Defective Vaginal Mesh Sold for Three Years Without FDA Approval

The Gynecare Prolift, made by Johnson & Johnson/Ethicon, went on the market in March, 2005, without approval or clearance by the U.S. Food and Drug Administration (FDA). The agency did not find out about the device for over two years. By the time the device received FDA clearance, in 2008, it has been on the market for three years and 123 complaints of complications had been reported to the FDA. If you have been injured by J&J vaginal mesh, please contact our defective vaginal mesh attorneys right away.

Study Halted Due to Complications

A trial study of Prolift was cut short due to a high rate of complications. The trial ran from January, 2007 through August, 2009, and was halted when the rate of vaginal erosion hit 15.6%. The results were published in the August 2010 issue of Obstetrics & Gynecology.

Fast-Track Clearance

The 510(k) process is a fast-track clearance process for medical devices. Through 510(k) medical devices which are deemed similar to devices which have already been approved do not have to go through the approval process to get clearance for market. The FDA found out about the Gynecare Prolift when J&J submitted a 510(k) application for another device, citing the Prolift as the “similar” pre-existing device.

The FDA did not sanction J&J for selling Prolift without clearance, but required that it apply for clearance, and granted that clearance in May, 2008.

Devices cleared through 510(k) often get their clearance based on defective devices. Current law requires the FDA to clear devices based on approved devices even if those devices have known safety problems. Proposed legislation, called the Safety of Untested and New Devices (SOUND) Act, would allow the FDA to require device makers to show that they have addressed known safety issues before granting clearance.

If you or a loved one has been injured by defective vaginal mesh, please call our defective vaginal mess attorneys at 1-877-567-7732 or submit an online questionnaire. Your initial consultation with defective vaginal mesh lawyer 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.