News for Your Practice

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy and myomectomy may be riskier than many have thought. That’s the conclusion reached by the US Food and Drug Administration (FDA) in a safety communication issued April 17, 2014. In its communication, the FDA “discouraged” use of power morcellation during hysterectomy and myomectomy. Shortly afterward, Brigham and Women’s and Massachusetts General hospitals in Boston banned power morcellation in all hysterectomy and myomectomy procedures. The hospitals may resume power morcellation at some future date using a containment system, pending guidance from the Institutional Review Board.

Robert L. Barbieri, MD, who is chair of obstetrics and gynecology at Brigham and Women’s Hospital, recently wrote about this concern for OBG Management in his capacity as editor in chief of the journal.

“When used to treat tumors presumed to be fibroids, open power morcellation [without a containment system] is associated with an increased risk of disper­sing benign myoma tissue and occult malignant leiomyosarcoma tissue throughout the abdominal cavity,” he wrote.¹ “Dispersion of benign myoma tissue may result in the growth of fibroids on the peritoneal surface, omentum, and bowel, causing abdominal and pelvic pain and necessitating reoperation. Dispersion of leiomyosarcoma tissue throughout the abdominal cavity may result in a Stage I cancer being upstaged to a Stage IV malignancy, requiring additional surgery and chemotherapy. In cases in which open power morcellation causes the upstaging of a leiomyosarcoma, the death rate is increased.”¹

The two Boston hospitals are not the only institutions reconsidering the use of power morcellation. Temple University Hospital in Philadelphia banned use of the procedure without a containment system in late February 2014.

And in December 2013, the Society of Gynecologic Oncology issued a position statement on the issue, which said, “power morcellation or other techniques that cut up the uterus in the abdomen have the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity. For this reason, the Society of Gynecologic Oncology (SGO) asserts that it is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery.”²

For its part, at the time of this writing, the AAGL, previously known as the American Association of Gynecologic Laparoscopists, “is reviewing the scientific evidence and best practices reported by our members,” stated an article in its Association News. “We recognize that, in rare cases, the use of power morcellators can lead to the dissemination of an occult malignancy of endometrial or myometrial origin, and also to dissemination of benign morcellated tissues. We encourage our members to fully research and understand the risks of power morcellation and to learn more about when alternative methods of tissue extraction may be appropriate.”³

FDA STOPS SHORT OF A BAN
In laying out its concerns, the FDA stopped short of an outright ban on power morcellation. Instead, it stated that, “based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”⁴

It also noted that approximately 1 in 350 women “undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma.”⁴

Among its recommendations for health-care providers:

• avoid laparoscopic uterine power morcellation in women with suspected or known uterine cancer
• carefully consider all available treatment options for women with symptomatic uterine fibroids
• thoroughly discuss the benefits and risks of all treatments with patients.⁴

The FDA also noted that “some clinicians and medical institutions now advocate using a specimen ‘bag’ during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.”⁴

ACOG HAS YET TO WEIGH IN
At the time of this writing, the most recent committee opinion on choosing a hysterectomy route from the American College of Obstetricians and Gynecologists (ACOG) to touch on the issue states that, “the decision to perform a hysterectomy via [minimally invasive surgery] (with or without morcellation) is based on a patient evaluation, including the patient’s history and general health, tests, and procedures, such as pre-surgery biopsies. The evaluation and diagnostic process also provides an opportunity to identify any cautions or contraindications, such as finding a gynecological cancer.”⁵

FILLING THE TECHNOLOGY GAP
Now that power morcellation appears to be receding as an option for minimally invasive gynecologic surgeons, what is the best approach?

In its position statement, the SGO recommends that, “Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellation should be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini-laparotomy or morcellating the uterus inside a laparoscopic bag.”²

K. Anthony Shibley, MD, a Minneapolis-area ObGyn, has developed a novel strategy to prevent tissue dissemination during open power morcellation, which is demonstrated in a video at obgmanagement.com. Similarly, Ceana Nezhat, MD, and Erica Dun, MD, demonstrate enclosed vaginal morcellation of a large uterus. Click here to access these and other features in the Morcellation Topic Collection.

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com Please include your name, and the city and state in which you practice.

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy and myomectomy may be riskier than many have thought. That’s the conclusion reached by the US Food and Drug Administration (FDA) in a safety communication issued April 17, 2014. In its communication, the FDA “discouraged” use of power morcellation during hysterectomy and myomectomy. Shortly afterward, Brigham and Women’s and Massachusetts General hospitals in Boston banned power morcellation in all hysterectomy and myomectomy procedures. The hospitals may resume power morcellation at some future date using a containment system, pending guidance from the Institutional Review Board.

Robert L. Barbieri, MD, who is chair of obstetrics and gynecology at Brigham and Women’s Hospital, recently wrote about this concern for OBG Management in his capacity as editor in chief of the journal.

“When used to treat tumors presumed to be fibroids, open power morcellation [without a containment system] is associated with an increased risk of disper­sing benign myoma tissue and occult malignant leiomyosarcoma tissue throughout the abdominal cavity,” he wrote.¹ “Dispersion of benign myoma tissue may result in the growth of fibroids on the peritoneal surface, omentum, and bowel, causing abdominal and pelvic pain and necessitating reoperation. Dispersion of leiomyosarcoma tissue throughout the abdominal cavity may result in a Stage I cancer being upstaged to a Stage IV malignancy, requiring additional surgery and chemotherapy. In cases in which open power morcellation causes the upstaging of a leiomyosarcoma, the death rate is increased.”¹

The two Boston hospitals are not the only institutions reconsidering the use of power morcellation. Temple University Hospital in Philadelphia banned use of the procedure without a containment system in late February 2014.

And in December 2013, the Society of Gynecologic Oncology issued a position statement on the issue, which said, “power morcellation or other techniques that cut up the uterus in the abdomen have the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity. For this reason, the Society of Gynecologic Oncology (SGO) asserts that it is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery.”²

For its part, at the time of this writing, the AAGL, previously known as the American Association of Gynecologic Laparoscopists, “is reviewing the scientific evidence and best practices reported by our members,” stated an article in its Association News. “We recognize that, in rare cases, the use of power morcellators can lead to the dissemination of an occult malignancy of endometrial or myometrial origin, and also to dissemination of benign morcellated tissues. We encourage our members to fully research and understand the risks of power morcellation and to learn more about when alternative methods of tissue extraction may be appropriate.”³

FDA STOPS SHORT OF A BAN
In laying out its concerns, the FDA stopped short of an outright ban on power morcellation. Instead, it stated that, “based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”⁴

It also noted that approximately 1 in 350 women “undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma.”⁴

Among its recommendations for health-care providers:

• avoid laparoscopic uterine power morcellation in women with suspected or known uterine cancer
• carefully consider all available treatment options for women with symptomatic uterine fibroids
• thoroughly discuss the benefits and risks of all treatments with patients.⁴

The FDA also noted that “some clinicians and medical institutions now advocate using a specimen ‘bag’ during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.”⁴

ACOG HAS YET TO WEIGH IN
At the time of this writing, the most recent committee opinion on choosing a hysterectomy route from the American College of Obstetricians and Gynecologists (ACOG) to touch on the issue states that, “the decision to perform a hysterectomy via [minimally invasive surgery] (with or without morcellation) is based on a patient evaluation, including the patient’s history and general health, tests, and procedures, such as pre-surgery biopsies. The evaluation and diagnostic process also provides an opportunity to identify any cautions or contraindications, such as finding a gynecological cancer.”⁵

FILLING THE TECHNOLOGY GAP
Now that power morcellation appears to be receding as an option for minimally invasive gynecologic surgeons, what is the best approach?

In its position statement, the SGO recommends that, “Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellation should be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini-laparotomy or morcellating the uterus inside a laparoscopic bag.”²

K. Anthony Shibley, MD, a Minneapolis-area ObGyn, has developed a novel strategy to prevent tissue dissemination during open power morcellation, which is demonstrated in a video at obgmanagement.com. Similarly, Ceana Nezhat, MD, and Erica Dun, MD, demonstrate enclosed vaginal morcellation of a large uterus. Click here to access these and other features in the Morcellation Topic Collection.

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com Please include your name, and the city and state in which you practice.

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy and myomectomy may be riskier than many have thought. That’s the conclusion reached by the US Food and Drug Administration (FDA) in a safety communication issued April 17, 2014. In its communication, the FDA “discouraged” use of power morcellation during hysterectomy and myomectomy. Shortly afterward, Brigham and Women’s and Massachusetts General hospitals in Boston banned power morcellation in all hysterectomy and myomectomy procedures. The hospitals may resume power morcellation at some future date using a containment system, pending guidance from the Institutional Review Board.

Robert L. Barbieri, MD, who is chair of obstetrics and gynecology at Brigham and Women’s Hospital, recently wrote about this concern for OBG Management in his capacity as editor in chief of the journal.

“When used to treat tumors presumed to be fibroids, open power morcellation [without a containment system] is associated with an increased risk of disper­sing benign myoma tissue and occult malignant leiomyosarcoma tissue throughout the abdominal cavity,” he wrote.¹ “Dispersion of benign myoma tissue may result in the growth of fibroids on the peritoneal surface, omentum, and bowel, causing abdominal and pelvic pain and necessitating reoperation. Dispersion of leiomyosarcoma tissue throughout the abdominal cavity may result in a Stage I cancer being upstaged to a Stage IV malignancy, requiring additional surgery and chemotherapy. In cases in which open power morcellation causes the upstaging of a leiomyosarcoma, the death rate is increased.”¹

The two Boston hospitals are not the only institutions reconsidering the use of power morcellation. Temple University Hospital in Philadelphia banned use of the procedure without a containment system in late February 2014.

And in December 2013, the Society of Gynecologic Oncology issued a position statement on the issue, which said, “power morcellation or other techniques that cut up the uterus in the abdomen have the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity. For this reason, the Society of Gynecologic Oncology (SGO) asserts that it is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery.”²

For its part, at the time of this writing, the AAGL, previously known as the American Association of Gynecologic Laparoscopists, “is reviewing the scientific evidence and best practices reported by our members,” stated an article in its Association News. “We recognize that, in rare cases, the use of power morcellators can lead to the dissemination of an occult malignancy of endometrial or myometrial origin, and also to dissemination of benign morcellated tissues. We encourage our members to fully research and understand the risks of power morcellation and to learn more about when alternative methods of tissue extraction may be appropriate.”³

FDA STOPS SHORT OF A BAN
In laying out its concerns, the FDA stopped short of an outright ban on power morcellation. Instead, it stated that, “based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”⁴

It also noted that approximately 1 in 350 women “undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma.”⁴

Among its recommendations for health-care providers:

• avoid laparoscopic uterine power morcellation in women with suspected or known uterine cancer
• carefully consider all available treatment options for women with symptomatic uterine fibroids
• thoroughly discuss the benefits and risks of all treatments with patients.⁴

The FDA also noted that “some clinicians and medical institutions now advocate using a specimen ‘bag’ during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.”⁴

ACOG HAS YET TO WEIGH IN
At the time of this writing, the most recent committee opinion on choosing a hysterectomy route from the American College of Obstetricians and Gynecologists (ACOG) to touch on the issue states that, “the decision to perform a hysterectomy via [minimally invasive surgery] (with or without morcellation) is based on a patient evaluation, including the patient’s history and general health, tests, and procedures, such as pre-surgery biopsies. The evaluation and diagnostic process also provides an opportunity to identify any cautions or contraindications, such as finding a gynecological cancer.”⁵

FILLING THE TECHNOLOGY GAP
Now that power morcellation appears to be receding as an option for minimally invasive gynecologic surgeons, what is the best approach?

In its position statement, the SGO recommends that, “Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellation should be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini-laparotomy or morcellating the uterus inside a laparoscopic bag.”²

K. Anthony Shibley, MD, a Minneapolis-area ObGyn, has developed a novel strategy to prevent tissue dissemination during open power morcellation, which is demonstrated in a video at obgmanagement.com. Similarly, Ceana Nezhat, MD, and Erica Dun, MD, demonstrate enclosed vaginal morcellation of a large uterus. Click here to access these and other features in the Morcellation Topic Collection.

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: obg@frontlinemedcom.com Please include your name, and the city and state in which you practice.

On April 17, 2014, the US Food and Drug Administration (FDA) issued a Safety Communication discouraging the use of laparoscopic power morcellation in hysterectomy and myomectomy for uterine fibroids.

Based on an FDA analysis of current data, “… it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”¹

FDA recommendations
The FDA posted the following recommendations for health-care providers¹:

1. Laparoscopic uterine power morcellation should not be used in women with suspected or known uterine cancer
2. All available treatment options should be considered for women with symptomatic uterine fibroids
3. The benefits and risks of all treatments should be discussed thoroughly with each patient
4. If, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option for an individual patient, then:

• Inform the patient that her fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening her prognosis
• Some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.

Although many women choose laparoscopic hysterectomy or myomectomy because of the associated benefits, there are other treatments available, including vaginal or abdominal hysterectomy and myomectomy; laparoscopic hysterectomy or myomectomy without morcellation; minilaparotomy; uterine artery embolization; high-intensity focused ultrasound; and drug therapy.

FDA actions
To reduce the risk of inadvertent spread of unsuspected cancer to the abdomen and pelvis, the FDA has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to immediately review labeling for accurate risk information.

A to-be-convened public meeting of the FDA’s Obstetrics and Gynecological Medical Device Advisory Committee will discuss¹:

• the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids
• whether surgical techniques and/or use of accessories, such as morcellation and/or specimen bags, can enhance the safe and effective use of these devices
• if a boxed warning relating the risk of cancer spread should be required for laparoscopic power morcellators.

The FDA will continue to review adverse event reports and peer-reviewed literature, as well as patient information and evidence from health-care providers, gynecologic and surgical professional societies, and medical device manufacturers.

Adverse events should promptly be reported to the FDA by filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Institution reaction
Brigham and Women's Hospital had banned the use of open power morcellation on March 31, 2014, allowing for the use of power morcellators within a containment system. In light of the FDA notice that discourages the use of power morcellators during hysterectomy or myomectomy for the treatment of uterine fibroids, however, Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s advised surgical staff to "immediately suspend use of power morcellators in all cases until further notice."    

Massachusetts General, which also had placed restrictions on the use of power morcellators prior to the FDA communication, suspended the use of power morcellation.

“I have asked our doctors to stop the procedure immediately until more information is available,’’ Dr. Isaac Schiff, Massachusetts General’s chief of obstetrics and gynecology, told the Boston Globe.     

On April 17, 2014, the US Food and Drug Administration (FDA) issued a Safety Communication discouraging the use of laparoscopic power morcellation in hysterectomy and myomectomy for uterine fibroids.

Based on an FDA analysis of current data, “… it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”¹

FDA recommendations
The FDA posted the following recommendations for health-care providers¹:

1. Laparoscopic uterine power morcellation should not be used in women with suspected or known uterine cancer
2. All available treatment options should be considered for women with symptomatic uterine fibroids
3. The benefits and risks of all treatments should be discussed thoroughly with each patient
4. If, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option for an individual patient, then:

• Inform the patient that her fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening her prognosis
• Some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.

Although many women choose laparoscopic hysterectomy or myomectomy because of the associated benefits, there are other treatments available, including vaginal or abdominal hysterectomy and myomectomy; laparoscopic hysterectomy or myomectomy without morcellation; minilaparotomy; uterine artery embolization; high-intensity focused ultrasound; and drug therapy.

FDA actions
To reduce the risk of inadvertent spread of unsuspected cancer to the abdomen and pelvis, the FDA has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to immediately review labeling for accurate risk information.

A to-be-convened public meeting of the FDA’s Obstetrics and Gynecological Medical Device Advisory Committee will discuss¹:

• the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids
• whether surgical techniques and/or use of accessories, such as morcellation and/or specimen bags, can enhance the safe and effective use of these devices
• if a boxed warning relating the risk of cancer spread should be required for laparoscopic power morcellators.

The FDA will continue to review adverse event reports and peer-reviewed literature, as well as patient information and evidence from health-care providers, gynecologic and surgical professional societies, and medical device manufacturers.

Adverse events should promptly be reported to the FDA by filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Institution reaction
Brigham and Women's Hospital had banned the use of open power morcellation on March 31, 2014, allowing for the use of power morcellators within a containment system. In light of the FDA notice that discourages the use of power morcellators during hysterectomy or myomectomy for the treatment of uterine fibroids, however, Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s advised surgical staff to "immediately suspend use of power morcellators in all cases until further notice."    

Massachusetts General, which also had placed restrictions on the use of power morcellators prior to the FDA communication, suspended the use of power morcellation.

“I have asked our doctors to stop the procedure immediately until more information is available,’’ Dr. Isaac Schiff, Massachusetts General’s chief of obstetrics and gynecology, told the Boston Globe.     

On April 17, 2014, the US Food and Drug Administration (FDA) issued a Safety Communication discouraging the use of laparoscopic power morcellation in hysterectomy and myomectomy for uterine fibroids.

Based on an FDA analysis of current data, “… it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”¹

FDA recommendations
The FDA posted the following recommendations for health-care providers¹:

1. Laparoscopic uterine power morcellation should not be used in women with suspected or known uterine cancer
2. All available treatment options should be considered for women with symptomatic uterine fibroids
3. The benefits and risks of all treatments should be discussed thoroughly with each patient
4. If, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option for an individual patient, then:

• Inform the patient that her fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening her prognosis
• Some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.

Although many women choose laparoscopic hysterectomy or myomectomy because of the associated benefits, there are other treatments available, including vaginal or abdominal hysterectomy and myomectomy; laparoscopic hysterectomy or myomectomy without morcellation; minilaparotomy; uterine artery embolization; high-intensity focused ultrasound; and drug therapy.

FDA actions
To reduce the risk of inadvertent spread of unsuspected cancer to the abdomen and pelvis, the FDA has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to immediately review labeling for accurate risk information.

A to-be-convened public meeting of the FDA’s Obstetrics and Gynecological Medical Device Advisory Committee will discuss¹:

• the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids
• whether surgical techniques and/or use of accessories, such as morcellation and/or specimen bags, can enhance the safe and effective use of these devices
• if a boxed warning relating the risk of cancer spread should be required for laparoscopic power morcellators.

The FDA will continue to review adverse event reports and peer-reviewed literature, as well as patient information and evidence from health-care providers, gynecologic and surgical professional societies, and medical device manufacturers.

Adverse events should promptly be reported to the FDA by filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Institution reaction
Brigham and Women's Hospital had banned the use of open power morcellation on March 31, 2014, allowing for the use of power morcellators within a containment system. In light of the FDA notice that discourages the use of power morcellators during hysterectomy or myomectomy for the treatment of uterine fibroids, however, Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s advised surgical staff to "immediately suspend use of power morcellators in all cases until further notice."    

Massachusetts General, which also had placed restrictions on the use of power morcellators prior to the FDA communication, suspended the use of power morcellation.

“I have asked our doctors to stop the procedure immediately until more information is available,’’ Dr. Isaac Schiff, Massachusetts General’s chief of obstetrics and gynecology, told the Boston Globe.     

A new study¹ provides the first evidence of a direct effect of maternal metabolism on fetal brain activity, suggesting that insulin resistance, the precursor to type 2 diabetes, begins its formation prenatally.

DETAILS OF THE STUDY

Dr. Katarzyna Linder from the University Hospital Tübingen in Germany and colleagues included in their study 13 healthy pregnant women with normal, singleton pregnancies of between 27 and 36 weeks. All of the women underwent an oral glucose tolerance test, meaning that after a 5-hour overnight fast, each woman drank a solution containing 75 g glucose. The investigators ascertained blood glucose and plasma insulin levels from blood samples taken at 0, 60, and 120 minutes.

At approximately the same time points, but before they drew each blood sample, the authors obtained a fetal magnetoencephalography (fMEG) measurement in an effort to noninvasively record brain activity in utero. During each measurement, they presented an auditory sequence to the fetus. Most (75%) of the time, the sound presented had a frequency of 500 Hz, but 25% of the time the researchers presented a deviant tone with a frequency of 750 Hz to prevent habituation.

The researchers found that maternal insulin sensitivity significantly correlated with response latency of the fetus at the 60-minute time point, so that the higher the insulin sensitivity of the mother, the shorter the response time of the fetus to the sound. The association remained significant even after the investigators controlled for relative maternal weight gain, gestational age, and the child’s birth weight. No significant correlation existed at baseline or at 120 minutes.

The investigators then split the women into 2 groups: those who were insulin-resistant and those who were insulin-sensitive. They found that the fetuses of the insulin-resistant moms were almost 40% slower to respond to the auditory stimuli than those of the insulin-sensitive moms (mean [SD], 283 [79] ms vs 178 [46] ms; P=.03).

INTERPRETING THE FINDINGS

According to the US Centers for Disease Control and Prevention, almost one-third (30.3%) of US adults between the ages of 20 and 39 years—the primary child-bearing years—are obese,² as are 17% of our children and adolescents—triple the rate of 1 generation previous.³ Furthermore, 25.8 million people in the United States have diabetes, including 1 in every 400 children and adolescents.⁴

Experts know that the children of obese or diabetic mothers are at increased risk for obesity and type 2 diabetes as adults, and that the connection is not purely genetic; environmental and epigenetic (environmental elements that affect genetics) factors also play key roles. The latter is the basis for the fetal or developmental origins hypothesis,⁵ which posits that a pregnant woman’s exposure to certain environmental factors can affect the programming of her unborn child and impact adult health.

The authors of the current study demonstrate that the metabolism of a pregnant woman after a sugar load directly affects the response time and brain activity of her developing fetus. They suggest as a mechanism for the effect that “insulin-resistant mothers have higher glucose levels accompanied by increased insulin levels in the postprandial state. As glucose passes the placenta, these postprandially increased glucose levels induce hyperinsulinaemia in the fetus.” The resulting chronic hyperinsulinemia “might induce insulin resistance in the fetal brain.”

A new study¹ provides the first evidence of a direct effect of maternal metabolism on fetal brain activity, suggesting that insulin resistance, the precursor to type 2 diabetes, begins its formation prenatally.

DETAILS OF THE STUDY

Dr. Katarzyna Linder from the University Hospital Tübingen in Germany and colleagues included in their study 13 healthy pregnant women with normal, singleton pregnancies of between 27 and 36 weeks. All of the women underwent an oral glucose tolerance test, meaning that after a 5-hour overnight fast, each woman drank a solution containing 75 g glucose. The investigators ascertained blood glucose and plasma insulin levels from blood samples taken at 0, 60, and 120 minutes.

At approximately the same time points, but before they drew each blood sample, the authors obtained a fetal magnetoencephalography (fMEG) measurement in an effort to noninvasively record brain activity in utero. During each measurement, they presented an auditory sequence to the fetus. Most (75%) of the time, the sound presented had a frequency of 500 Hz, but 25% of the time the researchers presented a deviant tone with a frequency of 750 Hz to prevent habituation.

The researchers found that maternal insulin sensitivity significantly correlated with response latency of the fetus at the 60-minute time point, so that the higher the insulin sensitivity of the mother, the shorter the response time of the fetus to the sound. The association remained significant even after the investigators controlled for relative maternal weight gain, gestational age, and the child’s birth weight. No significant correlation existed at baseline or at 120 minutes.

The investigators then split the women into 2 groups: those who were insulin-resistant and those who were insulin-sensitive. They found that the fetuses of the insulin-resistant moms were almost 40% slower to respond to the auditory stimuli than those of the insulin-sensitive moms (mean [SD], 283 [79] ms vs 178 [46] ms; P=.03).

INTERPRETING THE FINDINGS

According to the US Centers for Disease Control and Prevention, almost one-third (30.3%) of US adults between the ages of 20 and 39 years—the primary child-bearing years—are obese,² as are 17% of our children and adolescents—triple the rate of 1 generation previous.³ Furthermore, 25.8 million people in the United States have diabetes, including 1 in every 400 children and adolescents.⁴

Experts know that the children of obese or diabetic mothers are at increased risk for obesity and type 2 diabetes as adults, and that the connection is not purely genetic; environmental and epigenetic (environmental elements that affect genetics) factors also play key roles. The latter is the basis for the fetal or developmental origins hypothesis,⁵ which posits that a pregnant woman’s exposure to certain environmental factors can affect the programming of her unborn child and impact adult health.

The authors of the current study demonstrate that the metabolism of a pregnant woman after a sugar load directly affects the response time and brain activity of her developing fetus. They suggest as a mechanism for the effect that “insulin-resistant mothers have higher glucose levels accompanied by increased insulin levels in the postprandial state. As glucose passes the placenta, these postprandially increased glucose levels induce hyperinsulinaemia in the fetus.” The resulting chronic hyperinsulinemia “might induce insulin resistance in the fetal brain.”

A new study¹ provides the first evidence of a direct effect of maternal metabolism on fetal brain activity, suggesting that insulin resistance, the precursor to type 2 diabetes, begins its formation prenatally.

DETAILS OF THE STUDY

Dr. Katarzyna Linder from the University Hospital Tübingen in Germany and colleagues included in their study 13 healthy pregnant women with normal, singleton pregnancies of between 27 and 36 weeks. All of the women underwent an oral glucose tolerance test, meaning that after a 5-hour overnight fast, each woman drank a solution containing 75 g glucose. The investigators ascertained blood glucose and plasma insulin levels from blood samples taken at 0, 60, and 120 minutes.

At approximately the same time points, but before they drew each blood sample, the authors obtained a fetal magnetoencephalography (fMEG) measurement in an effort to noninvasively record brain activity in utero. During each measurement, they presented an auditory sequence to the fetus. Most (75%) of the time, the sound presented had a frequency of 500 Hz, but 25% of the time the researchers presented a deviant tone with a frequency of 750 Hz to prevent habituation.

The researchers found that maternal insulin sensitivity significantly correlated with response latency of the fetus at the 60-minute time point, so that the higher the insulin sensitivity of the mother, the shorter the response time of the fetus to the sound. The association remained significant even after the investigators controlled for relative maternal weight gain, gestational age, and the child’s birth weight. No significant correlation existed at baseline or at 120 minutes.

The investigators then split the women into 2 groups: those who were insulin-resistant and those who were insulin-sensitive. They found that the fetuses of the insulin-resistant moms were almost 40% slower to respond to the auditory stimuli than those of the insulin-sensitive moms (mean [SD], 283 [79] ms vs 178 [46] ms; P=.03).

INTERPRETING THE FINDINGS

According to the US Centers for Disease Control and Prevention, almost one-third (30.3%) of US adults between the ages of 20 and 39 years—the primary child-bearing years—are obese,² as are 17% of our children and adolescents—triple the rate of 1 generation previous.³ Furthermore, 25.8 million people in the United States have diabetes, including 1 in every 400 children and adolescents.⁴

Experts know that the children of obese or diabetic mothers are at increased risk for obesity and type 2 diabetes as adults, and that the connection is not purely genetic; environmental and epigenetic (environmental elements that affect genetics) factors also play key roles. The latter is the basis for the fetal or developmental origins hypothesis,⁵ which posits that a pregnant woman’s exposure to certain environmental factors can affect the programming of her unborn child and impact adult health.

The authors of the current study demonstrate that the metabolism of a pregnant woman after a sugar load directly affects the response time and brain activity of her developing fetus. They suggest as a mechanism for the effect that “insulin-resistant mothers have higher glucose levels accompanied by increased insulin levels in the postprandial state. As glucose passes the placenta, these postprandially increased glucose levels induce hyperinsulinaemia in the fetus.” The resulting chronic hyperinsulinemia “might induce insulin resistance in the fetal brain.”

Experts generally have not considered H influenzae disease to be a substantial contributor to severely adverse fetal outcomes. Yet new research from England and Wales finds that even though pregnant women in their study tended to be younger and healthier than their nonpregnant counterparts, they were far more likely to develop the invasive unencapsulated form of disease and far more likely to present with bacteremia. Not to mention that almost all of their pregnancies resulted in miscarriage, stillbirth, extremely preterm birth, or, at best, the birth of infants with respiratory distress with or without sepsis. 

DETAILS OF THE STUDY

Collins and colleagues queried prospectively general practitioners who cared for women of reproductive age (15 to 44 years) with invasive H influenzae disease during the 4-year period of 2009 to 2012. One hundred percent of those queried responded. The study encompassed more than 45 million woman-years of follow-up.

Of the 171 women who developed the infection (confirmed by positive culture from a normally sterile site), approximately 84% (144) had unencapsulated disease. Not quite half (44% or 75) of the 171 women were pregnant at the time of infection. The overall incidence of confirmed invasive H influenzae disease was low at 0.50 per 100,000 women of reproductive age, but the 75 pregnant women were 17.2 (95% confidence interval [CI], 12.2-24.1; P<.001) times as likely to develop the infection as the 96 nonpregnant women (2.98/100,000 woman-years versus 0.17/100,000 woman-years, respectively). And, despite being previously healthy, almost three times as many pregnant as nonpregnant women presented with bacteremia (90.3% versus 33.3%, respectively).

Of 47 women who developed unencapsulated H influenzae infection during the first 24 weeks of pregnancy, 44 lost the fetus and three had extremely preterm births. Of 28 women who developed the infection during the second half of their pregnancy, two had stillbirths. Eight of the 26 live births were preterm, and 21 of the 26 infants had respiratory distress with or without sepsis at birth. The researchers calculated that the rate of pregnancy loss following invasive H influenzae disease was almost 3 times higher than the average rate of pregnancy loss in England and Wales.

CLINICAL RECOMMENDATIONS

It is generally reported that up to one-quarter of the approximately 26,000 stillbirths occurring yearly in the United States are due to some type of maternal or fetal infection.^2,3 Dr. Morven S. Edwards, in an editorial⁴ appearing in the same issue of JAMA as the study, comments, “Given the magnitude of the burden of perinatal deaths, clarifying the extent that bacterial infections result in stillbirth and preterm delivery could potentially inform interventions to improve child and maternal health globally.”

Experts generally have not considered H influenzae disease to be a substantial contributor to severely adverse fetal outcomes. Yet new research from England and Wales finds that even though pregnant women in their study tended to be younger and healthier than their nonpregnant counterparts, they were far more likely to develop the invasive unencapsulated form of disease and far more likely to present with bacteremia. Not to mention that almost all of their pregnancies resulted in miscarriage, stillbirth, extremely preterm birth, or, at best, the birth of infants with respiratory distress with or without sepsis. 

DETAILS OF THE STUDY

Collins and colleagues queried prospectively general practitioners who cared for women of reproductive age (15 to 44 years) with invasive H influenzae disease during the 4-year period of 2009 to 2012. One hundred percent of those queried responded. The study encompassed more than 45 million woman-years of follow-up.

Of the 171 women who developed the infection (confirmed by positive culture from a normally sterile site), approximately 84% (144) had unencapsulated disease. Not quite half (44% or 75) of the 171 women were pregnant at the time of infection. The overall incidence of confirmed invasive H influenzae disease was low at 0.50 per 100,000 women of reproductive age, but the 75 pregnant women were 17.2 (95% confidence interval [CI], 12.2-24.1; P<.001) times as likely to develop the infection as the 96 nonpregnant women (2.98/100,000 woman-years versus 0.17/100,000 woman-years, respectively). And, despite being previously healthy, almost three times as many pregnant as nonpregnant women presented with bacteremia (90.3% versus 33.3%, respectively).

Of 47 women who developed unencapsulated H influenzae infection during the first 24 weeks of pregnancy, 44 lost the fetus and three had extremely preterm births. Of 28 women who developed the infection during the second half of their pregnancy, two had stillbirths. Eight of the 26 live births were preterm, and 21 of the 26 infants had respiratory distress with or without sepsis at birth. The researchers calculated that the rate of pregnancy loss following invasive H influenzae disease was almost 3 times higher than the average rate of pregnancy loss in England and Wales.

CLINICAL RECOMMENDATIONS

It is generally reported that up to one-quarter of the approximately 26,000 stillbirths occurring yearly in the United States are due to some type of maternal or fetal infection.^2,3 Dr. Morven S. Edwards, in an editorial⁴ appearing in the same issue of JAMA as the study, comments, “Given the magnitude of the burden of perinatal deaths, clarifying the extent that bacterial infections result in stillbirth and preterm delivery could potentially inform interventions to improve child and maternal health globally.”

Experts generally have not considered H influenzae disease to be a substantial contributor to severely adverse fetal outcomes. Yet new research from England and Wales finds that even though pregnant women in their study tended to be younger and healthier than their nonpregnant counterparts, they were far more likely to develop the invasive unencapsulated form of disease and far more likely to present with bacteremia. Not to mention that almost all of their pregnancies resulted in miscarriage, stillbirth, extremely preterm birth, or, at best, the birth of infants with respiratory distress with or without sepsis. 

DETAILS OF THE STUDY

Collins and colleagues queried prospectively general practitioners who cared for women of reproductive age (15 to 44 years) with invasive H influenzae disease during the 4-year period of 2009 to 2012. One hundred percent of those queried responded. The study encompassed more than 45 million woman-years of follow-up.

Of the 171 women who developed the infection (confirmed by positive culture from a normally sterile site), approximately 84% (144) had unencapsulated disease. Not quite half (44% or 75) of the 171 women were pregnant at the time of infection. The overall incidence of confirmed invasive H influenzae disease was low at 0.50 per 100,000 women of reproductive age, but the 75 pregnant women were 17.2 (95% confidence interval [CI], 12.2-24.1; P<.001) times as likely to develop the infection as the 96 nonpregnant women (2.98/100,000 woman-years versus 0.17/100,000 woman-years, respectively). And, despite being previously healthy, almost three times as many pregnant as nonpregnant women presented with bacteremia (90.3% versus 33.3%, respectively).

Of 47 women who developed unencapsulated H influenzae infection during the first 24 weeks of pregnancy, 44 lost the fetus and three had extremely preterm births. Of 28 women who developed the infection during the second half of their pregnancy, two had stillbirths. Eight of the 26 live births were preterm, and 21 of the 26 infants had respiratory distress with or without sepsis at birth. The researchers calculated that the rate of pregnancy loss following invasive H influenzae disease was almost 3 times higher than the average rate of pregnancy loss in England and Wales.

CLINICAL RECOMMENDATIONS

It is generally reported that up to one-quarter of the approximately 26,000 stillbirths occurring yearly in the United States are due to some type of maternal or fetal infection.^2,3 Dr. Morven S. Edwards, in an editorial⁴ appearing in the same issue of JAMA as the study, comments, “Given the magnitude of the burden of perinatal deaths, clarifying the extent that bacterial infections result in stillbirth and preterm delivery could potentially inform interventions to improve child and maternal health globally.”

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy may be riskier than many have thought, especially when morcellation is performed in an “open” fashion (without use of a protective bag) in the peritoneal cavity. That’s the conclusion reached by two top Boston hospitals recently, when Brigham and Women’s and Massachusetts General both banned use of open power morcellation in gynecologic surgery.

Both hospitals assert that, when used outside of a containment system such as a morcellation bag, intraperitoneal open morcellation can spread tumor tissue throughout the peritoneal cavity. Robert L. Barbieri, MD, who is chair of obstetrics and gynecology at Brigham and Women’s Hospital, recently wrote about this concern for OBG Management in his capacity as editor in chief of the journal.

“When used to treat tumors presumed to be fibroids, open power morcellation is associated with an increased risk of dispersing benign myoma tissue and occult malignant leiomyosarcoma tissue throughout the abdominal cavity,” he wrote.¹ “Dispersion of benign myoma tissue may result in the growth of fibroids on the peritoneal surface, omentum, and bowel, causing abdominal and pelvic pain and necessitating reoperation. Dispersion of leiomyosarcoma tissue throughout the abdominal cavity may result in a Stage I cancer being upstaged to a Stage IV malignancy, requiring additional surgery and chemotherapy. In cases in which open power morcellation causes the upstaging of a leiomyosarcoma, the death rate is increased.”¹

Related article: Options for reducing the use of open power morcellation of uterine tumors  Robert L. Barbieri, MD (Editorial, March 2014)

The two Boston hospitals are not the only institutions reconsidering the use of open power morcellation. Temple University Hospital in Philadelphia banned the procedure in late February 2014.

And in December 2013, the Society of Gynecologic Oncology issued a position statement on the issue, which said, “power morcellation or other techniques that cut up the uterus in the abdomen have the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity. For this reason, the Society of Gynecologic Oncology (SGO) asserts that it is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery.”²

For its part, the AAGL, previously known as the American Association of Gynecologic Laparoscopists, “is reviewing the scientific evidence and best practices reported by our members,” stated an article in its Association News. “We recognize that, in rare cases, the use of power morcellators can lead to the dissemination of an occult malignancy of endometrial or myometrial origin, and also of dissemination of benign morcellated tissues. We encourage our members to fully research and understand the risks of power morcellation and to learn more about when alternative methods of tissue extraction may be appropriate.”³

The most recent committee opinion on choosing a hysterectomy route from the American College of Obstetricians and Gynecologists (ACOG) to touch on the issue states that, “the decision to perform a hysterectomy via [minimally invasive surgery] (with or without morcellation) is based on a patient evaluation, including the patient’s history and general health, tests, and procedures, such as pre-surgery biopsies. The evaluation and diagnostic process also provides an opportunity to identify any cautions or contraindications, such as finding a gynecological cancer.”⁴

FILLING THE TECHNOLOGY GAP
Now that open power morcellation appears to be receding as an option for minimally invasive gynecologic surgeons, what is the best approach?

In its position statement, the SGO recommends that, “Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellation should be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini-laparotomy or morcellating the uterus inside a laparoscopic bag.”²

K. Anthony Shibley, MD, a Minneapolis-area ObGyn, has developed a novel strategy to prevent tissue dissemination during open power morcellation. His strategy involves utilization of a large bowel isolation bag. For more on this approach, click here.

AAGL is in the process of formulating a policy on the use of open power morcellation. ACOG has not signaled its intent to weigh in on the issue.

Brigham and Women’s Hospital intends to carefully review requests for permission to utilize open power morcellation on a case-by-case basis, provided the surgeon presents all case details and a rationale for exemption from the new rule.

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy may be riskier than many have thought, especially when morcellation is performed in an “open” fashion (without use of a protective bag) in the peritoneal cavity. That’s the conclusion reached by two top Boston hospitals recently, when Brigham and Women’s and Massachusetts General both banned use of open power morcellation in gynecologic surgery.

Both hospitals assert that, when used outside of a containment system such as a morcellation bag, intraperitoneal open morcellation can spread tumor tissue throughout the peritoneal cavity. Robert L. Barbieri, MD, who is chair of obstetrics and gynecology at Brigham and Women’s Hospital, recently wrote about this concern for OBG Management in his capacity as editor in chief of the journal.

“When used to treat tumors presumed to be fibroids, open power morcellation is associated with an increased risk of dispersing benign myoma tissue and occult malignant leiomyosarcoma tissue throughout the abdominal cavity,” he wrote.¹ “Dispersion of benign myoma tissue may result in the growth of fibroids on the peritoneal surface, omentum, and bowel, causing abdominal and pelvic pain and necessitating reoperation. Dispersion of leiomyosarcoma tissue throughout the abdominal cavity may result in a Stage I cancer being upstaged to a Stage IV malignancy, requiring additional surgery and chemotherapy. In cases in which open power morcellation causes the upstaging of a leiomyosarcoma, the death rate is increased.”¹

Related article: Options for reducing the use of open power morcellation of uterine tumors  Robert L. Barbieri, MD (Editorial, March 2014)

The two Boston hospitals are not the only institutions reconsidering the use of open power morcellation. Temple University Hospital in Philadelphia banned the procedure in late February 2014.

And in December 2013, the Society of Gynecologic Oncology issued a position statement on the issue, which said, “power morcellation or other techniques that cut up the uterus in the abdomen have the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity. For this reason, the Society of Gynecologic Oncology (SGO) asserts that it is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery.”²

For its part, the AAGL, previously known as the American Association of Gynecologic Laparoscopists, “is reviewing the scientific evidence and best practices reported by our members,” stated an article in its Association News. “We recognize that, in rare cases, the use of power morcellators can lead to the dissemination of an occult malignancy of endometrial or myometrial origin, and also of dissemination of benign morcellated tissues. We encourage our members to fully research and understand the risks of power morcellation and to learn more about when alternative methods of tissue extraction may be appropriate.”³

The most recent committee opinion on choosing a hysterectomy route from the American College of Obstetricians and Gynecologists (ACOG) to touch on the issue states that, “the decision to perform a hysterectomy via [minimally invasive surgery] (with or without morcellation) is based on a patient evaluation, including the patient’s history and general health, tests, and procedures, such as pre-surgery biopsies. The evaluation and diagnostic process also provides an opportunity to identify any cautions or contraindications, such as finding a gynecological cancer.”⁴

FILLING THE TECHNOLOGY GAP
Now that open power morcellation appears to be receding as an option for minimally invasive gynecologic surgeons, what is the best approach?

In its position statement, the SGO recommends that, “Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellation should be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini-laparotomy or morcellating the uterus inside a laparoscopic bag.”²

K. Anthony Shibley, MD, a Minneapolis-area ObGyn, has developed a novel strategy to prevent tissue dissemination during open power morcellation. His strategy involves utilization of a large bowel isolation bag. For more on this approach, click here.

AAGL is in the process of formulating a policy on the use of open power morcellation. ACOG has not signaled its intent to weigh in on the issue.

Brigham and Women’s Hospital intends to carefully review requests for permission to utilize open power morcellation on a case-by-case basis, provided the surgeon presents all case details and a rationale for exemption from the new rule.

The use of power morcellation to remove the uterus or uterine tumors during hysterectomy may be riskier than many have thought, especially when morcellation is performed in an “open” fashion (without use of a protective bag) in the peritoneal cavity. That’s the conclusion reached by two top Boston hospitals recently, when Brigham and Women’s and Massachusetts General both banned use of open power morcellation in gynecologic surgery.

Both hospitals assert that, when used outside of a containment system such as a morcellation bag, intraperitoneal open morcellation can spread tumor tissue throughout the peritoneal cavity. Robert L. Barbieri, MD, who is chair of obstetrics and gynecology at Brigham and Women’s Hospital, recently wrote about this concern for OBG Management in his capacity as editor in chief of the journal.

“When used to treat tumors presumed to be fibroids, open power morcellation is associated with an increased risk of dispersing benign myoma tissue and occult malignant leiomyosarcoma tissue throughout the abdominal cavity,” he wrote.¹ “Dispersion of benign myoma tissue may result in the growth of fibroids on the peritoneal surface, omentum, and bowel, causing abdominal and pelvic pain and necessitating reoperation. Dispersion of leiomyosarcoma tissue throughout the abdominal cavity may result in a Stage I cancer being upstaged to a Stage IV malignancy, requiring additional surgery and chemotherapy. In cases in which open power morcellation causes the upstaging of a leiomyosarcoma, the death rate is increased.”¹

Related article: Options for reducing the use of open power morcellation of uterine tumors  Robert L. Barbieri, MD (Editorial, March 2014)

The two Boston hospitals are not the only institutions reconsidering the use of open power morcellation. Temple University Hospital in Philadelphia banned the procedure in late February 2014.

And in December 2013, the Society of Gynecologic Oncology issued a position statement on the issue, which said, “power morcellation or other techniques that cut up the uterus in the abdomen have the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity. For this reason, the Society of Gynecologic Oncology (SGO) asserts that it is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery.”²

For its part, the AAGL, previously known as the American Association of Gynecologic Laparoscopists, “is reviewing the scientific evidence and best practices reported by our members,” stated an article in its Association News. “We recognize that, in rare cases, the use of power morcellators can lead to the dissemination of an occult malignancy of endometrial or myometrial origin, and also of dissemination of benign morcellated tissues. We encourage our members to fully research and understand the risks of power morcellation and to learn more about when alternative methods of tissue extraction may be appropriate.”³

The most recent committee opinion on choosing a hysterectomy route from the American College of Obstetricians and Gynecologists (ACOG) to touch on the issue states that, “the decision to perform a hysterectomy via [minimally invasive surgery] (with or without morcellation) is based on a patient evaluation, including the patient’s history and general health, tests, and procedures, such as pre-surgery biopsies. The evaluation and diagnostic process also provides an opportunity to identify any cautions or contraindications, such as finding a gynecological cancer.”⁴

FILLING THE TECHNOLOGY GAP
Now that open power morcellation appears to be receding as an option for minimally invasive gynecologic surgeons, what is the best approach?

In its position statement, the SGO recommends that, “Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellation should be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini-laparotomy or morcellating the uterus inside a laparoscopic bag.”²

K. Anthony Shibley, MD, a Minneapolis-area ObGyn, has developed a novel strategy to prevent tissue dissemination during open power morcellation. His strategy involves utilization of a large bowel isolation bag. For more on this approach, click here.

AAGL is in the process of formulating a policy on the use of open power morcellation. ACOG has not signaled its intent to weigh in on the issue.

Brigham and Women’s Hospital intends to carefully review requests for permission to utilize open power morcellation on a case-by-case basis, provided the surgeon presents all case details and a rationale for exemption from the new rule.

3/26/14. Day 3 at SGS
Debates, rebuttals, and relaxation

The morning at SGS was divided up between the small-group academic roundtables with experts in the fields. Topics ranged from mesh complications to coding and billing, and even a primer on urology for the gynecologist.

In the main hall, Drs. Dee Feener and Mark Walters outlined the challenges and opportunities for training the next generation of gynecologic surgeons. Dr. Feener argued that there simply are not enough cases, not enough time, and not enough people to train excellent surgeons. A perfect storm. Dr. Walters outlined his program and resident support at the Cleveland Clinic, showing how to provide robust experience and feedback to residents and fellows. Questions from the audience were pointed, and questioned the need to track obstetrics and gynecology separately for trainees.

Oral posters today also added to the debate with Vanderbilt sharing their hysterectomy training experience both before and after adding a fellowship. They did not see any change in vaginal hysterectomy participation over time. Most interesting was a study looking at abstract acceptance rates if an institution, research network, or author were disclosed in the body of a blinded abstract. They saw a much higher rate of acceptance if the source of the research was known by the reviewer. In his discussion, Dr. John Gebhart mused if the quality of these studies were somehow better, or if this perceived association resulted in any true bias. Nevertheless, the audience was actively engaged in the discussion.

The morning's highlight was certainly the debate over cosmetic gynecologic surgery. Dr. Rachel Pauls advocated FOR labiaplasty and Dr. Becky Rogers AGAINST. Though spirited and based largely on the principals of medical ethics, the final blow came from Dr. Rogers as she distributed Love Our Labia (LOL) buttons to the audience and presented Dr. Pauls with a pink LOL t-shirt. The Twitter feed exploded after this. 

Follow us on Twitter @obgmanagement #SGS14.

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends. 

We were also honored to have Dr. Clifford Ko, director of the American College of Surgeons Quality Improvement Program, as the esteemed Telinde lecturer. This robust and data-filled talk underlines his thesis that accurate, believable, and actionable data can be used to create quality in surgery. Quality improvement is local, he stated, and culture is the hardest institutional characteristic to change. Though any team working together on quality will elevate their culture if the data are good and the benefit to patients is clear. Dr. Ko, a colorectal surgeon at UCLA, is also now an honorary member of SGS.

The afternoon adjourned after the business meeting, and members were able to play golf, tour the desert in 4-wheel drive, or just relax in the lazy river by the pool. Activities were threatened by a large dust storm in Phoenix, but I have heard of no reports of problems.

Everyone convened at the outside terrace for the evening Fiesta Margarita reception. Over drinks and Southwest-themed sombreros, the new Michael Aronson Fund was announced to support Surgeons Helping Advance Research and Education (SHARE). This was the result of more than $25,000 raised by the program committee and SGS Board. Tomorrow looks to be an excellent conclusion to a well-planned and very well-executed meeting.

Follow us on Twitter @obgmanagement #SGS14.

3/25/14. Day 2 at SGS
Scientific sessions and socializing

The first day of the SGS scientific sessions was another energetic and interactive day. Oral posters stimulated heated debates on uterine morcellation, asymptomatic prolapse, and resident training. The Fellows Pelvic Research Network (FPRN) presented their work on the introduction of robotic hysterectomies to training centers. They showed that number of hysterectomies went down, and participation in robotic cases was poor. 

This was followed by the exceptional keynote address by Dr. Barbara Levy. She shared her expertise of health policy and described the coming of quality-based payment, value in Supervises, and the need to protect resources. She predicted that hospitals need to cut costs by 25% to 30% in the next 5 years just to survive.

The afternoon videofest included surgical techniques, anatomy instruction, and a comprehensive review on bowel surgery for the practicing gynecologist. 

For the second year running, the SGS hosted a mock NIH study session. Dr. Katherine Hartmann of Vanderbilt University provided background prep to prepare fellows for a K or R award application. Combined with a most-study section review of two actual applications demystified the process of grant review (and rejection). 

The FPRN met to update their ongoing projects and to review new proposals. This was an enlightening and engaging session which should give everyone great hope to see the creativity and energy of the next generation of researchers. 

SGS President Dr. Holly Richter had the great honor to present the best poster and video awards, as well as recognize the largest new-member class in the history of SGS. Dr. Norton was recognized for the best member presentation, which was on long-term prolapse follow-up in the TOMUS trial cohort. The FPRN was also recognized for their work on the impact of robotic hysterectomy in training. 

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends.

3/24/14. Day 1 at SGS
Postgraduate course examines cautions and takeaways from published research

Our first day at the annual Society of Gynecologic Surgeons Scientific Meeting was off to a running start at the Postgraduate Courses. Program Chair Dr. Cheryl Iglesia joined me for a rapid-fire account of the evidence-based medicine course on social media.

The SGS birth on Twitter was explosive, with our four social media Fellow Scholars linking real-time comments to the courses. Dr. Vivian Sung put together an amazing team to review and apply the principles of evidence-based medicine for the course attendees. Once we accepted that most published research was bad and not terribly generalizable, small break-out groups were quick to use the PICO-S model to define (or try to define) a Population, Intervention, Comparator, Outcomes, and Study design.

This was followed by Dr. Ethan Balk of Tufts Center for Clinical Evidence Synthesis helping us wrap our heads around the randomized controlled trial (RCT). His caution was to consider the costly and underpowered trial, and lack of generalizability needed to define rigorous study inclusion and outcome criteria.

More bad news followed when Dr. Sung reviewed the cautionary tale of surrogate outcomes. While the perfect surrogate would allow us to shorten studies and save money, the seduction of association and causation can lead to some questionable conclusions. Are anatomical and urodynamic outcomes the same as patient perception of cure and improvement?

It wasn't all doom and gloom, as reflected in the lively tweets and posts by @obgmanagement and @gynsurgery. The strong work of the SGS Systemic Review Committee was lauded by Dr. Miles Murphy in his "How to Use a Clinical Practice Guideline." A systematic review needs to be included, though a meta-analysis is not always required, he said. What limits us is the poor quality and paucity of randomized trials for most patient populations. Treatment effect is best shown in RCTs, but minimizes harm; cohort and case series are better. Patient registries may allow for better determining a denominator and harm "rates," though they will miss clinical patient-based outcomes. With the coming of comparative effectiveness, these registries will be online quickly. Further, Dr. Balk showed us that, with more than 13,000 gynecologic research papers published each year, no one could ever keep track.

Dr. Ike Rahn gave an excellent presentation of subgroup analysis. To summarize: do it cautiously, describe which groups you analyze and have statistical back-up for your power and P-value calculations.

To round out the course, Dr. John Wong took us through his crystal ball on the future of evidence-based medicine. Because RCTs are expensive and comprise less than 2.5% of published studies, he proposed the analysis of observational studies as RCTs. Using patient-centered outcomes, efficacy data, and multiple providers, we will be better able to inform our patient and our colleagues on the best treatments. Again, as comparative effectiveness broadens policy decision, we must be agile, adaptive, and accountable.

Follow us on Twitter @obgmanagement #SGS14

3/26/14. Day 3 at SGS
Debates, rebuttals, and relaxation

The morning at SGS was divided up between the small-group academic roundtables with experts in the fields. Topics ranged from mesh complications to coding and billing, and even a primer on urology for the gynecologist.

In the main hall, Drs. Dee Feener and Mark Walters outlined the challenges and opportunities for training the next generation of gynecologic surgeons. Dr. Feener argued that there simply are not enough cases, not enough time, and not enough people to train excellent surgeons. A perfect storm. Dr. Walters outlined his program and resident support at the Cleveland Clinic, showing how to provide robust experience and feedback to residents and fellows. Questions from the audience were pointed, and questioned the need to track obstetrics and gynecology separately for trainees.

Oral posters today also added to the debate with Vanderbilt sharing their hysterectomy training experience both before and after adding a fellowship. They did not see any change in vaginal hysterectomy participation over time. Most interesting was a study looking at abstract acceptance rates if an institution, research network, or author were disclosed in the body of a blinded abstract. They saw a much higher rate of acceptance if the source of the research was known by the reviewer. In his discussion, Dr. John Gebhart mused if the quality of these studies were somehow better, or if this perceived association resulted in any true bias. Nevertheless, the audience was actively engaged in the discussion.

The morning's highlight was certainly the debate over cosmetic gynecologic surgery. Dr. Rachel Pauls advocated FOR labiaplasty and Dr. Becky Rogers AGAINST. Though spirited and based largely on the principals of medical ethics, the final blow came from Dr. Rogers as she distributed Love Our Labia (LOL) buttons to the audience and presented Dr. Pauls with a pink LOL t-shirt. The Twitter feed exploded after this. 

Follow us on Twitter @obgmanagement #SGS14.

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends. 

We were also honored to have Dr. Clifford Ko, director of the American College of Surgeons Quality Improvement Program, as the esteemed Telinde lecturer. This robust and data-filled talk underlines his thesis that accurate, believable, and actionable data can be used to create quality in surgery. Quality improvement is local, he stated, and culture is the hardest institutional characteristic to change. Though any team working together on quality will elevate their culture if the data are good and the benefit to patients is clear. Dr. Ko, a colorectal surgeon at UCLA, is also now an honorary member of SGS.

The afternoon adjourned after the business meeting, and members were able to play golf, tour the desert in 4-wheel drive, or just relax in the lazy river by the pool. Activities were threatened by a large dust storm in Phoenix, but I have heard of no reports of problems.

Everyone convened at the outside terrace for the evening Fiesta Margarita reception. Over drinks and Southwest-themed sombreros, the new Michael Aronson Fund was announced to support Surgeons Helping Advance Research and Education (SHARE). This was the result of more than $25,000 raised by the program committee and SGS Board. Tomorrow looks to be an excellent conclusion to a well-planned and very well-executed meeting.

Follow us on Twitter @obgmanagement #SGS14.

3/25/14. Day 2 at SGS
Scientific sessions and socializing

The first day of the SGS scientific sessions was another energetic and interactive day. Oral posters stimulated heated debates on uterine morcellation, asymptomatic prolapse, and resident training. The Fellows Pelvic Research Network (FPRN) presented their work on the introduction of robotic hysterectomies to training centers. They showed that number of hysterectomies went down, and participation in robotic cases was poor. 

This was followed by the exceptional keynote address by Dr. Barbara Levy. She shared her expertise of health policy and described the coming of quality-based payment, value in Supervises, and the need to protect resources. She predicted that hospitals need to cut costs by 25% to 30% in the next 5 years just to survive.

The afternoon videofest included surgical techniques, anatomy instruction, and a comprehensive review on bowel surgery for the practicing gynecologist. 

For the second year running, the SGS hosted a mock NIH study session. Dr. Katherine Hartmann of Vanderbilt University provided background prep to prepare fellows for a K or R award application. Combined with a most-study section review of two actual applications demystified the process of grant review (and rejection). 

The FPRN met to update their ongoing projects and to review new proposals. This was an enlightening and engaging session which should give everyone great hope to see the creativity and energy of the next generation of researchers. 

SGS President Dr. Holly Richter had the great honor to present the best poster and video awards, as well as recognize the largest new-member class in the history of SGS. Dr. Norton was recognized for the best member presentation, which was on long-term prolapse follow-up in the TOMUS trial cohort. The FPRN was also recognized for their work on the impact of robotic hysterectomy in training. 

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends.

3/24/14. Day 1 at SGS
Postgraduate course examines cautions and takeaways from published research

Our first day at the annual Society of Gynecologic Surgeons Scientific Meeting was off to a running start at the Postgraduate Courses. Program Chair Dr. Cheryl Iglesia joined me for a rapid-fire account of the evidence-based medicine course on social media.

The SGS birth on Twitter was explosive, with our four social media Fellow Scholars linking real-time comments to the courses. Dr. Vivian Sung put together an amazing team to review and apply the principles of evidence-based medicine for the course attendees. Once we accepted that most published research was bad and not terribly generalizable, small break-out groups were quick to use the PICO-S model to define (or try to define) a Population, Intervention, Comparator, Outcomes, and Study design.

This was followed by Dr. Ethan Balk of Tufts Center for Clinical Evidence Synthesis helping us wrap our heads around the randomized controlled trial (RCT). His caution was to consider the costly and underpowered trial, and lack of generalizability needed to define rigorous study inclusion and outcome criteria.

More bad news followed when Dr. Sung reviewed the cautionary tale of surrogate outcomes. While the perfect surrogate would allow us to shorten studies and save money, the seduction of association and causation can lead to some questionable conclusions. Are anatomical and urodynamic outcomes the same as patient perception of cure and improvement?

It wasn't all doom and gloom, as reflected in the lively tweets and posts by @obgmanagement and @gynsurgery. The strong work of the SGS Systemic Review Committee was lauded by Dr. Miles Murphy in his "How to Use a Clinical Practice Guideline." A systematic review needs to be included, though a meta-analysis is not always required, he said. What limits us is the poor quality and paucity of randomized trials for most patient populations. Treatment effect is best shown in RCTs, but minimizes harm; cohort and case series are better. Patient registries may allow for better determining a denominator and harm "rates," though they will miss clinical patient-based outcomes. With the coming of comparative effectiveness, these registries will be online quickly. Further, Dr. Balk showed us that, with more than 13,000 gynecologic research papers published each year, no one could ever keep track.

Dr. Ike Rahn gave an excellent presentation of subgroup analysis. To summarize: do it cautiously, describe which groups you analyze and have statistical back-up for your power and P-value calculations.

To round out the course, Dr. John Wong took us through his crystal ball on the future of evidence-based medicine. Because RCTs are expensive and comprise less than 2.5% of published studies, he proposed the analysis of observational studies as RCTs. Using patient-centered outcomes, efficacy data, and multiple providers, we will be better able to inform our patient and our colleagues on the best treatments. Again, as comparative effectiveness broadens policy decision, we must be agile, adaptive, and accountable.

Follow us on Twitter @obgmanagement #SGS14

3/26/14. Day 3 at SGS
Debates, rebuttals, and relaxation

The morning at SGS was divided up between the small-group academic roundtables with experts in the fields. Topics ranged from mesh complications to coding and billing, and even a primer on urology for the gynecologist.

In the main hall, Drs. Dee Feener and Mark Walters outlined the challenges and opportunities for training the next generation of gynecologic surgeons. Dr. Feener argued that there simply are not enough cases, not enough time, and not enough people to train excellent surgeons. A perfect storm. Dr. Walters outlined his program and resident support at the Cleveland Clinic, showing how to provide robust experience and feedback to residents and fellows. Questions from the audience were pointed, and questioned the need to track obstetrics and gynecology separately for trainees.

Oral posters today also added to the debate with Vanderbilt sharing their hysterectomy training experience both before and after adding a fellowship. They did not see any change in vaginal hysterectomy participation over time. Most interesting was a study looking at abstract acceptance rates if an institution, research network, or author were disclosed in the body of a blinded abstract. They saw a much higher rate of acceptance if the source of the research was known by the reviewer. In his discussion, Dr. John Gebhart mused if the quality of these studies were somehow better, or if this perceived association resulted in any true bias. Nevertheless, the audience was actively engaged in the discussion.

The morning's highlight was certainly the debate over cosmetic gynecologic surgery. Dr. Rachel Pauls advocated FOR labiaplasty and Dr. Becky Rogers AGAINST. Though spirited and based largely on the principals of medical ethics, the final blow came from Dr. Rogers as she distributed Love Our Labia (LOL) buttons to the audience and presented Dr. Pauls with a pink LOL t-shirt. The Twitter feed exploded after this. 

Follow us on Twitter @obgmanagement #SGS14.

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends. 

We were also honored to have Dr. Clifford Ko, director of the American College of Surgeons Quality Improvement Program, as the esteemed Telinde lecturer. This robust and data-filled talk underlines his thesis that accurate, believable, and actionable data can be used to create quality in surgery. Quality improvement is local, he stated, and culture is the hardest institutional characteristic to change. Though any team working together on quality will elevate their culture if the data are good and the benefit to patients is clear. Dr. Ko, a colorectal surgeon at UCLA, is also now an honorary member of SGS.

The afternoon adjourned after the business meeting, and members were able to play golf, tour the desert in 4-wheel drive, or just relax in the lazy river by the pool. Activities were threatened by a large dust storm in Phoenix, but I have heard of no reports of problems.

Everyone convened at the outside terrace for the evening Fiesta Margarita reception. Over drinks and Southwest-themed sombreros, the new Michael Aronson Fund was announced to support Surgeons Helping Advance Research and Education (SHARE). This was the result of more than $25,000 raised by the program committee and SGS Board. Tomorrow looks to be an excellent conclusion to a well-planned and very well-executed meeting.

Follow us on Twitter @obgmanagement #SGS14.

3/25/14. Day 2 at SGS
Scientific sessions and socializing

The first day of the SGS scientific sessions was another energetic and interactive day. Oral posters stimulated heated debates on uterine morcellation, asymptomatic prolapse, and resident training. The Fellows Pelvic Research Network (FPRN) presented their work on the introduction of robotic hysterectomies to training centers. They showed that number of hysterectomies went down, and participation in robotic cases was poor. 

This was followed by the exceptional keynote address by Dr. Barbara Levy. She shared her expertise of health policy and described the coming of quality-based payment, value in Supervises, and the need to protect resources. She predicted that hospitals need to cut costs by 25% to 30% in the next 5 years just to survive.

The afternoon videofest included surgical techniques, anatomy instruction, and a comprehensive review on bowel surgery for the practicing gynecologist. 

For the second year running, the SGS hosted a mock NIH study session. Dr. Katherine Hartmann of Vanderbilt University provided background prep to prepare fellows for a K or R award application. Combined with a most-study section review of two actual applications demystified the process of grant review (and rejection). 

The FPRN met to update their ongoing projects and to review new proposals. This was an enlightening and engaging session which should give everyone great hope to see the creativity and energy of the next generation of researchers. 

SGS President Dr. Holly Richter had the great honor to present the best poster and video awards, as well as recognize the largest new-member class in the history of SGS. Dr. Norton was recognized for the best member presentation, which was on long-term prolapse follow-up in the TOMUS trial cohort. The FPRN was also recognized for their work on the impact of robotic hysterectomy in training. 

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends.

3/24/14. Day 1 at SGS
Postgraduate course examines cautions and takeaways from published research

Our first day at the annual Society of Gynecologic Surgeons Scientific Meeting was off to a running start at the Postgraduate Courses. Program Chair Dr. Cheryl Iglesia joined me for a rapid-fire account of the evidence-based medicine course on social media.

The SGS birth on Twitter was explosive, with our four social media Fellow Scholars linking real-time comments to the courses. Dr. Vivian Sung put together an amazing team to review and apply the principles of evidence-based medicine for the course attendees. Once we accepted that most published research was bad and not terribly generalizable, small break-out groups were quick to use the PICO-S model to define (or try to define) a Population, Intervention, Comparator, Outcomes, and Study design.

This was followed by Dr. Ethan Balk of Tufts Center for Clinical Evidence Synthesis helping us wrap our heads around the randomized controlled trial (RCT). His caution was to consider the costly and underpowered trial, and lack of generalizability needed to define rigorous study inclusion and outcome criteria.

More bad news followed when Dr. Sung reviewed the cautionary tale of surrogate outcomes. While the perfect surrogate would allow us to shorten studies and save money, the seduction of association and causation can lead to some questionable conclusions. Are anatomical and urodynamic outcomes the same as patient perception of cure and improvement?

It wasn't all doom and gloom, as reflected in the lively tweets and posts by @obgmanagement and @gynsurgery. The strong work of the SGS Systemic Review Committee was lauded by Dr. Miles Murphy in his "How to Use a Clinical Practice Guideline." A systematic review needs to be included, though a meta-analysis is not always required, he said. What limits us is the poor quality and paucity of randomized trials for most patient populations. Treatment effect is best shown in RCTs, but minimizes harm; cohort and case series are better. Patient registries may allow for better determining a denominator and harm "rates," though they will miss clinical patient-based outcomes. With the coming of comparative effectiveness, these registries will be online quickly. Further, Dr. Balk showed us that, with more than 13,000 gynecologic research papers published each year, no one could ever keep track.

Dr. Ike Rahn gave an excellent presentation of subgroup analysis. To summarize: do it cautiously, describe which groups you analyze and have statistical back-up for your power and P-value calculations.

To round out the course, Dr. John Wong took us through his crystal ball on the future of evidence-based medicine. Because RCTs are expensive and comprise less than 2.5% of published studies, he proposed the analysis of observational studies as RCTs. Using patient-centered outcomes, efficacy data, and multiple providers, we will be better able to inform our patient and our colleagues on the best treatments. Again, as comparative effectiveness broadens policy decision, we must be agile, adaptive, and accountable.

Follow us on Twitter @obgmanagement #SGS14