FDA Recommends Product Label Warnings for Power Morcellators

December 3, 2014 | Risk Management News

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​The U.S. Food and Drug Administration (FDA) has issued a November 24, 2014, safety communication updating its warning against the use of laparoscopic power morcellation for the removal of uterine fibroids. Originally issued in April 2014 to address the potential risk of cancer associated with the procedure (see the April 23, 2014, HRC Alerts), the safety communication has been revised to include a recommendation that manufacturers of laparoscopic power morcellators use specific safety statements (two contraindications and a boxed warning) in their product labeling.

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