As more people with DePuy A.S.R. hip implants are realizing that their pain, revision surgeries, and permanent disabilities are the result of a defective product, more people are wondering how this could happen in the U.S.
As the New York Times recently highlighted in the article The Implants Loophole, the current system for allowing orthopedic devices to enter the market is not protecting all users. It is reasonable for users to assume that if the FDA allows a product to be on the market, then it has undergone sufficient testing and is safe. Unfortunately, that is not the case.
The New York Times article describes how faulty products can be placed on the market through the current FDA screening process:
Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients. That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing.
The DePuy hips have now been recalled, but that was long after DePuy first had evidence of high failure rates. Doctors and patients reported problems to DePuy long before the recall and there was also evidence of high failure rates in Europe before the product was marketed in the U.S. Barry Meier describes the problem with the DePuy A.S.R. implants:
Working with an engineer at Newcastle University, Dr. Nargol and Dr. Langton concluded by early 2009 that the design of the A.S.R. cup — the very component that the F.D.A. had allowed to be sold without clinical testing — was at the heart of the problem. Its interior surface was so shallow, the researchers asserted, that it was particularly vulnerable to edge-loading and shedding debris.
So how do we stop this from happening in the future? One way is to implement mandatory orthopedic reporting, as done in many European countries, requiring reporting and registry of medical device implants, rate of revision surgery, and issues that patients are having with the medical device. Companies like DePuy would not longer be able to ignore concerns from doctors and patients. The FDA also needs to take a look at the procedures that are allowing companies like DePuy to sell defective products.
It is estimated that hundreds of millions of dollars in public funds are spent every year on premature device replacement procedures. Tens of thousands of people are suffering from life-altering disabilities as a result of a defective device that slipped through the cracks. If medical device companies are not going to make sure that the products they put on the market are safe, then we need to.