The
DePuy ASR hip implant was approved by the FDA in 2005, yet a mere five years later, in August of 2010, the device was recalled. The ASR gained approval through the FDA’s 510(k) process based on the device being substantially equivalent to DePuy’s Pinnacle hip implant. While the ASR is an all-metal hip implant device, the Pinnacle includes ceramic and polyethylene models as well. Over 93,000 ASR devices were implanted across the globe with over half of those in the United States alone. From 2011, over 500 complaints regarding the ASR have been lodged with the FDA.
At the time of the recall, DePuy placed the failure rate of the ASR at approximately 12%, however an article in PubMed.gov states that a Kaplan-Meier analysis of the ASR showed a failure rate of 25% at six years for the ASR resurfacing and 48.8% at six years for the ASR total hip replacement. Considering these extremely high failure rates, even those implant recipients who have had no overt adverse effects from the all-metal hip implant are advised to contact an attorney as soon as possible due to the statute of limitations regarding product liability cases. While the ASR recall was two years ago, there are instances under which a skilled attorney can circumvent the statute of limitations—which, in at least half of the states, ended in August, 2012.
The failure rate numbers indicate that at least half of all ASR recipients are likely to experience problems with their hip implant even if they have not yet had any adverse health effects. Considering that as of August, 2012 only about 8,000 victims of the ASR had filed a lawsuit against DePuy and Johnson & Johnson, you can see how there are thousands of potential victims who may be unaware the ASR was recalled or may not have been notified of the risks of the ASR by their physician. The ASR’s metal head and acetabular cup have been found to rub against one another during periods of activity. That causes metal ions to shear away, lodging into the surrounding tissues or entering into the bloodstream. Pain can result as the tissues degrade and even suffer necrosis, and, in some cases, the hip implant can fail completely, requiring revision surgery.
Although every person’s body is different, and some will respond differently to cobalt and chromium buildup in the bloodstream than others, there are serious issues connected with these metals. Neurological, cardiovascular, renal and thyroid issues have all been noted in those with elevated levels of cobalt and chromium as well as disruptions or alterations in DNA. Others have noted such adverse health effects as vertigo, hearing and vision disturbances, gastrointestinal disorders, skin problems and loss of memory. Due to the extremely serious nature of metal toxicity and in light of the ASR recall, whether an ASR implant recipient has yet to experience negative side effects or not, it is extremely important that they
contact an experienced attorney who has the appropriate knowledge, skills and information regarding the ASR recall and risks. If you have an ASR implant, you do not want to be forever barred from pursuing legal action against DePuy and Johnson & Johnson even if you are currently not experiencing pain or other problems.