Fears of toxins tied to defective metal-on-metal hip implant devices are gaining attention in Europe, especially the DePuy all-metal devices.
According to the Telegraph, there have been subsequent developments in the ongoing controversy concerning the all metal medical devices. The Telegraph reports that risks from the devices are greater than first believed and failure rates are even higher than prior reports indicated, the Buckingham and Winslow Advertiser and Bicester Review (BuckinghamToday) reported.
The Telegraph also reports that the Medicines and Healthcare products Regulatory Agency MHRA is creating a new alert for people who have been implanted with any type of metal-on-metal hip replacement device, according to BuckinghamToday.
In March 2011, delegates at the British Hip Society annual conference discussed the all-metal devices and units in Europe researched short- and long-term outcomes for patients who were implanted with these devices, BuckinghamToday wrote. The groups found that many metal-on-metal devices produced by other manufacturers revealed similar premature and high failure rates as those seen in the since-recalled DePuy Orthopaedics metal-on-metal hip device.
Overall, the groups found that metal-on-metal hip replacement devices experienced higher-than-expected early failure rates. In fact, some 49 percent of people implanted with the recalled DePuy required revision surgery to remove and replace the device within six years, despite that most hip devices are designed to last 20-30 years, Buckingham Today reported. Between 12-15 percent of patients implanted with other metal-on-metal devices underwent revision surgery within five years.
The devices are also associated with increased cobalt and chromium levels being released into patients bloodstreams and area tissue due to the metal components rubbing against one another during normal activities, such as walking. The MHRA advises physicians to monitor chromium and cobalt levels in metal-on-metal hip implant recipients to determine if follow-up is necessary, according to Buckingham Today.
New data from Canada also suggests that patients implanted with specific metal-on-metal devices are likelier to undergo revision surgery within five years, according to the Winnipeg Free Press.
The DePuy ASR and other metal-on-metal hip implants were approved without clinical testing for safety or efficacy under the 510(k) approval route. The 510(k) exempts devices from clinical testing if the manufacturers are able show that their product is similar to a previously approved device. The U.S. Food and Drug Administration (FDA) reported on January 18, 2013, that it was attempting to change the 510(k) process; the agency has proposed that all-metal hip replacements go through pre-market approval, which would require device makers to prove that their products are safe and effective.
Johnson & Johnson, which owns DePuy Orthopaedics as a subsidiary, recalled 93,000 ASR hips in 2010, citing a failure rate of 12 percent in five years, according to Bloomberg News. In Australia, failure rates have exceeded 40 percent in seven years.
The hip implants were created for increased durability and longevity and with the intention that the seemingly stronger components would be superior over their traditional counterparts constructed with plastic or ceramic elements.
In the U.S, the FDA issued new guidelines to patients implanted with all-metal hip replacements. Among other things, the agency advised that physicians conduct physical examinations, diagnostic imaging, and metal ion testing, as needed. The agency has also proposed implementing more stringent regulations that would require manufacturers to prove the implants are safe and effective before selling them. From a legal standpoint, these changes are an important step in attempting to hold manufacturers responsible for dangers associated with their products.