Gaps in FDA’s adverse event reporting system allowed power morcellator risks

Editor's Note

A Government Accountability Office (GAO) report finds that gaps in the Food and Drug Administration’s (FDA’s) adverse event reporting system allowed the widespread use of laparoscopic power morcellators for years before their risk for spreading cancer became known, according to the February 10 Mass Device.

Immediate Congressional action is needed to reform the system and save lives, and Reps Louise Slaughter (D-NY) and Brian Fitzpatrick (R-Pa) say they will move forward to find bipartisan legislative solutions to address the shortcomings in the system.

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.