When you sign the hospital consent form you should be informed
- 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.
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