F.D.A. Proposes Rules To More Strictly Regulate All-Metal Implants

Following the wide-spread failures of all-metal hip implants such as the failures of the Johnson & Johnson Depuy ASR hip implants (see Johnson Depuy hip implant defect lawyers), the Food and Drug Administration is set to propose rules to more tightly regulate the all-metal hip implant industry.

As reported in today’s New York Times, the FDA’s proposed rules would require the manufacturers of artificial hips and all-metal components to prove the devices were safe before they can continue selling existing ones or obtain approval for new all-metal designs. Under current rules, manufacturers merely have to show that their hip devices resemble ones already on the market, and they are not required to conduct clinical studies before marketing them. The result of the current rules has been that implant manufacturers were able to start selling a new generation of all-metal hips approximately ten years ago without running clinical tests.

The FDA’s proposed rules arise amid one of the largest ever medical device failures. Hip implants have been failing early at an alarming rate, and have caused severe tissue and bone damage caused by the release of tiny particles of harmful metal debris as the implant components grind against each other as the patients walk normally. Thousands of patients with such implants have been forced to undergo revision surgery to replace the failing implants, and many have become disabled from tissue and bone damage. Thousands of lawsuits by hip implant recipients have been filed and court trials in these lawsuits are beginning.