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, August 18, 2011
Welcome to FiDA Blog!
We are asking for allies to heighten the safety and effectiveness of implanted medical devices. This blog is to share with a diverse audience the necessity of better regulation of this industry and more transparency so that patients and their doctors can select the best devices and our economy can grow based upon healthier citizens and business practices with integrity.
Steven had an elbow implant on 5/19/08 that was "revised" on 9'29/08 by removing two components. The surgeon was also the designer of the device. Steven remains in intense pain and with little function. He is also in medical and legal purgatory.
This story is not an isolated one. Poor oversight of this industry has allowed failed implanted surgical mesh, DePuy J&J hips and other "innovative" devices onto the market without accounting for how to care for those who are not fortunate to select a doctor/hospital/manufacturer that will stand behind a product that fails.
Please select to receive an email each time a new blogpost is added. Follow my progress as I speak at the FDA CDRH Town Hall meeting in SF 9/22/11 and participate in the Patient Walking Gallery (Regina Holliday) in SF 9/25/11-9/27/11. I will include articles that will inform and inspire you to write to your Senators & Representatives for this cause. Please share this blog with those who are in the medical community, public policy activists and others who will act to improve implanted medical devices. Thank you!