DePuy May Not Escape From A Pinnacle Hip Replacement Recall
In the late 1800s, DePuy Manufacturing had its beginnings in the medical device industry manufacturing synthetic splints and has become a billion dollar company over the last century. Since its acquisition in 1998 by Johnson & Johnson, DePuy has grown exponentially over the last decade earning roughly $5 billion in revenue annually. Over the last few months, the company has experienced some major setbacks with the recall of its ASR hip replacement system and a potential DePuy Pinnacle recall due to reports that these metal-on-metal devices have high failure rates among recipients. All DePuy can do is wait for the wave of litigation that is surely imminent.
The U.S. Food and Drug Administration (FDA) made it possible to market the DePuy ASR system by the highly scrutinized 510(k) approval process. Through this process, the FDA allows a medical device to enter the market without undergoing obligatory clinical trials as long as the company can demonstrate that the device is “substantially equivalent” to a device already approved on the market. Many concerns were raised because the ASR system avoided necessary clinical trials by showing similarities with the approved DePuy Pinnacle system.
Over 500 complaints have subsequently been received by the FDA against the Pinnacle system, mostly because the device is prone to loosen prematurely. In addition to this, a disturbing report from the New York Times claims that metal-on-metal devices, like Pinnacle, carry the increased risk of metallosis in recipients. Since the metal components of these devices experience constant friction, metal particles are then released into the soft tissue surrounding tissue and into the bloodstream. Build up of these metallic particles may cause the patient to suffer symptoms of metallosis. The symptoms of metallosis vary, but typically manifest as feelings of disorientation and unexplained depression.
As more victims come forward with complaints against the Pinnacle system, the possibility of a DePuy Pinnacle recall becomes more likely.Recipients that are experiencing symptoms of metallosis, or have loosening devices should seek legal consultation. Visit the DePuy Pinnacle recall website for more information.