The FDA has made a commitment to inform the public about urogynecologic surgical mesh for pelvic organ prolapse (POP) and maintains information on their website for patients about POP and the use of surgical mesh for repair of POP.
The information provided by the FDA for mesh used in the treatment of pelvic organ prolapse is not specific to any company or specific product line. To ensure you receive the full list of potential risks for any specific mesh device, please discuss with your health care provider.
The information below has been taken directly from the FDA’s website regarding urogynecologic surgical mesh. Please note that these excerpts include information on mesh used to treat stress urinary incontinence and pelvic organ prolapse.
Page Last Updated: 03/26/2018
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 can be 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 to treat pelvic floor disorders with surgical mesh:
Each of these procedures has unique risks and benefits and it is important not to confuse the procedures and the risks and benefits.
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.
Page Last Updated: 01/07/2018
It is important that women are aware of the risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP). Women who have mesh surgery may be at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.
Ask your surgeon these questions before you decide to have POP surgery:
If you have had POP surgery but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.