GAO flags gaps in FDA ’ s adverse event system in power morcellator report

Limitations in the FDA’s adverse event reporting system for medical devices helped allow the widespread use of laparoscopic power morcellators for years before the risk that they can spread cancer became known, a government watchdog said this week. Medical device manufacturers and importers are required to tell the FDA about any device-related adverse events within 30 days. “FDA officials noted, however, the limitations in the current, passive, medical device reporting system, which relies on people to identify that a harm occurred or a risk is present, recognize that the harm or risk is associated with the use of a particular device, and take the time to report it,” the Government Accountability Office found in its report. Power morcellators, 1st cleared for the U.S. market in 1991, are designed to shred benign uterine tissue using small, rotating blades. But if the patient has an undiagnosed cancer called uterine sarcoma, the malignant cells are strewn throughout the abdominal cavity along with the benign morcellated tissue. The FDA estimates that women undergoing hysterectomies or myomectomies with the devices 1-in-350 odds of having an undetected cancer. The FDA didn’t receive its 1st adverse event report on the link between power morcellators and cancer until December 2013, meaning that power morcellators were used for nearly 23 years. And although the cancer incidences were the type that usually would trigger an adverse event report,...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Wall Street Beat Women's Health Capitol Hill U.S. Government Accountability Office (GAO) Source Type: news