FDA finally acts to take dangerous surgical mesh for pelvic repair off the market.
- 2002 Year that the FDA approved surgical mesh for pelvic repair without clinical testing.
- 1,500 Reports of serious complications associated with use of surgical mesh devices for pelvic repair from 2008 to 2010.
- 8 Number of years it took the FDA to ban the mesh.
In 2002, the U.S. Food and Drug Administration (FDA) approved the use of surgical mesh to repair pelvic organ prolapse, a condition that occurs when pelvis muscles and tissues grow weak or become damaged, causing one or more pelvic organs to drop into or press out of the vagina. However, no clinical trial evidence for the product was available at the time of approval.
In 2008, the FDA issued a warning to patients and doctors about reports of adverse events caused by the mesh, including erosion, infection, pain and urinary problems such as incontinence. There were also reports of injuries to the bowels, bladder and blood vessels during the mesh insertion process. In some cases, vaginal scarring, mesh erosion and contraction or shrinkage of the mesh caused patients severe pelvic discomfort and pain. Some of these complications required additional surgeries and could still remain unresolved in spite of treatment.
The agency continued to receive reports of serious complications associated with the use of surgical mesh for pelvic organ prolapse repairs, receiving more than 1,500 reports from 2008 to 2010. A 2011 FDA report revealed that three patients had died due to complications related to the mesh placement procedure. It also indicated that the use of surgical mesh for pelvic repair provided no clinically significant benefits compared to repairs without mesh.
So in 2011, Public Citizen petitioned for a ban of surgical mesh for the transvaginal repair of pelvic organ prolapse.
The FDA denied Public Citizen’s request in 2014, saying that although the agency had concerns about mesh, a ban wasn’t warranted. But in 2016, the FDA reclassified the products as high-risk devices, putting them under the agency’s most stringent regulatory oversight. The agency then gave manufacturers three years to submit documentation that provided evidence of the devices’ effectiveness and safety. In the meantime, the mesh products continued to remain on the market, and women continued to be injured.
On Feb. 12, 2019, an FDA advisory committee convened to seek expert opinion on the evaluation of risks and benefits of using surgical mesh for pelvic organ prolapse. Public Citizen testified before the advisory committee, reiterating the dangers of using such products and urging the agency to ban them.
On April 16, the FDA finally 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.. In its announcement, the agency noted that the manufacturers of these devices, Boston Scientific and Coloplast, “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”
The agency’s reckless delay in removing these mesh products from the market belies the assertion on April 16 by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, that “patient safety is our highest priority.” Had the agency granted Public Citizen’s 2011 petition promptly, thousands of women would have been spared serious, preventable, life-altering harm. Unless the FDA fundamentally changes its approach to the oversight of medical devices, similar tragedies will continue to occur in the future.
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.Dr. Michael Carome, director of Public Citizen’s Health Research Group