The FDA today recommended that manufacturers of laparoscopic power morcellators, which have been implicated in the spread of cancer, add noticeable and easy-to-read boxed warnings about the risks in using the devices in gynecologic procedures.
In its final guidance on the topic, the agency recommends that laparoscopic power morcellation (LPM) be limited to use with certain tissue containment systems and only in premenopausal women who have suspected fibroid tumors and are under 50 years of age. The guidance released today follows preliminary guidance issued in February.
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