Exposing the LASIK Scam

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 Post subject: FDA Panel meeting links - please provide more with comments
PostPosted: Sat Dec 10, 2005 8:01 pm 
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http://www.fda.gov/ohrms/dockets/ac/02/ ... 3883t1.doc

This FDA panel meeting has a rather disgusting section where concealing the fact that refractive surgery induces dry eye from the consumer is discussed. The panel decided not to require that ALCON disclose that dry eye after refractive surgery is an industry-wide problem... because they hadn't required other LASER companies to include dry eye warnings in their labeling previously. So they claimed it wouldn't be FAIR to ALCON to have to admit in their labelling that refractive surgery induces dry eye. How about being fair to patients so that they can be properly informed about LASIK dry eye BEFORE they decide to have surgery?

Loss of corneal nerve density averaging more than 40% at the 3 year point after LASIK? No thank you!


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 Post subject:
PostPosted: Sun Dec 11, 2005 1:40 am 
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http://www.fda.gov/ohrms/dockets/ac/acmenu.htm

This link will allow you to find transcripts of all Ophthalmic Devices Panel meetings. Click on the year, then scroll down and look for Ophthalmic Devices.

Before you start clicking and reading, it helps to know which meetings were called to review lasers for refractive surgery.

Here's a link to the summaries of these meetings from 1997 through 2000:

http://www.fda.gov/cdrh/odp.html

More recent meeting summaries can be found at this link:

http://www.accessdata.fda.gov/scripts/c ... search.cfm

Click on "Ophthalmic Devices Panel", "Past Meetings".

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject: I agree, the FDA is useless at BEST!
PostPosted: Tue Apr 18, 2006 4:50 am 
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It's a shame...where are our elected officials when we need them? Where is our government? Why are these people not looking out for our best interests?

I truly believe that if someone from the FDA was hurt by Lasik, that it wouldn't matter. American Human nature's greed is what controls and runs things these days, old days too!

I learned something recently: "Believe nothing you hear and only 1/3 - 1/2 of what you see." Even then, it may be wrong...

Hopefully, we all will continue to warn others about Lasik...every barbeque, every party, every event, posting flyers here and there and everywhere to make sure others are not left to hang like we have been...thrown asside like scraps of food...

It is what it is...Just know from here on out, you have to research anything, everything and anybody!


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 Post subject: 2000 FDA Ophthalmic devices panel discussion of dry eye
PostPosted: Sat Apr 29, 2006 6:00 pm 
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http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3598t1c.pdf
p. 203.


Quote:
DR. GRIMMETT: I would recommend including a comment about the one in four rate of dryness, worse or significantly worse, happened in one in four.
CHAIRMAN McCULLEY: Those are both symptoms and signs.
DR. ROSENTHAL: May I just ask, what about in precaution? This issue of dryness--
CHAIRMAN McCULLEY: It's common after LASIK.
DR. ROSENTHAL: In everybody?
CHAIRMAN McCULLEY: Yes.
DR. ROSENTHAL: So what about people who preoperatively have dry eyes?
CHAIRMAN McCULLEY: They're going to be in worse shape.
DR. MACSAI: Treat them.
DR. ROSENTHAL: What?
DR. MACSAI: They should be screened and treated.
DR. ROSENTHAL: Well, I mean, you know, mild dry eyes. I don't know how we've dealt--I mean, I don't think it's relative to this LASIK procedure, but--
CHAIRMAN McCULLEY: It's not, and we're learning more as time goes on. Now we know, so we don't want to ignore it. It's real. And it's probably important from a patient's information and informed consent to be certain that they're aware, because it can lead to sufficient dissatisfaction to seek attorney help.?


Gee, as if pre-existing dry eye can be treated to such an extent that they can later go ahead and sever and burn corneal nerves and leave the patient safe from more severe dry eye!

Why aren't they excluding pre-existing dry eye patients? They seem more concerned about litigation against THEMSELVES than patients eye health and comfort. Hmmmm.


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 Post subject:
PostPosted: Mon May 01, 2006 9:55 pm 
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I like Dr. McCulley. I went to see him back in the late 1990s when I was having problems with TLC. He spent several hours giving me an exam and performing tests.

I got the impression that he was a pretty straight shooter. I think anyone that goes to see him will be treated much better than they would, going to a lasik mill.


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 Post subject:
PostPosted: Tue May 02, 2006 11:42 am 
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From reading this transcript, it looks like McCulley blew a perfect opportunity to hold Casebeer's feet to the fire on the pupil size issue. McCulley will forever be part of the coverup in my opinion.

FDA Transcript
July, 1999


DR. BULLIMORE: A couple of very quick questions while he is still at the table. Firstly, do you think pupil size is an important factor in patient satisfaction with this procedure?
DR. CASEBEER: As a personal matter, I mean do I, personally, think that?
DR. MC CULLEY: No, I don't think we want personal --
DR. BULLIMORE: Does the sponsor believe that pupil size is an important determinant in -- okay.
DR. CASEBEER: I want to answer, but it doesn't seem appropriate.
DR. MC CULLEY: No, I think you told us before you did not assess pupil size.
DR. CASEBEER: Correct. So, we have no opinion.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Tue May 02, 2006 12:22 pm 
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When I saw Dr. McCulley he was very straightforward with me, and did not cover up any of my problems. He probably spent 2-3 hours going over my case to fully understand my problems.


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 Post subject:
PostPosted: Wed May 03, 2006 11:33 am 
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That's great, Brent. He helped at least one patient, but possibly contributed to the injury of thousands, including me.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Sun Oct 22, 2006 7:42 pm 
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I have very dry eyes. As far as I'm concerned, the FDA screwed me hard.

I know a lot of patients like Grimmett, but Grimmett voted for approval, didn't he? So he screwed me, too.

There wasn't one person on the panel who had the moral courage to stand up to the industry.


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