Link here: NYT: Mounting Evidence about Failed Implanted Joints
Demand that Congress act to
-give FDA Patient & Consumer Representatives full voting stakeholder rights
-revoke Supreme Court 2/2008 decision Riegel v. Medtronic - which violates citizen basic rights to justice
-require a device warranty on a percentage of the defined life of the product
-have a robust registry similar to the Clarimed system that was launched at Health 2.0 conference 9/2011
Safe and effective products: the medical device industry must look inward and respond with integrity to this criticism. A defensive posture is status quo.
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.
Please share what you have learned!