J&J’s Ethicon, via its legal representative has written to a federal judge in West Virginia stating it intends to stop selling four vaginal mesh implants after being sued by more than 600 women who say the products caused internal injuries. The letter can be found here.
If one “googles” the words Ethicon and Vaginal mesh the majority of links are either to press articles…. or lawyers, as the company continues to be embroiled in legal actions relating to this troublesome product range. It seems Ethicon wants to do the right thing and grasp the nettle, so has taken the bold step of offering a planned withdrawal of the four meshes. In a letter, dated June 4th, Ethicon notified the Court that it had advised FDA that it will stop commercialising the GYNECARE TVT SECUR™ system, GYNECARE PROSIMA™ Pelvic Floor Repair System, GYNECARE PROLIFT™ Pelvic Floor Repair System, and GYNECARE PROLIFT+M™ Pelvic Floor Repair System in the United States.
It furthermore states that it has requested of FDA what amounts to a cooling off period of 120 days during which it will presumably continue to supply the product while its customers find alternatives.
Back in March we covered the most recent hoo haa, which revolved around whether Ethicon had been selling device iterations without having notified FDA. That item is here and its easy to conclude that the knives were out for the company and so it could do little right. Regardless of the rectitude of its past actions however, it seems Ethicon has now decided that grabbing the moral high ground is its first priority. Indeed a spokesman for the company is reported as saying in an email that it would also halt sales of the devices worldwide.
However the company appears to be stopping well short of admitting any liability at this time, spokesman Matthew Johnson saying to Bloomberg that the cessation is not a recalling of meshes already sold or implanted and that its decision isn’t based on any safety concerns.
“We came to this decision after carefully considering numerous factors” including “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women,” Johnson said.
“We continue to have confidence in the safety and efficacy of these products,” he said.
Sales will be ended on a region-by-region basis, with the entire process to be completed by the first quarter of 2013, Johnson said. The Gynemesh will remain on the market only for abdominal implantation, he said.
Ethicon Endo continues to sell incontinence and prolapse meshes.
Blaine Davis, the company’s senior vice-president for corporate affairs said in a telephone interview that Ethicon’s Endo division will continue selling incontinence and prolapse mesh.
“While publicity about the products’ safety has hurt sales, Endo sees the devices as a “very beneficial treatment option” when doctors choose the right patients”, he said.
Source: PR Web, Bloomberg