Ethicon Inc. has decided to no longer sell its Gynecare Prolift, Prolift+ M, TVT Secur and Prosima transvaginal mesh systems. The company’s decision was revealed in a letter it filed with the U.S. District Court, Southern District of West Virginia where Ethicon and its parent, Johnson & Johnson, are named in hundreds of lawsuits alleging their transvaginal mesh products seriously injured women who received the devices for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
According to the letter, Ethicon has asked the U.S. Food & Drug Administration (FDA) to allow it to stop selling the four transvaginal mesh devices. The company also asked the FDA to allow it to continue selling its Gyencare Gynemesh product, but is seeking to change its label to restrict its use. The FDA has yet to respond to the company’s requests.
In the letter, Ethicon asked the FDA for 120 days to end sales so it can “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.”
it is not recalling any transvaginal mesh products that have already been sold or implanted.
An Ethicon spokesperson told Bloomberg News in an email that it is not recalling any transvaginal mesh products that have already been sold or implanted. The official also denied that it was ending sales of the devices due to safety issues, and asserted that the decision was made due to “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.”
Ethicon to Stop Selling its Gynecare Prolift, Prolift+ M, TVT Secur and Prosima Transvaginal Mesh Systems