| Trulytelling@yahoo.com 2005-11-29, 5:59 pm |
| Glenn, if a physician wants to do an off label procedure he is required
to explain to the patient that the procedure is not FDA approved and
obtain a special informed consent to proceed. How many refractive
surgeons really do this?
Informed consent for refractive surgery is such a joke - lack of
consent for an off-label procedure is just another piece of
information a patient deserves to know and isn't told, yet another
breach of medical ethics.
Glenn - USAEyes.org wrote:
> Even the speed limit analogy is too strong.
>
> A physician can legally use an FDA approved medical device for a
> procedure for which it was not specifically approved (off-label) if in
> the doctor's best judgment the off-label use is appropriate. This has
> been long established.
>
> Glenn Hagele
> Executive Director
> USAEyes.org
>
> "Consider and Choose With Confidence"
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
|