The DePuy ASR XL Acetabular Hip Replacement System recall may have been prevented if the US had a better way of approving and tracking orthopedic devices. Because of these inadequacies,The New York Times said, <"http://www.yourlawyer.com/topics/overview/Johnson-and-Johnson-DePuy-Hip-Implant">DePuy (Johnson and Johnson unit)Â was able to sell a hip implant made with a component that had never been approved by the Food & Drug Administration (FDA). What’s more, doctors were unaware that the problems their patients were reporting with the DePuy ASR XL Acetabular Hip Replacement System were widespread.
J&Jâ€™s companyÂ first notified US doctors that there were <"http://www.yourlawyer.com/topics/overview/DePuy-Hip-Implant-Recall-Johnson-and-Johnson">DePuy hip implant problems with the ASR hip replacement system in March 2010. Then in August, DePuy issued a worldwide recall for the ASR XL Acetabular Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the <"http://www.yourlawyer.com/topics/overview/Johnson-and-Johnson-DePuy-Hip-Implant">recalled hip replacements had to undergo revision surgery within five years of receiving it. By then, more than 93,000 patients worldwide were fitted with an ASR hip implant. It is believed that roughly a third of those were patients in the US.
According to The New York Times, unlike new drugs, the FDA allows critical implants to be sold without extensive testing if a device, like an artificial hip, resembles an implant already approved and used on patients. While this allows device makers to make small changes that improve products, critics told the Times that the system has created a loophole that lets producers bundle a component from an unapproved implant into an existing design and sell it with minimal testing.
That’s apparently what happened with the DePuy ASR XL Acetabular Hip Replacement System. According to the Times, DePuy developed the ASR hip as a so-called resurfacing implant, and began selling it overseas in 2003. But because resurfacing is a new procedure, the FDA required that implant to undergo extensive clinical testing. In 2007, DePuy submitted data to the FDA in order to have that implant approved, but withdrew the application last year.
However, in 2005, according to the Times, DePuy was allowed by the FDA to sell a modified standard hip replacement that used the same ASR cup found in the companyâ€™s unapproved resurfacing device. That’s the device that tens of thousands of US patients received. Not only was DePuy never required to perform any patient testing on the device, it was also able to cite clinical data it had used five years earlier to get the FDA to approve another all-metal hip implant that used a differently designed cup. According to the Times, companies don’t have to let the FDA know when they bundle together components from approved and unapproved devices the way DePuy did, and the FDA typically gives such devices scant scrutiny.
According to the Times, an internal FDA review released several months ago found numerous flaws with the very process DePuy used to get it to approve the ASR, and the FDA is proposing changes to it.
The DePuy hip replacement debacle also points to problems the way orthopedic devices are tracked – or for that matter, not tracked – in the US. According to Times, within a short time of its coming on the market, patients began complaining of pain with their ASR implant, and surgeons where discovering mysterious masses of dead tissue near the thighs of some patients when they went to replace the hip implants. DePuy, however, maintained that the ASR was performing on a par with competing devices.
In some cases, the Times said, DePuy blamed surgeons for the problems, saying that complications were the result of improper placement. But in many cases, well-placed implants were the ones that were failing.
In mid-2008, a study presented at a medical meeting showed that many ASR patients had elevated blood levels of cobalt and chromium, the Times said. That same year, Australiaâ€™s National Joint Replacement Registry (NJRR) was showing that the ASR was failing early at a fast growing rate. Doctors doing replacements were finding metallic debris shed by the device had set off a reaction that was destroying muscle and bone, according to the Times.
In 2009, some British surgeons concluded that the design of the ASR Cup was faulty. The interior surface was so shallow that it made it particularly vulnerable to shedding debris. Those doctors met with DePuy, but told the Times that company officials insisted the device was safe. DePuy maintained that many other doctors had used it successfully and that it was not aware of similar complaints.
In late 2009, DePuy announced it would be phasing out the ASR, ostensibly because of low sales. But according to The New York Times, Professor Stephen Graves, who heads up the Australian joint registry, said he ‘had to laugh” when he heard about DePuy’s reason for the ASR phase out. As we reported previously, Professor Graves recently wrote in an Australian newspaper that DePuy was contacted â€œat least 17 different occasionsâ€ about problems with the hip implant.
Unfortunately, until DePuy issued its first safety alert on the ASR in March 2010, many doctors were not aware that problems with the implant were widespread. The Times pointed out that because the US has no system for tracking problems with implants, manufacturers get to decide when and if safety alerts are issued.
Some officials have renewed efforts to begin an orthopedic registry in the US, but it is only voluntary, and according to the Times, only 15 medical centers nationwide are reporting data. To make such a system effective, some experts believe that the federal government would need to mandate reporting as a condition of payment through taxpayer-financed programs like Medicare, the Times said.