[lurkingforacure]

I think I know the answer to this but cannot find confirmation anywhere, yet.

Can a doctor/hospital do a surgery in the USA for a condition that the surgery is not "accepted practice" for? In other words, a "black label" surgery, much like people take drugs for a condition other than the one the drug was approved for.

I know the FDA regulations do not come into play unless the surgery uses/involves a medical device, like DBS, but I cannot find if there is some other actual law that prohibits this. I have read of surgeries that were completely unorthodox, but were done in the USA.

I realize being legal is not the same as actually convincing a doc/hospital to do what you want, but if there were no legal prohibition, you would at least have a chance.

Anyone know?

[madamlash]

Originally Posted by lurkingforacure

I think I know the answer to this but cannot find confirmation anywhere, yet.

Can a doctor/hospital do a surgery in the USA for a condition that the surgery is not "accepted practice" for? In other words, a "black label" surgery, much like people take drugs for a condition other than the one the drug was approved for.

I know the FDA regulations do not come into play unless the surgery uses/involves a medical device, like DBS, but I cannot find if there is some other actual law that prohibits this. I have read of surgeries that were completely unorthodox, but were done in the USA.

I realize being legal is not the same as actually convincing a doc/hospital to do what you want, but if there were no legal prohibition, you would at least have a chance.

Anyone know?

My best guess would be no because of insurance issues. Pretty much no one does anything that is not covered by insurance (malpractice). We are a litigious bunch here in the states and that is a real two edged sword.