FDA Warns Against Procedure for Uterine Fibroids
By Dennis ThompsonHealthDay ReporterTHURSDAY, April 17, 2014 (HealthDay News) -- A surgical technique used to grind up uterine growths and remove them through tiny incisions could increase a woman's risk of cancer, the U.S. Food and Drug Administration warned Thursday.
The FDA said that the procedure, known as "laparoscopic power morcellation," can inadvertently spread cancerous tissue beyond a woman's uterus and into other parts of her body.
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 agency.
The FDA estimates that about one in 350 women undergoing a hysterectomy or fibroid removal has an unsuspected type of cancer called uterine sarcoma.
If a surgeon performs power morcellation on these women, there's a risk the procedure will spread the cancerous tissue within the patient's abdomen and pelvis.
About 60,000 of these procedures are performed every year, estimated Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health.
The FDA stopped short of banning the power morcellation device from the market, but is urging physicians and patients to weigh the risk prior to its use.
"Women should ask their health care provider if power morcellation will be used during the procedure, and explain why it's the best option," Maisel said at a Thursday news conference.
Women who already have undergone power morcellation don't need to get 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 agency has instructed manufacturers of power morcellators to review their current product labeling for accurate risk information for patients and health care professionals.
The FDA also will convene a public meeting this summer of its obstetrics and gynecological medical devices panel to discuss the matter and weigh whether further measures are required.
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.
The medical community has been aware of the risk of cancer spread during power morcellation since the device came onto the market, but "the magnitude of the risk appears to be higher than what was appreciated in the clinical community," Maisel said.
Brigham and Women's Hospital in Boston and the Cleveland Clinic both recently strengthened their informed consent for the procedure, warning women of the potential cancer risk, according to recent news reports.
In particular, specialists at Brigham and Women's tell patients about their own in-house research, which found a ninefold higher rate of unexpected uterine sarcoma during a review of the medical records of more than 1,000 women who received morcellation for fibroids, according to The New York Times.
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SOURCES: April 17, 2014, U.S. Food and Drug Administration news briefing with William Maisel, M.D., M.P.H., deputy director for science and chief scientist, Center for Devices and Radiological Health; March 17, 2014, The New York Times; Dec. 24, 2013, Wall Street Journal
