Medical Device Manufacturers Ordered to Study Risk of Surgical Mesh Injuries

In an order issued January 4, 2011 by the Food & Drug Administration (FDA), manufacturers of surgical mesh were required to study the products’ risks.

But this may be too little too late for the thousands of women who have suffered serious injuries from the medical devices, including infections, mesh erosion, bleeding, and pain. An estimated 30 to 50 percent of American women suffer from pelvic organ prolapse, which is commonly treated by implanting transvaginal mesh into the affected area.

Surgical mesh is not the first dangerous medical device that has slipped through the oversight of the FDA. Last year, the FDA required manufacturers of all-metal artificial hips to undertake additional studies after thousands of reports came in that the artificial hips were causing serious injuries in patients.

Both the surgical mesh and the artificial hips were evaluated under 510(k) review, which allows moderate-risk devices that are substantially equivalent to devices already on the market to be approved in as little as 90 days. Companies that get their devices through 510(k) review do not have to conduct additional studies on the devices before marketing them to consumers.

After a medical device has been cleared under 510(k), the manufacturer is required to report any serious injury associated with the device to the FDA within 30 working days of becoming aware of the injury. Any deaths associated with the device must be reported within 10 working days of the manufacturer becoming aware of the death.

The new requirement comes nearly four years after the FDA issued a warning that the use of surgical mesh could cause complications in some patients. At that time, the FDA reported that the problems were rare, but between 2008 and 2010, the number of adverse events reported with surgical mesh increased nearly five times.

The FDA has been criticized for its 510(k) review process, but the agency has not shown any indication that it plans to get rid of the process completely. For now, the FDA is using its authority to order emergency studies be conducted by manufacturers that have had potentially dangerous devices approved under 510(k) review.

If you or a loved one has been injured by surgical mesh, you may have a claim against the device manufacturer. Call experienced defective medical device attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082 to learn more about your legal rights.