After receiving tens of thousands of complication reports, the Food and Drug Administration (FDA) decided to issue a list of recommendations for women who may undergo transvaginal mesh surgery to treat pelvic organ prolapse (POP).

Transvaginal mesh, implanted in more than 500,000 women each year, is a plastic netting inserted in the vagina to treat POP, which occurs when the bladder, uterus, bowel or rectum drops or descends into the vaginal canal.

Mesh, which supports the organs from falling further past the pelvic floor, has been linked to a high complication rate. Thousands of women have been injured by transvaginal mesh implant procedures.

Many women with vaginal mesh implants developed side effects than led to serious pain and changes in quality of life, including erosion or exposure of the material, pain during intercourse, infection, urinary problems, bleeding, and organ perforation.

Vaginal mesh has also been linked to recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, emotional problems, hospitalizations, and the need for multiple revision surgeries. However, additional surgeries may or may not resolve the complications.

In order to inform women of the risks, the FDA released a mesh procedure checklist for those considering mesh implants to treat POP. The FDA encourages all candidates for mesh surgery to discuss alternative treatment options with their health care provider, including non-surgical options, and surgical repair without mesh.

Mesh Surgery Questions

In addition, the FDA has created a list of preoperative questions for women to ask their surgeons before undergoing a mesh procedure:

  • Are you planning to use mesh in my surgery?
  • Why do you think I am a good candidate for surgical mesh?
  • Why is surgical mesh being chosen for my repair?
  • What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
  • What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
  • Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
  • If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
  • What can I expect to feel after surgery and for how long?
  • Which specific side effects should I report to you after the surgery?
  • If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
  • What if the mesh surgery doesn’t correct my problem?
  • If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
  • If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
  • If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?

The FDA urges women who have had surgery with mesh to repair POP to:

  • Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
  • Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.
  • Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
  • Talk to your health care provider about any questions you may have.

If you have already received surgical treatment for POP, the FDA encourages you to ask your health care providers if mesh was used. For women experiencing abdominal pain and other unexplained side effects, failed mesh may be the culprit. 

Learn more about the dangerous medical device by connecting with an advocate or reading our comprehensive guide to Vaginal Mesh.