Although the medical community has generally recognized that the risks of utilizing metal-on-metal hip implants outweighs any benefit they may provide, Stuart Talley, Product Liability Attorney at Kershaw, Cutter & Ratinoff, says the FDA has refused to take action with respect to the vast majority of these potentially defective hips that are on the market. As a result, he adds that this oversight is causing significant harm to many patients who have these metal-on-metal-hip-implants. Tally goes on to assert, “What we have seen again and again is that patients with metal-on-metal hips are reporting numerous problems to their surgeons. However, because their prosthetic hip has not been officially recalled by the FDA, the surgeons are not performing the appropriate tests to determine whether patient’s hip replacement problems are being caused by cobalt and chromium leaching from the hip. As a result, patients often do not become aware that their hip device is slowly causing irreversible soft tissue damage until is too late.”
Unlike traditional prosthetic hips that utilize a metal ball and a cup with a plastic liner, metal-on-metal hips do not have plastic liners. Instead, the metal ball and metal cup are in direct contact. World renowned metal toxicologist, Dr. Michael McCabe of Robson Forensics, cautions that over time some of these hips are shedding small cobalt and chromium particles into the hip joint. Additionally, McCabe warns that this metal debris can slowly destroy the muscles, tendons, and nerves in the hip region and eventually spread toxins throughout the body.
Although these metal-on-metal hips were originally intended to be an improvement over traditional hips, they have proven to be one of the biggest disasters in orthopedic history according to a senior surgeon interviewed by the British Medical Journal in 2011. It is estimated that several hundred thousand individuals throughout the United States are recipients of these metal-on-metal hips.
Talley goes on to point out that if the problem hips are discovered and taken out earlier, a lot of hip patients would be much better off.
Under the FDA’s rules, private citizens can petition the agency to bring public health issues to its attention and urge the FDA to take action. To draw attention to these hip replacement problems, KCR is in the process of filing a petition with the FDA asking the agency to initiate a hip implant recall of all metal-on-metal hips. Moreover, the petition will additionally request that the FDA order manufacturers send out advisory letters to all doctors who have implanted these hip devices. At a minimum, Talley says, the FDA needs to issue an urgent advisory letter to orthopaedic surgeons directing them to contact their patients, alert them to the potential problem and order blood tests to determine whether cobalt and chromium is being released into the hip joint.