An Overview of the DePuy ASR Hip Implant
The DePuy ASR hip implant was approved by the FDA in 2005 following approval of its predecessor, the Pinnacle, in 2000. In fact, the ASR hip implant gained FDA approval by claiming it was substantially equivalent to the Pinnacle—even though the Pinnacle has its own set of problems. A mere three years after approval of the ASR, adverse reports began coming into the FDA from implant recipients who were experiencing significant medical issues as a direct result of the DePuy ASR hip implant. DePuy and its parent company, Johnson & Johnson issued a voluntary recall of the ASR on August 26, 2010 due to the reported increase of complications and the necessity of revision surgeries.
Many attorneys, physicians and implant recipients believe the recall was a bit of a delayed reaction since DePuy knew in 2006 that the ASR had caused problems, particularly among women and those with weakened bones. Rather than immediately addressing those problems, DePuy continued to market the ASR until the DePuy hip lawsuits started piling up. In fact, the first DePuy hip lawsuit was filed in June of 2010 prior to the recall. The 510(k) FDA process has had its own troubles as many believe it does not fully protect the public from defective medical devices since there is no actual human testing done prior to approval and marketing.
Prior to the 2010 recall, the FDA had information which pointed to the fact that approximately 13% of ASR implant recipients had been forced to undergo painful and potentially dangerous revision surgery within a few short years of the initial implant. A year prior to the ASR hip recall, Australia discontinued sales of the hip implant however Johnson & Johnson and DePuy maintained that the country pulled the implant due to a decline in sales rather than due to safety issues.
Symptoms of a Defective DePuy Hip Implant
When the metal components of a metal-on-metal hip implant rub against one another during periods of activity by the implant recipient, friction occurs. This friction can, in turn, lead to metal shear which sends microscopic cobalt and chromium ions into the body. These tiny metal ions can literally wreak havoc with the body’s defenses as it attempts to “fight” the invaders by spending special white blood cells to rid the body of the intruders. Unfortunately, the body is no match for these shards of cobalt and chromium and will react with severe inflammation, leading to tissue necrosis and bone loss as well as chronic and severe pain for the implant recipient.
When the metal ions make their way into the bloodstream and begin to accumulate, metal toxicity is likely. Symptoms of metal toxicity include cardiovascular issues, gastrointestinal disorders, neurological disorders, loss of vision and hearing, depression, irritability, anxiety, the formation of pseudo-tumors, kidney and thyroid issues, skin rashes, vertigo and even the disruption of DNA. Those who have an ASR hip implant—or any other type of metal-on-metal hip implant—should be vigilant about having blood work done frequently to monitor the levels of cobalt and chromium in the bloodstream.
When It May Be Time for aDePuy Hip Lawsuit
As of January, 2013, over 8,000 lawsuits have been filed against DePuy and Johnson & Johnson for health issues experienced as a result of the ASR hip implant. While adverse side effects do not happen in every case of a metal hip implant, some research points to a 40% revision rate within three years of the initial implant. This means that a huge number of patients will experience adverse symptoms as a direct result of their DePuy ASR hip implant and will likely want to file a DePuy hip lawsuit at some point in time.