The term “guinea pig” is often used jokingly by patients who feel that their medical treatment is underdeveloped or experimental. But when it comes to the Food and Drug Administration’s fast-track approval of certain medical devices such as DePuy’s ASR XL Acetabular and ASR Hip Resurfacing implants, “guinea pig” is sometimes an apt description.
The FDA often approves medical devices without requiring proper clinical testing if the manufacturer demonstrates that the new unproven device is substantially similar to an already-approved one. This process, called the 510k process, spares the manufacturer thousands of dollars in clinical testing and usually takes just weeks to complete. Compared to the traditional premarket approval process (PMA), which generally costs companies upwards of $250,000 and often takes 2 years to complete, the 510k process comes as a bargain at around $5,000 and allows the device in question to enter the marketplace without the usual extensive medical trials that would demonstrate its risks.
That in turn means such devices, including Depuy’s hip implants, can be surgically implanted in patients even though neither the manufacturer nor the federal government fully understands the potential dangers. DePuy’s ASR XL system also happens to be designated as a Class III medical device, meaning it is considered high-risk to the patient’s health, and still it shot through the approval process without rigorous testing.
Unfortunately, the medical device’s defects and other dangers sometimes come to light only once they are widely implanted throughout the general population, effectively leaving patients to serve unwittingly as guinea pigs.
This is exactly what happened with DePuy’s hip implants, which were recalled last August after being implanted in 93,000 patients. Even when the implants showed a troubling rate of early failure, they continued to be surgically implanted in patients who believed they were receiving the best, most durable hip implants on the market.
Even in the midst of the DePuy hip implant disaster, the FDA has showed no signs of changing its ways. The agency recently rejected a proposed rule change that would have eliminated the approval shortcut for medical devices by subjecting all of them to rigorous clinical trials that would help stop defective medical devices from harming patients on a massive scale.
FDA records show 12 percent of patients who received DePuy’s ASR resurfacing device and 13 percent of patients who received the ASR total hip replacement needed a second hip replacement surgery after just five years because of device failure. Each corrective or revision surgery is more difficult for surgeons to perform, leaving patients at risk of another hip failure and longer recovery period.