Signaling more trouble for metal-on-metal hip devices and their manufacturers, the U.S. Food & Drug Administration (FDA) announced it has planned a 2-day review of the controversial medical devices, which have become the subject of thousands of personal injury lawsuits around the world.
“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.
Hip replacement systems made with all metal components were first conceived about a decade ago. By replacing ceramic and plastic components used in traditional artificial hip devices with cobalt and chromium parts, device manufacturers intended to create more durable devices that could outlive their conventional counterparts by years.
Mounting evidence, however, suggests some all-metal hip devices are failing prematurely and injuring patients, sometimes severely. Friction between the metal parts that sometimes leads to device failure may also send metallic debris into the patient’s tissue and blood – a process that allegedly has had devastating consequences for recipients of metal-on-metal hip-replacement devices.
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-two (moderate-risk) medical devices, such as the DePuy ASR hip implants, which were recalled in 2010, are usually fast-tracked through the approval process with minimal or no testing.
It makes sense for the FDA to call for a review of metal hips, but the real underlying defect may actually be the agency’s own medical-device approval methods, which allow thousands of potentially dangerous medical devices to bypass clinical safety trials and go straight to market.
Consumer Reports recently criticized this process, known as the 510k or fast-track process, for helping to create a “nightmare scenario” for public safety – one in which the use of a pacemaker, heart stent, artificial hip, or other medical device has become a crap shoot for patients and their health.