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FDA In Brief: FDA Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries

December 29, 2020

Via: BioSpace

“Providing women with access to safe medical devices to meet their health care needs is a top priority for the FDA. Today, we’ve taken two important steps on laparoscopic power morcellators as a result of listening to and acting on public comments to our draft guidance as well as considering the available scientific data.

“Reflecting that feedback and scientific review, our updated recommendations for health care providers include shared decision-making with patients, a thorough preoperative screening with the patient and a warning about the spread of benign uterine tissue, potentially requiring additional surgeries, when using uncontained laparoscopic power morcellators in gynecologic surgeries.

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