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FDA Proposes PMAs For Pelvic Organ Prolapse Mesh Devices

FDA is proposing class III, PMA status for surgical mesh used to treat pelvic organ prolapse based on evidence of health risks including mesh exposures and extrusions, pelvic pain, infections and repeat surgery for complications.

FDA says that surgical mesh used for transvaginal repair of pelvic organ prolapse should be regulated under tougher standards based health risks associated with the devices.

Under proposals issued by the agency on April 29, FDA would reclassify

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