The warp is with the FDA.
“The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients and there has never been a safety issue associated with the device.”
My problem isn’t with the product, it is with the influence peddling.
That doesn’t really excuse the unethical and probably illegal manner in which those four Congress critters acted does it?
‘“The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients and there has never been a safety issue associated with the device.”’
In the US medical treatments are never approved based upon licensing or usage in foreign countries. Only FDA regulated clinical trials, in the US or abroad are accepted. The reason is that both safety and efficacy trials there are less trustworthy.
I agree...the problem is the FDA.....Congress critters shouldn’t even be involved!