Thursday, November 17, 2011

Mayo Clinic Elbow Replacement "opportunity".

Link to Mayo Clinic YouTube video about elbow replacement.

It takes a mighty good joint replacement to be better than no joint replacement at all.  Joint replacements are now the #1 expenditure of Medicare.

Where is the scientific evidence?  There is no public accessible post-market registry.  No plan to care for patients with the 20% or so failed joint replacements.  No legal requirement for the surgeons to notify the FDA of adverse events.  No warranty on product.  Cleared through 510(k) process that the IOM Institute of Medicine 7/29/11 stated does not protect the patient from unsafe and ineffective joint replacements.  Patient representatives/consumer representatives are restricted from full voting stakeholder position on FDA orthopedic medical device advisory panel.  Aggressive marketing direct-to-consume and no transparency in surgeons' financial incentives from the medical device industry.  How is this patient-centered?

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