July 13, 2011 -- The risks of placing mesh through the vagina to repair pelvic organ prolapse may outweigh its benefits, according to the FDA.
Risks include mesh protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from tools used in the mesh placement, and urinary problems. Additional surgeries and/or hospitalization may be needed to treat the complications or remove the mesh.
During pelvic organ prolapse, the internal structures that support the pelvic organs such as the bladder, uterus, and bowel drop from their normal position and “prolapse” into the vagina. Pelvic organ prolapse surgery can also be performed through the abdomen or vagina with stitches or surgical mesh to reinforce the repair and correct the anatomy. Surgical mesh is also widely used in hernia repairs and to treat stress incontinence.
In 2010, there were at least 100,000 pelvic organ prolapse repairs that used surgical mesh, and about 75,000 of these were transvaginal. These are the only procedures that the new FDA mesh warning applies to.
The FDA first issued a safety communication in 2008 after they received reports of adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has increased, although they don't always differentiate between transvaginal and abdominal procedures. The group also reviewed the literature on the use of mesh for this procedure.
Now, the FDA will convene an outside panel of experts in obstetrics and gynecology to meet in September 2011 and discuss the safety and effectiveness of surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence.
FDA: Risks Outweigh Benefits
“We do not see conclusive evidence that using mesh for the transvaginal approach to pelvic organ prolapse improves clinical outcomes anymore than transvaginal procedures that do not use mesh,” says William Maisel, MD, the deputy center director for science at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md. “These devices appear to expose patients to greater risks."
“Mesh is a permanent implant, and complete removal may not be possible and may not result in complete resolution of complications," he says.
“This is not an indictment of surgical mesh,” he says. “We are talking about a very specific use of surgical mesh."
There may still be a role for mesh in certain transvaginal pelvic organ prolapse procedures, he says.
“Some clinicians believe that the use of mesh for transvaginal pelvic organ prolapse is appropriate and is the best treatment option for selective patients such as those with severe pelvic organ prolapse,” he says.
Women who have had surgery for pelvic organ prolapse need to understand whether or not their procedure involved mesh. “For someone considering having a procedure for pelvic organ prolapse, speak with a doctor and understand if the surgery is going to use mesh, and ask about the benefits and why the decision was made,” he says.
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.”