FDA reclassifies transvaginal mesh as high-risk device

posted on:
January 11, 2016

author:
Amanda Burbank

As of Jan. 4, 2016, surgical mesh used to repair pelvic organ prolapse (POP) transvaginally, known as transvaginal mesh or TVM, has been reclassified by the U.S. Food and Drug Adminstration (FDA) from a class II, moderate-risk, to a class III, high-risk device. Manufacturers of devices that are already on the market will have 30 months to submit a premarket approval (PMA) application demonstrating the safety and effectiveness of their devices. Manufacturers of new devices will be required to submit a PMA before devices are approved.

First cleared by the FDA for use as a class II device in 2002, the FDA states that in the past several years there has been a significant increase in the number of reports of adverse events associated with the use of mesh for transvaginal POP repair, saying they’ve received thousands of reports of complications. Commonly reported problems include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.

The FDA issued safety communications warning doctors and consumers regarding these devices in both 2008 and 2011, and in 2011 an advisory panel determined that more data was needed to establish the safety of these devices. The following year, the FDA issued orders to manufacturers to begin postmarket surveillance studies, culminating in the two orders issued this week, reclassifying the devices as class III, high-risk, and requiring manufacturers to submit a PMA application.

In the press release on the U.S. Department of Health and Human Services website, William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health said: “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

Source: U.S. Food and Drug Administration

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