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Home > Archive > Lasik Eyes Surgery > January 2005 > Damaged LADARvision Patients? Where are they?
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Damaged LADARvision Patients? Where are they?
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| Glenn - USAEyes.org 2005-01-18, 7:13 pm |
| I have an open question for Rebecca and all others who desire to
crucify the Alcon LADARvision excimer laser: Where are the damaged
patients? If the laser is as dangerous as you profess it to be, where
are the patients who got bad results?
Since none of you have offered any evidence that a reasonable person
would consider unbiased that affirms these claims, I've been
researching the heck out of this. I've looked through all the
ophthalmic journals including Ophthalmology, Journal of Cataract and
Refractive Surgery, Survey of Ophthalmology, Journal of Refractive
Surgery, and American Journal of Ophthalmology. I've looked through
the trade magazines like Ocular Surgery News, Ophthalmology Times,
Ophthalmology Management, Review of Ophthalmology, Cataract and
Refractive Surgery Today, EyeWorld, and EuroTimes. I've looked at
available filings in the two royalty collection lawsuits where these
issues were first publicly raised. Nothing indicates that any
patients had a bad outcome because the Alcon LADARvision excimer laser
is somehow defective. According to the FDA
(http://www.fda.gov/cdrh/pdf/p970043.html) the laser provides results
that are excellent compared to others and has no unusual problems.
I have looked at actual patient outcomes that we have directly
reviewed and have found nothing that indicates the Alcon LADARvision
laser has irregular patient outcomes. I've talked with doctors who
use the Alcon laser PLUS other lasers, and they do not report anything
unusual after the normal learning curve. I've talked with
representatives of competing laser manufacturers to see what they may
have...nothing.
What I have found are the accusations of two groups who didn't want to
pay their royalties, and anecdotal statements from early users of the
laser that they had unexpected results requiring enhancement surgery,
but nobody, NOBODY, has claimed patients are being or have been
damaged.
Rebecca, you have devoted a lot of time, money, and an entire website
to condemning the Alcon laser. Where are the damaged patients? Where
is there any reasonably substantiation that a patient seeking
refractive surgery with an Alcon LADARvision laser has any higher
probability of a poor outcome than with any other laser?
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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| C. Gates 2005-01-18, 10:10 pm |
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Glenn - USAEyes.org wrote:
> I have an open question for Rebecca and all others who desire to
> crucify the Alcon LADARvision excimer laser: Where are the damaged
> patients? If the laser is as dangerous as you profess it to be, where
> are the patients who got bad results?
I'm not out to crucify the machine, but I am answering your question in
the subject line -- "Where are the patients?"
You won't find my name in any of the journals you list. You won't find
my name in any lawsuit. I have not been included in any followup
studies. But my life has been permanently changed for the worse thanks
to a procedure done with this machine. That's a fact. Except for this
newsgroup, I'm anonymous. So are thousand of other patients who got bad
results. Many are ashamed to admit their mistake, which was expensive in
so many ways.
Where are all the patients who got bad results? I'll tell you where they
are -- they are out there, uncounted and anonymous, no longer driving at
night perhaps, and finding other ways to alter their lifestyle and get
on with life. And a few are committed to warning others to use extreme
caution about false claims, misleading information, and unethical surgeons.
Until somebody like the FDA requires a mandatory database of every
surgery, the patients with bad results -- to all degrees of bad -- will
remain invisible and, pardon the pun, out of sight.
> I've talked with doctors who
> use the Alcon laser PLUS other lasers, and they do not report anything
> unusual after the normal learning curve.
Learning curve!? Holy shit, Glenn, what learning curve?!
Where are the poor people unfortunate enough to be on the learning
curve? Does the surgeon or manufacturer warn them of this?
I can hear them now, "Ahh, gee, Mr/Ms Patient, I'm new at this and you
might not get good results." Hello? How many surgeons said something
like this to their patients?
Until your organization, or the government, or somebody, keeps track of
ALL the results, the bad outcomes are going to disappear back into the
general population, and you can recite all the studies you want to.
Your question is worse than insensitive, Glenn. Get real. It is not a
coverup,
but if some agency could go in and size a bunch of medical records
throughout the country, I believe Fox would have one heck of a news
story on bad outcomes.
Whenever I'm in an airport and watch all the people getting off a plane,
I think, "If all those people had flown in from having refractive
surgery, at least two of them are experiencing serious problems." Then,
when another plane unloads, I watch the next load of passengers, and see
two more out of that crowd. And the planes keep coming in, day in and
day out. And this is just one airport in one city. I don't know where
all those people go after they get off the planes. I guess they just go
on about their daily business, blending back into society. But if they
had bad results, there sure would be a hell of a lot of them in the
world. And nobody would know where they were. But they'd still be out there.
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| In article <41EDB4C4.6060902@tiac.net>, "C. Gates" <rcjwampum@tiac.net>
wrote:
> You won't find my name in any of the journals you list. You won't find
> my name in any lawsuit. I have not been included in any followup
> studies. But my life has been permanently changed for the worse thanks
> to a procedure done with this machine. That's a fact.
This is a genuine question: Do you believe that it was the machine that
lead to your bad outcome--not your surgeon, your own healing pattern or
pre-existing conditions? Do you have any proof? You carefully state
"the procedure done with this machine" not the machine itself. Do you
believe yourself to be a victim of a "wildly erratic" machine? I would
be interested in hearing the details of how that particular machine
damaged your eyes. And if so, did your doctor tell you this and still
continue to use the same machine? If yes, that's worrisome, to say the
least. Criminal at best.
--
~RT
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| Glenn - USAEyes.org 2005-01-18, 10:11 pm |
| It is very unfortunate that you have had a bad outcome. There are
waaaaaay too many like you, but bad outcomes are not the exclusive
domain of Alcon's laser. Bad outcomes occur across the board with all
lasers, with all techniques, in all of medicine. What is being
alleged and promoted by Rebecca is that the Alcon LADARvision laser is
inherently dangerous and by design has flaws that cause more bad
outcomes than other lasers. Nobody is saying LADARvision is perfect.
If it is so dangerous, then there should be many more patients with
bad outcomes when the Alcon is used than with any other laser. This
would show up in the outcomes studies, the FDA trails, studies Alcon's
competitors sponsor, and our own outcomes analysis. No one has come
up with anything that resembles an unbiased study showing solid
evidence that Alcon has an unusual problem.
>Until somebody like the FDA requires a mandatory database of every
>surgery, the patients with bad results -- to all degrees of bad -- will
>remain invisible and, pardon the pun, out of sight.
A mandatory database of the outcomes of all surgeries is not required
for any surgery of any kind in the US, and it most certainly is not
going to happen with something that has such a relatively high success
rate as LASIK.
>
>Learning curve!? Holy shit, Glenn, what learning curve?!
>Where are the poor people unfortunate enough to be on the learning
>curve? Does the surgeon or manufacturer warn them of this?
If you don't think there is a learning curve in surgery, then you are
woefully naive. If you look at our 50 Tough Questions For Your Doctor
you will see that we emphasize the necessity of practical experience.
Even surgeons with thousands of procedures behind them are a rookie
(albeit an educated rookie) with new technology or technique.
>I can hear them now, "Ahh, gee, Mr/Ms Patient, I'm new at this and you
>might not get good results." Hello? How many surgeons said something
>like this to their patients?
Probably not many, but some. For reasons that I personally do not
understand, some patients actually feel a level of pride in being the
first to have something done to them. I guess they think being the
first means being first to receive an advancement. While that is
technically correct, I often question the wisdom of such a decision.
>Until your organization, or the government, or somebody, keeps track of
>ALL the results, the bad outcomes are going to disappear back into the
>general population, and you can recite all the studies you want to.
Not only is keeping track of all results not practical and not going
to happen, it is not necessary. Statistical analysis is able to
determine the safety and efficacy of a medical procedure - including
the bad results
>Your question is worse than insensitive, Glenn. Get real. It is not a
>coverup,
>but if some agency could go in and size a bunch of medical records
>throughout the country, I believe Fox would have one heck of a news
>story on bad outcomes.
The bushwhacking techniques of some news agencies are not necessary.
There are more than enough bad outcomes readily acknowledge for a Fox
story. In fact, many of the folks at SurgicalEyes did very well at
spreading gloom and doom in the press a few years back.
>Whenever I'm in an airport...
Well said, and of personal interest. I do exactly the same thing
every time I step on a plane. I wonder who would have a good result,
which ones would have a poor result, and who would be the disastrous
result.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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| C. Gates 2005-01-19, 11:09 am |
|
RT wrote:
> This is a genuine question: Do you believe that it was the machine that
> lead to your bad outcome--not your surgeon, your own healing pattern or
> pre-existing conditions? Do you have any proof? You carefully state
> "the procedure done with this machine" not the machine itself. Do you
> believe yourself to be a victim of a "wildly erratic" machine? I would
> be interested in hearing the details of how that particular machine
> damaged your eyes. And if so, did your doctor tell you this and still
> continue to use the same machine? If yes, that's worrisome, to say the
> least. Criminal at best.
I don't know whether it was the machine or the operator. I just can't
get that information. I'm not sure anybody can. One of the main parts of
the bad outcome was off-center ablations in both eyes. I have followup
topo maps from a different doctor that show this. If the machine was
supposed to be so high tech that it would prevent this problem, why did
it happen? Operator error? Maybe. Erratic operation of the machine? Maybe.
We all have to deal with screwups by machines and by people. The one
thing that is hard to excuse was the cover-ups, denials, and "canned"
expressions of how my brain hadn't learned to catch up with my new
vision. Worse, was the delay until the retreatment period was up, and
then after the year, the demand that I either pay for followup checks --
or get my health insurance company to pay by having me enter a false
claim of "dry eyes." If someone suggests that I do something unethical,I
guess that gives me some insight into that person's ethics.
The icing on the cake was the anniversary letters inviting me to parties
to celebrate my new freedom from glasses -- and the encouragement to
bring a friend who would like to get rid of their glasses too. The
dammed office didn't have to decency to document their failures and
cross-check with their marketing people.
By background is in systems and a systems approach. A defective, or
intermittently defective machine is just one part of a whole system that
starts with one surgeon, an office staff, and then extends to
manufacturers, PR and marketing organizations -- and the FDA. You can't
begin to understand the system and make predictions until you can get a
valid set of data, which for all the money being made in this business,
nobody is willing to fund.
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| In article <41EE5F15.3010200@tiac.net>, "C. Gates" <rcjwampum@tiac.net>
wrote:
> I don't know whether it was the machine or the operator. I just can't
> get that information. I'm not sure anybody can. One of the main parts of
> the bad outcome was off-center ablations in both eyes. I have followup
> topo maps from a different doctor that show this. If the machine was
> supposed to be so high tech that it would prevent this problem, why did
> it happen? Operator error? Maybe. Erratic operation of the machine? Maybe.
I'm very sorry this happened to you. How frustrating not to know why
your eyes ended up the way they did while others have good outcomes.
What are you doing now to correct your vision? Did you have a
retreatment or do you wear RGPs?
--
~RT
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| Glenn - USAEyes.org 2005-01-19, 7:12 pm |
| It looks like SurgicalEyes is in the business of breaking copyright
laws too. Fox Chicago has not released the rights to republication to
anyone, but that does not seem to stop Hanson or the folks at
SurgicalEyes.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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| C. Gates 2005-01-19, 10:08 pm |
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RT wrote:
> I'm very sorry this happened to you. How frustrating not to know why
> your eyes ended up the way they did while others have good outcomes.
Thanks for the understanding. The injury is a lot easier to deal with
than the arrogance, insults, cover-ups, and denials by individuals who
refuse to even acknowledge their failures (never mind accept any part of
responsibility), and are getting rich in the process.
To me, this arrogance extends to anyone who has to ask where all the bad
outcomes are (like bad outcomes don't even exist) -- and states that any
broad database is not necessary. A broad database could reveal the
truths, and I guess a lot of powerful interests are not interested in
the truths (even when it might have the power to support their special
interests).
> What are you doing now to correct your vision? Did you have a
> retreatment or do you wear RGPs?
I'm staying away from retreatment for a lot of different reasons, and
RGPs have not been a good solution for me, but I'd like to give them
another try, because when I can wear them, they really do get rid of the
multiple images. But there are drawbacks.
| |
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| In article <41EF0DC7.6050609@tiac.net>, "C. Gates" <rcjwampum@tiac.net>
wrote:
> I'm staying away from retreatment for a lot of different reasons, and
> RGPs have not been a good solution for me, but I'd like to give them
> another try, because when I can wear them, they really do get rid of the
> multiple images. But there are drawbacks.
I hope you find something that works. Good luck.
--
~RT
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| In article <41EF0DC7.6050609@tiac.net>, "C. Gates" <rcjwampum@tiac.net>
wrote:
> Thanks for the understanding. The injury is a lot easier to deal with
> than the arrogance, insults, cover-ups, and denials by individuals who
> refuse to even acknowledge their failures (never mind accept any part of
> responsibility), and are getting rich in the process.
That sucks and I really feel for you. It must be incredibly frustrating.
--
~RT
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| Glenn - USAEyes.org 2005-01-27, 8:51 am |
| >To me, this arrogance extends to anyone who has to ask where all the bad
>outcomes are (like bad outcomes don't even exist) --
Apparently I did not articulate my points very well. Bad results do
exist. We make this very clear all over our website, I make it clear
in my statements here, and it is included in what we state are the
current reasonable expectations in refractive surgery:
(http://www.usaeyes.org/faq/do_it.htm)
My subject line of this thread is too brief to be clear. I apologize.
What I seek are the studies that show the Alcon laser has a greater
frequency of bad outcomes than other excimer lasers. If the laser is
so "dangerous" as has been implied by Rebecca and a few others, then
the damaged patients would be showing up in the studies sponsored by
Alcon's competitors and independent physicians. I've reviewed many
sources in an attempt to confirm what Rebecca says is true. Thus far,
every concern raised is by someone being sued for not paying his bill,
or early isolated complaints by individual surgeons, most of whom
continue to use the Alcon LADARvision to this day.
>and states that any
>broad database is not necessary. A broad database could reveal the
>truths, and I guess a lot of powerful interests are not interested in
>the truths (even when it might have the power to support their special
>interests).
For analysis purposes a database of the outcomes of all refractive
surgeries is not necessary. Just ask any statistician. It may be
nice to have, but it is never going to happen and is not required.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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