FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.

Jul 31st, 2011 | By | Category: FDA

This is the second notice issued by the FDA on the complications association with synthetic surgical mesh. This one, issued July 13, 2011, says:

  • “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. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.” 
  •  “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from the first notification by the FDA issued Oct. 20, 2008.”  See that original notice here.
  • “Furthermore, it is not clear that transvaginal POP (pelvic organ prolapse) repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” 
  • “From Jan 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI (stress urinary incontinence), with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.”
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.