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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Sunday, July 29, 2012

FDA Webcast Videos: Harmed Patients Testify

Metal on metal hips have harmed thousands.  June 27and 28, 2012, FDA allowed each harmed patient just 4 minutes to testify.  Patients paid for their own flights/hotels/meals.  Testimony begins at 1:34 (one hour, 34 minutes).  The meeting was nearly 20 hours over two days.  On this second video, at the end, you will see two women who are the FDA Patient Representative (Barbara Berney) and the FDA Consumer Representative (Connie Whittington) who are paid and hand selected by FDA to represent our interests.

It is instructive to confirm that the realization of harm came from foreign countries that had registries!  Medical device companies continued to market devices for years though there was evidence of their harm and ineffectiveness.  FDA was late in stepping in.

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