It’s saddening to say that all too often it’s hard to know whom the medical industry finds more important; the patient or themselves. Perhaps that is not fair to say across all spectrums, but frequently this seems to be the case when it comes to certain medical paraphernalia and care.
With the DePuy ASR, DePuy and Johnson & Johnson fell flat into this controversial question as to whether they put profits ahead of their patients care and safety. The combination of a dangerous metal-on-metal combination between the DePuy ASR and Pinnacle systems led to a high failure rate, hip fractures, loosened implants, and device dislocations.
Though internal human implants are not without controversy and dismay throughout history, care must be taken to align with best principles. The fact that DePuy took the ASR to market without clinical trials and used a known risk method such as metal-on-metal leads to strong conclusive evidence that the almighty dollar was in sight and not the patient.
In 2005, the FDA actually granted DePuy approval for sale of the ASR without demanding they undergo clinical trial first.
In 2007, there began the reports of DePuy ASR controversial findings when the Australian Orthopaedic’s National Joint Replacement Registry reported failures rates double that of industry standards. Within the first five years following implantation the DePuy ASR failed at a 13% rate compared to the industry standard of 3%. Even in 2007, those are not good odds.
In 2008, it found England and Wales National Joint Registry at odds with the DePuy ASR. They reported over a 3-year time period the ASR had the highest failure rate among all hip implants and required further surgery to fix the associated issues.
Because of a lifetime teamed with worsening statistical evidence, in 2010, DePuy and Johnson & Johnson issued a worldwide recall for the DePuy ASR. Around the world there were an estimated 93,000 patients who received the questionable ASR before the companies finally pulled it from the marketplace.
Lawsuits abound related to the DePuy ASR and Pinnacle devices. As of 2010, over 10,000 lawsuits had already been filed. In 2011, the company had already set aside three billion dollars to address lawsuits with $800 million considered to pay for the medical recall itself.
If you know someone who has a hip implant or perhaps you do yourself, be sure it’s not a DePuy ASR. This product has been recalled and places anyone with the product at high risk for injury.