Consumer reports: fast-tracked medical devices a “nightmare scenario”
Hundreds of patients who have been implanted with a Pinnacle hip implant system made by DePuy Orthopaedics have filed complaints against the manufacturer, alleging the all-metal device is to blame for a multitude of injuries and illnesses. But unlike DePuy’s ASR XL Acetabular and Hip Resurfacing implants, two all-metal hip devices recalled by DePuy in 2010, no recall of the company’s Pinnacle system lies in sight.
Medical devices like the Pinnacle and its ASR cousins compelled Consumer Reports President Jim Guest to email subscribers last month and warn them about a “nightmare scenario” these medical devices may be creating for the American public. Each of these DePuy hip implant devices were approved for use via the U.S. Food and Drug Administration’s “fast-track” or 510(k) approval process — a shortcut designed to speed low- and moderate-risk medical devices to market when their designs are similar to already approved devices, thereby bypassing costly and time-consuming clinical safety trials.
“This isn’t science fiction,” Mr. Guest warned in his email. “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.”
Federal law allows the majority of Class I and Class II medical devices, including the DePuy Pinnacle, to gain FDA approval through the 510(k) process. Low- and Moderate-risk medical devices similar to devices that have been recalled by the federal government or a court are not fast-tracked, but such devices are fewer and fewer. Moreover, a loophole in these rules allows devices that are similar to those voluntarily recalled by the manufacturer to be fast-tracked for approval. The majority of recalled devices are actually recalled in this manner.
All-metal hips like the DePuy Pinnacle implant have fallen under intense criticism as evidence mounts that the devices may not only fail prematurely but also harm patients in sometimes chronic ways. Metal debris released from the metal-on-metal components may cause fractured bones, muscle and tissue decay, chronic pain, and immobility. Some metal hip recipients suffer more systemic damage to the central nervous system, thyroid, and heart as a result of excessive levels of cobalt and chromium in the blood, a condition known as metallosis, which some doctors fear may be linked to tumors, cancer, and other serious problems.
Consumer Reports and its advocacy arm Consumers Union aren’t the only organizations calling for an overhaul of the 501(k) approval process. According to Reuters, “The Institute of Medicine, a nongovernmental, nonprofit organization that provides medical advice to policy makers and the public, characterized the 510(k) approval process as ‘fatally flawed’ and said it should be scrapped.”
Medical device companies, of course, argue for leaving the fast-track process intact or making it even easier for untested devices to reach the market. Approximately 4,000 new medical devices were fast-tracked to approval in 2009 alone.
Last month, a new bill introduced by Democrats to the House Energy and Commerce committee for review aims to close loopholes in the FDA’s 501(k) process and thus prevent potentially dangerous devices from going to market without the appropriate safety trials.