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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Thursday, October 15, 2015

Call for Resignations of FDA/CDRH Directors Shuren and Maisel

Allison Shuren, wife of FDA/CDRH Director

William Maisel, FDA/CDRH Deputy Director

PREVENTABLE Patient Harm from lax FDA/CDRH regulation
Bayer Essure 20,000
Power Morcellator for pelvic surgeries
Duodenoscope infections

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