Public Citizen to FDA: Recall Surgical Mesh

Public Citizen to FDA: Recall Surgical MeshPublic Citizen, a consumer advocacy agency, has requested that the U.S. Food and Drug Administration recall all surgical mesh products used in transvaginal surgery, as the material used in the treatment allegedly exposes patients to serious and life-altering complications.

The recall was requested because the non-absorbable synthetic material, which is used to repair pelvic organ prolapse (POP), offers no major health benefits, but instead, has been shown to expose patients to serious risks and permanent harm. The petition is working in cooperation with an OBGYN professors at Washington University in St. Louis and a urologic surgeon at the Mayo Clinic in Rochester, Minnesota.

According to Medscape, POP is a common condition among many adult women, and occurs when there is an abnormal descent of organs in the pelvic region from their original position, and can cause complications in the uterus and vaginal areas. Prolapses are a common occurrence, and many times do not require medical intervention.

About 300,000 women in the U.S. had surgery to repair POP in 2010, 67,500 of whom received non-absorbable mesh during the procedure.

Public Citizen has urged the FDA to cease the marketing of all surgical mesh products used for transvaginal repair of POP, and to require the product to be labeled as a class III medical device, making it subject to higher, more stringent approval requirements.

"Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life," Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a recent statement. "Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately."

The FDA received 1,503 reports of complications linked to surgical mesh devices used in POP treatments from 2008 to 2010, with the most frequent complaint being erosion of the product, infection, pain and incontinence. Bowl, bladder and blood vessel injuries were also reported during insertion of the material.

Other adverse effects of the treatment have included vaginal scarring or contraction and shrinkage of the material, which has reportedly caused women to experience a decrease in quality of life, with severe pelvic discomfort and pain felt during sex.

"I have refused to use any transvaginal mesh kits for POP," Dr. Daniel S. Elliott, a urologic surgeon at the Mayo Clinic, stated. "On a weekly basis, either I or my colleagues evaluate and treat patients suffering from the consequences of the non-absorbable mesh kits."