The FDA Reclassifies Transvaginal Mesh to a High Risk Device

Posted on Tuesday, January 5, 2016

by Christopher T. Kirchmer

In response to thousands of reports of adverse events and increased concern among doctors and FDA regulators, the FDA has reclassified transvaginal meshes used to repair pelvic organ prolapse from moderate-risk devices (class II) to high-risk devices (class III).

In addition, the FDA is requiring surgical mesh manufacturers to address well documented safety concerns by demonstrating the devices' effectiveness and safety for transvaginal repair. “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health.

Documented TVM complications have included bleeding, infection, organ perforation, pain during intercourse, severe pelvic pain, and urinary difficulties caused by mesh eroding into adjacent tissue. Both new devices and those currently on the market will be subject to the new requirements. Unfortunately, these new requirements come too late for the millions of women who already have transvaginal meshes implanted. For those women, additional surgeries and legal action remain the only remedies.

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