London, UK Politicians and Professors of medicine in the U.K. are condemning the decision to launch transvaginal mesh without a clinical trial and demanding a public inquiry into the mesh.
Court documents during Ella Ebaugh’s trial in Philadelphia revealed that J&J’s Ethicon unit launched its TVT-Secur mesh in 2006 ahead of its competitors that had similar products waiting for approval and the mesh, was described as “priceless” in company documents. According to the Guardian it was approved for use without a trial under US and European equivalence rules—the fast-track 501(k) process. This regulation allows a device to enter the market when it is similar to an existing product.
September’s Ebaugh trial, which resulted in a record $57 million award in damages, has spurred outrage overseas. A public inquiry has been called, saying the mesh should never have been approved before a clinical trial and in doing so, “Led to direct patient harms… It has made it impossible to provide informed choice to women, and points to a regulatory system that is failing patients,” said Carl Heneghan, professor of evidence-based medicine at the University of Oxford.
And French gynecologist Prof. Bernard Jacquetin, who studied the TVT-Secur before its launch and caused doubts among J&J management, told the Guardian that Ethicon had acted “irresponsibly” by launching the device without adequate evidence, i.e., without clinical trials. Jacquetin’s study after the device was approved found success rates of 77 percent two months after surgery, but Ethicon’s original TVT mesh—which was the TVT Secur similar product in the fast-track process--reported 85-90 percent success rate.
Despite Jacquetin’s disappointing results, Ethicon proceeded to launch the mesh without any clinical trials. And in spite of his study—Jacquetin told the Guardian that he was invited to the US to give advice on the new design, but he was presented with a boxed-up TVT-Secur, ready for release. And the transvaginal mesh stayed on the market for more than five years. As for the 77 percent success rate, Ethicon’s marketing manager Fabrice Degeneve emailed his superiors: “How should we handle this without compromising the use of this new technique?” Rather than withdraw the mesh and despite Jacquetin telling Ethicon it was “not a good device,” the director of sales replied: “This is for sure a big concern…No way to hide the truth but to make sure it has been done correctly in terms of procedure and inclusion.”
TVT-Secur was withdrawn from the market in 2012, along with three other mesh products. J&J declined to provide the Guardian with exact figures on how many women had received the implants. Meanwhile, along with the U.S., the results of this trial and other verdicts favoring plaintiffs have triggered transvaginal mesh class action lawsuits in the U.K., Australia, Canada and other countries.
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