- the device company has a federal entitlement that prevents you from filing a lawsuit.
- the surgeon is only required to report an adverse event to the FDA if you die.
- you may be in pain and disfigured from a failed device and the hospital/surgeon are legally able to send you a letter stating that only federally mandated medical care will be provided in the future.
- during "revision" surgery the surgeon can remove components and not be required to give them to you.
- there are no UDI's (unique device identifiers).
- the U.S. does not keep a registry of implanted devices.
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!
Tuesday, March 27, 2012
Hospital Consent Forms do not inform patients about joint replacement purgatory.
When you sign the hospital consent form you should be informed