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Transvaginal Mesh Manufacturer Must Turn Over FDA Communications

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Transvaginal mesh paperwork

A judge’s ruling on evidence in New Jersey superior court could affect numerous state and federal lawsuits filed against manufacturers of defective transvaginal mesh devices. The Honorable Carol E. Higbee has ordered the defendant, Ethicon Inc., to disclose its communications with the U.S. Food and Drug Administration (FDA) regarding the safety of its Gynecare line of transvaginal mesh products.

Judge Higbee’s case management order is likely to bring to light new post-market information about Ethicon’s Gynecare line because of many recent interactions between the agency and the Johnson & Johnson subsidiary.

FDA Requests Post-Market Data on Mesh Products

In January 2012, the FDA imposed a Section 522 Order on 40 manufacturers of transvaginal mesh and bladder slings. This mandate required the companies to provide up to three years of post-market data on the safety and effectiveness of their devices. Typically, information from clinical trials that occur before a device is approved by the FDA is made public, but that’s not always the case with studies conducted while the device is on the market.

The report from the 522 Order is only one of many known communications between Ethicon and the FDA that could be revealed. In July, Bloomberg reported that Ethicon sold the Gynecare Prolift for three years without FDA approval. Ethicon claimed the device was “substantially equivalent” to its Gynemesh device, which already had been approved, and the 510(k) process allows this fast-tracking of similar devices to market. But when numerous complaints from patients poured into the FDA, the agency was forced to take another look at the Gynecare Prolift.

The FDA demanded Ethicon take the transvaginal mesh device off shelves in 2007 while it determined whether the Gynecare Prolift was safe. Instead, Ethicon blatantly disregarded that order and continued its sales, putting thousands of additional women at risk.

Bloomberg reported that Johnson & Johnson received a letter from the FDA stating, “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”

That correspondence and others related to the Gynecare line could be made public under Judge Higbee’s ruling.

Ethicon Recalls Gynecare Mesh Products

Earlier this summer, Johnson & Johnson announced it would halt sales of its Gynecare line, which included the TVT Secur, Prosima, Prolift and Prolift+M systems. The company stopped short of a recall, saying it was a business — not a safety — decision. In doing so, the company asked the FDA to suspend its 522 Order.

Regardless of the FDA’s response, Judge Higbee’s ruling will force Johnson & Johnson to disclose its post-market studies. In doing so, hundreds of women may gain more proof that the manufacturer knew its medical devices were dangerous and defective and continued to sell them anyway, placing its profits above its customers.

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