Medical Devices

Concerns about Surgical Mesh for POP

Based on an updated analysis of adverse events reported to the FDA and complications described in recent scientific literature, on July 13, 2011 an FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse was issued to inform the medical community and patients that:

  1. serious complications associated with surgical mesh for transvaginal repair of POP are not rare; and
  2. it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair

Additional Information

Page Last Updated: 08/28/2018
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