Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
Note: Today, the U.S. Food and Drug Administration (FDA) ordered the manufacturers of all surgical mesh products for the transvaginal repair of pelvic organ prolapse to stop selling their products in the U.S. immediately. The FDA noted that the agency “has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.” In February, Public Citizen testified before an FDA advisory committee and urged the agency to ban the products. Public Citizen first petitioned for a ban in 2011, which the agency denied in 2014.
Although we welcome this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had “not demonstrated a reasonable assurance of safety.” Since at least 2011, there has been clear evidence that these products are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits.
The agency’s reckless delay in removing these mesh products from the market belies the assertion today by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, that “patient safety is our highest priority.”
If the agency had granted our 2011 petition promptly, thousands of women would have been spared serious, preventable life-altering harm.