Concerned about transvaginal mesh complications associated with treatments for pelvic floor disorders? Here's what you need to know.By Mayo Clinic Staff
If you're a woman who has a pelvic floor disorder, you've likely heard of treatments involving transvaginal mesh. However, reports about complications might have you confused or hesitant to seek treatment. Understand the concerns about transvaginal mesh and what they might mean for you.
Surgical mesh is a medical device that is used to provide extra support when repairing weakened or damaged tissue. Most surgical mesh devices are made from synthetic materials or animal tissue.
Surgical mesh can be used to treat:
- Pelvic organ prolapse (POP). When the muscles and ligaments supporting a woman's pelvic organs weaken, the pelvic organs can slip out of place (prolapse). To treat POP, surgical mesh can be implanted to reinforce the weakened vaginal wall. Surgery can be done through the abdomen (transabdominal) or through the vagina (transvaginal).
- Stress urinary incontinence (SUI). This is the unintentional loss of urine due to a physical movement or activity — such as coughing, sneezing, running or heavy lifting — that puts pressure (stress) on your bladder. Surgical mesh can be implanted through the vagina to support the urethra or bladder neck. This is known as a midurethral sling or a mesh sling procedure.
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 2011, the FDA stated that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. The agency also said that it's not clear whether surgical mesh for transvaginal repair of POP is more effective than traditional nonmesh repair in people with POP, and that transvaginal repair with mesh might expose women to greater risk.
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.
The FDA has issued two proposed orders to address the health risks associated with surgical mesh for transvaginal repair of POP. If finalized, they would reclassify surgical mesh for transvaginal repair of POP from a moderate-risk device to a high-risk device. They would also require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.
The proposed orders do not involve the mesh sling treatment for SUI or transabdominal mesh treatment for POP.
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.
Aug. 09, 2014
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- 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.
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