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Mar 21, 2012


Joleen Chambers

Thank you, POGO!
March 4, 2099 FOI/CDRH responded "after searching our files, we did not find the requested records" for my brother, Steven Baker's, patient-submitted 11/18/2008 FDA/MedWatch Adverse Event report MW5009052. Joint replacements are the #1 expenditure of Medicare. These devices are approved by the FDA with no clinical testing based upon predicates that may or may not be safe. There is no national registry. There is no way for a patient to make an informed decision just as consumers are able to compare appliances or automobiles. Yet, if a device fails, they are in medical and legal purgatory plus in pain and disfigured. Federal public policy must place patient safety first. Transparency will prevent others from peril and will save taxpayers billions of dollars annually.

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