What are the safety concerns about use of surgical mesh to treat pelvic floor disorders?
Each type of mesh procedure carries its own risks and benefits.
In 2008, the Food and Drug Administration (FDA) warned of potentially serious complications associated with surgical mesh placed through the vagina to treat POP and SUI. Then, in 2016, the FDA changed the classification of surgical mesh to repair POP transvaginally from a moderate-risk device to a high-risk device.
Research has shown that surgical mesh for transvaginal repair of POP can cause complications such as mesh erosion, pain, infection, bleeding, pain during sex, organ perforation and urinary problems. Many of these complications require additional treatment, including surgery.
Treating SUI with a mesh sling also can cause complications, including mesh erosion, infection and pain. However, research suggests that the complications are infrequent and less severe than are complications associated with surgical mesh for transvaginal repair of POP, and rarely require follow-up surgery.
What questions should I ask before seeking a mesh treatment for a pelvic floor disorder?
If you're considering treatment for a pelvic floor disorder that involves surgical mesh, be sure to have your health care provider explain all of your options, as well as their possible risks and benefits. In particular, be aware of the risks associated with surgical mesh for transvaginal repair of POP, such as the need for additional surgery due to mesh-related complications.
Jan. 17, 2016
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- Abbott S, et al. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: A multicenter study. American Journal of Obstetrics and Gynecology. 2014;210:163.e1.
- Myers E, et al. Estimating the early impact of the FDA safety communication on the use of surgical mesh. Southern Medical Journal. 2013;106:684.
- Gutman RE, et al. Three-year outcomes of vaginal mesh for prolapse: A randomized controlled trial. Obstetrics and Gynecology. 2013;122:770.
- Position statement on mesh midurethral slings for stress urinary incontinence. American Urogynecologic Society. http://www.augs.org/p/bl/et/blogid=16&blogaid=194. Accessed May 30, 2014.
- Frequently asked questions by patients: Mid-urethral slings for stress urinary incontinence. American Urogynecologic Society. http://www.augs.org/p/bl/et/blogid=16&blogaid=194. Accessed May 30, 2014.
- FDA safety communication: Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. U.S. Food and Drug Administration. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Accessed May 30, 2014.
- American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. Committee Opinion No. 513: Vaginal placement of synthetic mesh for pelvic organ prolapse. Obstetrics & Gynecology. 2011;118:1459.
- FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse. U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm#. Accessed May 30, 2014.
- Urogynecologic surgical mesh implants. U.S. Food and Drug Administration. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm2025152.htm. Accessed May 30, 2014.
- FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Accessed Jan. 5, 2016.