Safety Information

Page Last Updated: 03/26/2018

This information can be accessed electronically by clicking here.²⁶

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

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.

Page Last Updated: 01/07/2018

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345205.htm

Recommendations for Patients:

Before surgery:

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:

• 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 will be provided with detailed information on mesh material? 

After surgery:

• 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 had POP surgery but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.