FDA Adds 'Boxed Warning' to Devices Used to Remove Uterine Fibroids

FDA Adds 'Boxed Warning' to Devices Used to Remove Uterine Fibroids

FDA Adds 'Boxed Warning' to Devices Used to Remove Uterine Fibroids

Risk of spreading unsuspected cancers prompted new warnings, agency says

SOURCES: Nov. 24, 2014, news release, U.S. Food and Drug Administration; April 17, 2014, U.S. Food and Drug Administration news briefing with William Maisel, M.D., M.P.H., deputy director, science, and chief scientist, Center for Devices and Radiological Health; Wall Street Journal

MONDAY, Nov. 24, 2014 (HealthDay News) -- The U.S. Food and Drug Administration on Monday announced that new "boxed warning" labels will be added to devices called laparoscopic power morcellators, which are used to grind up uterine fibroid growths.

The warning labels follow a recommendation issued in July by an FDA advisory panel that stated there's no way to guarantee surgical morcellation wouldn't increase the risk of spreading cancer to other parts of a woman's body.

The new warning will let surgeons and patients know 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," the FDA said in a news release.

Two other warnings will state that the morcellators should not be used in patients who are in or around menopause or in most patients who would need to undergo hysterectomy due to fibroids. The morcellators are also not to be used "in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous," the FDA added.

That's because in about one in every 350 cases, women who undergo hysterectomy for fibroids may have an unsuspected uterine sarcoma, the FDA said, and morcellation might help spread that cancer.

"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," Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said 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 added.

The FDA did not rule out the safe use of morcellating devices in some patients. The new warning label should help narrow the candidate patient population, however. "For example, 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.

Surgeons frequently use laparoscopic power morcellation when they perform a hysterectomy or remove uterine fibroids, which are noncancerous growths on the smooth muscle tissue on the wall of the uterus.

The minimally invasive procedure uses a power tool to chop up the tissue of the fibroids or, in the case of a hysterectomy, the uterus itself. These tissue fragments are then removed through tiny incisions, according to background information from the FDA.

At the end of July, Johnson & Johnson, the largest maker of laparoscopic power morcellators, pulled their devices from the market. In a letter sent to customers, J&J asked that its laparoscopic power morcellators be returned to the company, the Wall Street Journal reported.

In April, the FDA stopped short of banning the power morcellation devices from the market, but the agency is urging physicians and patients to weigh the risks involved with the devices prior to their use.

Women who already have undergone power morcellation don't need to undergo a cancer screening, because some of the tissue removed during the procedure would have been sent for pathologic analysis, Maisel said. If cancer had been detected, they would have been informed, he added.

"We think that most women who have undergone these procedures require routine care," he said. "If they don't have any ongoing or recurrent symptoms, they should be fine."

Most women will develop uterine fibroids at some point in their lives, according to the U.S. National Institutes of Health. These fibroids can cause symptoms such as heavy or prolonged menstrual bleeding, pelvic pain or frequent urination.

Women who need a hysterectomy or fibroid removal can still undergo traditional or laparoscopic surgery, just without the use of a power morcellator, Maisel said.

The FDA approved the first power morcellator for use in 1995, Maisel said. A non-power version of the morcellator received FDA approval in 1991.

More information

For more about uterine sarcoma, visit the U.S. National Cancer Institute.

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