Unapproved Vaginal Mesh Sold for Over Two Years Before Discovery by the FDA

Gynecare Prolift vaginal mesh went on the market in March, 2005 without approval by or clearance from the U.S. Food and Drug Administration (FDA). Two year later, the agency discovered the problem, but did not penalize J&J. If you have been injured by defective vaginal mesh our Georgia defective transvaginal mesh attorneys can help.

Transvaginal mesh is used in some surgeries to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Complications have increased five-fold since vaginal mesh came into use in these procedures.

Clearance for Medical Devices

Many medical devices can go to market without clinical trials and a lengthy approval process. An expedited process called 510(k) requires the FDA to clear new medical devices that are deemed “similar” to devices which have already been approved, even if safety problems were discovered in the older device after it received approval.

J&J did not get 510(k) clearance or any kind of approval for the Gynecare Prolift before it began selling the product. The FDA required the company to apply for clearance after discovering the unapproved device in 2007, but did not pull it from the market while that clearance was pending. The device was cleared in May, 2008, more than three years after it went on the market.

If you or a loved one has been injured by defective vaginal mesh and you live in Georgia, please contact or call our Georgia drug recall attorneys at 1-877-LOSS-RECOVER (567-7732). Our successful product liability lawyers will win you the compensation you deserve so that you can move on with your life.