ahall2006 wrote:Thanks. Then would it be reasonable to be asked to sign a consent for off-label use in Epi-lasik with the CustomView equipment?
It would be expected. You get to decide if it is reasonable.
ahall2006 wrote:Also was asked to sign a consent release on MMC (mitomycin C) for use during epi-lasik, as off-label non-FDA approved.
Topical Mitomycin C as a prophylactic to reduce the probability of corneal haze is an off-label use of the pharmaceutical and appropriate under scope of medicine rules.
ahall2006 wrote:This all may be standard practice but, unfortunately, was surprised within days before scheduled surgery. Glenn, did see the question on the 50 questions list as to what was FDA approved (procedure and parameters) and asking for explanation. Wish I was more thorough with that question earlier.
The method by which these devices and pharmaceuticals are being used appear to be common medical practice, but I can certainly understand how the term "off-label" can raise anxiety when considering elective surgery and faced with a legal document that you need to understand fully before signing.