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Mayo Clinic Q and A: Complications Associated With Mesh Used to Repair Pelvic Organ Prolapse
DEAR MAYO CLINIC: Seven years ago I had surgery to repair pelvic organ prolapse. My doctor used the transvaginal mesh, and I am concerned that I will have issues down the road. Is there anything I can do now? Can it be removed?
ANSWER: Transvaginal mesh used to treat pelvic organ prolapse is associated with a number of potentially very serious complications. Unfortunately, due to the way the mesh is manufactured and implanted, it cannot be removed once it is in place. If you notice any problems that could be due to the mesh — vaginal bleeding, pain, irritation, discharge or discomfort during sex — see your doctor right away.
Pelvic organ prolapse happens when the muscles and ligaments that support the pelvic organs weaken, allowing those organs, such as the bladder, intestines or uterus, to slip out of place. That can lead to a feeling of pelvic pressure or fullness, or a feeling of a bulge in the vagina. Childbirth, obesity, surgery to remove the uterus and menopause all raise a woman’s risk for pelvic organ prolapse.
The traditional surgical approach to fix the problem involves repositioning the organs in their proper places, and then repairing and securing the supportive tissue with stitches. This is the procedure surgeons at Mayo Clinic have used consistently over the years. Because there was no evidence to support that transvaginal mesh kits were more effective than the traditional surgical repair, Mayo Clinic surgeons did not use them.
Beginning in 2005, however, some surgeons in the United States began using transvaginal mesh kits to treat pelvic organ prolapse. The mesh kits are medical devices intended to provide extra support when repairing weakened or damaged tissue. For pelvic organ prolapse, the mesh is implanted to reinforce the weakened vaginal wall.
In 2008, the Food and Drug Administration, or FDA, warned of potentially serious complications associated with transvaginal mesh for treatment of pelvic organ prolapse. Then in 2011, it stated that serious complications associated with mesh used for transvaginal repair of pelvic organ prolapse are not rare. Finally, in January 2016, the FDA reclassified transvaginal mesh for pelvic organ prolapse, defining it as a high-risk medical device.
This reclassification was based on reports of frequent complications such as vaginal bleeding, pain, scarring, irritation, discharge and discomfort during sexual intercourse. The mesh also can work its way through the tissue, eventually protruding through the vaginal wall.
It is important to note that the new FDA classification applies only to surgical mesh devices used for transvaginal repair of pelvic organ prolapse. The FDA order does not affect the use of surgical mesh for the treatment of other problems, such as urinary incontinence.
Because of the significant amount of mesh used for pelvic organ prolapse, and because the mesh typically extends into a wide range of tissue areas, many times it cannot be surgically removed safely. Trying to do so can cause extensive damage to the bladder, vagina and rectum, leading to many more complications. However, a thorough evaluation is needed by an expert to determine the best treatment options for a woman suffering from mesh complications. At times, certain treatments can reduce the problems caused by the mesh.
If problems do arise due to transvaginal mesh, doctors may be able to help control and manage symptoms. But there is no overall solution. If you notice symptoms start to develop, see your doctor as soon as possible. In some cases, complications from transvaginal mesh may be more successfully managed when they are detected early. — Dr. Daniel Elliott, Urology, Mayo Clinic, Rochester, Minn.