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FDA Warns of Power Morcellator Cancer Risk

FDAOn November 24, the U.S. Food and Drug Administration issued a statement that “boxed warning” labels would be added to laparoscopic power morcellators ─ a device used to grind up uterine fibroid growths. This hysterectomy morcellation warning follows a July FDA recommendation stating it isn’t possible to guarantee surgical morcellation won’t increase the risk of spreading cancer to other regions of a woman’s body.

The warning isn’t a morcellator recall, but it will notify patients and surgeons that “uterine tissue may contain unsuspected cancer [and] the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients,” said the FDA in a news release.

Two additional warnings will caution against using the morcellators in patients who are currently in menopause or nearing it, and in the majority of patients who would need to submit to a hysterectomy caused by fibroids. The FDA warns against using the morcellators “in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.”

Morcellators aren’t new to the market ─ the first power morcellator received FDA approval in 1995 and the first non-power model was approved in 1991.

Power morcellator cancer risk

Nearly one in every 350 women who undergo a hysterectomy due to fibroids may have an undetected uterine sarcoma and morcellation may assist in spreading the cancer, the FDA said.

“The FDA’s primary concern is the safety and well-being of patients, and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, in the agency’s news release.

“Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed,” he noted.

Morcellation may be beneficial to some women

The FDA does believe morcellation can benefit some patients. The new warning label is intended to effectively narrow down the number of women using morcellator devices.

“Some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may [still] be candidates for this procedure,” the agency said in the news release.

Many surgeons use laparoscopic power morcellation when removing uterine fibroids or performing a hysterectomy. Minimally invasive procedures use a power tool to sever the tissue of the fibroids ─ or the uterus, during a hysterectomy. Consequently, tissue fragments are removed through small incisions, according to the FDA.

The largest manufacturer of laparoscopic power morcellators, Johnson & Johnson, suspended sales of their morcellator devices this past July. The company sent a letter to customers asking them to return the devices to the company.

The FDA is advising patients and physicians to thoroughly evaluate the morcellator cancer risks prior to using them. Women who need to undergo surgery for fibroid removal or a hysterectomy can still submit to traditional or laparoscopic surgery, without using morcellation.

  1. Health, FDA Adds ‘Boxed Warning’ to Devices Used to Remove Uterine Fibroids

  2. The Washington Post, FDA Toughens Warning that Uterine Procedure Can Spread Cancer