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.
FDA Orders Mesh Manufacturers to Stop Selling Devices for Transvaginal Repair of Pelvic Organ Prolapse
On April 16, 2019, after reviewing their premarket approval (PMA) applications, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse (Boston Scientific Uphold Lite, Boston Scientific Xenform, Coloplast Direct Fix Anterior) to stop selling and distributing their products immediately. The FDA determined that the manufacturers, Boston Scientific and Coloplast, did not demonstrate reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to transvaginal mesh for pelvic organ prolapse since the agency reclassified them into class III (high risk) in 2016. For details, see the press release: FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. Following the FDA order in April 2019, the manufacturers withdrew these devices from the market.
People who 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.
On this page:
Related pages by topic:
|Pelvic Organ Prolapse|
|Stress Urinary Incontinence|
Surgical mesh may be made from synthetic materials or from animal-derived materials.
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.
Non-absorbable materials will remain in the body permanently. Mesh made of these materials are used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable materials will degrade and lose strength over time. Mesh made with these materials are 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.
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).
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.
* There are currently no FDA-approved surgical mesh products for transvaginal repair of prolapse marketed in the United States.