The FDA has recently taken a number of actions concerning transvaginal mesh product treatments for repair in pelvic organ prolapse (POP). For one, the FDA is considering reclassifying urogynecologic surgical mesh from a class II to class III high risk product. Also, the FDA has ordered manufacturers to conduct a large number of studies to make further determinations concerning use of such products in these surgical procedures.

Safety concerns have been brought up in North Carolina and elsewhere concerning use of surgical mesh for POP and for stress incontinence. Depending on the results of studies concerning these safety concerns, the FDA will likely follow up with other actions and recommendations.

As mentioned in our October 17, 2011 entry into this blog, complications from use of this mesh in surgical procedures can include:

  • Pain
  • Infection
  • Mesh erosion through the vagina
  • Bleeding
  • Pain during sexual intercourse
  • Organ perforation from surgical tools
  • Urinary problems

A spokesperson for one of the larger manufacturers of such surgical mesh states that use of the mesh is a safe and effective option for treatment of the symptoms mentioned above. The manufacturer also stresses that they welcome any guidance provided by the FDA. Though this appears to be a step in the right direction, such manufacturers have not yet demonstrated that the benefit of use of such a product in surgical procedures has come close to outweighing the risks.

Manufacturers of medical devices have lobbied heavily to have their devices marketed and used by medical providers. Saying such products are a safe and effective option fails to explain why there have been more than a thousand reports of complications associated with the use of such product. Manufacturers of the product must be able to back up their claims and be held accountable for injuries that result from the use of such products.

Source: Modern Medicine, "FDA orders new studies on mesh used in transvaginal repair," Jan. 18, 2012