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Urogynecologic Surgical Mesh Implants

Urogynecologic Surgical Mesh Implants

On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016.  

Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness. The companies will have 10 days to submit their plans to withdraw these products from the market.

Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their 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 any complications or symptoms. You should 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. You should also let your health care provider know if you have surgical mesh, especially if you plan to have another surgery or other medical procedures. If you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, you should discuss other treatment options with your doctor. If you have had pelvic organ prolapse surgery but do not know whether your surgeon used mesh, ask your surgeon at your next scheduled visit.

Additional information for patients and health care providers about the use of surgical mesh for transvaginal pelvic organ prolapse is provided in this websection.

Providing patients with access to the safest possible medical devices on the market to meet their health care needs remains a top FDA priority. Learn more about FDA's Recent Activities.

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.

Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine).

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Surgical mesh has been 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. There are three main surgical procedures performed with surgical mesh to treat pelvic floor disorders with surgical mesh:

  • Transvaginal mesh to treat POP *
  • Transabdominal mesh to treat POP
  • Mesh sling to treat SUI

Each of these procedures has unique risks and benefits and it is important not to confuse the procedures and their risks and benefits.

* On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse into class III and required submission of premarket approval (PMA) applications, the agency's most stringent device review pathway. The FDA mandated that premarket approval applications be filed by July 5, 2018 for any surgical mesh marketed for transvaginal pelvic organ prolapse repair. As a result of the FDA's actions, all manufacturers stopped marketing surgical mesh intended for transvaginal repair of posterior compartment prolapse (rectocele).

On April 16, 2019, the FDA ordered manufacturers of surgical mesh products intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. Therefore, there are no FDA-approved surgical mesh products for transvaginal repair of prolapse marketed for use in the U.S. Based on the review of available evidence, the FDA believes that the benefit-risk profile of mesh placed transabdominally to treat POP and mesh used to treat SUI remains favorable. However, we continue to review new evidence as it becomes available.

Women who have received transvaginal mesh for the surgical repair of prolapse should continue with their 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 any complications or symptoms. You should 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. You should also let your health care provider know if you have surgical mesh, especially if you plan to have another surgery or other medical procedures. If you were planning to have mesh placed transvaginally for the repair of prolapse, you should discuss other treatment options with you doctor. If you have had pelvic organ prolapse surgery but do not know whether your surgeon used mesh, ask your surgeon at your next scheduled visit.

In this website, the FDA describes POP and SUI, the different surgical and non-surgical treatment options, recommendations for health care providers that treat women with POP and/or SUI, recommendations for patients who are considering surgery for these conditions and steps to report problems to the FDA. This information is to help patients make informed decisions about their health care and to facilitate a discussion between patients and their health care providers about treatment options. The information provided on this website is not meant to replace a discussion with your health care provider.