The Food and Drug Administration has ordered all producers of metal-on-metal artificial hips to study their implants, which have been linked to high early failure rates and severe health effects in some patients. Makers of the device must conduct studies of patients who received the hips to determine if the implants are shedding high levels of metallic debris. Some patients have encountered that problem, including soft tissue damage that has disabled them.
Metal-on-metal hips, in which the ball-and-socket components are made from metals like cobalt and chromium, accounted until relatively recently for about one-third of the estimated 250,000 hip replacement procedures performed annually in the United States. However, over the last two years, the use of the implants has fallen off in part due to reports that they were prone to early failure and that some patients had developed serious health problems related to particles of metallic debris that are shed by the devices as they wear.
Approximately 20 manufacturers including the DePuy division of Johnson & Johnson, Zimmer, Stryker, Biomet and Wright Medical are required to study their products.
Each manufacturer may determine how to conduct its individual studies, but under the agency rule, has 30 days to file a proposed plan with the FDA. The companies must collect information from patients who received the devices, including taking blood samples to determine the levels of metallic ion in their systems. They are also being asked to determine how frequently the devices are failing.
The attorneys at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of attorneys and medical experts has successfully pursued litigation and obtained verdicts and settlements for victims of medical device injuries. If you or a loved one has suffered serious injuries as a result of an artificial hip replacement, please contact us at 1-877-MessaLaw.
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