In a previous blog post, Panish Shea & Boyle LLP discussed the DePuy hip recall of two replacement devices, the ASR Hip Resurfacing System and the ASR XL Acetabular System, which was announced on August 26, 2010. We mentioned that some common defective hip implant symptoms include difficulty walking and hip pain. Reports to date estimate a five-year revision rate of about 12% for the ASR Hip Resurfacing System and about 13% for the ASR XL Acetabular System.
Since our previous post, we have continued our investigation into the recalled DePuy hip implants. We now know that DePuy was notified years ago of reports that the ASR systems had an unexpectedly high failure rate. Despite these reports, DePuy continued to sell the implants worldwide. Even after withdrawing the ASR implants from the market in Australia in December 2009, DePuy continued to sell the implants in the United States.
Late last year, DePuy announced that it would be phasing out sales of the implant by the end of 2010 because of commercial reasons, including declining sales, but did not include in the announcement any information regarding the continuing safety issues that had been discovered. On March 6, 2010, DePuy finally sent an “urgent field notice” to physicians that merely warned them that there was a higher than expected failure rate of the implant in patients of smaller stature (often women) and patients with weakened bones. However, the letter did not advise physicians to stop using the implant altogether. It was not until August 26, 2010 that DePuy finally recalled the implants in the United States. It has been reported that the FDA, (and, presumably, DePuy) received hundreds of reports of problems with the implants over the last several years, and the number of individuals who have actually had complaints is almost certainly much higher because the FDA typically receives reports in only a small percentage of cases.
It is reported that over 90,000 of the DePuy systems have been sold worldwide. While DePuy estimates a thirteen percent (13%) five (5) year failure rate, many are estimating that the failure rate could rise to as much as twenty-five percent (25%) or more in seven (7) years.
The research to date supports that the defect in the implant relates, among other possible causes, to the shallow cup design and the fact that the implants are metal on metal, which means that there is a metal ball in a metal socket. Some surgeons have suggested that the shallow cup used in the ASR may be more difficult to properly align when installed causing excessive friction and wear between the metal parts. When the shallow metal cup and metal ball rub together, they release metal ions of cobalt and chromium into the surrounding areas. Among other problems, the metal debris or a loose cup can cause swelling, inflammation, damage to muscle and tissue, an allergic reaction to the metal and problems walking. The long term impact of the implant, including the effect on the body of the metal ions that has been reported in some patients, is not fully known.
Depending on a patient’s circumstances, the potential damages from this defective implant can include revision surgery and rehabilitation costs, costs to cover on-going monitoring for metal ion levels and poisoning, pain and suffering and loss of earnings.
As more and more information comes to light regarding DePuy hip replacement systems and the injuries they may cause, patients who have had or may need corrective surgery are in search of answers regarding their rights and whether they should go through the claims process set up by DePuy. The hip implant injury lawyers at Panish Shea & Boyle are currently investigating cases relating to patients who have suffered because of defective DePuy ASR systems and are handling claims throughout the country. Please visit our blog again for more information about the hip implant recall or call 1-877-800-1700 for a free consultation about your hip replacement injury case.
