In August 2010, Johnson & Johnson’s medical device division announced a DePuy ASR Hip recall of approximately 93,000 hip implant devices, because of high rates of revision surgeries. For thousands of people who have these devices implanted, this means either the risk of a painful and complicated revision surgery, or anxiety and stress as they wonder whether their implant is in danger of failing.
The two devices being recalled by Johnson & Johnson’s subsidiary, DePuy Orthopedics, are the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. In 2009, DePuy Orthopedics decided to discontinue these devices because of slowing demand. In 2010, however, Johnson & Johnson announced that new data from 2010 from the National Joint Registry of England and Wales show higher revision surgery risks for these devices. According to the data, there is a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System. There is also a revision rate of 13% for the ASR XL Acetabular System. According to Johnson & Johnson, the revision rate seems to be the highest with ASR head sizes below 50 MM in diameter.
In August 2010, Johnson & Johnson decided to recall the devices. That recall announcement came only two days after the Food and Administration warned DePuy about promoting other hip replacement devices for unapproved uses.
Johnson & Johnson now advises patients who have these hip implants to consult with their surgeon for a reevaluation of their implant performance. The company is urging patients to speak with their doctors, even if they do not currently suffer symptoms indicating the need for a revision surgery. Over the next few months, thousands of persons who already have these hip implants are likely to face serious stress, trauma and anxiety as they wait for symptoms that might indicate the need for a revision surgery.
Johnson & Johnson is now facing allegations that it was aware of the defects in the ASR systems for years before it finally decided to make the data public. Patients with these implants were reporting problems as early as 2008. The company had known for at least two years that people implanted with these devices were much more likely require revision surgeries. Yet, the company failed to inform customers who had these devices implanted. It waited until the very last moment after it received a warning from the Food and Drug Administration to desist from off label promotion of its other two replacement devices.
If you have been implanted with an ASR XT Acetabular System or the DePuy ASR Hip Resurfacing System implant, consult with your doctor immediately to evaluate the performance of your device, and determine the risks of a revision surgery.
To understand your legal options, call or contact a Los Angeles DePuy hip implant recall lawyer for a free consultation. The medical device attorneys at Arias Sanguinetti Wang & Torrijos have the experience to assist you with your claim.