· TVT Secur
· Prosima Pelvic Floor Repair System
· Prolift Pelvic Floor Repair System
· Prolift MTM Pelvic Floor Repair System
J&J made the announcement in a letter, sent both to the FDA as well as to the judges presiding over the multidistrict litigation (MDL) in West Virginia, saying it would voluntarily pull these devices. J&J also stated that it would continue to sell the Gynecare Gynemesh, but with stronger warning labels.
However, J&J asked the FDA to waive some requirements, in exchange for the voluntary recall. In January of this year, the FDA ordered J&J, as well as several other vaginal mesh manufacturers, to conduct thorough after-market studies on the product. As of now, J&J has not complied with this order, and the FDA has issued no specific product recall for any vaginal mesh products.
The FDA has not officially recalled any transvaginal mesh products yet.
Sarah Clark-Lynn, a spokesperson for the FDA, said that the request has been received, and the FDA will issue a reply by August 4th.
If you or a loved one suffer from pelvic organ prolapsed or stress urinary incontinence, and are suffering further because of a faulty mesh implant, you are not alone. Transvaginal mesh was originally marketed as a device that could stop pelvic organ prolapse and stress urinary incontinence in women with minimal invasion, but for many women, it has only caused more problems, and lasting physical and psychological damage. The experienced lawyers at Strom Law, LLC are now accepting cases nationally regarding faulty mesh devices. Please contact us for a free consultation – we can get you on the road to recovery. 803.252.4800