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FDA Advisers Weigh Risks of Procedure for Removal of Uterine Fibroids
Date:7/12/2014

ures 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 in April of banning the power morcellation devices from the market, but is urging physicians and patients to weigh the risks prior to their 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 an April 17 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 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 devices came onto the market, Maisel said, but "the magnitude of the risk appears to be higher than what was appreciated in the clinical community."

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