FDA issues proposals to address risks associated with vaginal mesh


The FDA issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse, or POP. If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device, or class II, to a high-risk device, or class III, and require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness. Makers of vaginal mesh include Johnson & Johnson (JNJ), C.R Bard (BCR), Endo Health (ENDP) and Boston Scientific (BSX).

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