Metal-on-Metal Hip Implant Systems: Unique Risks
By Attorney Fred Pritzker
I’ve spent a considerable amount of time litigating cases against medical device companies that manufacture hip implants. The latest iteration involves claims against DePuy, the manufacturer of the metal-on-metal ASR total hip system that has since been recalled.
The reason for the recall and a new advisory by the FDA about “Concerns about Metal-on-Metal Hip Implant Systems” is that these implants have “unique risks” (the FDA’s language, not mine) relating to the tiny metal fragments that inevitably get worn off the implant and enter the space around it. This same metal debris may find its way into the blood stream. The problem is that these metal particles are toxic to some patients. They may trigger a reaction that destroys tissue and bone and causes the implant to loosen. This process is extremely painful and may lead to revision surgery – removal of the prosthesis and re-implantation of a new one. For a subset of patients, the blood-borne metal particles can result in high levels of metal ions that may cause symptoms or illness in other parts of the body including the central nervous system, heart, and thyroid gland.
The FDA and orthopedic surgeons are quick to point out that they don’t really understand how these processes work. Really? You would think they should know about these problems before they start sticking them in people’s bodies.
After the FDA issued its official “Concern” documents about metal-on-metal implants, the President of the American Academy of Orthopaedic Surgeons, John Callaghan, MD, issued a response that touts the safety and efficacy of metal-on-metal implants for the “significant majority” of patients and promises to share information about them with the FDA. All in all, an extremely tepid response designed to sound meaningful without calling for any real action or overhaul of the system that caused the problem in the first place. The AAOS response from Dr. Callaghan ends with this: “Disclosures: John J. Callaghan, MD, receives royalties from DePuy, A Johnson & Johnson Company.” ¹
Surprised? I’m not. Some things never seem to change.
