In recent years, surgeons have used a device called surgical mesh to support the organs of a woman’s pelvis that have sagged after childbirth and pressed upon the vagina. The condition is called pelvic organ prolapse or POP.
A woman’s estimated lifetime risk of POP is 30 to 50 percent, according to the U.S. Food and Drug Administration (FDA). About 2 percent of these women experience symptoms. Surgery to reinforce the vaginal walls has been a common way to correct the problem. Over the last couple of decades surgeons have been using surgical mesh to help support the tissue.
Originally, surgeons used the mesh “off label,” meaning this specific use for surgical mesh didn’t have FDA approval. But in 2002, the FDA cleared the first surgical mesh product specifically for use in POP.
“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,” Elizabeth A. Poynor, MD, as quoted by Web MD.
“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 said.
“This has been a long time coming,” another physician, J. Eric Jelovsek, M.D., told Web MD.
“Quality of life is not different if mesh is placed or not, and women have a higher risk of complications,” she said. “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.”
Jelovsek is a staff physician in the Obstetrics, Gynecology, & Women’s Health Institute of the Cleveland Clinic in Ohio.
According to the FDA, the most frequent complications that were reported by consumers from 2008 to 2010 were vaginal mesh erosion, pain (including painful intercourse), infection, urinary problems, bleeding and organ perforation.
The federal agency said it plans to sponsor an advisory meeting Sept. 8 and 9, 2011 to discuss the safety and effectiveness of transvaginal mesh for POP and SUI (stress urinary incontinence) procedures.
If you’ve experienced complications after surgery for POP, you should speak with a qualified transvaginal mesh attorney about your rights. To learn more, contact us today.