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FDA Advisory Committee Issues Recommendations on Morcellation

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Silver Springs, MDAn FDA advisory committee has recommended informed consent regarding the risks of morcellation for women whose treatment of benign fibroids involves laparoscopic uterine surgery via power morcellator. The advisory committee also recommended a boxed warning be included on the labels of laparoscopic power morcellators, developing strategies to lessen the risks of adverse events during treatment and determining patients that may have sarcoma before treatment begins.

According to Ob. Gyn. News (7/12/14), the advisory panel was not asked to consider taking laparoscopic power morcellators off the market or to reclassify them. Laparoscopic power morcellators are a concern in cases where women have are receiving treatment for benign uterine fibroids when they actually have uterine sarcoma. In those cases, laparscopic power morcellation may spread cancerous tissue in the patient's abdomen and pelvis, drastically decreasing the patient's chances of survival.

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