FDA Holds Meeting on Orthopaedic and Rehabilitation Devices

Many patients who were offered a metal-on-metal hip replacement implant were sold on the benefits of the device: greater durability and longevity. Now, many of those patients are facing the exact opposite: increased failure rates and complications that just aren’t present in traditional hip implants.

Even though it seems a bit “too little, too late”, the FDA is increasingly involved in dealing with the aftermath of these faulty medical devices. Most recently, at the end of June, the agency held a two-day advisory committee meeting to discuss metal-on-metal hip systems. Specifically, the meeting was focused on the current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems and sought expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.

A number of scientific studies provide the background for the advisory committee meeting and the need to address safety concerns related to metal-on-metal devices. Those studies have shown increased failure rates of the metal-on-metal systems at only the five year mark, which in turn requires patients to undergo revision surgery. Studies have also highlighted a risk of metallosis as the friction between the metal components in the implant releases small metal particles into the blood stream.

The advisory committee was tasked with examining: device mechanisms of failure, metal ion testing, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical follow-up considerations for patients with metal-on-metal hip systems.