Johnson & Johnson (JNJ), the world’s second-biggest health-care products maker, is facing many lawsuits over its Gynecare TVT vaginal implant. The Gynecare TVT implant is based on a similar device pulled from the medical device market more than a decade ago for safety reasons.
The lawsuits are the latest to implicate the shoddy and perfunctory approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and malfunctioning defibrillators.
In the case of vaginal mesh implants, the FDA continued approving the mesh devices made by J&J and other companies based on their similarity to Boston Scientific Corp’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.
The devices treat urinary incontinence and pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the premise that if one device has been cleared by the FDA then similar devices need little if any testing in patients.
In July, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery. The statement came three years after the agency first acknowledged a problem in a 2008 report that said mesh complications were serious. An advisory panel of physicians said last month that the FDA should demand more clinical testing of the devices.
According to J&J, its vaginal mesh products are safe and the J&J’s Gynecare TVT was based on the Boston Scientific product.
But according to 510(k) critics, the chain of approvals that began with Boston Scientific’s device highlight a major flaw in the 510(k) process. The system lets manufacturers get clearance for a product by citing its similarity to an already approved device, known as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on. And if a first device is recalled, they don’t necessarily look at the second, third or fourth device that are based on that.
The unfortunate Vaginal Mesh story began in 1996, when Boston Scientific gained clearance for ProteGen, the first vaginally implanted mesh designed specifically to treat incontinence. Two years later, J&J won approval for a similar device, called Gynecare TVT. Under the 510(k) system, J&J was not required to conduct human testing because the company claimed its device was “substantially equivalent” to the Boston Scientific device.
A year later, Boston Scientific voluntarily pulled about 20,000 ProteGen meshes, saying it had received 123 reports of problems, including discomfort, pain during sex, and erosion of vaginal tissue. But J&J and at least two other manufacturers, American Medical Systems and Covidien Plc (COV), soon came out with products that traced their design back to ProteGen.
The FDA has said it does not know the number of women who have received the implants since 1998, though it estimates almost 300,000 were used in 2010. All of the devices were approved through the 35-year-old 510(k) system, used by the FDA to review some 90 percent of device applications each year. The same process was used to clear the 93,000 artificial hips pulled by J&J last year due to high failure rates, as well as hundreds of external heart defibrillators recalled since 2005 by Minneapolis-based Medtronic Inc. (MDT)
J&J named ProteGen as a basis for the Gynecare TVT, noting in its application that “technologically, both the new device and predicate device are the same.” By that time, complaints about Boston Scientific’s device were already reaching the FDA. A year after J&J’s TVT won clearance, Boston Scientific voluntarily recalled about 20,000 of its meshes.
J&J’s Gynecare TVT later became a predicate for the IVS Tunneller I, made by Dublin-based Covidien, and the Sparc Sling, made by the American Medical Systems unit of Endo Pharmaceuticals Holdings Inc. (ENDP), based in Chadds Ford, Pennsylvania. Those, in turn, were cited to clear future versions, each said to be “substantially equivalent” to its predecessors, according to FDA records. In 2003, Boston Scientific settled 738 suits over its mesh for an undisclosed sum.
The safety debate has presented a dilemma for manufacturers, who have avoided clinical tests for the devices by calling them similar to one another and now say the products have advanced far beyond the earlier versions.
The FDA advisory panel disagreed. The 17-member group, comprised mostly of pelvic surgeons, recommended at last month’s hearing that some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market.
The FDA appears to be inching toward a decision. At the September hearing, Colin Pollard, director of the FDA’s obstetrics and gynecology devices branch, said it may take as long as three years to issue new rules. Until then, current models can stay on the market, he said.
