Johnson & Johnson was ordered by the U.S. Food and Drug Administration to stop sales of the Gynecare Prolift vaginal mesh device on August 24, 2007. It now appears that the company continued to sell the dangerous product for nine months after receiving this letter. The FDA ordered the halt so it could decide whether the device was “substantially equivalent” to devices already on the market and to analyze the “potential high risk for organ perforation” that had been connected to the device’s use.
The FDA ordered Johnson & Johnson to stop marketing the device until it had provided information regarding 16 potential deficiencies of the device and received FDA approval to recommence sales. J & J faces numerous lawsuits regarding the vaginal mesh device. Many of the suits allege that the device caused them intense pain, organ perforation, scarring and nerve damage. The devices were intended to help support weakened pelvic tissue.
The cases have shed some light on the complex process of medical device approval through the FDA. It has also demonstrated the limitations of the FDA’s power to hold companies liable for misbehavior. The women who have been damaged by dangerous vaginal mesh implants may face lifelong consequences and now must decide how best to proceed.
If you or a loved one has been injured by a vaginal mesh implant, you need to speak to an attorney as soon as possible.
Source: New Jersey On-Line, “Johnson & Johnson kept selling vaginal mesh implants after warnings,” 26 June 2012