Once again there’s bad news for people with DePuy hip implants.
According to a recent article, internal email between the FDA and DePuy Orthopaedics, the maker of hip implant knew that the medical device was not going to be approved by the FDA because of the demand for revision surgery caused by early failure problems.
So the hip implant device that was rejected by the FDA was only sold overseas, but its companion version that was recalled around the same time, the ASR Hip Resurfacing System, was implanted in 30,000 patients in the United States and 93,000 worldwide. The DePuy rejected hip device was also a type of resurfacing which is an alternative to standard surgery. The company started selling the implants abroad around 2003 but because resurfacing was a new procedure, the FDA required DePuy to run clinical trials before selling the device in the United States.
In order to win FDA approval for a medical device, the hip implant must show that it’s reasonably safe and effective and at least as effective as, or not inferior to a traditional hip implant.
There are some volatile hip safety issues here.
Why promote a rejected hip implant oversees when it is rejected here in the United States?
Why use and promote a metal on metal component knowing its failure rate and the problems like excessive pain and cobalt-poisoning risks?
If DePuy does not have to share its failure or rejection findings with doctors, hospitals, and other countries’ health agencies – isn’t that some ethical breach of negligence?
DePuy is a subsidiary of Johnson & Johnson whose credo is, “Our credo challenges us to put the needs and well-being of the people we serve first.” Really?