FDA Proposes Reclassification of Transvaginal Mesh Devices to High-Risk Category

FDA_Reclassifies_Transvaginal_Mesh_to_High_Risk_CategoryToday, the U.S. Food and Drug Administration (FDA) issued two proposed orders for the reclassification of transvaginal mesh devices used for repair of pelvic organ prolapse (POP).

If these orders are finalized, surgical mesh devices implanted to treat POP would be reclassified from class II (moderate-risk device) to class III (high-risk device) and the manufacturer would be required to submit a premarket approval (PMA) application for the agency to evaluate the safety and effectiveness of the device, according to an FDA news release. Transvaginal mesh devices would no longer be permitted to go through the 510(k) approval route by which a manufacturer can seek expedited approval by demonstrating a device’s similarity to a previously approved device. Under the hgh-risk classification, the manufacturer would be required to do clinical testing to prove the device is safe and effective.

Women with POP – which occurs when the internal structures that support the pelvic organs become weak, stretched, or broken, and the organs drop from their normal position and bulge (prolapse) into the vagina – can experience pelvic discomfort, disruption of urinary, defecatory, and sexual functions, and reduction in quality of life, the FDA explains.

Surgical mesh devices are implanted to provide support for the organs, but the devices themselves have been shown to cause injuries and complications, including pain, bleeding, urinary problems, and infections. Many women need to undergo additional surgeries to remove the mesh and repair organ damage. In July 2011, the FDA issued an updated safety communication about serious complications associated with transvaginal mesh devices, and in 2012 the FDA ordered manufacturers to conduct postmarket studies to address safety and effectiveness concerns. Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said his agency has “identified clear risks associated with surgical mesh … and is now proposing to address those risks for more safe and effective products.”

Thousands of women injured by transvaginal mesh devices have filed lawsuits against manufacturers including Boston Scientific, C.R. Bard, Endo, and Johnson & Johnson’s Ethicon division.



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