FDA discourages use of laparoscopic power morcellation during hysterectomy and myomectomy

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.