Patients Must Better Understand Risks of Their
This past fall, there was a recall issued on the DePuy ASR hip replacement system that resulted in loss of much of the public's faith in DePuy, which is one of the medical device industry's biggest players. When the recall was issued, the ASR was reportedly failing in 12-13% of all patients who had the device used in their hip replacement surgery. The people in whom the device failed had to undergo revision surgery in order to fix the issue. That amounts to about one out of every eight people having to undergo a second surgery just five years after their initial replacement. Now, DePuy will have to face litigation over their failure to ensure the product was safe.
The U.S. Food and Drug Administration (FDA) approved the ASR for sale to the public through its controversial 510(k) approval process based on the product's substantial similarity to the DePuy Pinnacle hip replacement system, which was already approved for sale in the United States. Both products are metal-on-metal hip replacement systems, utilizing a metal ball and cup to replicate the natural movement of a hip joint. Metal-on-metal systems are differentiated from hip replacement systems that use a plastic cup and are typically much more durable than their counterparts.
The DePuy ASR shows how important it is for patients to stay on top of the breaking news regarding their particular medical device. Patients often assume that there has been a sufficient amount of testing on the product they purchased to be used in their hip replacement surgery, but the 510(k) approval process allows for FDA approval of devices without their undergoing pre-market testing. Much is learned about medical devices after they are brought to market, often to the detriment of the patients in whom the devices have been implanted.
Although loosening is the most common problem that people suffer after undergoing hip replacement surgery, there are other less common but serious occurrences of which anyone who undergoes such surgery should be aware. Bacterial infection is one of the more serious, and occurs more commonly in the elderly or obese after undergoing hip replacement surgery. Another potentially life-threatening occurrence is the formation of blood clots that potentially travel through the blood stream to the lungs and could result in major complications. Though rare, these are risks of which everyone who undergoes hip replacement surgery should be aware.
If you have suffered from any ailment, including loosening or metal toxicity, related to your Pinnacle hip replacement system then you could have the basis for a DePuy Pinnacle lawsuit. The attorneys at the Rottenstein Law Group have a total of over 25 years of fighting negligent corporations like DePuy.