The U.S. Food and Drug Administration (FDA) has proposed new regulatory rules that, if passed, will require orthopedic device manufacturers to test their all-metal hip replacement and resurfacing systems for safety and efficacy before approval.
The proposed measures come in response to alarmingly high rates of failure and injury associated with metal-on-metal hip devices, such as the ASR XL Acetabular and Hip Resurfacing Systems made by DePuy Orthopedics, which were recalled for safety concerns in August 2010 after being implanted in about 93,000 patients worldwide, including approximately 40,000 Americans.
The FDA’s proposed order would require manufacturers to file a premarket approval application or a notice of completion of a product development protocol for metal-on-metal hip prostheses. The FDA said any final order based on its proposed order would become effective 90 days after date of publication in the Federal Register.
Many U.S. citizens may be surprised that the FDA doesn’t require thorough clinical testing of class III medical devices, such as hip implants, before approving them for market. Instead, FDA regulators allows certain devices to gain approval through its 510(K) system, which fast-tracks them through the approval process if demonstrated to be sufficiently similar to already approved devices.
This shortcut to market, however, has fallen under heavy criticism after a proliferation of medical device failures have sickened and maimed thousands of people. Medical devices such as DePuy’s faulty ASR implants compelled Consumer Reports President Jim Guest to warn these untested devices have become “a nightmare scenario” for the American public.
“This isn’t science fiction,” Mr. Guest warned in an email sent to Consumer Reports subscribers. “Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled — 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market.”
A few years after DePuy’s ASR hip replacement systems were approved, clinical data in Australia and the U.S. started to show that 12 to 13 percent of the devices failed after just 5 years. Further studies found that many patients implanted with these metal-on-metal hips suffered from high levels of chromium and cobalt in their blood and tissue – a condition sometimes referred to as metallosis, brought about when the all-metal implant parts release particles of metal.
Many patients implanted with DePuy’s ASR hip devices have chosen to sue DePuy and its parent company Johnson & Johnson for damages related to the systemic illnesses, injuries, and pain they blame on the metal-on-metal devices.