Exposing the LASIK Scam

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 Post subject: customized retreatments unapproved by FDA
PostPosted: Sat Oct 07, 2006 6:40 pm 
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Joined: Sat Mar 04, 2006 8:13 pm
Posts: 168
http://www.escrs.org/PUBLICATIONS/EUROT ... soften.pdf


"American ophthalmologists can use
approved medical devices and medications
for other than intended uses (so-called
off-label) without the permission of the
FDA, but should inform their patients
about the off-label nature of the
treatment."


?The FDA tries to protect patients
from unsafe treatments, but treating
surgeons are an innovative group, always
trying to improve standard options in the
quest for better treatment
,? Dr O?Brien
told EuroTimes."

?It?s been trickier where technology is
developing at a rapid pace, like laser vision
correction. After a LASIK procedure, a
patient might complain of glare and halo
at night and show significant spherical
aberrations on the wavefront analysis.
We?d like to go back and perform a retreatment
using a wavefront-guided laser
to reduce those aberrations. This is an offlabel
use because currently in the US no
laser is approved for customised retreatment
,?
he said."


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