Urogynecologic Surgical Mesh Implants
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:
- 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 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.
- FDA Press Release: FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse
- 513(e) Proposed Order for Reclassification of Surgical Mesh for Transvaginal POP Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation
- 513(b) Proposed Order for Premarket Approval for Surgical Mesh for Transvaginal POP Repair
UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July 2011)(PDF - 243KB)
- Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks [ARCHIVED]
Federal Register Notice: Urogynecologic Surgical Mesh
- Federal Register Notice Ammendment: Urogynecologic Surgical Mesh
2011 Meeting Materials of the Obstetrics and Gynecology Devices Panel