J&J’s Vaginal Mesh Introduced Without US Approval

Johnson & Johnson’s Gynecare Prolift vaginal mesh is the subject of at least 550 injury lawsuits, and it turns out that the device was on the market for three years before it received appropriate clearance from the U.S. Food and Drug Administration (FDA). If you have been injured by J&J vaginal mesh our Massachusetts transvaginal mesh attorneys can help.

Transvaginal mesh is implanted in a woman’s body during surgery to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI). One of the known dangers of Prolift vaginal mesh is a complication called erosion. One study of the Prolift was cut short because of the high rate of erosion in study subjects.

J&J introduced the Prolift in March, 2005. It did not receive 510(k) clearance for market from the FDA until May, 2008.

New Devices Cleared Based on Defective Devices

510(k) clearance is a fast-track process that gets new medical devices to market very quickly without requiring clinical trials, as long as they are considered “substantially equivalent” to an existing approved device. One of the major flaws with the process is that new devices can be cleared even if they are based on devices which are known to be defective. In fact, the FDA is required to grant clearance, under the current law.

New legislation has been proposed which would give the FDA the power to require device makers to show documentation that they have addressed any known safety issues. The legislation is called the Safety of Untested and New Devices (SOUND) Act.

If you or a loved one has been harmed or killed by defective vaginal mesh and you live in Massachusetts, please contact our Massachusetts drug recall attorneys at 1-877-LOSS-RECOVER (567-7732). Our experienced product liability lawyers will recover the compensation you deserve.