FDA LASIK hearing on 4/25

[kurt]

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.

You can make a adverse event--that's the term--report. The web interface will want to know the doctors you have seen. See YGB's post near the bottom of this thread http://www.dryeyezone.com/talk/showthread.php?t=5811

If you've been wondering how you can help or what you can do, this is it. If every LASIK patient who had a bad outcome filed a MedWatch report, the FDA would be flooded with adverse events reports. The web link below will take you to the "MedWatch Online Voluntary Reporting Form (3500)".
Then click on the BEGIN button to the right of the page. The Patient Identifier field can be left blank. On the next page, for #1 click on "Adverse Event", for #2 click "Disability or Permanent Damage" (assuming that is applicable to you), on #5 describe the problem, and #6 is not applicable to LASIK.

Note that you can always leave fields blank and still move on from one screen to the next. However, you should be able to fill in most of the fields using the steps above. Please do this. It would be great to get more than 140 complaints in less than a month.

Here is the link to the MedWatch Online Voluntary Reporting Form (3500): http://tinyurl.com/pqy6l Just click the big BEGIN button on the right. Leave the patient identifier field blank on the ensuring page.

[brockwells]

thanks for the adverse event info

Dear Kurt: Thank you for the great information to report adverse events. I will get my report off and I hope many more of us do as well. As I was watching the Today show this morning, I was dismayed at how casual the segment was. I'm not much of an advocate, but I am ready to speak up publically about my experience. The sad thing is, I've told my friends about my dry eye problems, but one of my friends still had PRK done just last week. She was assured by her surgeon that she was a good candidate, but get this, she has dry eyes and can't wear contacts. It's only been a week, and she still can't see well (as with PRK recoveries) so we don't know what her complications could be. So that's why I want to really do this. People and surgeons need to be more aware of the debilating effects of our so-called "minor" dry eye complications.

[Rebecca Petris]

A quickie report from DC...

Well, it was a full and intensely interesting day.

I am at a hotel slowly digesting the day's proceedings and my first meal in a day and a half . I took copious notes and I think I will be doing an awful lot of blogging about it over the next several days.

A few quick random highlights:

- I confess I was disappointed in the overall patient turnout.

- BUT there were quite a number of presentations by, or on behalf of, patients, and some very important points came across loud and clear from the totality of the public hearing part of the meeting.

- AMONG THE FOREMOST OF WHICH, I am SO pleased to be able to say, is that dry eye is a big deal - a really, really big deal.

- AND so far as I saw quite a few of the patients present had press interviews. I'm not sure who all was there of the press. I think I talked to Fox and NBC or ABC and I saw several others. There was a Canadian reporter there too.

- INCLUDING our own YGB and his lovely wife and two kids. YGB and his wife gave separate presentations and I must say they were amongst the most compelling of the day.

- On the "pro-lasik" side, there were many presentations by surgeons, some of which were on behalf of organizations (AAO, ASCRS); some patients including a quadriplegic reporting the quality of life benefits they've experienced; and - though this was during a different part of the proceedings - a lengthier presentation by the Navy.

- I thought the meeting chair (Jayne Weiss) was, overall, excellent. She picked up on and reiterated some of the key points that were coming across from patients.

As for me.... I finally bought a ticket yesterday afternoon, threw some wrinkled clothes in a bag, packed my daughter off to my sister's farm and drove like crazy to get a flight to LA to get the last available flight that would land me in Dulles in time. Redeye, quick shower, arrived almost exactly on time for the meeting.

I honestly did not think they would call on me because they had so many booked speakers (I had missed the deadline for a scheduled slot) so I had not prepared any comments but I was called on towards the very end. I'd scribbled down a couple of notes during the break. Instead of presenting what was in the letter I'd mentioned - and which in my haste I'd left at home - I went with a rather more emotional appeal about the sheer overwhelming cloud of unaddressed LASIK dry eye. I told how intensely unremitting pain affects people, told them what it's like hearing from people day after day who are in so much pain and near, if not already in, despair and what it's like to not having answers for them. Told the LASIK doctors in the room (of whom there were many of the best known in the country) I wished they could be flies on the wall in my office on a typical day. I challenged the industry, from whom I had honestly not heard any slightest indication of compassion towards this increasingly notorious 'small minority' with severe dry eye to give the consumer groups some more tangible evidence that they in fact care by offering their support and cooperation to ensure patients get the care they need.

I'll report more about the actual proceedings as I get time, here and/or in my blog.

[dianat]

Brd888

Brd888,

Nuff said.

What exactly do you mean by this?

[Rebecca Petris]

Don't be too discouraged by the way any small numbers available are used, abused, taken out of context or left unexplained. That is inevitable.

If the FDA believed that only 140 people out of several million were dissatisfied, they would not have held this hearing.

[Peggy]

I know this hearing and news report seemed like baby steps but I cannot tell you the amount of people who came up to me at work and home and said Peggy, I heard the report on the news about lasik and I am so sorry this happened to you...How refreshing to hear this instead of I never heard of anyone in pain from Lasik!!! I taped the Today show and heard two things that caught my attention 1) Meredith Viera was turned down for lasik because of aging eyes over 50 ...something my surgeon never addressed. 2) The surgeon she was talking to, who does their health topics said most surgeons do not have this surgery because they know the risks !!!
YGB thanks for all your efforts to bring this topic to the forefront.
Rebecca thanks for taking time out of your busy schedule to fly to D.C. and relay our frustrations and pain.
I continue to hope there are more positive outcomes from the publicity and hearings. Peggy

[Rebecca Petris]

2) The surgeon she was talking to, who does their health topics said most surgeons do not have this surgery because they know the risks !!!

Interestingly, the chair of the FDA ODP was wise enough to address this during the meeting. She voluntarily pointed out that most of the panel was wearing glasses and more or less spurred the rest to explain why they do.

Her own reasons:

1) She likes her near vision and doesn't want to lose it. Incidentally Paula Cofer (as the Consumer Advocate to the FDA) did a good job of pointing out in her questions/comments during the proceedings that the loss of near vision needs to be clearly explained on the FDA website and in product labelling.

2) She is not willing to put her vision to ANY risk at all.

[Rojzen]

deepest appreciation

Thank you, dear Rebecca, for the impassioned plea you made at the hearing. It strikes me that leaving the determination of what to say for the last minute was a stroke of genius, which ultimately maximized the impact of your appearance.

However humbly you may describe your presentation and press interviews, I feel certain, because of your enormous talent and intellect, that these were history-making. For a few days, I have been worried about a rather critical comment I dropped here, a few days back, regarding a famous dry eye M.D. who recently said some surprisingly callous things about our patient population, in print. . .But if you held the LASIK docs' feet to the fire, at the hearing, by imploring them to provide compassionate post-LASIK care, then it cannot be wrong, at this point in the game, sometimes to challenge those in power quite directly. . .

In other words, because of your astounding effectiveness, over a relatively short period of years, I look to you for leadership on how we can move people in power to do the right things. That kind of leadership is terribly rare. We lack it on a national political level, for sure. . .and desperately need much more of it in the healthcare domain, in relation to our affliction and so many others. . .

[Natalie06]

Rebecca

At the risk of being too emotional, I just want to say how proud I am of you, having "met" you, having you be my inspiration for whatever small things I have accomplished in this battle to tell patients the truth.

I will say it again, I just don't know how you do it. And to thank you one more time for being here after those first, few dark days, weeks and months after my Lasik surgery.

Natalie

[ding]

lasik woes

I am new to this so bear with me. I am the man rebecca talked to on the phone before she went to dc. I just want to say I am amazed how kind she was to a total stranger calling her out of the blue. she talked to me for almost 2 hours. about lasik dry eyes and treatments she really is a very good person. I am also amazed how strong all of you are in dealing with this problem because I am really having a hard time handling the dry eyes and pain I seem to get worse every day. my body just see
ms to be shutting down no energy nausea, pain. I know I am only 3 months

[ding]

lasik woes

I am new to this so bear with me. I am the man rebecca talked to on the phone before she went to dc. I just want to say I am amazed how kind she was to a total stranger calling her out of the blue. she talked to me for almost 2 hours. about lasik dry eyes and treatments she really is a very good person. I am also amazed how strong all of you are in dealing with this problem because I am really having a hard time handling the dry eyes and pain I seem to get worse every day. my body just seems to be shutting down no energy nausea, pain. I know I am only 3 months post lasik but I need to see some improvement soon. if anyone knows a good doctor in arkansas please let me know

[dianat]

Rebecca is indeed an angel. She is one of the strongest and brightest people I know.

Ding, hang in there and know that all of us here have been where you are. At one point I couldn't eat, sleep, take care of my kids... I came back around and am now coping with my new "normal". Life is still good, it really is, but the road behind me was certainly rough.

Pay attention to what's on this board with regard to improving your comfort. There's a lot here and a lot to try...a lot of hope.

My best to you.

Diana

[brd888]

Diana

Diana,
"nuff said"
It was a comment reflecting on the Ophthalmologist's opinon. No sympathy or consideration for folk for whom it went wrong - just an offhand statistic that few folk have complained. As if a couple of numbers show the whole story.
He sounded more like a sports pundit than a responsible surgeon.
Bruce.

[blackberry]

Depression

I am so glad LASIK surgery is finally getting the negative attention it deserves. And I cannot believe how emotional these stories are making me. I have been in tears for the past two days. My LASIK surger 7 years ago was a disaster.

But -- I just learned, through the grapevine in my office, that a coworker is scheduled to get LASIK on Tuesday from the VERY SAME DOCTOR who ruined my eyes. I just got off the phone with him and am hoping my story will dissuade him. Sigh.

[kurt]

I was dismayed at how casual the segment was...

I am very thankful for the exposure that the news and morning programs have brought to the wider public. I think it is great. Several friends commented today to me that they had seen one the reports which had aired.