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Information on Urogynecologic Surgical Mesh Implants

Thu, 07/14/2011 - 6:31am
U.S. Food & Drug Administration

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.

Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI.

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
  2. it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair

The FDA continues to evaluate the effects of using surgical mesh for treatment of urine leakage during moments of physical activity (stress urinary incontinence) and will provide updates on this webpage at a later date.

On this webpage, the FDA provides information about the use of surgical mesh placed transvaginally for the treatment of POP, recommendations for health care providers and women to help reduce risks, and steps to report problems to the FDA. The information provided on this webpage is not meant to replace a discussion with your health care provider.

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