The New York Times reports the U.S. Food and Drug Administration (FDA) has received a huge number of complaints in recent months about failed metal-on-metal hip implants. Looking at the FDA data based on adverse events, the newspaper found more than 5,000 reports since January, which is more than the prior four years combined.
Who is having problems? The Times reports many have had the all-metal hip removed or have experienced a device failure after a few years instead of the 15 years they are supposed to last. All of this is leading up to what could be the biggest implant problem since a Medtronic heart led was recalled in 2007 following nearly 8,000 complaints.
The complaints come from the tiny bits of metal – cobalt and chromium – that appear to shed from the metal-on-metal wearing and can cause crippling injury and tissue damage. All metal hip implants, until recently, accounted for about one-third of all of the 250,000 hip implants in the U.S. performed every year, with about a half million patients in all who have received the metal replacement hip. Manufacturers of these medical devices include Johnson & Johnson, maker of the A.S.R. or Articular Surface Replacement, which accounted for about three-quarters of the complaints into the FDA found by the Times. J & J recalled the A.S.R. last year.
Many of these medical devices are sold to consumers and implanted without undergoing the rigorous premarket testing that drugs must undergo and they were sold with no process to do follow-up monitoring on implanted patients. Patients may know they have to have repeat surgery if they are in pain, though pain is not a consistent indicator that the metallic debris is causing damage.
In the meanwhile, manufacturers have been told by the FDA to study why the devices are failing. Not surprisingly, the market for metal hips has declined to about five percent of the market. Other manufacturers include DePuy (Johnson & Johnson) and Zimmer Holdings makers of A.S.R. and the Durom Cup.
If you have been injured or have suffered serious adverse effects due to a hip implant, talking with a hip replacement recall injury lawyer in Florida can help you understand what legal options are available to you, based upon your specific circumstances.
Sources: http://www.nytimes.com/2011/08/23/business/complaints-soar-on-hip-implants-as-dangers-are-studied.html?_r=2&pagewanted=1&ref=health and http://www.nytimes.com/2010/03/04/health/04metalhip.html
