Congressional Leaders Push FDA to Monitor Morcellator Safety

Twelve lawmakers have taken to the U.S. Government Accountability Office seeking investigation into the FDA’s track record in monitoring power morcellators, surgical devices used to remove uterine fibroids that have recently been reported to spread aggressive cancer. Rep. Mike Fitzpatrick (R-PA) and Rep Louise Slaughter (D-NY) are two of the congressional leaders pushing for the federal government to intervene.

Morcellators work by grinding up and removing uterine tissue through a small incision in the abdomen. The FDA issued a warning in November 2014 indicating that the device poses a risk of unsuspected uterine sarcoma in 1 in 350 women that undergo the procedure. The warning led to backlash from consumer advocates and the medical community, but some morcellators still remain on the market—spurring the recent intervention by Congress to keep a closer eye on the FDA’s monitoring of the device.

Real Time Analytics