Hip Implant Complaints Rising At Staggering Rate
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As reported in the New York Times of August 23, 2011, there has been a dramatic surge in recent months in complaints to the U.S. Food & Drug Administration about hip implants. There have been more than 5,000 reports since the beginning of 2011 about the failure of several prevalent devices called metal-on-metal hips, more than the agency received in the past four years in total.
Experts fear that the devices will be the biggest and most expensive implant problem since Medtronic recalled a popular heart implant device.
Hip replacement is one of the most common procedures in the U.S., with about 250,000 replacements being performed each year. Metal-on-metal replacements account for about one-third of that total. While the problems with the metal-on-metal replacements are usually non-threatening at first, some patients have suffered serious injuries when particles of cobalt and chromium break off as the metal devices endure wear and tear.
Under FDA rules, manufacturers do not need to track the performance of their devices. But in May, the agency required producers to study how well their devices work. Unfortunately, with no patient registries, it is difficult for the manufacturers to follow up with people who received the implants.
In addition to trying to figure out how they will obtain the information about those who have replaced hips, researchers are also trying to establish the relationship between the metallic debris of the all-metal parts and tissue damage. The New York Times article notes that while some patients experience pain when suffering from tissue damage, other patients with the same damage have no pain. This discrepancy makes it very hard to gauge whether or not the devices should be removed.
Researchers project that it may be a year before protocols are hammered out for studying the problem.
