FDA tightens clinical requirements for transvaginal devices

(Reuters) – The U.S. Food and Drug Administration said on Monday it had taken steps to strengthen the data requirements for surgical mesh devices when used to repair pelvic organ prolapse (POP) via the vagina. Over the past several years, the FDA has received thousands of reports of complications, including bleeding, organ perforation and urinary problems, involving the use of mesh for transvaginal POP repair, the agency said. In the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990's, for the transvaginal repair of POP.

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FDA tightens clinical requirements for transvaginal devices