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Amid continuing concerns about the risk of problems with metal-on-metal hip replacements, which have been linked to high failure rates and a potentially “toxic” impact on the body, the United Kingdom has banned use of the controversial hip implant design at all hospitals funded by the National Health Service (NHS).
The National Institute for Health and Care Excellence (NICE) in the U.K. issued a draft guidance earlier this month, which requires all hip replacement systems have a 5% or less failure rate over 10 years.
The requirement excludes all metal-on-metal hip implants, because none of them have a success rate that high. The guidance came shortly after a report indicated that the DePuy ASR metal-on-metal hip systems had a failure rate of more than 40% over 10 years.
Virtually all hospitals in England would be required to stop using metal-on-metal hip replacement systems of any kind due to the ruling. The country has a publicly funded health system that requires all of the NHS hospitals to abide by the guidance.
Previously, NICE guidance allowed a failure rate as high as 10%, which would still have excluded many metal-on-metal hip implant designs. However, officials said that the new rate came following information on how long artificial hips can and should last.
Concerns have surfaced in recent years about potentially “toxic” side effects of metal-on-metal hip replacements, due to the release of metallic debris as the parts rub against each other, a condition known as metallosis. In large numbers of patients who received the implants, these problems may cause the hip replacements to loosen or fail catastrophically, often resulting in the need for revision surgery.
In the United States, the FDA released new guidance for metal-on-metal hip replacements early this year, advising doctors that metal-on-metal hip implants should only be used if other artificial hip replacements were not appropriate.
Information from a British joint registry first highlighted the risk of problems with DePuy ASR hip replacements, indicating in 2010 that users were experiencing a failure rates of 12 to 13% after only just a few years. These findings resulted in a worldwide DePuy ASR metal-on-metal hip recall in August 2010.
Thousands of former patients in the U.S. are now pursuing DePuy ASR lawsuits against Johnson & Johnson and their DePuy Orthopaedics subsidiary. At least two cases have already gone to trial, with one case in California resulting in an $8.3 million damage award and a second case in Illinois state court resulting in a defense verdict.
In addition, a number of product liability lawsuits have been filed over other metal-on-metal hip systems, which feature similar designs, including the DePuy Pinnacle hip implants, Biomet M2A Magnum metal hips and Wright Medical Conserve Cup.