The FDA notes receipt of 16,800 adverse reports associated with metal-on-metal hip replacement devices between 2000 and 2011.10 More than 14,000 of those adverse reports involved revision surgery to remove a failing metal hip implant. During 2011, another 12,137 metal-on-metal hip implant complaints were made to the FDA.10 In June, 2012, the FDA held a two-day meeting to evaluate the safety of metal-on-metal hip implants. An 18-member panel of health experts was at this meeting, recommending guidelines for monitoring patients with a metal-on-metal hip implant device.
The panel told the FDA that they see few reasons to continue using metal-on-metal hip implants, particularly because other implant materials have a solid record of good results. Even though metal hips implanted in over half a million Americans could be experiencing early failure and causing serious health problems, it could still be years before the FDA has a clear picture of the scope of the issue.
British experts with the world’s largest artificial joint registry, told doctors flatly to stop using metal-on-metal hip replacements, yet the FDA continues to drag its feet, saying it wants to consider all available information prior to making any recommendations. This deliberate approach makes sense from one perspective; unlike other countries, the United States has no national registry to track performance of metal-on-metal hip implant devices (or other medical devices) over time.
Although the FDA has received adverse event reports regarding metal hips, the fact remains that many doctors do not report problems to the FDA, neither do many consumers harmed by metal hips. With little data to base their recommendations on, the FDA has asked manufacturers of metal hips (Johnson & Johnson, Zimmer Holdings and Biomet, to name a few) to conduct long-term follow-up studies of the metal hip implants currently on the market. The FDA believes these studies will answer specific questions, including the exact effect of metal ions seeping into the bloodstream. Considering it could be a decade or more before that information is compiled, the question remains as to who is protecting consumers from defective medical devices.