Metal-on-Metal Hip Replacements Under FDA Review

Metal-on-Metal Hip Replacements Under FDA Review

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The DePuy hip replacement recall, the Zimmer Durom Acetbular cup recall, the torrents of hip replacement lawsuits, and concerns over other hip replacements like the DePuy Pinnacle system have resulted in a web site by the FDA. The agency has created a new web site. At the top, it claims, “FDA is actively working in several areas to further assess the safety and effectiveness of metal-on-metal hip implants.” It will then undertake a comprehensive review of:

· Risk-benefit profiles

· Utilization trends

· Patient selection criteria

· Pre-operative patient counseling

· Surgical technique

· Follow-up

· Revision rates associated with metal-on-metal hip systems in the United States

While the Rottenstein Law Group applauds the FDA’s resolve to deal with these issues, torrent this web site won’t make up for the remarkably ineffective 510(k) preapproval process that these types of hip replacements use. The 510(k) process allows companies to claim their products are “substantially equivalent” to existing ones and sell them on the market without clinical trials, yet in the case of DePuy’s defective ASR hip replacements, the substantially equivalent products themselves were approved by the same process going back to a set of hip implants from the 1970s. These implants were actually grandfathered into the current system, and they bear no resemblance to a metal-on-metal hip replacement.

No matter what the FDA does, DePuy sold you a defective hip replacement that injured you. If you want compensation, contact the Rottenstein Law Group for a free initial consultation by completing their contact form to the right side of their website.

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