Get the facts about transvaginal mesh complications
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.
What is surgical mesh?
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.
How is surgical mesh used to treat pelvic floor disorders?
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). Surgery through the vagina (transvaginal) has also been an option in the past. However, in 2019 the FDA ordered manufacturers of surgical mesh for the transvaginal repair of POP to stop selling and distributing their products in the U.S.
- 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.
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.
Treating SUI with a mesh sling can cause complications, including mesh erosion, infection and pain.
Before the FDA ordered manufacturers of surgical mesh for the transvaginal repair of POP to stop selling and distributing their products in the U.S., there were growing safety concerns. 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 applied only to transvaginal use of surgical mesh to treat POP, not 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.
If you've had transvaginal mesh placed for the surgical repair of POP, continue with your checkups and follow-up care. If you have complications or symptoms, talk to your doctor.
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 doctor explain all of your options, as well as their possible risks and benefits.
April 17, 2019
See more In-depth
- 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.
- FDA takes action to protect women's health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. U.S. Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636114.htm?utm_campaign=2019-04-16%20FDA%20orders%20manufacturers%20of%20surgical%20mesh%20intended%20for%20transvaginal%20repair&utm_medium=email&utm_source=Eloqua. Accessed April 16, 2019.