FDA Warns Against Morcellation in Hysterectomy, Myomectomy

Deborah Flapan

Disclosures

April 17, 2014

Laparoscopic power morcellators should no longer be used for hysterectomy or myomectomy in most women with uterine fibroids because of the risk of spreading unsuspected cancerous tissue, the US Food and Drug Administration (FDA) announced today.

Women with symptomatic uterine fibroids may choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter postoperative recovery time and a reduced risk for infection compared with abdominal hysterectomy and myomectomy, the FDA notes in a press release. Many of these laparoscopic procedures are performed using a power morcellator.

The FDA is discouraging the use of these devices because morcellation, or dividing the tissue into smaller pieces or fragments, can spread cancerous tissue, such as uterine sarcomas, beyond the uterus, which "can significantly worsen a patient's prognosis," said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, Silver Spring, Maryland, during a press briefing today.

Because there is no reliable method for predicting whether a women has uterine cancer, the FDA has decided to discourage the device's use.

Healthcare providers should consider available alternative treatment options for symptomatic uterine fibroids, according to the agency.

Dr. Maisel pointed out that a number of alternative procedures for symptomatic uterine fibroids are available, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy, myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy.

"Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy," Dr. Maisel said.

According to an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids has an unsuspected uterine sarcoma.

"Younger women will have a lower risk and older women will have a higher risk," Dr. Maisel noted. "Most women who have undergone these procedures just require routine [follow-up] care."

He estimated that about 500,000 to 600,000 hysterectomies are performed each year, and about 50% of those are for uterine fibroids.

The first power morcellators were cleared through the FDA's 510(k) process in 1995, Dr. Maisel noted. About 2 dozen devices are currently cleared for laparoscopic power morcellation in gynecologic indications.

Premarket studies did not look at spread of cancer, but "given the low risk, a conventional clinical study would not have been likely to identify this risk," he said. "This is why postmarketing studies are so important."

Recommendations for Healthcare Providers

The FDA recommends that clinicians:

  • 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, and

  • thoroughly discuss the benefits and risks of all treatments with patients.

For individual patients for whom, after a careful benefit–risk evaluation, laparoscopic power morcellation is considered the best therapeutic option, clinicians should:

  • inform patients that their fibroid or fibroids may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis, and

  • 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 for spread in the abdomen and pelvis.

Use of a specimen bag "is not a panacea," Dr. Maisel warned. It will not completely remove the risk because cancerous tissue can spread before it gets into the bag and/or the bag can tear or perforate.

"In those who haven't been properly trained in its use, a specimen bag can obstruct view of operative field, and there are rare reports of organ damage with use of a specimen bag," he added.

The FDA 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 providers.

A future meeting of the Obstetrics and Gynecological Medical Device Advisory Committee will discuss the role of laparoscopic power morcellation in the clinical treatment of uterine fibroids; whether surgical techniques and/or use of accessories, such as morcellation/specimen bags, can enhance the safe and effective use of these devices; and whether a "boxed warning" related to the risk for cancer spread should be required for laparoscopic power morcellators.

"Our recommendations today are based on currently available information," Dr. Maisel said. However, the agency will continue to review data from various sources to determine whether additional changes in clinical practice are needed.

More information about today's announcement is available on the FDA Web site.

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