In 2013, DePuy Orthopaedics, Inc. removed its Pinnacle metal on metal hip implant from the market. The company claims that the device was discontinued due to declining sales. However, some medical experts and safety advocates allege that defects forced the company to remove the device from the market. But how could a medical device approved by the Food and Drug Administration (FDA) have defects? It may be due to the fact that the DePuy Pinnacle was never tested in humans.
Were Pinnacle Hip Implants Tested on Humans?
The FDA is viewed as the gatekeeper between the public and medical devices. The agency is supposed to vet the safety of these products. But that testing doesn’t always happen.
A process known as the 510(k) regulatory pathway can skirt clinical testing. If a company can prove its medical device is “substantially equivalent” to a similar device that’s already on the market, then it can release it without clinical trials DePuy used this process to get the Pinnacle implant on the market as soon as possible.
Does the DePuy Metal on Metal Pinnacle Implant Have Defects?
About 150,000 Americans received Pinnacle hip implants before they were discontinued in 2013. The device was considered the company’s “Billon Dollar Baby,” but complaints about the Pinnacle are increasing.
A report from 1995 found that metal on metal hip implants similar to DePuy’s Pinnacle showed signs of “sudden catastrophic breakdown”. And in 2004, a study of DePuy’s metal implant Ultima revealed that the device was releasing metal ions that were destroying bone and soft tissue near the implantation site. In a 2010 email to the company, one of DePuy Pinnacle’s designers warned that the product was hurting patients.
Despite these reports and complaints, DePuy never recalled its Pinnacle hip implants while they were still on the market. This is why many victims have turned to the law for help. The attorneys at Kershaw, Cook & Talley, P.C. represent hundreds of hip replacement patients. Our knowledge and expertise may be the determining factor in winning cases against the manufacturers of defective medical devices. Call (916) 520-6639 for a free consultation.