DePuy ASR Hip Implant Recall Lawsuits Triggered By Multiple Debilitating Side Effects

DePuy Orthopaedics issued in August 2010 a global recall of its ASR Hip Resurfacing System and ASR Acetabular System. The action resulted from the data provided by the National Joint Registry of England and Wales. It showed that 1 in every 8 individuals (about 12%-13%) who were implanted with the devices needed revision surgery only after five years of receiving it. Prior to the issuance of the recall, there were about 93,000 defective ASR Hip Implants sold and implanted in individuals in the U.S. and abroad. The DePuy ASR Hip Implants were sold between 2005 and 2009. An individual who received the metal-on-metal hip implant within this period, and is suffering serious complications due to the implant’s failure requiring corrective surgery, may have been a victim of DePuy ASR Hip Implant. Symptoms usually occur as follows: Swelling or pain in the effected hip or surrounding areasrn Difficulty walking or pain in the hip when doing sorn Grinding or popping noises originating in the hip arearn Inflammation or infection in the affected hip arearn Implant loosening Dislocation of the implant componentsrn Bone fractures at the hiprnMetal poisoning, akametallosis, resulting from metal debris shed by device components rubbing each other Awareness of this recall by those who are not even yet affected by these problems is necessary. The absence of these symptoms is not an indication that the implant has not failed or is not affecting the health of the user. Thus, it is imperative that every individual who have received a DePuy ASR Hip Implant contact their physician for reevaluation, despite feeling no problems with the device. Though recall was issued in 2010, there is apparent reason for DePuy Orthopaedics to know that its ASR Hip Implant devices pose dangers to patients years before its recall. In fact, in March 2006, DePuy already wrote to doctors to alert them of the ASR devices’ higher-than-expected failure rate with the clarification that this only affects certain patients: women, patients of short stature, and those with weak bones. Then, come December 2009, units of ASR were withdrawn from the Australian market and released plans to do so worldwide in 2010. In DePuy ASR hip lawsuit pre-trials, the company insists that the recall the ASR Hip Implant in Australian was due to poor sales. The DePuy ASR hip implant was approved by the U.S. Food & Drug Administration (FDA) through its 510(k) approval process. This process of streamlined clearance allowed medical devices such DePuy’s to gain approval without human clinical trials by showing that the device is “substantially equivalent” to existing products being distributed in the market. Nonetheless, a report by the New England Journal of Medicine (NEJM) says that the DePuy ASR’s approval by the FDA was based on the similarities to existing implants, though the device has significant changes in material as it used a metal alloy cup from a different hip device that retrofits to a standard hip implant. This metal-on-metal design change was thought of as a major innovation despite lack of test, the NEJM reported. What are the dangers of a metal-on-metal hip implant? The DePuy ASR Hip Replacement devices subjected to the recall of August 2010 are metal-on-metal hip implants. It is a class of devices that recently have been suspected of serious complications and injuries. Individuals with metal-on-metal hip implants, these include the DePuy ASR devices, suffered loss of bone, the demise of surrounding tissue, the development of pseudo-tumors in the same area, and early failure that requires corrective surgery. There is the belief that these complications are resulted from minute metal shards being shed by the rubbing metals into the blood stream. This leads to metallosis and cobalt poisoning. Come 2011, the rising number of complications reported by people with metal-on-metal hip implants prompted the FDA to direct DePuy Orthopaedics and 20 more manufacturers of hip replacement to conduct post-market studies of their devices to see if the metal shedding result to dangerous amounts of metallic debris among its users. The foregoing medical findings, combined with the FDA’s directives and consequent recall, scores of individuals are now geared towards filing Depuy ASR hip lawsuits.