Pharmaceutical

FDA plans 2-day metal hip device review

 FDA plans 2 day metal hip device reviewResponding to growing concerns over complications associated with metal-on-metal hip implant devices, the U.S. Food and Drug Administration (FDA) said it has planned a two-day review of the devices in June that could result in tougher regulations.

A global recall of two different all-metal hip implants made by DePuy Orthopaedics in 2010 compounded fears that such devices could fail prematurely and harm recipients, sometimes in serious, debilitating ways. A number of other companies manufacture metal-on-metal hip implants, but most complaints center around DePuy’s ASR XL Acetabular and Hip Resurfacing systems.

“We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” Dr. William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health, said in a statement.

The FDA’s review, which will take place on June 27-28, isn’t the agency’s first effort to collect more information about the controversial devices. In May 2011, the FDA ordered DePuy and other manufacturers of metal-on-metal hip implants to conduct a three-year study to determine how safe the devices are.

Many Americans believe medical devices are thoroughly tested before they get the FDA’s stamp of approval, but class-one (low-risk) and class-two (moderate-risk) medical devices, such as DePuy’s ASR hip implants, are usually fast-tracked through the approval process with minimal or no testing.

Consumer Reports recently criticized the FDA, asserting the agency had created a “nightmare scenario” for public safety for allowing medical device manufacturers to bypass costly and time-consuming clinical trials. Hip implants were just one of the devices Consumer Reports cited as evidence of the FDA’s failure to protect consumers.

The FDA said that its review will focus on two categories of metal hip replacement systems: total hip systems consisting of a metal ball (femoral head), metal femoral stem in the thigh bone, and a metal cup in the hip bone (acetabular component); and resurfacing systems consisting of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone.

Among the subjects concerning all-metal hip devices the panel will discuss are: failure rates; modes of failure; metal debris concerns; imaging methods; local and systemic complications; patient risk factors; and considerations for post-surgery follow-up.

Source:

FDA

Consumer Reports