| gospa68@aol.com 2005-01-31, 11:54 am |
| Contrary to much of what Glenn Hagele has said about ALCON's
ladarvision problem, those considering LASIK should take the time to
check this out http://www.alconladarvision.com/waxler.html
This underscores what I have been saying for sometime. Surgeons and
manufacturers are under-reporting complications. This is worse than
buyer beware. It is also contrary to what Glenn Hagele has been
advocating in his role as a "supposed patient advocate."
Here is an excerpt that will be of interest to all.
DR. WAXLER:... The raison d'etre for this laser should [be you] go in
and you come out with vision that is closer to being able to see
20/20.... The biggest concern I have frankly is that, I know that there
are overcorrections that require retreatment. How many of those, I
have no idea. But that, that number of 10.5 represented
undercorrections. You have to remember when you look at that section
in the labeling, it says "10.5 due to undercorrections." So when you
have a higher rate of overall, gross number, the overall average number
of 11 or 12 or 15 or 30, you know, maybe it represents only
undercorrections, but maybe it represents overcorrections which is a
much more serious problem.... to me, that would be a trigger for both
the manufacturer and FDA to say, what's going on here? Why do we have
a, an overall retreatment rate that exceeds the treatment rate that we
expected and was a part of the clinical trial? Is it due to an
excessive number of undercorrections? Why? Is it due to an excessive
number of overcorrections, that's alarming. Is it due to a lot of
off-label use? That's another set of issues. You know, so there are,
you -- when you start pulling at that string, there, it raises a lot of
concerns.
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