FDA Recommends Product Label Warnings for Power Morcellators

December 12, 2014 | Strategic Insights for Ambulatory Care


​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, 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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