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Vaginal Mesh for POP Repair is Class III “High-Risk” Device

Vaginal Mesh for POP Repair is Class III “High-Risk” Device

January 4, 2016 — The FDA has reclassified vaginal mesh implants for pelvic organ prolapse (POP) repair as Class III “high-risk” devices.

The agency also announced that manufacturers will be required to submit Pre-Market Approval (PMA) applications for devices already on the market within 30 months.

The PMA process is the strictest approval application the FDA can require. Manufacturers must submit scientific evidence showing the device is safe and effective for its intended use. According to Dr. William Maisel of the FDA’s Center for Devices & Radiological Health:

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse.”

Only vaginal mesh products for transvaginal pelvic organ prolapse (POP) repair are affected by the new requirements. The FDA said implants for stress urinary incontinence (SUI) and abdominal POP repair are not affected.

In the last few years, the FDA has seen a “significant increase” in the number of reported adverse events associated with the devices. Several warnings have been issued and approximately 100,000 product liability lawsuits have been filed by women who were injured. Last month, a woman whose Prolift implant eroded into her bladder was awarded $12.5 million by a jury in Philadelphia.

In the past, most vaginal mesh products were approved with 510(k) applications. This allows manufacturers to avoid new safety studies so long as their device is “equivalent” to another device on the market.

Several of these devices were approved despite their “equivalence” to Boston Scientific’s ProteGen mesh, an implant that was recalled in the 1990s for safety reasons. Not surprisingly, many of the safety risks linked to the ProteGen have been found in similar devices.

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