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FDA NEWS RELEASE

For Immediate Release: April 17, 2014
Media Inquiries: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA, dsmica@fda.hhs.gov

FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids
Procedure poses risk of spreading undetected cancerous tissue in women with unsuspected cancer

In a safety communication notice issued today, the U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.

Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.

Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health, most women will develop uterine fibroids at some point in their lives. While most uterine fibroids do not cause problems, they can cause symptoms, such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes requiring medical or surgical therapy.

Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, 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.

“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options.

The FDA will convene a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss information related to laparoscopic power morcellation.

“Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices,” said Maisel. “We anticipate the discussion will include whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and health care professionals are adequately informed of the risks.” 

In the interim, the agency has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and health care professionals.

Based on currently available information, the FDA’s recommendations for health care professionals include:

  • Be aware that the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
  • Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
  • Carefully consider all the available treatment options for women with symptomatic uterine fibroids.
  • Discuss the benefits and risks of all treatments with patients.

After carefully weighing the risks and benefits of the procedure, if a health care professional nonetheless determines that laparoscopic power morcellation is the best therapeutic option for his or her patient, the health care professional should:

  • Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
  • Be aware 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 cancer spread in the abdomen and pelvis.

FDA’s recommendations for women include:

  • Discuss all the options available to treat your condition, including the risks and benefits of each with your health care professional.
  • If laparoscopic hysterectomy or myomectomy is recommended, ask your health care professional if power morcellation will be performed during your procedure and why it is the best treatment option for you.
  • If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care professional.  

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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