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.
Due to reports of complications during or after surgery for POP, in 2016 the FDA changed the classification of surgical mesh to repair POP transvaginally from a moderate-risk device to a high-risk device. The FDA orders apply only to transvaginal use of surgical mesh to treat POP. The orders don't apply to the use of transvaginal mesh for SUI.
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, some research suggests that the complications are less frequent and usually less severe than are complications associated with surgical mesh for transvaginal repair of POP, and usually do not 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.
July 22, 2017
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- Maher C, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database of Systematic Reviews. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012079/full. Accessed May 22, 2017.
- Trabuco EC, et al. Overview of transvaginal placement of mesh for prolapse and stress urinary incontinence. http://www.uptodate.com/home. Accessed May 22, 2017.
- Obstetrical and gynecological devices: Reclassification of surgical mesh for transvaginal pelvic organ prolapse repair. Office of the Federal Register. https://www.federalregister.gov/documents/2016/01/05/2015-33165/obstetrical-and-gynecological-devices-reclassification-of-surgical-mesh-for-transvaginal-pelvic. Accessed May 22, 2017.
- Caveney M, et al. Short-term complications associated with the use of transvaginal mesh in pelvic floor reconstructive surgery: Results from a multi-institutional prospectively maintained dataset. Neurourology and Urodynamics. 2017;9999:1.
- ACOG practice advisory on the FDA's reclassification of mesh for pelvic organ prolapse. The American College of Obstetricians and Gynecologists. http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/ACOG-Practice-Advisory-on-the-FDAs-Reclassification-of-Mesh-for-Pelvic-Organ-Prolapse. Accessed May 22, 2017.
- Surgery for stress urinary incontinence. The American College of Obstetricians and Gynecologists. http://www.acog.org/Patients/FAQs/Surgery-for-Stress-Urinary-Incontinence. Accessed May 22, 2017.