FDA: Repairing Pelvic Organ Prolapse With Mesh Risky
Risks Include Pain, Infection, Need for Additional Surgery
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.