Comments on the FDA's Proposed Order to Reclassify Surgical Mesh for Repair of Pelvic Organ Prolaspe
July 28, 2014
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Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposed orders to up-classify surgical mesh for transvaginal repair of pelvic organ prolapse (POP) and to require the filing of premarket approval applications for these medical devices. Unfortunately, the FDA’s reckless delays and inadequate action regarding surgical mesh for POP repair have resulted, and will continue to result, in thousands of women being unnecessarily exposed to a wide array of serious risks, many of which can permanently alter their quality of life.