Jan. 31, 2019
Public Citizen Urges FDA to Ban Dangerous Surgical Mesh for Pelvic Repair
Thousands of Women Have Been Permanently Injured by This Hazardous Device
WASHINGTON, D.C. – No more women should be put at risk of harm by undergoing surgery with dangerous internal surgical mesh that the U.S. Food and Drug Administration (FDA) should have banned eight years ago, Dr. Michael Carome, director of Public Citizen’s Health Research Group, will tell the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on Tuesday.
From 2002 to 2011, dozens of nonabsorbable surgical mesh products labeled for transvaginal repair of pelvic organ prolapse were cleared for marketing without clinical testing. However, the use of such products offers no clinically significant benefits in comparison to nonmesh repair, and the agency in 2011 said that serious complications associated with the use of such devices “are not rare.”
Despite that conclusion, the agency in 2014 denied Public Citizen’s 2011 petition to ban these mesh products.
As a result of the FDA’s reckless and inadequate actions regarding these devices, thousands of women have been unnecessarily injured, many permanently, and some have died as a result of the treatment, Carome will tell the panel.
“Surgical mesh for repair of pelvic organ prolapse is a quintessential example of the fundamental deficiencies in the FDA’s oversight of medical devices, particularly those that are permanently implanted,” Carome said. “If the agency had promptly granted our 2011 petition, countless women would have been spared serious, life-altering harm.”
Read Carome’s testimony (PDF).