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Aug. 25, 2011

Surgical Mesh in Pelvic Repair Procedures Should Be Recalled, Public Citizen Tells FDA

Treatment for Pelvic Organ Prolapse Needlessly Exposes Patients To Serious, Life-Altering Complications

WASHINGTON, D.C. – All surgical mesh products made of non-absorbable synthetic material that are used during transvaginal surgery to repair pelvic organ prolapse (POP), a common condition in women, should be recalled because they offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm, Public Citizen said in a petition sent today to the Food and Drug Administration (FDA). Joining Public Citizen as co-petitioners were a professor of obstetrics and gynecology at Washington University in St. Louis and a urologic surgeon specializing in female urology and POP at the Mayo Clinic in Rochester, Minn.

POP involves bulging or descent of one or more of the pelvic organs, such as the bladder, rectum or uterus, into the vagina, sometimes past the opening of the vagina. This common condition is due to weakness in the connective tissue and muscles that surround and support the pelvic organs. Most women with POP have no symptoms. For symptomatic patients, treatment can involve surgical or non-surgical interventions; in surgical procedures, non-absorbable mesh often is implanted transvaginally (through incisions and punctures made through the wall of the vagina) with the intent of reinforcing the tissues around the pelvic organ that prolapsed and increasing the longevity of the repairs.

In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA. Public Citizen estimates that approximately 67,500 of these procedures used non-absorbable mesh. But the mesh offers no clinically significant benefits and has high rates of serious complications, which may or may not be able to be fixed with additional surgery, Public Citizen said in the petition.

Public Citizen calls on the FDA to ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP, to order the manufacturers of these products to recall them, and to require that any future versions be classified as a class III medical device and be subject to more stringent approval requirements. Some of these requirements would include mandatory testing in well-designed studies with human subjects to assess whether they are safe and effective before being marketed for widespread clinical use.

“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,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately.”

On July 13, the FDA issued a safety announcement stating that serious complications associated with transvaginal repair of POP are “not rare” and it is “not clear that transvaginal POP repair with mesh is any more effective than traditional [transvaginal surgery without mesh] … and may expose patients to greater risk.”

In fact, the agency said that over the past three years (from 2008 to 2010), it had received 1,503 reports of complications that were associated with surgical mesh devices used to repair POP. The most frequent complications reported to FDA and described in scientific journals included vaginal mesh erosion (in which tissue between the implanted non-absorbable mesh and the lining of the vagina breaks down and the mesh becomes exposed on the surface of the vagina), infection, pain and urinary problems such as incontinence. There were also reports of injuries to the bowel, bladder and blood vessel during transvaginal insertion of the mesh for POP repair. In some cases, vaginal scarring, mesh erosion, and contraction or shrinkage of the mesh led to a significant decrease in patient quality of life due to severe pelvic discomfort and pain, including pain during sex. Many of the complications seen with transvaginal surgery for POP repair with non-absorbable mesh do not occur following POP surgery without mesh.

Further, women whose transvaginal POP surgery involved non-absorbable surgical mesh did not experience better outcomes in terms of symptom relief and quality of life – the clinically significant indicators for measuring treatment success for this condition – than women who underwent transvaginal POP repair surgery without mesh, Public Citizen’s petition said.

“Indeed, there is substantial evidence that such mesh is neither safer nor more effective than traditional native tissue repair operations for these conditions, without the use of synthetic mesh, and that the use of such mesh is associated with serious and sometimes irreversible harm to the patients in whom it is used,” said Dr. L. Lewis Wall, a professor of obstetrics and gynecology and a bioethicist at Washington University in St. Louis and a co-petitioner. “I commonly see patients who have been harmed by these mesh products in my own clinical practice.”

Added Dr. Daniel S. Elliott, a urologic surgeon specializing in female urology and POP at the Mayo Clinic in Rochester, Minn., “I have refused to use any transvaginal mesh kits for POP. On a weekly basis, either I or my colleagues evaluate and treat patients suffering from the consequences of the non-absorbable mesh kits. The patients have suffered needlessly because the standard POP repair without mesh, in properly trained hands, is easy, fast and effective, avoiding the unique complications associated with non-absorbable mesh kits.” 

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