July 12, 2012 — The DePuy Pinnacle hip implant, manufactured by the DePuy unit of Johnson & Johnson, was intended to replace the DePuy ASR hip implant.
Both hip implants are a metal-on-metal design, but the Pinnacle has a smaller femoral head. The ASR was recalled in 2010 due to a high failure rate. However, there is growing evidence linking all metal-on-metal hip implants to high rates of failure. There are already almost 1,600 Pinnacle hip implant lawsuits pending in U.S. courts.
The problem with metal-on-metal hip implants (including the Pinnacle) is that the metal femoral head scrapes against the metal cup. Tiny particles of chromium accumulate in nearby tissue. When they are absorbed by white blood cells, the chromium oxidizes, corrodes, and releases charged cobalt ions. Cobalt is genotoxic, which means that it kills cellular DNA. Cobalt is also highly-soluble, and it can leak into the bloodstream, causing metal poisoning, or accumulate in nearby organs. The short-term side effects of metal debris is pain, swelling, inflammation, decreased mobility, metallosis, pseudotumors, and other side effects that require revision surgery. The long-term health consequences are still unknown.
In recent years, there have been several major recalls and critical scientific studies, with some experts now calling for a ban of metal-on-metal hip implants. In the past, about 1 in 3 hip replacements were metal-on-metal. Today, the American Academy of Orthopedic Surgeons estimates that only around 10% of surgeons use the metal-on-metal hips.
An estimated 500,000 people in the U.S. are currently implanted with one of these hip implants, including 150,000 people with the Pinnacle hip implant (plastic, ceramic, or metal), and 37,000 with the ASR hip implant. There have already been 3,000 ASR hip implant lawsuits filed in the U.S., for which J&J has set aside $3 billion. As the Pinnacle litigation continues to grow, it is possible that J&J will face even more significant costs.
Early hip implant failure can cause severe pain and suffering. Most people will require a revision surgery to remove, repair, or replace their defective hip implant. A revision surgery is very painful, requires months of recovery time, and incurs enormous medical expenses. J&J has paid the out-of-pocket expenses for the ASR recall, but they have refused to pay for revision surgeries for the Pinnacle hip implant.
J&J maintains that the Pinnacle has a comparable risk-benefit safety profile as other metal-on-metal hip implants. However, the company has not publicized the actual revision rate. Outside attempts to determine the Pinnacle’s failure rate have been unsuccessful. The U.S. government does not keep track of medical device side effects. The FDA’s adverse event reporting system does not differentiate between plastic, ceramic, or metal Pinnacle hip implants. DePuy will not reveal the total number of Pinnacle hip implants, which makes estimating the failure rate imprecise.
Recently, an FDA panel convened to discuss what to do about metal-on-metal hip implants. They failed to reach any major conclusions, except that there was little evidence to support using the metal-on-metal design instead of plastic or ceramic devices. Last month, the FDA required 31 hip implant manufacturers to conduct new safety studies. Unfortunately, it could be up to a decade before those studies are complete.
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