FDA calls for manufacturers to prove that metal-on-metal hip replacements are safe

The United States Food and Drug Administration (FDA) has called upon manufacturers metal-on-metal hip implants to prove to both regulators and consumers, that their products will not cause harm to recipients. Concern over the safety of such implants has grown in recent months following the DePuy ASR hip implant recall scandal which saw close to 100,000 people around the world implanted with devices that had a failure rate of 13% within 5 years. Indeed, DePuy’s parent company, Johnson & Johnson, is currently fighting the first of an anticipated 10,000 law suits from patients who suffered cobalt and chromium poisoning due to breakdown of the metal components. However, devices from other manufacturers such as the Biomet M2A Magnum and the Wright Medical Conserve Cup have also received high numbers of complaints recently.

The FDA has suggested to doctors that they only implant patients with metal-on-metal devices if other safer implants are found to be inappropriate. In order to demonstrate the safety of their products, manufacturers of the questionable implants will be forced to carry out comprehensive human clinical trials to ensure that failure rates are low and that the mechanisms are fully functional.

Faulty DePuy ASR Metal on Metal Hip Replacement? Get in touch today

There is an awful lot of stress associated with hip implant recalls. Not only are you concerned about the device in your body or already experiencing pain but there is the ordeal of a revision surgery as well. Our medical negligence solicitors can make the claims process less stressful due to our expertise and experience handling such claims.

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