FDA LASIK hearing on 4/25

[Rebecca Petris]

I know that many of the LASIK patients on DEZ (myself included) are very much concerned with the progress and outcome of tomorrow's hearing, which is a truly unique opportunity for LASIK dry eye patients to make their concerns known.

There have been many pre-meeting press reports already and I expect there will be a lot of follow-on press.

While you all know that LASIK complications are a concern I've been involved with for many years and indeed it is my own experience of them that directly led to the formation of this website and company, I started this website to serve people with dry eye from all causes and we have a great many 'disease' groups represented here. It's important to me to avoid having the board dominated by any one group or another and keep things focused as much as possible on what we have in common, from our needs and our hard times to our breakthroughs and treatment successes.

So....

I'm going to suggest that rather than starting a whole lot of individual threads with new reports relative to the FDA panel meeting, we try to keep them concentrated on THIS THREAD, which will both make them easy to find and help ensure the topic doesn't take over the board.

I want to share the letter I sent to the FDA, who have invited written submissions from the public. Having a little trouble uploading it but I will try to get it up before I leave for the airport.

[MyDryEyes]

Do you know if PRK will be mentioned at the FDA hearings?

[lboogie]

thanks

I just wanted to say thanks. this site has felt more welcoming and easy to be a part of than other lasik forums. So I find myself here talking about my issues, even beyond dry eyes.

I hate that I have to be here and that I am consumed by my decision and regret. But I am grateful to have a place to learn how to cope.

[liz56]

Issue in the news

I turned on the morning news (CBS) today while I was getting ready for work. With Dwelle calming my eyes, I watched the story about the FDA hearings. There really is resistance to acknowledging the problems that follow Lasik.

The patient they had was articulate and calm. (I wouldn't have thought anything of it if I did not have my eye problems, but she was blinking a lot. I thought, "How much pain those blinks belie." She looked so composed that I think that people may think, if they do not understand, that she is more okay than she is.) The doctor on there said that he turns away 20% of patients he screens and spoke about getting second opinions. I think that he was too minimal about the dangers (both people affected and the things that he considers to screen people out).

Thanks to all of the people here who have helped me to understand not only my own condition, which is not Lasik related, but also what happens when this procedure does not produce its expected outcomes.

--Liz

[Lucy]

My local news is talking about the FDA hearing that will occur tomorrow. I believe we're seeing the networks compete for information and are trying to "be first". This is my local CBS station on the 5:00 o'clock local news. It will repeat at 6:00 p.m.

Lucy

[Rebecca Petris]

One of the reasons I'm on a redeye tonight rather than already in DC is I find it so hard to tear myself away from the phone. Examples, this morning I heard from a 3 month post LASIK gentleman who has had suicidal thoughts. This afternoon, a psychiatrist with severe dry eye who brought up the PTSD-like effects of severe dry eye from an elective surgery. Feels like triage around here sometimes. It just goes on and on, more every day.

We MUST get the attention of the FDA on this. Hopefully tomorrow will produce results; if not, we'll press on until we can get the help we need to prevent this kind of unnecessarily suffering of people who had no way of appreciating the risks they were going to be subjected to.

[kurt]

We MUST get the attention of the FDA on this. Hopefully tomorrow will produce results; if not, we'll press on until we can get the help we need to prevent this kind of unnecessarily suffering of people who had no way of appreciating the risks they were going to be subjected to.

Ditto to that thought. YGB was one the NBC evening news. They interviewed him in his house and backyard and showed his moisture chamber glasses.
Also from http://www.msnbc.msn.com/id/24277759/ dated April 23, 2008

Regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' quality of life after surgery.

This is what one individual thinks of an industry that harms many people investigating itself: http://www.krounerlaw.com/images/FDAletter042508.pdf

[kurt]

MSNBC news report on FDA Investigation of LASIK that aired on Arpil 24th, 2008:
NBC News Report

[kitty]

What did you think of last night's evening news?

The evening news story (told by Brian Williams) about the man post-lasik was interesting, but it was too short and I don't think it made a convincing story for how disabling DES can be. the man said he was disabled, wearing moisture chamber glasses and in pain, yet sat there working at his puter and was outside playing in the yard with his kids. When my DES is "disabling", the last things I want to be doing are working at a computer and being outside. I might be too close to this topic, but I think they could have done a better job at showing what real DES disability looks like, e.g. explaining why that man can't do those things that he used to enjoy (puter and playing outside with his kids). Just my two cents.

[dianat]

I hear you on this, Kitty, but they'll never come on strong enough for me on the topic of dry eye. I can't even convince a doctor how debilitating it is when I'm standing on my head bawling... How could it ever be portrayed in a four-minute news segment? What's more is the reports this week are addressing the hearing on the safety of LASIK, not dry eye specifically.

This hearing and all the press is still effective... There's a lot of chatter this week. Perhaps the cautionary tone will dissuade some. It will certainly put LASIK surgeons on the defensive.

Did you know that the subject of the news segment was our very own "YaGottaBelieve"? I don't think I'm mistaken about that...his name is Matt.

D

[brd888]

Ophthalmologist

An Ophthalmologist interviewed on Fox News said out of one hundred thousand or so folk having had Lasik only 140 filed complaints to the FDA. Nuff said.

[lboogie]

feeling super stressed

All this news coverage is making me feel so nervous and anxious and regrettful..........anyone else?

It only ads to my self pity, and self blame and worry. I can't hardly function today. I know I probably need some emotional help to start dealing with my feelings -- it's so hard to admit.

I'm getting plugs today and it sucks b/c I feel embarrassed going to my non-lasik opth. --- I wonder what he thinks about it all. I just hate all of this second-guessing. ARRRRRGGGGHHHH I want my life back ;(

Sorry for the rant, thanks for listening.

[brockwells]

What can we do to let FDA know that this is a bigger problem for lasik dry eye?

To Rebecca and everyone else: I've been a member for a while, but never posted onto a thread before. I want to know how to let the FDA know that it is more that "less than 1%" of lasik recipients that are adversely affected. According to the FDA website, 95% of patients are satisfied with their lasik. I find that hard to believe as I see wonderful sites like this and others as well and many of us have lasik complications. I was a little dismayed when I saw that only 140 compliants were actually reported to the FDA (according to a Forbes report). I want to report my dry eye problem due to my lasik surgery in 2005. I've left a message with an FDA complaint coordinator to find out how to do this. Rebecca, you've mentioned a letter to the FDA. Is this what is recommended by this website? Can you give me some direction or instructions? I get angry thinking about all of us who were screened improperly and not given the full facts about complications. I could go on about my experience, etc. It seems that now that I've starting writing for the first time about this, it all wants to come out! Anyway, thanks for any help and I'd like to see the lasik industry changed dramatically to protect future patients.

[LasikLady]

I think more of us need to file complaints with the FDA. There has to me so many people out there like us that had a bad reaction but didn't file a complaint. How do you file a complaint?

[MyDryEyes]

I would like to file a complaint as well, but I had PRK instead of LASIK. I feel that all refractive surgury practices need to be reviewed for the poor screening standards the industry has in place.