Public Citizen Petitions FDA to Recall Transvaginal Mesh

Consumer advocacy group, Public Citizen, filed a Petition last Thursday, August 25, 2011, asking the FDA to order a recall of all non-absorbable surgical mesh products marketed for transvaginal repair of pelvic organ prolapse (POP).

There have been lawsuits pending for a number of years by women who have been injured by these products. The sale of the surgical mesh kits has been highly profitable for the commercial manufacturing companies that have been promoting the products. The pending lawsuits as well as the Petition by Public Citizen cite the medical literature which has never shown any real benefit of the mesh implantation over surgeries to correct pelvic organ prolapse that do not involve use of the mesh products. The pending lawsuits and the Public Citizen petition both allege that profit motives prevailed over concern for patient safety.

The FDA never required data from well-designed clinical trials before allowing commercial sale of these mesh kits. Under the FDA 510(k) process the agency allows manufacturers to market medical devices and products without clinical data showing the products are safe and effective if the manufacturers can convince the FDA that the products are "substantially equivalent" to surgical mesh products that are already on the market. The FDA puts the responsibility for assessing the safety and efficacy of such products on the manufacturers. However, sometimes the manufacturers are more interested in profit than safety.

The mesh manufacturers hired highly credentially physicians to convince other obstetricians and gynecologists that implanting the mesh would result in beneficial outcomes in patients. Surgeries to implant the mesh were also profitable to the implanting surgeons.

The original draft of a Practice Bulletin about pelvic organ prolapse (POP) by the American College of Obstetricians and Gynecologists (ACOG) had called the mesh implant procedure "experimental" but that language was changed because insurance companies will not pay for procedures that are experimental. Again, here is evidence that profit was more important than patient safety.

The companies marketing the transvaginal mesh products in the U.S. are:

1.Avaulto support System by C.R. Bard,

2.Gyncare Prolift and Gynemesh Prolene by Ethicon (Johnson & Johnson),

3.AMS Prolapse Repair System by American Medical Systems,

4.Pinnacle Pelvic Floor Repair Kits by Boston Scientific,

5 Polyform Synthetic Mesh by Proxy Biomedical, Ltd.,

Public Citizen estimates that the surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse were used in about 67,500 surgical procedures in 2010 alone.

The side effects of the surgical mesh have been devastating for many women who will suffer permanent pain and limitation of activity. The mesh can move and protrude or extrude into the vagina. It can also contract or shrink and cause painful adhesions or fistulae. The mesh can even make the conditions worse that it was intended to treat. It can cause or worsen incontenence. It can cause repeated bleeding. Surgeries to remove the mesh are difficult and frequently cause additional injury. Many times the mesh cannot be removed and the women may suffer forever with pain. Many women have reported that they can no longer have sexual relations with their husbands and may have lost this part of their marital relationship forever.

The Public Citizen Petition points out that even though selling this mesh was legal under the FDA rules it was not ethical because there was no documented benefit to patients according to the medical literature and science and it exposed the patients to this risk of life changing injuries.

I hope that Public Citizen will be successful in getting the FDA to recall the pelvic surgical mesh products and I believe that our lawsuits against these irresponsible and greedy manufacturers will give some measure of justice to the women who have been injured by these products.