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?
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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