FDA approval for epi-lasik or PRK using VISX 4 customview?

[ahall2006]

Is it true that VISX4 CustomView is not FDA approved for use in surface ablation type surgery? It was explained to me that the FDA approved the "below-the-flap" method, e.g. lasik, but not the surface ablation.

If that is true is there equipment that is FDA for surface ablation technique?

Thanks, in advance.

[LasikExpert]

Off-label use means any use of an FDA approved medical device or pharmaceutical for which it was not specifically approved. The off-label use of a device is considered appropriate when a surgeon in his or her opinion deems the use to be beneficial for the patient. There are many, many examples of off-label use, such as giving a person suffering from a heart attack an aspirin. Aspirin is not approved to treat heart attacks.

Excimer lasers are approved for one procedure, either Lasik or PRK, therefore any other use would be considered an off-label use of the excimer laser, however this use would be within the "practice of medicine" rules and thereby appropriate.

FYI: At first all excimer lasers were approved for PRK and Lasik was an off-label use. Recent approvals are for Lasik and PRK is an off-label use.

[ahall2006]

Thanks. Then would it be reasonable to be asked to sign a consent for off-label use in Epi-lasik with the CustomView equipment?
Also was asked to sign a consent release on MMC (mitomycin C) for use during epi-lasik, as off-label non-FDA approved.

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.

[LasikExpert]

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.

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.

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.