Neither the FDA nor device manufacturers recalled many transvaginal mesh products, which are used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Some manufacturers simply stopped selling their products after women filed lawsuits.
In January 2012, the FDA issued postmarket surveillance study orders – called 522 orders– to all manufacturers of urogynecologic surgical mesh products. After the FDA issued the orders, some mesh manufacturers quietly withdrew their products from the market.
These actions by the FDA came after women nationwide experienced post-surgery complications ranging from severe bleeding and infection to reports of the synthetic mesh cutting through the vaginal walls and eroding into nearby organs. Consumer advocates and some experts in law and medicine are pushing for these medical devices to be recalled and banned. Many also demand new legislation to prevent injury to more women in the future.
Problems with mesh led to thousands of lawsuits filed against manufacturers, and some of the companies withdrew their products from the market or issued voluntary recalls.
Boston Scientific Recalls ProtoGen Mesh
Boston Scientific’s ProtoGen was the first transvaginal mesh product on the market and the first to be recalled. The company voluntarily pulled the product in 1999 amid safety concerns, just three years after it launched.
Within a year of ProteGen being released, other manufacturers created their own transvaginal mesh products. Because of the similarities between these products and ProteGen, all of them bypassed stringent clearance requirements by utilizing the U.S. Food and Drug Administration’s 510(k) clearance system, which allows medical manufacturers to sidestep human testing and deliver a product directly to the market as long as it is similar to an already approved product.
Mentor Corporation’s ObTape
Mentor Corporation’s ObTape Vaginal Sling is a piece of mesh called a bladder sling used to treat incontinence in women. It was implanted between 2003 and 2006.
About 35,000 women received the implant. One of the biggest problems with this product was a high rate of vaginal erosion, and many doctors discontinued use of the product. Experts claimed the product was too dense and did not allow capillaries and tissue to grow through it, causing the body to reject it.
Ethicon Pulls Mesh Products
In June 2012, Johnson & Johnson’s Ethicon unit stopped selling four of its Gynecare mesh products after more than 600 women filed lawsuits against the mesh manufacturer.
|The following products were discontinued:|
|Gynecare Prolift Kit|
|Gynecare Prolift + M Kit|
|Gynecare TVT Secur|
|Gynecare Prosima Pelvic Floor Repair System Kit|
While the company stopped selling these products worldwide, it is not recalling mesh that was already sold or implanted. Ethicon continues to sell Gynecare Gynemesh, but changed the labeling to restrict its use to abdominal implantation.
A spokesperson for Ethicon, Matthew Johnson, denied that the decision was based on safety concerns. He told Bloomberg, “We continue to have confidence in the safety and efficacy of these products.”
The FDA and Mesh Recalls
When the FDA’s advisory committee convened on this topic in September 2011, the 15-person panel was met by frustrated medical professionals who witnessed the damage caused by the mesh firsthand. The panel refused to recommend a recall, but is considering reclassifying transvaginal mesh as a Class III device, which would require stringent premarket testing before widespread distribution. If The agency usually follows its advisory committee recommendations and has ordered dozens of mesh manufacturers to conduct safety reviews of their products. Even with that, legal and governmental spotlights on transvaginal mesh may force the FDA to take a harder stance.
In April 2014, the FDA submitted two proposed orders to reclassify mesh. If the orders are finalized, this will change the way mesh products are cleared for sale.
Doctors are also weighing in on possible mesh bans. The American Urogynecologic Society (AUGS) disagrees that mesh should be banned. Urogynecologists are doctors who specialize in treating pelvic floor disorders and incontinence. Dr. Anthony G. Visco, AUGS president and division chief of urogynecology at Duke University, told ObGyn News, “We really feel that the best decision making is left between the patient and her physician without outside interference. Instead of a ban on mesh, I think hospitals and health systems should adopt strict credentialing guidelines so that qualified surgeons are performing these procedures.”
Consumer Advocacy Group Calls for Mesh Ban
Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, urged the FDA’s advisory committee to recommend a recall of the device. According to the group, mesh poses significant risks to the public. Public Citizen petitioned the FDA to ban the device in 2011.
The group pointed to the lack of testing before mesh implants were released to the public and urged the FDA to require testing on mesh products – including testing on humans.
“Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable,” Carome said. He also believes surgical mesh needlessly exposes women to serious, life-altering risks.
Transvaginal Mesh Manufacturers Face Mounting Lawsuits
Legal challenges to seven major mesh manufacturers — American Medical Systems, Boston Scientific, C.R. Bard, Johnson & Johnson’s Ethicon, Coloplast Corp., Cook Medical and Neomedic — were consolidated into separate multidistrict litigations (MDLs) in the U.S. District Court for the Southern District of West Virginia. Chief Judge Joseph R. Goodwin is presiding over all six MDLs.
More than 75,921 lawsuits are included in the seven MDLs, and thousands more are being filed in state courts. Cases for the Mentor ObTape vaginal sling were consolidated in a separate MDL in the U.S. District Court for the Middle District of Georgia, presided over by Judge Clay D. Land.