FDA Warns Against Procedure for Uterine Fibroids
'Laparoscopic power morcellation' may increase women's cancer risk, agency says
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.