FDA: Repairing Pelvic Organ Prolapse With Mesh Risky
Risks Include Pain, Infection, Need for Additional Surgery
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Many Support FDA Action
Elizabeth A. Poynor, MD, a pelvic surgeon at Lenox Hill Hospital in New York City, has never used mesh for transvaginal pelvic organ prolapse and likely never will.
“I don’t use mesh in my practice because I have seen a significant number of complications from other surgeons, and have seen how mesh erosion can be devastating for patients,” she says.
As to why use of mesh implants for this surgery took off in the first place, she says it may have a lot to do with the complexity of the procedure.
“This is one of the most detailed and complicated surgeries that we do and unless it is done correctly, it can have a significant chance of failing,” she says. Some surgeons believe the mesh boosts the chances of a successful surgery.
“There has been the general feeling that repairs are better and sounder if mesh is used, but mesh may not be better than the proper surgical correction,” she says.
“Women who are considering prolapse surgery should review the risks, benefits, and alternatives with their surgeon to make sure that it is the right choice,” Poynor says.
“This has been a long time coming,” says J. Eric Jelovsek, MD, a staff physician in the Obstetrics, Gynecology, & Women's Health Institute of the Cleveland Clinic in Ohio.
Mesh placed transvaginally for pelvic organ prolapse does have some anatomical benefit, but that is it, he says. “Quality of life is no different if mesh is placed or not, and women have a higher risk of complications,” he says.
“This doesn’t mean that you should never have mesh placed transvaginally. It means you have to have an in-depth discussion with your surgeon of the options,” he says.
For women who have had the procedure with mesh, “if you are feeling fine and doing well, there is no reason to come in and get this checked out, but if you have question or concerns, then come in,” he says.
Most of the complications will occur in the year or two after the surgery, but others such as vaginal bleeding, pain with sex, and severe pelvic pain may develop later on.
Robert F. Porges, MD, MPH, director of the division of pelvic reconstructive surgery and urogynecology and a professor of obstetrics and gynecology at New York University Langone Medical Center in New York City, seldomly uses mesh during transvaginal pelvic organ prolapse repair.
But, he says, “in some severe cases where the muscles of the pelvic floor have been severely damaged or failed to develop, replacing the muscle with mesh may play a role,” he says. “Most women deserve an attempt to repair the prolapse using their native tissues and unless it is a failure or a repeat failure, using the mesh may not be as valuable as made out to be,” he says.
In a written statement, the American College of Obstetricians and Gynecologists applauded the FDA's efforts. “The College supports FDA's upcoming initiative to convene an advisory committee, the Obstetrics Gynecology Devices Panel, to discuss the safety and effectiveness of [mesh] and notes with appreciation FDA's willingness to reconsider how it clears mesh products for marketing.”