FDA Warns Against Procedure for Uterine Fibroids
Friday, April 18, 2014 (Last Updated: 04/21/2014)
FRIDAY, April 18, 2014 (HealthDay News) -- Laparoscopic power morcellation for treatment of fibroids could increase a woman's risk of cancer, the U.S. Food and Drug Administration warned Thursday.
The FDA said that the procedure can inadvertently spread cancerous tissue beyond a woman's uterus and into other parts of her body. The FDA estimates that about one in 350 women undergoing a hysterectomy or fibroid removal has an unsuspected 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.
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. About 60,000 of these procedures are performed every year, said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health 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 at the news conference. 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."
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Hematology & Oncology
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