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Ireland has become the latest country to launch a review into reports of problems with metal-on-metal hip implants, amid continuing concerns over their safety and long-term complications associated with the all-metal designs.
More than 8,000 patients in Ireland have received metal-on-metal hip relacement in recent years, and the country’s Health Service Executive (HSE), the country’s public health administration, is planning on sending letters to those patients to notify them of the review.
HSE officials indicate that the review was not sparked by any one particular event, but comes as the country prepares to launch its own database to track hip and knee implants.
Concerns have surfaced in recent years about metallic debris from metal-on-metal hip implants, which could cause tissue damage and metal blood poisoning, also known as metallosis. In large number of patients who received the implants, these problems have caused 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.
The U.S. regulatory agency also called on manufacturers to provide information establishing that their implants are safe enough to stay on the market. Future metal-on-metal hip designs will have to undergo extensive human clinical trials before being made available for sale, the FDA decreed.
Updated information was provided by the FDA to orthopedic surgeons, advising that doctors should pay close attention to patients with metal-on-metal hip replacements and to look for signs and symptoms of common problems associated with those artificial hips.
Implant Registries First Identified Problems
Concerns over metal-on-metal hip implant problems arose several years ago, after alarming data was seen in British and Australian implant registries, which track implant failures and reports. The registries identified high failure rates among metal-on-metal hip implants.
The HSE has announced that Ireland will launch its own database, the Irish National Orthopaedic Register (INOR), in September. INOR will collect data on hip and knee replacement implants.
In August 2010, Johnson & Johnson issued a recall for the DePuy ASR metal-on-metal hip system, after registry data suggested that as many as one out of every 8 implants were failing within five years. However, by the time the hip replacement was removed from the market, more than 90,000 of the components were sold worldwide. An estimated 3,500 Irish citizens received ASR implants.
Johnson & Johnson now faces thousands of DePuy ASR lawsuits in the U.S., where at least two cases have gone to trial so far, 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.