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FDA removes pelvic mesh from the market

Kate Halloran May 9, 2019

On April 16, the FDA announced that it has ordered manufacturers to stop selling and distributing pelvic mesh immediately due to concerns about its safety and efficacy. Because medical device manufacturers have not been able to provide “reasonable assurance” to the agency that the mesh’s benefits outweigh its risks, it cannot meet the standard for a Class III (high risk) medical device. Transvaginal mesh was reclassified as Class III in 2016 in the wake of many adverse event reports about injuries resulting from its implantation.

Transvaginal mesh, which is used to treat pelvic organ prolapse, has been at the center of litigation over its safety for years, as Trial News previously reported. Plaintiffs allege that the mesh can erode and cause infection, bleeding, and organ tearing. The FDA has received more than 10,000 serious injury complaints and reports of approximately 80 deaths linked to the device.

The first transvaginal mesh device was approved in 2002 through the 510(k) process—which requires a showing that the device is substantially equivalent to an existing legally marketed device—as a Class II (moderate risk) device. But a significant number of adverse event reports followed, and the FDA repeatedly warned doctors and patients about the risks. The FDA has been issuing warnings about pelvic mesh since 2008, and it gathered an expert panel in 2011 to review the devices. The panel concluded that more data was needed about the devices’ safety. In January 2016, the FDA announced that it had reclassified transvaginal surgical mesh used to treat pelvic organ prolapse as a Class III device, requiring a premarket approval application from manufacturers of devices that are already on the market, as well as for any new devices, to address safety concerns.

Thousands of women have sued pelvic mesh manufacturers—including Johnson & Johnson’s Ethicon, C.R. Bard, and Boston Scientific—in state mass tort actions and in federal multidistrict litigation. Many cases were settled with manufacturers ending sales of the device. But Boston Scientific and Coloplast, a Danish company, continued to sell pelvic mesh in the United States. The companies had 10 days from the FDA’s order to submit plans for how they intended to withdraw their mesh products from the market.