Johnson & Johnson/Ethicon’s Gynecare Prolift vaginal mesh product went on the market in March, 2005, even though it had not received approval or clearance from the U.S. Food and Drug Administration (FDA). In fact, J&J had not even applied for clearance of the device. The Prolift was eventually cleared for market in 2008, after 123 complaints of complications had already been reported to the FDA. If you have been injured by J&J transvaginal mesh or any defective vaginal mesh, please talk to our transvaginal mesh attorneys right away.

The FDA discovered the Gynecare Prolift in 2007, after it had been in use without clearance for over two years. Even though the agency says that the product was on the market without appropriate clearance, it did not sanction J&J. Instead, it simply required that the device maker apply for clearance, which it granted.

The Prolift was cleared through the expedited 510(k) process. This process allows new medical devices to go to market quickly because it skips the normal approval process including clinical trials. As long as the new device is deemed “substantially equivalent” to a device which has already been approved, the FDA is required to grant clearance, even if the older device has been recalled for safety issues.

Many devices cleared through 510(k) are based on defective devices.

If you or a loved one has been injured by transvaginal mesh, please call our transvaginal mesh attorneys at 1-877-LOSS RECOVER or submit an online questionnaire. Your initial consultation with our transvaginal mesh attorneys is free of charge, and if we agree to handle your case, in most cases we will work on a contingency fee basis so we get paid when you recover monetary damages.