FDA Changes Approval Process Following DePuy Hip Replacement Recall

by Thomas Stroble | May 23rd, 2013

May 23, 2013

The U.S. Food and Drug Administration initiated a recall on several brands of metal-on-metal hip replacement devices, including the DePuy ASR XL Acetabular system. This particular recall is being conducted due to the premature wearing that can lead to several serious health problems.

Some of these health problems can include pain, swelling, and inflammation at the surgical site or, more seriously, a condition called metallosis. A patient develops the latter condition when small metallic fragments from the device wear off and are absorbed into the bloodstream. This can result in toxic levels of certain metal ions building up in a patient’s body.

In conjunction with the DePuy Hip Replacement Recall, the FDA announced it would be reforming the way that the premarket approval process for medical implant devices is conducted. Old regulations allowed for a device to be brought to the market without extensive testing as long as the device was similar to another product already on the market. Now, all devices will have to be tested for safety before they receive FDA approval.

The hope is that the new system will help prevent dangerous products from being used in the healthcare industry.

The Michigan Personal Injury Lawyers with Michigan Injury Lawyers point out that an individual harmed by a defective medical device may be entitled to compensation. The firm urges anyone who has suffered such an injury to consult an attorney.

Posted In: Personal Injury