The U.S. Food and Drug Administration (FDA) has concluded that metal-on-metal hip implants are more likely to break down after being implanted, resulting in potential danger from exposure to metallic particles. It was originally believed that the metal-on-metal hip implants would be more durable and longer lasting than their plastic or ceramic counterparts. However, some studies conducted in the United Kingdom, as well as other places, have revealed just the opposite.
Dr. William Rohr, Chairman of the FDA Meeting, said that he does not use metal-on-metal hips and sees no reason to do so.
The studies revealed that those patients who have had a metal-on-metal hip replacement can be at risk for metallic particles leaking into tissue. This can cause bone and muscle damage resulting in long term disability. If the metallic ions make their way into the bloodstream, the kidneys, lymph nodes and liver can all be damaged. Other doctors feel that long term exposure to elevated levels of metallic particles can result in cardiac and neurological problems.
As the design of implants continued to evolve, physicians moved to metal hip replacements for use in the thousands of baby boomers needing them. Prior to this, ceramic and plastic implants were primarily used. Contrary to the expectation for metal hips having a longer life than their predecessors, studies have shown that they are having higher failure rates than ceramic or plastic joints.
According to a British medical journal report, a ban on metal hip replacements was called for, after discovering that there was a failure rate of over 6% in five years versus a 1.7% rate for plastic hips and 2.3% for ceramic ones. Expectations were that they would last from 10 to 15 years.
Unfortunately, most of the metal hips marketed and sold in the U.S. received FDA approval without going through clinical trials, just like the majority of all other medical products. Why? The FDA has a fast track system called the 510K, which allows new products similar to ones already in use to piggyback into the market without being tested.
With some 400,000 people having hip replacement surgery every year, the number of complaints received by the FDA has been on the rise. Reportedly, it received nearly 17,000 complaints about problems related to metal hip implants between 2000 and 2010. Over 80% of those were forced to undergo another operation to have another replacement.
According to the FDA, the number of metal hips being implanted in patients is decreasing. In 2008, they were used in 40% of all hip replacements. In 2010, that number dropped to 27% and is said to be only around 10% now.
Some of the metal hip devices manufactured by Stryker and Depuy were recalled by the FDA. Recent attention has been focused on metal hip devices manufacture by Biomet and beleaguered Zimmer Corporation.
If you or someone you know has had hip replacement surgery involving a metal hip device, it would be a good idea to consult with a Chicago attorney experienced in handling product liability cases.