A Loophole Allowed the DePuy Hip to be FDA Approved Without Testing
A enlightening article in the New York Times discusses this “Implant Loophole” and how DePuy (owned by Johnson & Johnson) skirted the clinical testing requirement in order to get this product on the market as soon as possible.
There is a significant controversy about the recalled DePuy ASR XL replacement hip. Studies of people that have received this product show that it needs to be removed and replaced at a significantly higher rate than other devices and that the shedding of metallic particles into the body can result in permanent damage. In fact, the director of Australia’s orthopedic database which tracks success of replacement joints said that he believed that DePuy had been less than forthright about the A.S.R. data in that country:
“When it is clear to the orthopedic community that a company has not been honest, that is a problem,” said Australia’s registry’s director, Dr. Stephen Graves. “I think that J. & J. has a major issue with DePuy.”
The recent inquiry centers on the following question: “Why was this product approved by the FDA in the first place?”
The short answer: A FDA approval loophole exists for medical implants to be approved without clinical testing as long as the manufacturer claims the product similar to implants already approved.
The DePuy ASR may have been similar, but it was different in its rate of failure and in the dangers posed by the claimed defects. Click here to view the DePuy FDA Application (and the FDA’s response) for yourself.
As a result of the relaxed standards the “testing” occurs on the general public after approval:
“You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr. Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime FDA critic.
The article continues and discusses the FDA’s requirements, symptoms of the defective DePuy hip, the increasing worldwide concern, and DePuy’s response to that concern. Click here to read more of The New York Times: The Implants Loophole.
If you or a loved one has a DePuy hip, please click here to learn more about the Brandi Law Firm DePuy Attorneys.