No more than a month after DePuy Orthopaedics issued a recall for its ASR Hip Resurfacing System and ASR XL Acetabular System, several lawsuits and a motion to consolidate have been filed against the Johnson & Johnson unit. The recall came after data illustrating the systems’ alarmingly high failure rates (12% and 13%, respectively, or 1 out of every 8 patients) was published by the National Joint Registry of England and Wales.
The artificial hips manufactured by DePuy are all-metal constructions intended to replace the ball-and-socket hip joints. Due to the metal-on-metal construction of these implants, dangerous metal debris can damage the surrounding tissue and muscle. This debris results from the two metals rubbing against each other. Additionally, the debris can cause increased cobalt and chromium levels in patients.
An article stored on the National Center for Biotechnology Information website (NCBI ) and originally published in October 2006, notes that cobalt and chromium have been shown to be carcinogenic and mutagenic in both humans and animals and, as such, are commonly passed over as potential materials during implant conception and construction in favor of ceramics or plastics, as the potential dangers of these materials are heightened when they are implanted directly into muscle and/or under the skin (as opposed to the normal ingested amounts through air and water).
Problems reported following hip replacement surgeries involving DePuy’s systems include: unexplained hip pain; swelling or inflammation of tissue surrounding the implant; difficulty walking; pseudo tumors; and loosening of the hip replacement. Reportedly, the company knew as far back as 2007 that these problems were caused by its implants. The FDA has received about 400 complaints concerning these artificial hips since the beginning of 2008.
For more information on medical device recalls and alerts, and other safety information, visit: www.fda.gov/Safety/Recalls/default.htm