One type of transvaginal mesh called, Gynecare Prolift, was sold and used in surgeries for three years before it was cleared by the U.S. Food and Drug Administration (FDA). Johnson & Johnson/Ethicon introduce the Prolift in March, 2005. The FDA did not catch wind of it for about two years. If you have been injured by J&J transvaginal mesh, please contact a transvaginal mesh injury attorney right away.

Medical Device Clearance

Medical devices are often cleared for market through the 510(k) process. It is an expedited process which lets device makers avoid the normal approval process including clinical trials, as long as the new device is considered substantially equivalent to an existing approved device.

One of the biggest problems with 510(k) is that the predicate devices are often defective. The FDA has to clear the new device even if the old device has been recalled for safety problems.

Prolift Sold Before it was Cleared

The Prolift was on the market for three years before 510(k) clearance. When the FDA discovered that the device was on the market without approval or clearance, it did not impose sanctions on J&J, but required that the company apply for clearance. That clearance was granted in 2008.

If you or a loved one has been injured by transvaginal mesh, please call our transvaginal mesh injury attorney at 1-877-LOSS RECOVER or submit an online questionnaire. Your initial consultation with transvaginal mesh injury attorney is free of charge, and if we agree to handle your case, in most cases we will work on a contingency fee basis, which means we get paid for our services only if there is a monetary recovery of funds. In many cases, a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. Please call right away to ensure that you do not waive your right to possible compensation.