Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Saturday, December 24, 2011

Foreign Medical Device Implant Registry Study: New Not Better

New York Times: New Models of Hip and Knee Implants Not Better Study Finds / Barry Meier

"The study, which draws on data from Australia's orthopedic registry, covered implants introduced from 2003 to 2007 and was published this week.  The findings are significant for patients in the United States because many of the new designs, like so-called metal-on-metal hips, are widely used here.  Those implants, which have both a ball and cup made of metal, are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do."

  • no new implant performed better than older ones
  • many new implants performed worse than older ones
  • newer implants tended to cost more
  • deficiencies in regulation must be addressed
  • focus on patient safety will save billions of dollars
  • an orthopedic registry can be a useful tool to identify implant problems
  • surgeon bias is widespread
  • regulation of "innovation"  protects patients and companies 


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