Many Transvaginal Mesh Device 510(K) Approvals Were Based on Defective Product

A Johnson & Johnson <"">transvaginal mesh implant that has been named in numerous personal injury lawsuits was based on an older Boston Scientific device that was ultimately pulled from the market. According to a Bloomberg News report, the Gynecare TVT device, made by Johnson & Johnson’s Ethicon division, was approved via the U.S. Food & Drug Administration’s (FDA) 510k approval process, which does not require that that a device be tested on humans before it comes on the market.

The FDA’s 510(k) clearance process is permitted for medical devices that can be proven to be “substantially” equivalent to products already on the market. According to Bloomberg, the <"">Gynecare TVT device and others like it, which act like hammocks to support the organs of women suffering pelvic organ prolapse (POP) and stress urinary incontinence (SUI), were based on the design of Boston Scientific’s ProteGen. The FDA allowed 510(k) approvals of transvaginal devices based on the ProteGen device even after it was removed from the market for safety issues.

According to Bloomberg, the approvals that started with the ProteGen transvaginal mesh device point to a key weakness with 510(k) clearances:

“The system lets manufacturers win clearance for a product by citing its similarity to an already approved device, known in FDA jargon as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on.”

There’s no system in place to ensure that devices based on defective, recalled products will be recalled as well.

ProteGen was approved in 1996, and according to Bloomberg, was the first surgical mesh approved to treat SUI. Two years later, Gynecare TVT was approved through the 510(k) process, after Johnson & Johnson claimed it was “substantially equivalent” to the Boston Scientific device.

A year after the Gynecare TVT approval, ProteGen was pulled from the market, after it was found to be associated wit a high number of complications, including discomfort, painful sex, and erosion of vaginal tissue. But even after the ProteGen debacle, Johnson & Johnson and other manufacturers, including American Medical Systems, continued to have transvaginal mesh devices based on the ProteGen design approved via the 510(k) process.

Now it seems hundreds – if not thousands – of women may be paying the price for the FDA’s lax oversight of transvaginal mesh devices. On July 13, 2011, the FDA issued a safety alert for transvaginal mesh, stating that between 2008 and 2010, it had received more than 2,800 reports of serious complications associated with surgical mesh products implanted transvaginally in POP and SUI repair, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The majority of complications – more than 1,500 – occurred in women who received transvaginal mesh for POP repair. According to the FDA, its review of the devices had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

In September, an FDA advisory panel backed a proposal by agency staff to reclassify transvaginal mesh as a Class III (high risk) medical device. Currently, the devices are classified as moderate risk (Class II), making them eligible for the 510(k) approval process, which does not require human trials before a device is brought to market.

Today, Johnson & Johnson faces around 270 lawsuits over its GyneCare transvaginal mesh and pelvic sling devices. In total, more than 600 lawsuits have been filed by women against various manufacturers of transvaginal mesh.

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