FDA Approval Process Changes: Too Little, Too Late.
In August 2005, the FDA approved an application for the DePuy ASRTM XL Acetabular System, allowing DePuy to market the new, metal-on-metal system to patients needing total hip replacement surgery. To those patients, this FDA approval meant one thing: the DePuy ASRTM XL Acetabular System was safe.
But, in its first five years, the ASR System failed at such catastrophic rates that DePuy issued a voluntary recall in August 2010, affecting tens of thousands of patients who have to undergo revision surgery.
How could this happen? Isn't it the FDA's job to verify and ensure the safety and effectiveness of medical devices sold in the United States?
The DePuy ASRTM XL Acetabular System gained FDA approval through the 510(k) process, which bypasses clinical testing altogether if the product is "sufficiently equivalent" to other products already on the market.
Which means the ASR System was never clinically tested before it was sold to patients, and it underwent only the most rudimentary safety tests. DePuy only had to state that their new product raised no new safety concerns. The FDA - evidently - took them at their word.
Congress and consumer advocacy groups have been calling for reform of the 510(k) process, in part due to similar recalls from DePuy and other medical device companies. As of August 2010, the FDA has issued two preliminary reports that recommend sweeping changes.
The reports indicate that consumer advocacy groups had strong concerns about "predicate quality"-that is, the quality of the already approved devices to which DePuy claimed their new product was substantially equivalent.
Per the current 510(k) requirements, a company can claim its product is substantially equivalent to a product that never underwent clinical testing, was made before 1976, or had been recalled. That's right: the ASR System got through on a kind of loophole, and now another manufacturer can come along and claim their product is substantially equivalent to it-and be approved.
Had this negligence been rectified years ago, the ASRTM XL Acetabular System might never have gone to market.
The preliminary reports also recommend getting rid of the rule that allows a company to base its substantial equivalence claims on more than one product. This change would almost surely have invalidated DePuy's ASRTM XL Acetabular System application, because DePuy based its substantial equivalence claim on no fewer than three devices.
Perhaps most important, the reports call for an improvement in the quality of the clinical data submitted to support substantial equivalence. How has the FDA justified making an educated decision about a new product's safety and effectiveness without strong clinical data?
If DePuy had been mandated to conduct clinical studies before the ASR System was sent to market, the terrible fact of a one-in-eight revision rate might've been avoided. Tens of thousands of patients might've been spared the painful truth that will need to undergo a second hip implant just a few years after receiving the first.
Critics have long argued that companies use the 510(k) process is a loophole that allows companies to get around the more arduous premarket approval process otherwise required by the FDA. While it's true that the 510(k) process saves companies a lot of time and money, the cost is merely passed on to the patients, who pay with their money, pain, and quality of life.
We can only hope that the proposed reforms to the current process take effect soon and prevent more tragedy from prematurely approved devices like the DePuy ASRTM XL Acetabular System.
If you think you have a DePuy hip implant and would like to know more about this case, give our offices a call at 1-800-677-7095. We have people standing by to answer your questions and explain how we can help.