FDA Proposes Changes to Prevent Defective Medical Devices from Hitting the Market

by Staff

In an effort to prevent defective medical devices from making their way to the public, the U.S. Food and Drug Administration (FDA) is proposing several changes to the approval process. The changes are being made after thousands of patients complained of problems with the Stryker metal-on-metal hip replacement device.

The prosthetic hip device was approved for use in 2008, but in July 2012, the FDA had received roughly 60 reports of adverse side effects, prompting the agency to implement a Stryker Hip Recall.

According to a story from DrugWatch, patients were complaining of pain, swelling, and irritation at the site where the devices had been implanted. It was later determined that corrosion and fretting, or wearing due to friction, was at fault. The fretting was also causing some patients to suffer from a condition known as metallosis. The condition is the result of small metal fragments from the device being absorbed into the bloodstream.

To prevent another potentially dangerous device from hitting the market, the FDA has proposed stricter regulations on the approval process for medical devices. The changes will stiffen the processes for a product receiving approval via a 510(k) status.

The Oklahoma Personal Injury Attorneys with J. Colbert Injury Lawyers are hopeful these changes are successful in better protecting patients from the dangers of defective medical devices.