Thankfully, after FDA approval, surgeons are free to use the device as they see fit.
Sadly, after FDA approval, surgeons are free to use the device as they see fit.
In the hands of the correct surgeon, it can be a blessing. In other hands, it can be a curse.
In some cases, the hospitals or their risk-management teams will decide what can and can't be done. In other cases, the manufacturer of the device will only allow procedures in 'expanded indications' cases only for surgeons that have proven themselves.
I know surgeons who have done 3-level ADR in the us only after they have had experience with ADR... one other procedure.
It's buyer beware. Some prostheses may be more appropriate than others in some indications... but the surgeons are not always free to use them.
Do your homework... make informed decisions.
Mark
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