According to an FDA press release today, the FDA has proposed two orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal 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 surgical mesh used to treat transvaginal POP. Surgical mesh indicated for surgical treatments of stress urinary incontinence (SUI), abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications are not part of the proposed order. The public comment period on the proposed order will be open for 90 days. Read More Alerts About Transvaginal Mesh.
[1] FDA News Release, "FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse," April 29, 2014.
[1] FDA News Release, "FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse," April 29, 2014.
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