According to a new report UK regulators were aware of problems associated with the all-metal implants long before they were ever recalled.
According to a report by the news site Wales Online, problems with metal-on-metal hip implants have been around since at least 2007, which is when regulators in Australia first uncovered the issues associated with the devices. The first recall was announced in 2009 by the Australian government. A larger, worldwide recall was not issued until August of 2010, a delay which may have caused injury to countless patients who were not aware of the trouble they could be facing down the road.
A report on the Regulation of Medical Implants in the EU and UK by the Science and Technology Committee leveled serious criticisms against the British Ministry of Health for delaying action against the dangerous metal-on-metal devices. The report pointed out that many people knew of the damage all-metal implants could cause and yet the government failed to take action as early as other countries, a delay that caused citizens to suffer needlessly. The same issue could be raised against American regulators, given that the FDA allowed the device to continue to be sold and implanted in patients for years after the first concerns were raised about their effectiveness.
The DePuy ASR was finally recalled due to poor performance in a large number of patients. The problem with the implant is that as it is used, tiny pieces of metal fragments are released into a patient’s blood stream. These pieces of metal contain cobalt and chromium that are absorbed into the blood and nearby tissues. The damage this can do has not been fully understood, but reports indicate it can cause muscle, bone and even neurological damage.
Though the recall began with the DePuy device, studies indicate that the problem applies to an entire class of all-metal implant products. Earlier this year the FDA asked all manufacturers to conduct a study of their metal-on-metal products to assess their long-term safety. Experts have recommended that those with the devices already implanted should undergo annual physicals and imaging scans to detect any bone loss or tissue damage. Patients are also advised to screen for metal ions in their blood.
About one million of these all-metal devices have been implanted in patients across the world over the past 15 years. This means that far too many patients are at possible risk of the dangerous effects of cobalt exposure. If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation.
Source: “Faulty hip implant response ‘slow’,” published at WalesOnline.co.uk.