Hospitals (1 - 1 of 1 item) in Past Year
Medical Devices: Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling
GAO-17-231: Published: Feb 7, 2017. Publicly Released: Feb 8, 2017.
Between 1991 and 2014, the Food and Drug Administration (FDA)—the federal agency responsible for the oversight of medical devices—cleared 25 submissions for laparoscopic power morcellators for the U.S. market. FDA cleared the submissions for these devices, which cut tissue into small pieces to facilitate removal through small incision sites of gynecological and other types of minimally invasiv...