FDA Proposes Changes to Address Vaginal Mesh Risks

Megan Brooks

April 29, 2014

The US Food and Drug Administration (FDA) wants to reclassify surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness of these devices.

The proposed changes are meant to address the health risks associated with surgical mesh used for transvaginal repair of POP, according to an announcement posted today on the FDA's Web site.

"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a statement.

"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair," added Dr. Maisel.

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body.

"Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product," the FDA said. "Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II)."

In July 2011, as reported by Medscape Medical News , the FDA warned of increasing reports of adverse events with use of surgical mesh for transvaginal POP repair.

In September 2011, the FDA's Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMAs.

Beginning in January 2012, the FDA has required manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

The FDA will take public comments on the proposals announced today for the next 90 days.

The agency notes that surgical mesh indicated for surgical treatments of stress urinary incontinence, abdominal POP repair with mesh, hernia repair, and other nonurogynecologic indications are not part of today's proposals.


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