Transvaginal Mesh–The Past Five Years

Washington, DC: From 2011, the FDA has warned health professionals and the public that transvaginal mesh was associated with serious complications that were not rare, and recommended the mesh be bumped up from moderate to high risk. Almost five years later, the agency has reclassified mesh products designed and marketed for transvaginal treatment of POP to Class III “High Risk Devices,” which means more stringent regulatory requirements for the manufacturers.






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