Hip replacements. Knee replacements. Hernia mesh products and cardiac stents. Implanted medical devices are not out of the ordinary. In fact, an estimated 32 million Americans have at least one medical device implanted – translating into approximately one in ten people. And while many medical devices have saved lives, countless others have harmed lives due to issues regarding safety and efficacy.
The Food and Drug Administration (FDA) – a federal agency of the United States Department of Health and Human Services – is responsible for protecting and promoting public health, including prescription and over the counter medications. Medical devices came under FDA regulatory control in 1976 and, at that time, the FDA grandfathered all devices that were already on the market.
Approval of medical devices
Under a regulatory provision known as 510(k), medical device companies may sell most new medical devices without performing clinical testing, providing the manufacturer states its product is “substantially equivalent” to an existing medical device. In addition, by informing the FDA that only a minor change was made to a previously approved device, manufacturers can sidestep clinical testing for medical devices. Using this method to introduce new devices on the market is widespread, resulting in a high percentage of implanted devices that do not meet the standard for drug testing.
Medical device recalls
Medical device recalls are on the rise in the United States. In 2003, there were eight FDA Class 1 device recalls, cited for products that may cause serious injury or death. Thirteen years later, in 2016, that recall number rose to 117, with hundreds of thousands of patients affected.
Risks of metal-on-metal hip implants
Metal-on-metal hip implants pose risks due to the release of metal where the two metal pieces rub against each other from daily wear. When tiny metal particles come off the device into the area around the hip implant, those metal particles will enter the bloodstream. Concerns stem from the damage this causes to the tissue and bone surrounding the implant and joint.
Johnson & Johnson withdrew its ASR XL metal-on-metal hip implant from the market in 2010 amidst safety issues. The company then proceeded to sell another, similarly problematic metal-on-metal hip implant — the Pinnacle – until 2013. Johnson & Johnson now faces more than 9,700 lawsuits from Pinnacle patients who suffered injury from the defective implants. In November 2017, six patients won a $247 trial verdict for serious harm caused by the Pinnacle and Johnson & Johnson’s failure to alert doctors and patients of its dangers.
While international regulatory agencies have issued safety alerts regarding metal-on-metal hip implants, the FDA states that unless patients with these hip implants exhibit the signs or symptoms of a malfunctioning device, then the agency recommends that patients continue standard follow-up with their orthopaedic surgeon.
Our New Jersey product liability attorneys help those who have sustained a medical injury
Implanted medical devices are common; unfortunately, some of those devices put patients at risk. If you or a loved one has suffered due to an implanted medical device, our experienced team can help. With more than 130 combined years serving New Jersey families, our New Jersey injury attorneys are compassionate, knowledgeable and aggressive in fighting for your just compensation. Our experienced legal team includes two medical professionals: a Board Certified medical doctor and a full time registered nurse. Contact our office at 732-482-9285 or contact us online to schedule a confidential consultation to discuss your situation.