Metal-on-Metal Hip Devices Continue to Raise IssuesDec 10, 2013
Some metal-on-metal hip implant devices have been tied to a number of open issues.
In one case, a double-hip device-recipient told WSLS10 (NBC) that she is still suffering from pain three years after being implanted with the two metal hips. "After I started having pain, I started looking into why I could possibly have more pain. I never really got better after I had the surgery. I never really got pain relief." The patient will be regularly monitored for metal toxicity as her physicians endeavor to understand what is leading to her pain.
In this case, the joint replacements were needed over the way in which the patient’s bones formed after birth. "The femurs had to kind of grow twisted, like a tree would grow through a fence. My femurs had to grow and twist to adapt, to allow me to walk," she explained. Her physicians recommended the metal-on-metal devices due their durability, according to WSLS10.
WSLS10 spoke with Dr. Michael Wolf, a Carilion Clinic Orthopaedic Surgeon, who said the neither he, nor his partners perform metal-on-metal hip replacements because of a number of open issues associated with the devices. "We do know that certain people, as I say, about one to two percent, develop this inflammatory response to the metal on metal implants, which we are really still trying to fully understand,” Dr. Wolf noted.
Metal-on-metal hip devices have been the focus of a growing debacle over unexpectedly high and premature failure rates and a host of adverse medical reactions that include increased blood metal levels. It is believed that the devices’ metal components wear against one another during normal, daily activities, such as walking. This wearing appears to release tiny metal shards into patients’ bodies, especially into their blood streams and area tissue, raising blood ion levels that may become toxic.
Very recently, Johnson & Johnson subsidiary, DePuy Orthopaedics, reached a $2.47 billion settlement to resolve thousands of lawsuits over its recalled ASR metal-on-metal hip implant devices. The settlement could reach as high as $4 billion.
In August 2010, 93,000 ASR hip implants were recalled worldwide. At the time of the recall, the firm indicated that 12 percent of the devices failed within five years; however, internal Johnson & Johnson documents revealed a 37 percent failure rate after just 4.6 years. The drug received U.S. Food and Drug Administration (FDA) approval in 2005.
The DePuy metal-on-metal devices were touted to last at least two decades and were also advertised to provide increased range of motion over traditional hip replacement devices that are constructed with plastic or ceramic components. Instead failure and injury reports mounted, as did litigation. Patients alleged serious injuries including dislocations; pain; metallosis (metal poisoning); fracture; difficulty ambulating, rising, standing, and balancing; noise emanating from the joint; and pseudotumors, to name just some. Patients also allege that debris shed from the chromium and cobalt hip device led to tissue death and increased blood metal ion levels.
The device maker faces some 12,000 lawsuits that have been filed in federal and state courts in Ohio, California, and New Jersey, noted Bloomberg.com. U.S. District Judge David Katz, in Toledo, Ohio, is coordinating the federal litigation; the settlement requires Judge Katz’ approval.
Prior to this accord, J&J lost one trial, won a second trial, and had scheduled seven more trials over the ASR devices. The devices were constructed in two similar models—the ASR XL Acetabular System and the ASR Hip Resurfacing System.