FDA Reclassifies Vaginal Mesh as a High-Risk Device

Disclosures

January 04, 2016

The US Food and Drug Administration (FDA) today reclassified surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a moderate-risk device (class ll) to a high-risk one (class lll) and gave manufacturers 30 months to prove that their products are safe and effective, the agency announced.

First proposed in April 2014, the regulations top off FDA warnings in 2008 and 2011 about the risk for severe pelvic pain, infection, painful intercourse, bleeding, organ perforation, and urinary problems with the use of the mesh. A tsunami of lawsuits triggered by those warnings prompted one manufacturer, Johnson & Johnson, to stop marketing its product.

Five other companies continue to sell surgical mesh for transvaginal POP repair in the United States. Under today's regulations, they must submit a premarket approval (PMA) application for their products, which entails demonstrating their safety and effectiveness in the agency's most rigorous vetting process. The FDA previously had cleared these mesh devices through its 510(k) process, which bypasses clinical trials and requires manufacturers to show only that their product is substantially equivalent to one already on the market.

New mesh devices for this indication also must undergo PMA scrutiny.

The agency's decisions do not apply to surgical mesh for other indications, including stress urinary incontinence and abdominal repair of POP.

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health, in a news release. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures."

With POP, muscles and tissues of the pelvic floor are stretched, torn, or weakened to the point of no longer supporting organs such as the bladder, bowel, or uterus. Implanted surgical mesh can keep these organs from prolapsing into the vagina, but the FDA said it has received thousands of reports of adverse events over the past several years for this kind of POP repair.

More information on today's announcement is available on the FDA website.

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