA) addressed some of the potential concerns about inhaled nitrous oxide analgesia.¹² Per their report:

“the potential teratogenic effect of N2O observed in experimental models cannot be extrapolated to humans. There is a lack of evidence for an association between N2O and reproductive toxicity. The incidence of health hazards and abortion was not shown to be higher in women exposed to, or spouses of men exposed to N2O than those who were not so exposed. Moreover, the incidence of congenital malformations was not higher among women who received N2O for anaesthesia during the first trimester of pregnancy nor during anaesthesia management for cervical cerclage, nor for surgery in the first two trimesters of pregnancy.”

There is a theoretical concern of an increase in neuronal apoptosis in neonates, demonstrated in laboratory animals in anesthetic concentrations, but the human relevance of this is not clear, since the data on animal developmental neurotoxicity is generally combined with data wherein potent inhalational anesthetic agents were also used, not nitrous oxide alone.¹³ The analgesic doses and time of exposure of inhaled nitrous oxide administered for labor analgesia are well below those required for these changes, as subanesthetic doses are associated with minimal changes, if any, in laboratory animals.

No labor analgesic is without the potential for fetal effects, and alternative labor analgesics such as systemic opioids in higher doses also may have potential adverse effects on the fetus, such as fetal heart rate effects or early tone, alertness, and breastfeeding difficulties. The low solubility and short half-life of inhaled nitrous oxide contribute to low absorption by tissues, thus contributing to the safety of this agent. Nitrous oxide via inhalation for sedation during elective cesarean has been reported to show no adverse effects on neonatal Apgar scores.¹⁴

Modern equipment keeps occupational exposure to nitrous oxide safe

One retrospective review of women exposed to high concentrations of inhaled nitrous oxide reported reduced fertility.¹⁵ However, the only effects on fertility were seen when nitrous was used without scavenging equipment, and in high concentrations. Moreover, that study examined dental offices, where nitrous was free flowing during procedures—quite a different setting than the intermittent inhalation, demand-valve modality as is used during labor—and when using appropriate modern, FDA-approved equipment, and scavenging devices. Per the recent ESA task force¹²:

“Members of the task force agreed that, despite theoretical concerns and laboratory data, there is no evidence indicating that the use of N2O in a clinically relevant setting would increase health risk in patients or providers exposed to this drug. With the ubiquitous availability of scavenging systems in the modern operating room, the health concern for medical staff has decreased dramatically. Properly operating scavenging systems reduce N2O concentrations by more than 70%, thereby efficiently keeping ambient N2O levels well below official limits.”

The ESA task force concludes: “An extensive amount of clinical evidence indicates that N2O can be used safely for procedural pain management, for labour pain, and for anxiolysis and sedation in dentistry.”¹²

Two important reminders

Inhaled nitrous oxide has been a central component of the labor pain relief menu in most of the rest of the world for decades, and the safety record is impeccable. This agent has now had extensive and growing experience in American maternity units. Remember 2 critical points: 1) patient selection is key, 2) analgesia is not like that provided by regional anesthetic techniques such as an epidural.

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

PART 1

• Leading best gynecologic surgical care into the next decade
• Optimal surgical management of stage 3 and 4 pelvic organ prolapse
• Patient experience: It’s not about satisfaction

‌

‌

Andrew P. Cassidenti, MD
Chief, Female Pelvic Medicine and Reconstructive Surgery
Kern Medical,
Bakersfield, California

Amanda White, MD
Assistant Professor, Department of Women’s Health
Female Pelvic Medicine and Reconstructive Surgery
Dell Medical School, University of Texas
Austin, Texas

Vivian Aguilar, MD
Assistant Professor, Obstetrics and Gynecology
Female Pelvic Medicine and Reconstructive Surgery
Dell Medical School, University of Texas
Austin, Texas

Rebecca G. Rogers, MD
Professor, Department of Women’s Health
Female Pelvic Medicine and Reconstructive Surgery
Associate Chair, Clinical Integration and Operations
Dell Medical School, University of Texas
Austin, Texas

Patrick Culligan, MD
Director, Urogynecology and The Center for Female Pelvic Health
Department of Urology
Weill Cornell Medical College, New York Presbyterian/Weill Cornell Medical Center
New York, New York

Sarah Huber, MD
Fellow, Female Pelvic Medicine and Reconstructive Surgery
Department of Urology
Weill Cornell Medical College, New York Presbyterian/Weill Cornell Medical Center
New York, New York

Vincent R. Lucente, MD, MBA
Chief, Gynecology, St. Luke’s University Health Network
Medical Director, The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania

Jessica B. Ton, MD
AAGL Fellow, Minimally Invasive Gynecologic Surgery
St. Luke’s University Health Network
Bethlehem, Pennsylvania

James I. Merlino, MD
President and Chief Medical Officer of Advisory and Strategic Consulting
Press Ganey Associates
Cleveland, Ohio

Amy A. Merlino, MD
Maternal Fetal Medicine Specialist
Department of Obstetrics and Gynecology
Enterprise Chief Informatics Officer
Cleveland Clinic, Cleveland, Ohio

PART 2

• Deep infiltrating endometriosis: Evaluation and management
• What’s new in simulation training for hysterectomy

‌

‌

‌

‌

Rosanne M. Kho, MD
Head, Section of Benign Gynecology
Women’s Health Institute
Department of Obstetrics and Gynecology
Cleveland Clinic
Cleveland, Ohio

Mauricio S. Abrão, MD
Associate Professor and
Director, Endometriosis Division
Department of Obstetrics and Gynecology
São Paulo University Medical School
São Paulo, Brazil

Alicia Scribner, MD, MPH
Director, Ob/Gyn Simulation Curriculum
Madigan Army Medical Center
Tacoma, Washington
Clinical Instructor
Department of Obstetrics and Gynecology
University of Washington, Seattle

Christine Vaccaro, DO
Medical Director, Andersen Simulation Center
Madigan Army Medical Center
Tacoma, Washington
Clinical Assistant Professor
Department of Obstetrics and Gynecology
University of Washington, Seattle
Uniformed Services University of Health Sciences
Bethesda, Maryland

PART 1

• Leading best gynecologic surgical care into the next decade
• Optimal surgical management of stage 3 and 4 pelvic organ prolapse
• Patient experience: It’s not about satisfaction

‌

‌

Andrew P. Cassidenti, MD
Chief, Female Pelvic Medicine and Reconstructive Surgery
Kern Medical,
Bakersfield, California

Amanda White, MD
Assistant Professor, Department of Women’s Health
Female Pelvic Medicine and Reconstructive Surgery
Dell Medical School, University of Texas
Austin, Texas

Vivian Aguilar, MD
Assistant Professor, Obstetrics and Gynecology
Female Pelvic Medicine and Reconstructive Surgery
Dell Medical School, University of Texas
Austin, Texas

Rebecca G. Rogers, MD
Professor, Department of Women’s Health
Female Pelvic Medicine and Reconstructive Surgery
Associate Chair, Clinical Integration and Operations
Dell Medical School, University of Texas
Austin, Texas

Patrick Culligan, MD
Director, Urogynecology and The Center for Female Pelvic Health
Department of Urology
Weill Cornell Medical College, New York Presbyterian/Weill Cornell Medical Center
New York, New York

Sarah Huber, MD
Fellow, Female Pelvic Medicine and Reconstructive Surgery
Department of Urology
Weill Cornell Medical College, New York Presbyterian/Weill Cornell Medical Center
New York, New York

Vincent R. Lucente, MD, MBA
Chief, Gynecology, St. Luke’s University Health Network
Medical Director, The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania

Jessica B. Ton, MD
AAGL Fellow, Minimally Invasive Gynecologic Surgery
St. Luke’s University Health Network
Bethlehem, Pennsylvania

James I. Merlino, MD
President and Chief Medical Officer of Advisory and Strategic Consulting
Press Ganey Associates
Cleveland, Ohio

Amy A. Merlino, MD
Maternal Fetal Medicine Specialist
Department of Obstetrics and Gynecology
Enterprise Chief Informatics Officer
Cleveland Clinic, Cleveland, Ohio

PART 2

• Deep infiltrating endometriosis: Evaluation and management
• What’s new in simulation training for hysterectomy

‌

‌

‌

‌

Rosanne M. Kho, MD
Head, Section of Benign Gynecology
Women’s Health Institute
Department of Obstetrics and Gynecology
Cleveland Clinic
Cleveland, Ohio

Mauricio S. Abrão, MD
Associate Professor and
Director, Endometriosis Division
Department of Obstetrics and Gynecology
São Paulo University Medical School
São Paulo, Brazil

Alicia Scribner, MD, MPH
Director, Ob/Gyn Simulation Curriculum
Madigan Army Medical Center
Tacoma, Washington
Clinical Instructor
Department of Obstetrics and Gynecology
University of Washington, Seattle

Christine Vaccaro, DO
Medical Director, Andersen Simulation Center
Madigan Army Medical Center
Tacoma, Washington
Clinical Assistant Professor
Department of Obstetrics and Gynecology
University of Washington, Seattle
Uniformed Services University of Health Sciences
Bethesda, Maryland

PART 1

• Leading best gynecologic surgical care into the next decade
• Optimal surgical management of stage 3 and 4 pelvic organ prolapse
• Patient experience: It’s not about satisfaction

‌

‌

Andrew P. Cassidenti, MD
Chief, Female Pelvic Medicine and Reconstructive Surgery
Kern Medical,
Bakersfield, California

Amanda White, MD
Assistant Professor, Department of Women’s Health
Female Pelvic Medicine and Reconstructive Surgery
Dell Medical School, University of Texas
Austin, Texas

Vivian Aguilar, MD
Assistant Professor, Obstetrics and Gynecology
Female Pelvic Medicine and Reconstructive Surgery
Dell Medical School, University of Texas
Austin, Texas

Rebecca G. Rogers, MD
Professor, Department of Women’s Health
Female Pelvic Medicine and Reconstructive Surgery
Associate Chair, Clinical Integration and Operations
Dell Medical School, University of Texas
Austin, Texas

Patrick Culligan, MD
Director, Urogynecology and The Center for Female Pelvic Health
Department of Urology
Weill Cornell Medical College, New York Presbyterian/Weill Cornell Medical Center
New York, New York

Sarah Huber, MD
Fellow, Female Pelvic Medicine and Reconstructive Surgery
Department of Urology
Weill Cornell Medical College, New York Presbyterian/Weill Cornell Medical Center
New York, New York

Vincent R. Lucente, MD, MBA
Chief, Gynecology, St. Luke’s University Health Network
Medical Director, The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania

Jessica B. Ton, MD
AAGL Fellow, Minimally Invasive Gynecologic Surgery
St. Luke’s University Health Network
Bethlehem, Pennsylvania

James I. Merlino, MD
President and Chief Medical Officer of Advisory and Strategic Consulting
Press Ganey Associates
Cleveland, Ohio

Amy A. Merlino, MD
Maternal Fetal Medicine Specialist
Department of Obstetrics and Gynecology
Enterprise Chief Informatics Officer
Cleveland Clinic, Cleveland, Ohio

PART 2

• Deep infiltrating endometriosis: Evaluation and management
• What’s new in simulation training for hysterectomy

‌

‌

‌

‌

Rosanne M. Kho, MD
Head, Section of Benign Gynecology
Women’s Health Institute
Department of Obstetrics and Gynecology
Cleveland Clinic
Cleveland, Ohio

Mauricio S. Abrão, MD
Associate Professor and
Director, Endometriosis Division
Department of Obstetrics and Gynecology
São Paulo University Medical School
São Paulo, Brazil

Alicia Scribner, MD, MPH
Director, Ob/Gyn Simulation Curriculum
Madigan Army Medical Center
Tacoma, Washington
Clinical Instructor
Department of Obstetrics and Gynecology
University of Washington, Seattle

Christine Vaccaro, DO
Medical Director, Andersen Simulation Center
Madigan Army Medical Center
Tacoma, Washington
Clinical Assistant Professor
Department of Obstetrics and Gynecology
University of Washington, Seattle
Uniformed Services University of Health Sciences
Bethesda, Maryland

Due to an increase in minimally invasive approaches to hysterectomy, including vaginal and laparoscopic approaches, gynecologic surgeons may need to turn to simulation training to augment practice and hone skills. Simulation is useful for all surgeons, especially for low-volume surgeons, as a warm-up to sharpen technical skills prior to starting the day’s cases. Additionally, educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency.

In this article, we provide an overview of the 3 approaches to hysterectomy—vaginal, laparoscopic, abdominal—through medical modeling and simulation techniques. We focus on practical issues, including current resources available online, cost, setup time, fidelity, and limitations of some commonly available vaginal, laparoscopic, and open hysterectomy models.

Simulation directly influences patient safety. Thus, the value of simulation cannot be overstated, as it can increase the quality of health care by improving patient outcomes and lowering overall costs. In 2008, the American College of Obstetricians and Gynecologists (ACOG) founded the Simulations Working Group to establish simulation as a pillar in education for women’s health through collaboration, advocacy, research, and the development and implementation of multidisciplinary simulations-based educational resources and opportunities.

Refer to the ACOG Simulations Working Group Toolkit online to see the objectives, simulation, and videos related to each module. Under the “Hysterectomy” section, you will find how to construct the “flower pot” model for abdominal and vaginal hysterectomy, as well as the AAGL vaginal and laparoscopic hysterectomy webinars. All content is reaffirmed frequently to keep it up to date. You can access the toolkit, with your ACOG login and passcode, at https://www.acog.org/About-ACOG/ACOG-Departments/Simulations-Consortium/Simulations-Consortium-Tool-Kit.

For a comprehensive gynecology curriculum to include vaginal, laparoscopic, and abdominal approaches to hysterectomy, refer to ACOG’s Surgical Curriculum in Obstetrics and Gynecology page at https://cfweb.acog.org/scog/. This page lists the standardized surgical skills curriculum for use in training residents in obstetrics and gynecology by procedure. It includes:

• the objective, description, and assessment of the module
• a description of the simulation
• a description of the surgical procedure
• a quiz that must be passed to proceed to evaluation by a faculty member
• an evaluation form to be downloaded and printed by the learner.

Takeaway. Value of Simulation = Quality (Improved Patient Outcomes) ÷ Direct and Indirect Costs.

Simulation models for training in vaginal hysterectomy

According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15; this number represents the minimum accepted exposure, however, and does not imply competency. Exposure to vaginal hysterectomy in residency training has significantly declined over the years, with a mean of only 19 vaginal hysterectomies performed by the time of graduation in 2014.¹

A wide range of simulation models are available that you either can construct or purchase, based on your budget. We discuss 3 such models below.

The Miya model

The Miya Model Pelvic Surgery Training Model (Miyazaki Enterprises) consists of a bony pelvic frame and multiple replaceable and realistic anatomic structures, including the uterus, cervix, and adnexa (1 structure), vagina, bladder, and a few selected muscles and ligaments for pelvic floor disorders (FIGURE 1). The model incorporates features to simulate actual surgical experiences, such as realistic cutting and puncturing tensions, palpable surgical landmarks, a pressurized vascular system with bleeding for inadequate technique, and an inflatable bladder that can leak water if damaged.

Mounted on a rotating stand with the top of the pelvis open, the Miya model is designed to provide access and visibility, enabling supervising physicians the ability to give immediate guidance and feedback. The interchangeable parts allow the learner to be challenged at the appropriate skill level with the use of a large uterus versus a smaller uterus.

New in 2018 is an “intern” uterus and vagina that have no vascular supply and a single-layer vagina; this model is one-third of the cost of the larger, high-fidelity uterus (which has a vascular supply and additional tissue layers).

The Miya model reusable bony pelvic frame has a one-time cost of a few thousand dollars. Advantages include its high fidelity, low technology, light weight, portability, and quick setup. To view a video of the Miya model, go to https://www.youtube.com/watch?time_continue=49&v=A2RjOgVRclo. To see a simulated vaginal hysterectomy, visit https://www.youtube.com/watch?time_continue=13&v=dwiQz4DTyy8.

The gynecologic surgeon and inventor, Dr. Douglas Miyazaki, has improved the vesicouterine peritoneal fold (usually the most challenging for the surgeon) to have a more realistic, slippery feel when palpated.

This model’s weaknesses are its cost (relative to low-fidelity models) and the inability to use energy devices.

Takeaway. The Miya model is a high-fidelity, portable vaginal hysterectomy model with a reusable base and consumable replacement parts. It can be tailored to the learner’s desired level of difficulty.

The Gynesim model

The Gynesim Vaginal Hysterectomy Model, developed by Dr. Malcolm “Kip” Mackenzie (Gynesim), is a high-fidelity surgical simulation model constructed from animal tissue to provide realistic training in pelvic surgery (FIGURE 2).

These “real tissue models” are hand-constructed from animal tissue harvested from US Department of Agriculture inspected meat processing centers. The models mimic normal and abnormal abdominal and pelvic anatomy, providing realistic feel (haptics) and response to all surgical energy modalities. The “cassette” tissues are placed within a vaginal approach platform, which is portable.

Each model (including a 120- to 240-g uterus, bladder, ureter, uterine artery, cardinal and uterosacral ligaments, and rectum) supports critical gaps in surgical techniques such as peritoneal entry and cuff closure. Gynesim staff set up the entire laboratory, including the simulation models, instruments, and/or cameras; however, surgical energy systems are secured from the host institution.

The advantages of this model are its excellent tissue haptics and the minimal preparation time required from the busy gynecologic teaching faculty, as the company performs the setup and breakdown. Disadvantages include the model’s cost (relative to low-fidelity models), that it does not bleed, its one-time use, and the need for technical assistance from the company for setup.

This model can be used for laparoscopic and open hysterectomy approaches, as well as for vaginal hysterectomy. For more information, visit the Gynesim website at https://www.gynesim.com/vaginal-hysterectomy/.

Takeaway. The high-fidelity Gynesim model can be used to practice vaginal, laparoscopic, or open hysterectomy approaches. It offers excellent tissue haptics, one-time use “cassettes” made from animal tissue, and compatibility with energy devices.

The milk jug model

The milk jug and fabric uterus model, developed by Dr. Dee Fenner, is a low-cost simulation model and an alternative to the flower pot model (described later in this article). The bony pelvis is simulated by a 1-gallon milk carton that is taped to a foam ring. Other materials used to make the uterus are fabric, stuffing, and a needle and thread (or a sewing machine). Each model costs approximately $5 and takes approximately 15 minutes to create. For instructions on how to construct this model, see the Society for Gynecologic Surgeons (SGS) award-winning video from 2012 at https://vimeo.com/123804677.

The advantages of this model are that it is inexpensive and is a good tool with which novice gynecologic surgeons can learn the basic steps of the procedure. The disadvantages are that it does not bleed, is not compatible with energy devices, and must be constructed by hand (adding considerable time) or with a sewing machine.

Takeaway. The milk jug model is a low-cost, low-fidelity model for the novice surgeon that can be quickly constructed with the use of a sewing machine.

Read about simulation models for training in laparoscopic hysterectomy.

Simulation models for training in laparoscopic hysterectomy

While overall hysterectomy numbers have remained relatively stable during the last 10 years, the proportion of laparoscopic hysterectomy procedures is increasing in residency training.¹ Many toolkits and models are available for practicing skills, from low-fidelity models on which to rehearse laparoscopic techniques (suturing, instrument handling) to high-fidelity models that provide augmented reality views of the abdominal cavity as well as the operating room itself. We offer a sampling of 4 such models below.

The FLS trainer system

The Fundamentals of Laparoscopic Surgery (FLS) Trainer Box (Limbs & Things Ltd) provides hands-on manual skills practice and training for laparoscopic surgery (FIGURE 3). The FLS trainer box uses 5 skills to challenge a surgeon’s dexterity and psychomotor skills. The set includes the trainer box with a camera and light source as well as the equipment needed to perform the 5 FLS tasks (peg transfer, pattern cutting, ligating loop, and intracorporeal and extracorporeal knot tying). The kit does not include laparoscopic instruments or a monitor.

The FLS trainer box with camera costs $1,164. The advantages are that it is portable and can be used to warm-up prior to surgery or for practice to improve technical skills. It is a great tool for junior residents who are learning the basics of laparoscopic surgery. This trainer’s disadvantages are that it is a low-fidelity unit that is procedure agnostic. For more information, visit the Limbs & Things website at https://www.fls-products.com.

Notably, ObGyn residents who graduate after May 31, 2020, will be required to successfully complete the FLS program as a prerequisite for specialty board certification.² The FLS program is endorsed by the American College of Surgeons and is run through the Society of American Gastrointestinal and Endoscopic Surgeons. The FLS test is proctored and must be taken at a testing center.

Takeaway. The FLS trainer box is readily available, portable, relatively inexpensive, low-tech, and has valid benchmarks for proficiency. The FLS test will be required for ObGyn residents by 2020.

The SimPraxis software trainer

The SimPraxis Laparoscopic Hysterectomy Trainer (Red Llama, Inc) is an interactive simulation software platform that is available in DVD or USB format (FIGURE 4). The software is designed to review anatomy, surgical instrumentation, and specific steps of the procedure. It provides formative assessments and offers summative feedback for users.

The SimPraxis training software would make a useful tool to familiarize medical students and interns with the basics of the procedure before advancing to other simulation trainers. The software costs $100. For more information, visit https://www.3-dmed.com/product/simpraxis%C3%82%C2%AE-laparoscopic-hysterectomy-trainer.

Takeaway. The SimPraxis software is ideal for novice learners and can be used on a home or office computer.

The LapSim virtual reality trainer

The LapSim Haptic System (Surgical Science) is a virtual reality skills trainer. The hysterectomy module includes right and left uterine artery dissection, vaginal cuff opening, and cuff closure (FIGURE 5). One advantage of this simulator is its haptic feedback system, which enhances the fidelity of the training.

The LapSim simulator includes a training module for students and early learners and modules to improve camera handling. The virtual reality base system costs $70,720, and the hysterectomy software module is an additional $15,600.

For more information, visit the company’s website at https://surgicalscience.com/systems/lapsim/. For an informational video, go to https://surgicalscience.com/systems/lapsim/video/.

Takeaway. The LapSim is an expensive, high-fidelity, virtual reality simulator with enhanced haptics and software for practicing laparoscopic hysterectomy.

The LAP Mentor virtual reality simulator

The LAP Mentor VR (3D Systems) is another virtual reality simulator that has modules for laparoscopic hysterectomy and cuff closure (FIGURE 6). The trainee uses a virtual reality headset and becomes fully immersed in the operating room environment with audio and visual cues that mimic a real surgical experience.

The hysterectomy module allows the user to manipulate the uterus, identify the ureters, divide the superior pedicles, mobilize the bladder, expose and divide the uterine artery, and perform the colpotomy. The cuff closure module allows the user to suture the vaginal cuff using barbed suture. The module also can expose the learner to complications, such as bladder, ureteral, colon, or vascular injury.

The LAP Mentor VR base system costs $84,000 and the modules cost about $15,000. For additional information, visit the company’s website at http://simbionix.com/simulators/lap-mentor/lap-mentor-vr-or/.

Takeaway. The LAP Mentor is an expensive, high-fidelity simulation platform with a virtual reality headset that simulates a laparoscopic hysterectomy (with complications) in the operating room.

Read about simulations models for robot-assisted lap hysterectomy and abdominal hysterectomy.

Simulation models for training in robot-assisted laparoscopic hysterectomy

All robot-assisted simulation platforms have highly realistic graphics, and they are expensive (TABLE). However, the da Vinci Skills Simulator (backpack) platform is included with the da Vinci Si and Xi Systems. Note, though, that it can be challenging to access the surgeon console and backpack at institutions with high volumes of robot-assisted surgery.

Other options that generally reside outside of the operating room include Mimic’s FlexVR and dV-Trainer and the Robotix Mentor by 3D Systems (FIGURES 7–11). Mimic’s new technology, called MaestroAR (augmented reality), allows trainees to manipulate virtual robotic instruments to interact with anatomic regions within augmented 3D surgical video footage, with narration and instruction by Dr. Arnold Advincula.

Newer software by Simbionix allows augmented reality to assist the simulation of robot-assisted hysterectomy with the da Vinci Xi backpack and RobotiX platforms.

Models for training in abdominal hysterectomy

In the last 10 years, there has been a 30% decrease in the number of abdominal hysterectomies performed by residents.¹ Because of this decline in operating room experience, simulation training can be an important tool to bolster residency experience.

There are not many simulation models available for teaching abdominal hysterectomy, but here we discuss 2 that we utilize in our residency program.

Adaptable task trainer

The Surgical Female Pelvic Trainer (SFPT) (Limbs & Things Ltd), a pelvic task trainer primarily used for simulation of laparoscopic hysterectomy, can be adapted for abdominal hysterectomy by removing the abdominal cover (FIGURE 12). This trainer can be used with simulated blood to increase the realism of training. The SFPT trainer costs $2,190. For more information, go to https://www.limbsandthings.com/us/our-products/details/surgical-female-pelvic-trainer-sfpt-mk-2.

Takeaway. The SFPT is a medium-fidelity task trainer with a reusable base and consumable replacement parts.

ACOG’s do-it-yourself flower pot model

The flower pot model (developed by the ACOG Simulation Working Group, Washington, DC) is a comprehensive educational package that includes learning objectives, simulation construction instructions, content review of the abdominal hysterectomy, quiz, and evaluation form.³ ACOG has endorsed this low-cost model for residency education. Each model costs approximately $20, and the base (flower pot) is reusable (FIGURE 13).Construction time for each model is 30 to 60 minutes, and learners can participate in the construction. This can aid in anatomy review and familiarization with the model prior to training in the surgical procedure.

The learning objectives, content review, quiz, and evaluation form can be used for the flower pot model or for high-fidelity models.

The advantages of this model are the low cost and that it provides enough fidelity to teach each of the critical steps of the procedure. The disadvantages include that it is a lower-fidelity model, requires a considerable amount of time for construction, does not bleed, and is not compatible with energy devices. This model also can be used for training in laparoscopic and vaginal hysterectomy. For more information, visit ACOG’s Surgical Curriculum website at https://cfweb.acog.org/scog/.

Takeaway. ACOG’s flower pot model for hysterectomy training is a comprehensive, low-cost, low-fidelity simulation model that requires significant setup time.

Simulation’s offerings

Simulation training is the present and future of medicine that bridges the gap between textbook learning and technical proficiency. Although in this article we describe only a handful of the simulation resources available, we hope that you will incorporate such tools into your practice for continuing education and skill development. Utilize peer-reviewed resources, such as the ACOG curriculum module and evaluation tools for abdominal, laparoscopic, and vaginal hysterectomy, which can be used with any simulation model to provide a comprehensive and complimentary learning experience.

The future of health care depends on the commitment and ingenuity of educators who embrace medical simulation’s purpose: improved patient safety, effectiveness, and efficiency. Join the movement!

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

Due to an increase in minimally invasive approaches to hysterectomy, including vaginal and laparoscopic approaches, gynecologic surgeons may need to turn to simulation training to augment practice and hone skills. Simulation is useful for all surgeons, especially for low-volume surgeons, as a warm-up to sharpen technical skills prior to starting the day’s cases. Additionally, educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency.

In this article, we provide an overview of the 3 approaches to hysterectomy—vaginal, laparoscopic, abdominal—through medical modeling and simulation techniques. We focus on practical issues, including current resources available online, cost, setup time, fidelity, and limitations of some commonly available vaginal, laparoscopic, and open hysterectomy models.

Simulation directly influences patient safety. Thus, the value of simulation cannot be overstated, as it can increase the quality of health care by improving patient outcomes and lowering overall costs. In 2008, the American College of Obstetricians and Gynecologists (ACOG) founded the Simulations Working Group to establish simulation as a pillar in education for women’s health through collaboration, advocacy, research, and the development and implementation of multidisciplinary simulations-based educational resources and opportunities.

Refer to the ACOG Simulations Working Group Toolkit online to see the objectives, simulation, and videos related to each module. Under the “Hysterectomy” section, you will find how to construct the “flower pot” model for abdominal and vaginal hysterectomy, as well as the AAGL vaginal and laparoscopic hysterectomy webinars. All content is reaffirmed frequently to keep it up to date. You can access the toolkit, with your ACOG login and passcode, at https://www.acog.org/About-ACOG/ACOG-Departments/Simulations-Consortium/Simulations-Consortium-Tool-Kit.

For a comprehensive gynecology curriculum to include vaginal, laparoscopic, and abdominal approaches to hysterectomy, refer to ACOG’s Surgical Curriculum in Obstetrics and Gynecology page at https://cfweb.acog.org/scog/. This page lists the standardized surgical skills curriculum for use in training residents in obstetrics and gynecology by procedure. It includes:

• the objective, description, and assessment of the module
• a description of the simulation
• a description of the surgical procedure
• a quiz that must be passed to proceed to evaluation by a faculty member
• an evaluation form to be downloaded and printed by the learner.

Takeaway. Value of Simulation = Quality (Improved Patient Outcomes) ÷ Direct and Indirect Costs.

Simulation models for training in vaginal hysterectomy

According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15; this number represents the minimum accepted exposure, however, and does not imply competency. Exposure to vaginal hysterectomy in residency training has significantly declined over the years, with a mean of only 19 vaginal hysterectomies performed by the time of graduation in 2014.¹

A wide range of simulation models are available that you either can construct or purchase, based on your budget. We discuss 3 such models below.

The Miya model

The Miya Model Pelvic Surgery Training Model (Miyazaki Enterprises) consists of a bony pelvic frame and multiple replaceable and realistic anatomic structures, including the uterus, cervix, and adnexa (1 structure), vagina, bladder, and a few selected muscles and ligaments for pelvic floor disorders (FIGURE 1). The model incorporates features to simulate actual surgical experiences, such as realistic cutting and puncturing tensions, palpable surgical landmarks, a pressurized vascular system with bleeding for inadequate technique, and an inflatable bladder that can leak water if damaged.

Mounted on a rotating stand with the top of the pelvis open, the Miya model is designed to provide access and visibility, enabling supervising physicians the ability to give immediate guidance and feedback. The interchangeable parts allow the learner to be challenged at the appropriate skill level with the use of a large uterus versus a smaller uterus.

New in 2018 is an “intern” uterus and vagina that have no vascular supply and a single-layer vagina; this model is one-third of the cost of the larger, high-fidelity uterus (which has a vascular supply and additional tissue layers).

The Miya model reusable bony pelvic frame has a one-time cost of a few thousand dollars. Advantages include its high fidelity, low technology, light weight, portability, and quick setup. To view a video of the Miya model, go to https://www.youtube.com/watch?time_continue=49&v=A2RjOgVRclo. To see a simulated vaginal hysterectomy, visit https://www.youtube.com/watch?time_continue=13&v=dwiQz4DTyy8.

The gynecologic surgeon and inventor, Dr. Douglas Miyazaki, has improved the vesicouterine peritoneal fold (usually the most challenging for the surgeon) to have a more realistic, slippery feel when palpated.

This model’s weaknesses are its cost (relative to low-fidelity models) and the inability to use energy devices.

Takeaway. The Miya model is a high-fidelity, portable vaginal hysterectomy model with a reusable base and consumable replacement parts. It can be tailored to the learner’s desired level of difficulty.

The Gynesim model

The Gynesim Vaginal Hysterectomy Model, developed by Dr. Malcolm “Kip” Mackenzie (Gynesim), is a high-fidelity surgical simulation model constructed from animal tissue to provide realistic training in pelvic surgery (FIGURE 2).

These “real tissue models” are hand-constructed from animal tissue harvested from US Department of Agriculture inspected meat processing centers. The models mimic normal and abnormal abdominal and pelvic anatomy, providing realistic feel (haptics) and response to all surgical energy modalities. The “cassette” tissues are placed within a vaginal approach platform, which is portable.

Each model (including a 120- to 240-g uterus, bladder, ureter, uterine artery, cardinal and uterosacral ligaments, and rectum) supports critical gaps in surgical techniques such as peritoneal entry and cuff closure. Gynesim staff set up the entire laboratory, including the simulation models, instruments, and/or cameras; however, surgical energy systems are secured from the host institution.

The advantages of this model are its excellent tissue haptics and the minimal preparation time required from the busy gynecologic teaching faculty, as the company performs the setup and breakdown. Disadvantages include the model’s cost (relative to low-fidelity models), that it does not bleed, its one-time use, and the need for technical assistance from the company for setup.

This model can be used for laparoscopic and open hysterectomy approaches, as well as for vaginal hysterectomy. For more information, visit the Gynesim website at https://www.gynesim.com/vaginal-hysterectomy/.

Takeaway. The high-fidelity Gynesim model can be used to practice vaginal, laparoscopic, or open hysterectomy approaches. It offers excellent tissue haptics, one-time use “cassettes” made from animal tissue, and compatibility with energy devices.

The milk jug model

The milk jug and fabric uterus model, developed by Dr. Dee Fenner, is a low-cost simulation model and an alternative to the flower pot model (described later in this article). The bony pelvis is simulated by a 1-gallon milk carton that is taped to a foam ring. Other materials used to make the uterus are fabric, stuffing, and a needle and thread (or a sewing machine). Each model costs approximately $5 and takes approximately 15 minutes to create. For instructions on how to construct this model, see the Society for Gynecologic Surgeons (SGS) award-winning video from 2012 at https://vimeo.com/123804677.

The advantages of this model are that it is inexpensive and is a good tool with which novice gynecologic surgeons can learn the basic steps of the procedure. The disadvantages are that it does not bleed, is not compatible with energy devices, and must be constructed by hand (adding considerable time) or with a sewing machine.

Takeaway. The milk jug model is a low-cost, low-fidelity model for the novice surgeon that can be quickly constructed with the use of a sewing machine.

Read about simulation models for training in laparoscopic hysterectomy.

Simulation models for training in laparoscopic hysterectomy

While overall hysterectomy numbers have remained relatively stable during the last 10 years, the proportion of laparoscopic hysterectomy procedures is increasing in residency training.¹ Many toolkits and models are available for practicing skills, from low-fidelity models on which to rehearse laparoscopic techniques (suturing, instrument handling) to high-fidelity models that provide augmented reality views of the abdominal cavity as well as the operating room itself. We offer a sampling of 4 such models below.

The FLS trainer system

The Fundamentals of Laparoscopic Surgery (FLS) Trainer Box (Limbs & Things Ltd) provides hands-on manual skills practice and training for laparoscopic surgery (FIGURE 3). The FLS trainer box uses 5 skills to challenge a surgeon’s dexterity and psychomotor skills. The set includes the trainer box with a camera and light source as well as the equipment needed to perform the 5 FLS tasks (peg transfer, pattern cutting, ligating loop, and intracorporeal and extracorporeal knot tying). The kit does not include laparoscopic instruments or a monitor.

The FLS trainer box with camera costs $1,164. The advantages are that it is portable and can be used to warm-up prior to surgery or for practice to improve technical skills. It is a great tool for junior residents who are learning the basics of laparoscopic surgery. This trainer’s disadvantages are that it is a low-fidelity unit that is procedure agnostic. For more information, visit the Limbs & Things website at https://www.fls-products.com.

Notably, ObGyn residents who graduate after May 31, 2020, will be required to successfully complete the FLS program as a prerequisite for specialty board certification.² The FLS program is endorsed by the American College of Surgeons and is run through the Society of American Gastrointestinal and Endoscopic Surgeons. The FLS test is proctored and must be taken at a testing center.

Takeaway. The FLS trainer box is readily available, portable, relatively inexpensive, low-tech, and has valid benchmarks for proficiency. The FLS test will be required for ObGyn residents by 2020.

The SimPraxis software trainer

The SimPraxis Laparoscopic Hysterectomy Trainer (Red Llama, Inc) is an interactive simulation software platform that is available in DVD or USB format (FIGURE 4). The software is designed to review anatomy, surgical instrumentation, and specific steps of the procedure. It provides formative assessments and offers summative feedback for users.

The SimPraxis training software would make a useful tool to familiarize medical students and interns with the basics of the procedure before advancing to other simulation trainers. The software costs $100. For more information, visit https://www.3-dmed.com/product/simpraxis%C3%82%C2%AE-laparoscopic-hysterectomy-trainer.

Takeaway. The SimPraxis software is ideal for novice learners and can be used on a home or office computer.

The LapSim virtual reality trainer

The LapSim Haptic System (Surgical Science) is a virtual reality skills trainer. The hysterectomy module includes right and left uterine artery dissection, vaginal cuff opening, and cuff closure (FIGURE 5). One advantage of this simulator is its haptic feedback system, which enhances the fidelity of the training.

The LapSim simulator includes a training module for students and early learners and modules to improve camera handling. The virtual reality base system costs $70,720, and the hysterectomy software module is an additional $15,600.

For more information, visit the company’s website at https://surgicalscience.com/systems/lapsim/. For an informational video, go to https://surgicalscience.com/systems/lapsim/video/.

Takeaway. The LapSim is an expensive, high-fidelity, virtual reality simulator with enhanced haptics and software for practicing laparoscopic hysterectomy.

The LAP Mentor virtual reality simulator

The LAP Mentor VR (3D Systems) is another virtual reality simulator that has modules for laparoscopic hysterectomy and cuff closure (FIGURE 6). The trainee uses a virtual reality headset and becomes fully immersed in the operating room environment with audio and visual cues that mimic a real surgical experience.

The hysterectomy module allows the user to manipulate the uterus, identify the ureters, divide the superior pedicles, mobilize the bladder, expose and divide the uterine artery, and perform the colpotomy. The cuff closure module allows the user to suture the vaginal cuff using barbed suture. The module also can expose the learner to complications, such as bladder, ureteral, colon, or vascular injury.

The LAP Mentor VR base system costs $84,000 and the modules cost about $15,000. For additional information, visit the company’s website at http://simbionix.com/simulators/lap-mentor/lap-mentor-vr-or/.

Takeaway. The LAP Mentor is an expensive, high-fidelity simulation platform with a virtual reality headset that simulates a laparoscopic hysterectomy (with complications) in the operating room.

Read about simulations models for robot-assisted lap hysterectomy and abdominal hysterectomy.

Simulation models for training in robot-assisted laparoscopic hysterectomy

All robot-assisted simulation platforms have highly realistic graphics, and they are expensive (TABLE). However, the da Vinci Skills Simulator (backpack) platform is included with the da Vinci Si and Xi Systems. Note, though, that it can be challenging to access the surgeon console and backpack at institutions with high volumes of robot-assisted surgery.

Other options that generally reside outside of the operating room include Mimic’s FlexVR and dV-Trainer and the Robotix Mentor by 3D Systems (FIGURES 7–11). Mimic’s new technology, called MaestroAR (augmented reality), allows trainees to manipulate virtual robotic instruments to interact with anatomic regions within augmented 3D surgical video footage, with narration and instruction by Dr. Arnold Advincula.

Newer software by Simbionix allows augmented reality to assist the simulation of robot-assisted hysterectomy with the da Vinci Xi backpack and RobotiX platforms.

Models for training in abdominal hysterectomy

In the last 10 years, there has been a 30% decrease in the number of abdominal hysterectomies performed by residents.¹ Because of this decline in operating room experience, simulation training can be an important tool to bolster residency experience.

There are not many simulation models available for teaching abdominal hysterectomy, but here we discuss 2 that we utilize in our residency program.

Adaptable task trainer

The Surgical Female Pelvic Trainer (SFPT) (Limbs & Things Ltd), a pelvic task trainer primarily used for simulation of laparoscopic hysterectomy, can be adapted for abdominal hysterectomy by removing the abdominal cover (FIGURE 12). This trainer can be used with simulated blood to increase the realism of training. The SFPT trainer costs $2,190. For more information, go to https://www.limbsandthings.com/us/our-products/details/surgical-female-pelvic-trainer-sfpt-mk-2.

Takeaway. The SFPT is a medium-fidelity task trainer with a reusable base and consumable replacement parts.

ACOG’s do-it-yourself flower pot model

The flower pot model (developed by the ACOG Simulation Working Group, Washington, DC) is a comprehensive educational package that includes learning objectives, simulation construction instructions, content review of the abdominal hysterectomy, quiz, and evaluation form.³ ACOG has endorsed this low-cost model for residency education. Each model costs approximately $20, and the base (flower pot) is reusable (FIGURE 13).Construction time for each model is 30 to 60 minutes, and learners can participate in the construction. This can aid in anatomy review and familiarization with the model prior to training in the surgical procedure.

The learning objectives, content review, quiz, and evaluation form can be used for the flower pot model or for high-fidelity models.

The advantages of this model are the low cost and that it provides enough fidelity to teach each of the critical steps of the procedure. The disadvantages include that it is a lower-fidelity model, requires a considerable amount of time for construction, does not bleed, and is not compatible with energy devices. This model also can be used for training in laparoscopic and vaginal hysterectomy. For more information, visit ACOG’s Surgical Curriculum website at https://cfweb.acog.org/scog/.

Takeaway. ACOG’s flower pot model for hysterectomy training is a comprehensive, low-cost, low-fidelity simulation model that requires significant setup time.

Simulation’s offerings

Simulation training is the present and future of medicine that bridges the gap between textbook learning and technical proficiency. Although in this article we describe only a handful of the simulation resources available, we hope that you will incorporate such tools into your practice for continuing education and skill development. Utilize peer-reviewed resources, such as the ACOG curriculum module and evaluation tools for abdominal, laparoscopic, and vaginal hysterectomy, which can be used with any simulation model to provide a comprehensive and complimentary learning experience.

The future of health care depends on the commitment and ingenuity of educators who embrace medical simulation’s purpose: improved patient safety, effectiveness, and efficiency. Join the movement!

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

Due to an increase in minimally invasive approaches to hysterectomy, including vaginal and laparoscopic approaches, gynecologic surgeons may need to turn to simulation training to augment practice and hone skills. Simulation is useful for all surgeons, especially for low-volume surgeons, as a warm-up to sharpen technical skills prior to starting the day’s cases. Additionally, educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency.

In this article, we provide an overview of the 3 approaches to hysterectomy—vaginal, laparoscopic, abdominal—through medical modeling and simulation techniques. We focus on practical issues, including current resources available online, cost, setup time, fidelity, and limitations of some commonly available vaginal, laparoscopic, and open hysterectomy models.

Simulation directly influences patient safety. Thus, the value of simulation cannot be overstated, as it can increase the quality of health care by improving patient outcomes and lowering overall costs. In 2008, the American College of Obstetricians and Gynecologists (ACOG) founded the Simulations Working Group to establish simulation as a pillar in education for women’s health through collaboration, advocacy, research, and the development and implementation of multidisciplinary simulations-based educational resources and opportunities.

Refer to the ACOG Simulations Working Group Toolkit online to see the objectives, simulation, and videos related to each module. Under the “Hysterectomy” section, you will find how to construct the “flower pot” model for abdominal and vaginal hysterectomy, as well as the AAGL vaginal and laparoscopic hysterectomy webinars. All content is reaffirmed frequently to keep it up to date. You can access the toolkit, with your ACOG login and passcode, at https://www.acog.org/About-ACOG/ACOG-Departments/Simulations-Consortium/Simulations-Consortium-Tool-Kit.

For a comprehensive gynecology curriculum to include vaginal, laparoscopic, and abdominal approaches to hysterectomy, refer to ACOG’s Surgical Curriculum in Obstetrics and Gynecology page at https://cfweb.acog.org/scog/. This page lists the standardized surgical skills curriculum for use in training residents in obstetrics and gynecology by procedure. It includes:

• the objective, description, and assessment of the module
• a description of the simulation
• a description of the surgical procedure
• a quiz that must be passed to proceed to evaluation by a faculty member
• an evaluation form to be downloaded and printed by the learner.

Takeaway. Value of Simulation = Quality (Improved Patient Outcomes) ÷ Direct and Indirect Costs.

Simulation models for training in vaginal hysterectomy

According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15; this number represents the minimum accepted exposure, however, and does not imply competency. Exposure to vaginal hysterectomy in residency training has significantly declined over the years, with a mean of only 19 vaginal hysterectomies performed by the time of graduation in 2014.¹

A wide range of simulation models are available that you either can construct or purchase, based on your budget. We discuss 3 such models below.

The Miya model

The Miya Model Pelvic Surgery Training Model (Miyazaki Enterprises) consists of a bony pelvic frame and multiple replaceable and realistic anatomic structures, including the uterus, cervix, and adnexa (1 structure), vagina, bladder, and a few selected muscles and ligaments for pelvic floor disorders (FIGURE 1). The model incorporates features to simulate actual surgical experiences, such as realistic cutting and puncturing tensions, palpable surgical landmarks, a pressurized vascular system with bleeding for inadequate technique, and an inflatable bladder that can leak water if damaged.

Mounted on a rotating stand with the top of the pelvis open, the Miya model is designed to provide access and visibility, enabling supervising physicians the ability to give immediate guidance and feedback. The interchangeable parts allow the learner to be challenged at the appropriate skill level with the use of a large uterus versus a smaller uterus.

New in 2018 is an “intern” uterus and vagina that have no vascular supply and a single-layer vagina; this model is one-third of the cost of the larger, high-fidelity uterus (which has a vascular supply and additional tissue layers).

The Miya model reusable bony pelvic frame has a one-time cost of a few thousand dollars. Advantages include its high fidelity, low technology, light weight, portability, and quick setup. To view a video of the Miya model, go to https://www.youtube.com/watch?time_continue=49&v=A2RjOgVRclo. To see a simulated vaginal hysterectomy, visit https://www.youtube.com/watch?time_continue=13&v=dwiQz4DTyy8.

The gynecologic surgeon and inventor, Dr. Douglas Miyazaki, has improved the vesicouterine peritoneal fold (usually the most challenging for the surgeon) to have a more realistic, slippery feel when palpated.

This model’s weaknesses are its cost (relative to low-fidelity models) and the inability to use energy devices.

Takeaway. The Miya model is a high-fidelity, portable vaginal hysterectomy model with a reusable base and consumable replacement parts. It can be tailored to the learner’s desired level of difficulty.

The Gynesim model

The Gynesim Vaginal Hysterectomy Model, developed by Dr. Malcolm “Kip” Mackenzie (Gynesim), is a high-fidelity surgical simulation model constructed from animal tissue to provide realistic training in pelvic surgery (FIGURE 2).

These “real tissue models” are hand-constructed from animal tissue harvested from US Department of Agriculture inspected meat processing centers. The models mimic normal and abnormal abdominal and pelvic anatomy, providing realistic feel (haptics) and response to all surgical energy modalities. The “cassette” tissues are placed within a vaginal approach platform, which is portable.

Each model (including a 120- to 240-g uterus, bladder, ureter, uterine artery, cardinal and uterosacral ligaments, and rectum) supports critical gaps in surgical techniques such as peritoneal entry and cuff closure. Gynesim staff set up the entire laboratory, including the simulation models, instruments, and/or cameras; however, surgical energy systems are secured from the host institution.

The advantages of this model are its excellent tissue haptics and the minimal preparation time required from the busy gynecologic teaching faculty, as the company performs the setup and breakdown. Disadvantages include the model’s cost (relative to low-fidelity models), that it does not bleed, its one-time use, and the need for technical assistance from the company for setup.

This model can be used for laparoscopic and open hysterectomy approaches, as well as for vaginal hysterectomy. For more information, visit the Gynesim website at https://www.gynesim.com/vaginal-hysterectomy/.

Takeaway. The high-fidelity Gynesim model can be used to practice vaginal, laparoscopic, or open hysterectomy approaches. It offers excellent tissue haptics, one-time use “cassettes” made from animal tissue, and compatibility with energy devices.

The milk jug model

The milk jug and fabric uterus model, developed by Dr. Dee Fenner, is a low-cost simulation model and an alternative to the flower pot model (described later in this article). The bony pelvis is simulated by a 1-gallon milk carton that is taped to a foam ring. Other materials used to make the uterus are fabric, stuffing, and a needle and thread (or a sewing machine). Each model costs approximately $5 and takes approximately 15 minutes to create. For instructions on how to construct this model, see the Society for Gynecologic Surgeons (SGS) award-winning video from 2012 at https://vimeo.com/123804677.

The advantages of this model are that it is inexpensive and is a good tool with which novice gynecologic surgeons can learn the basic steps of the procedure. The disadvantages are that it does not bleed, is not compatible with energy devices, and must be constructed by hand (adding considerable time) or with a sewing machine.

Takeaway. The milk jug model is a low-cost, low-fidelity model for the novice surgeon that can be quickly constructed with the use of a sewing machine.

Read about simulation models for training in laparoscopic hysterectomy.

Simulation models for training in laparoscopic hysterectomy

While overall hysterectomy numbers have remained relatively stable during the last 10 years, the proportion of laparoscopic hysterectomy procedures is increasing in residency training.¹ Many toolkits and models are available for practicing skills, from low-fidelity models on which to rehearse laparoscopic techniques (suturing, instrument handling) to high-fidelity models that provide augmented reality views of the abdominal cavity as well as the operating room itself. We offer a sampling of 4 such models below.