January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
In a June 4, 2012 letter, Johnson & Johnson announced that it will cease sales of four of its Ethicon pelvic mesh product systems.
Johnson & Johnson has requested approval from the Food & Drug Administration (FDA) to stop “commercializing” the following devices in 120 days: (1) TVT Secur; (2) Gynecare Prosima; (3) Gynecare Prolift; and (4) Gynecare Prolift +M. Johnson & Johnson and Ethicon have further requested from the FDA that post-market studies the FDA previously ordered for the TVT Secur; Gynecare Prosima; Gynecare Prolift; and Gynecare Prolift +M be no longer required. Should the FDA grant Johnson & Johnson and Ethicon’s request, this means women may not learn of the long term effects of the TVT Secur; Gynecare Prosima; Gynecare Prolift; and Gynecare Prolift +M mesh devices being implanted for the treatment of pelvic organ prolapse or stress urinary incontinence.
Recently, Johnson & Johnson and Ethicon were under scrutiny for the Gynecare Prolift when this pelvic organ prolapse mesh was placed onto the market in 2005 and then sold for three years without FDA clearance. Johnson & Johnson claimed the Gynecare Prolift was allowed to be on the market since it was “substantially similar” to mesh products that were already cleared by the FDA. However, the FDA did not clear this pelvic organ mesh product for the market until three years after it was already being implanted into women. Now, Johnson & Johnson and Ethicon are requesting that the Gynecare Prolift be no longer sold worldwide.
The Johnson & Johnson and Ethicon’s June 4, 2012 letter further stated they were requesting FDA permission to change the Gynecare Gynemesh PS instructions for use. Johnson & Johnson and Ethicon are requesting permission to change how the pelvic organ prolapse mesh product Gynecare Gynemesh PS is implanted from a transvaginal approach to a transabdominal approach. This means a physician would now implant the Gynecare Gynemesh PS, a mesh product used to treat a pelvic organ prolapse, through the stomach.