Sept. 8, 2011
FDA Proposal Fails to Protect Women From Dangers of Surgical Mesh in Pelvic Repair Procedures
Treatment for Pelvic Organ Prolapse Should Be Recalled and Banned, Public Citizen Tells FDA Advisory Committee
WASHINGTON, D.C. – The Food and Drug Administration’s (FDA) proposed partial remedy to protect women from the dangers of surgical mesh products that are used in pelvic repair procedures does not go far enough to protect public health, Public Citizen said in testimony delivered today before an FDA advisory committee.
The FDA should recall 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 – because the products offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm, Public Citizen told the FDA’s Obstetrics and Gynecology Device Panel.
Public Citizen petitioned the FDA in late August to recall these surgical mesh products immediately and impose more stringent approval requirements in the future. The agency has since proposed reclassifying the products as class III medical devices, which would intensify the approval process for future products. However, the FDA also appears ready to allow a grace period for manufacturers of current such mesh product to keep them on the market and require companies to conduct further studies.
Public Citizen maintains that further studies of the current mesh products would be highly unethical because there is sufficient data showing that these products are ineffective and harmful, and there should be no further delay in removing these products from the market.
“The FDA’s belated proposal to reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP to class III and require post-marketing approval evaluations is a step in the right direction, but this action alone is insufficient,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “To properly protect public health, the FDA also must immediately ban all such mesh products currently available and require manufactures to recall these dangerous and ineffective devices.
“A grace period allowing continued marketing of these devices would recklessly endanger women,” said Dr. Daniel S. Elliott, a urologic surgeon specializing in female urology and POP at the Mayo Clinic in Rochester, Minn., and a co-petitioner on Public Citizen’s petition. “There is sufficient data available for the currently marketed mesh products for transvaginal repair of POP indicating that the risks of serious complications from these devices far outweigh their benefits.”
Added Dr. L. Lewis Wall, a professor of obstetrics and gynecology and a bioethicist at Washington University in St. Louis and another co-petitioner on Public Citizen’s petition, “To allow further marketing of these products under the guise of conducting ‘clinical trials’ would be unethical in light of what is already known. It would represent a capitulation by the FDA to the economic interests of manufacturers at the expense of patient well-being. It is difficult to conceive how any further clinical trial could enroll and randomize patients to receive these operations with surgical mesh based on the knowledge that we already have. The FDA must uphold its public obligation to look after the best interests of patients as its first priority.”
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 its August petition.
The most frequent complications involving the surgical mesh 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 also were 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.
Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.