Lasik eye surgery: patients air grievances in front of U.S. Food and Drug Administration panel

Dr. Colman Kraff docks the femtosecond laser, flattening the cornea, of patient Steve Parker as the initial step in creating the Lasik flap during Parker’s eye surgery at Kraff’s offices in Chicago on Nov. 1, 2005. (AP / Charles Rex Arbogast)

Patients who experienced painful side effects after undergoing Lasik eye surgery are airing their grievances in front of a U.S. Food and Drug Administration panel on Friday.
David Shell of Washington, D.C. told the panel that after undergoing the eye surgery he has “not experienced a moment of crisp, good quality vision since.”
One patient’s father even told of his son’s suicide six years after having the popular vision-correcting procedure.
Gerald Dorrian described to the panel the six years of pain and blurred vision his son Colin endured before ending his life. Colin had been told he wasn’t a good candidate for the surgery but went ahead with the procedure anyway.

“I can’t and won’t continue facing this horror,” Colin Dorrian’s suicide note said.
The FDA is holding a public inquiry to investigate consumer complaints about Lasik and to determine if the information provided to patients about the risks and benefits is sufficient.
The FDA is also working on a study to investigate why some patients develop such negative side effects, while others don’t.
While most people who undergo Lasik end up with 20/20 vision and no side effects, a few come out with eye problems such as dry eyes, glare or compromised night vision.

“Clearly there is a group who are not satisfied and do not get the kind of results they expect,” Dr. Daniel Schultz, the FDA medical device chief, told The Associated Press.

The study should “help us predict who those patients might be before they have the procedure.”

Health Canada spokesperson Paul Duchesne said that the federal department won’t act on the findings of the inquiry if it’s a matter of how the procedure is performed.

“If there were an issue with the instruments, we would. But in this case it seems to be more on the way the surgery is done, so in that case it’s a practice-of-medicine issue, which is provincial,” he told CTV.ca.

Lasik stands for Laser-Assisted In Situ Keratomileusis, and is a procedure designed to change the shape of the cornea to correct vision in people who are dependent on corrective glasses or contact lenses.

It involves cutting a flap out of the cornea, which is pulled aside so a computer-controlled laser can vapourize a portion of the middle section of the cornea, called the stroma.
The FDA warns that some people may not be suitable candidates for Lasik. These include:

Children under age 18
Those who have had a change in their glasses or contact lens prescription in the last year
People who have an illness or take medication that may affect wound healing
People who suffer from dry eyes, which may be exacerbated by the procedure

ance
This is SURGERY, no matter how you slice it.
Who ever believed it was risk free???

I put laser eye surgery right down there with any other cosmetic procedure.

It’s not necessary surgery, it’s based solely in vanity or convenience for most people so don’t take the risk if you can’t face the consequences.

I wear glasses and would never risk my sight on this foolishness.

Frankly, it should be banned for most people along with breast implants, face lifts and any other frivolous risks that people take in the name of vanity.

We should be smarter than this.
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Lasik patients air grievances in front of FDA panel

Howard
I had laser surgery about 5 years ago, but I chose to pay quite a lot at the time - about $6,000.

For that I had the surgery performed by a world-renowned surgeon in Toronto, and I came out with 20/15 eyesite (better than 20/20, just in case I wrote that backwards).

For me the results were life-altering. I can read my alarm clock on my bedside table when I wake up. No glasses to collect rain drops or steam. I can read street signs while driving. Non-prescription sunglasses. My young children can’t grab and break my glasses anymore…

For all that, it was a difficult decision to arrive at. My eyes were after all, healthy organs. I ran a big risk of suffering damage or complications, which is why, with only one shot to really get it right, I opted for the best.

I would never, ever go to one of those cheap places. “Buy one eye, get the other free!”

Good God - there’s more to life than a good deal, and these are your eyes! Do you really want to roll the dice with your vision?

Jonny Rapport
To Ance… a ban, that’s ridiculous in a democracy that preaches capitalism. If there’s a market for a procedure, then so be it. To say, all cosmetic surgery is pure vanity is completely ignorant. While, I wouldn’t go with Lasik, I’ve had plastic surgery for my own psychological well being. I did the weight loss first, 100lbs in a year, and to resolve loose skin that I felt self concious over, I had a procedure done. I’m not vain, just wanted to feel better about myself, to hell with what people like you think !

beverly
I had not lasik but radial keretotomy surgery in sept 1996. Immediate results were amazing - imagine being able to clearly see my husband’s face making love to me??
By January 97, my astigmatism had returned, within 12 months I needed glasses for safe driving.
My current practitioner advises that vision problems stem from my pupils now being very unresponsive to light changes - night highway driving is out of the question & barely safe with city lighting. Camping in the wilderness means having to be escorted to and fron the campfire to avoid falls/injury.
Constant dry burning eyes compound the problem as the cornea dries and distorts my vision.
ALL THAT ASIDE, I am still able to function very well apart from these problems and own 3 types of glasses for specific situations - after all the expense.
I guess my surgeon, Dr Gimble wearing glasses should have been a clue.

ADVICE??? Ask LOTS of questions.

John
Hey ance, try informing yourself a bit before making such ridiculous statements. Many people suffer from very poor vision, for them lasik is a miracle. For me, it was not a cosmetic question but a quality of life question. As stated by Brian, there are risks, weigh them carefully and inform yourself when choosing a clinic.
Jason.
Wow, what happens now with applicants for police force like the RCMP where they request a certain standart… This may come as a shock to them since not everyone has 20/20 eye vision thus they need the surgery for the application. Scary!!!

Po
ance, I wouldn’t call it vanity, convenience yes, but not vanity. All people who get laser eye surgery want is to be able to see well in the morning without putting on glasses or contacts. To be able to put on a good pair of sunglasses without having to pay a fortune for a prescription lens.

I doubt that people who get laser eye surgery want to “look better”, maybe see better but not look better. I, for one, would just love to be able to get up in teh morning and see outside my window without having to first reach for my glasses… I don’t think that makes me vain, it just makes me want to enjoy a pleasure most people take for granted.
Mac
Make sure you find a reputable surgeon, and ask about their track record and number of past surgeries, and the complication rate from their past surgeries.
Don’t use a fly-by-night operation, and beware of those promising cheaper prices.
You get what you pay for.
With all surgeries come risks, if you don’t accept the risk, and haven’t done your homework, don’t have the surgery.

Nathan
I got 20/15 vision(better than 20/20) after my lasik surgery and I have had no side effects in 8 years. But! But, I was never told that there were nerves in my cornea that they would be cutting, I just found that out now.

I see clearly now the rain is gone
It’s not called vanity, it’s called quality of life. Sure there are risks, but life is risk. Do you not visit your parents or go to a movie because you might crash your car and die on route? Because those kind of odds seem more like a certainty in comparison to this LESS THAN TEN MINUTE surgery.

Myself, I have 20/10 vision (better than 20/20), with no problems. I shudder to now think how I could have spent my life with dealing the expense and awkwardness of glasses (contacts btw really took a serious health toll on my eyes, so why not ban those, Ance?).

If I had had complications, well, that would be unfortunate, but it was an informed risk I was willing to take, and I would do it again in a heartbeat.

Elaine
I used to be reluctant to have laser eye surgery until my brother had it successfully, and someone else I knew had it done successfully. I paid $4,500. My eyes were worse than -9 in each eye, and the average person getting the surgery I was told has vision of about -2 to -3. In other words, I had a lot to gain if it worked since I was almost blind without contacts (or glasses), but when I read the contract I had to sign it did say blindness was possible, wrinkles from rubbing eyes, halos which might not go away, the fact that I would need to wear my reading glasses for sure for close-up (whereas I managed without them before), and dryness could be a problem. I do have dry eyes, but I had it done 2 years ago and am now 51, so one of the reasons I got lasik was because I could no longer tolerate contacts all day at work and had them in so long that my eyes were very dry and sore. I got bad halos from the surgery but over a period of time they have gone away. If I use a halogen desk lamp as they advised, for reading or work at my computer it mitigates the need for wearing reading glasses, but I definitely need them to try to decifer someone’s handwritting at work. I had laser eye surgery because I needed an alternative to contacts, and a variety of contacts advertised as more lubricating to the eyes, was over a thousand dollars a year with all of the upkeep and bother of contacts, which I might not have been able to wear anyways. Overall I am quite happy I had it done. If I wake up in the middle of the night now I don’t have to fumble for glasses in order to find my way across the dark room; during power failures I don’t have to fumble contacts into my eyes by candle light. If there is an emergency I won’t feel blind and defenceless. If I want to have a nap I can close my eyes without having to worry about the contacts gluing to my eyes, causing cataracts and very red eyes. I think its worth it. It is a very big step to take and the worse part for me was not sleeping after deciding to get it, because of the fear of the Dr. cutting your eyes while you are awake and lasering them. But it is over very quick.

Tim
My wife and I both had it done 3 yrs ago, best $8000 we ever spent. BUT..I was lucky in that my sister is a health care professional with extensive experience with local eye surgeons…there are some she “wouldn’t send her dog to”

Angie
Cosmetic surgery is often not about vanity, it’s used in many cases such as reconstructive surgery after accidents, burns etc. The last thing this world needs are ignorant people and laws controlling people’s own decisions about their lives.
Ryan-Ann
Nann
I took a risk on Lasik surgery 2 months ago and have not regretted it.

Ance, as you obviously don’t have any experience to base your opinions on, I would like to share that my decision to have this surgery had nothing to do with vanity and everything to do with wanting to see unaided.

I no longer have to contend with foggy glasses when out for a run in less then perfect weather, headaches, eye-strain/fatigue, missing a rare view because my glasses were out of reach….the benefits go on.

In addition, glasses are very expensive. If I get a few years of good vision without glasses, the cost of the surgery compares to the glasses/perscription sunglasses I would have had to purchase.

Surgery doesn’t necessarily create perfection (though my vision is great better then 20/20 now) but any improvements are still improvements.

Let’s think a little harder ,people, before we pass judgement on issues we have little knowledge about.

Rush
As a recipient of Lasik surgery I would like to share that I prefer occational dry eye (particularly when I am tired) over needing glasses to see every waking moment.

Roger T
Thank goodness I didn’t participate in this surgery proceedure. Last year I went for a consultation and they over quoted me and was pretty aggressive at pursuing the surgery appointment for me. I never really trust these surgery anyways. Better to stick with contacts even thought it’s a little bit annoying but the question remains “Want To see or not to see”?.

Jennifer
Like Howard I too did my research and went the most expensive route and had Wavefront Lasik with the best most experienced Dr I could find in Toronto. Its been three years June 3 and although I do have to use eye drops here and there its a small price to pay to be able to drive at night and go skiing without having to crawl around on snow looking for my contacts. Before lasik I would spend an hour in the bathroom trying to put contacts in my eyes just so I would have to take them out as soon as I got to my destination.

YELC gave me freedom and showed me the world is a much brighter place without having to look through a lens.

Megan
I am going in for LASIK next month and it’s not something that I have taken lightly. I currently have a -6 to -7 prescription and am looking for some freedom from the glasses I have been dependent on since I was young. I’ve been told I’m a good candidate with thick corneas and after reading everything and weighing the risks with the benefits, I am very prepared for this.

I am so dependent on my glasses and several years of wearing contacts have already caused some slight damage.

Contrary to what people may think, I’m not doing this for cosmetic reasons - I’m doing this to improve my quality of life.

Damian
It’s all statistics and probability until you draw the sample, and you’re either on side A or side B. If something “bad” happens to you, it happens 100%, regardless how unlikely the chance was. That fact that the probability was low does not mitigate the effect/outcome.

Clearly a lot/most people are happy with the outcome. Great! The question then becomes, are you willing to risk being the 1 in 20 who isn’t happy/satisfied? Are you willing to deal with the realistic worst case scenario. If yes, go for it. If no, don’t do it.

Would I like to live without glasses? Of course. Am I willing to take the chance? Nope. But that’s me. Your mileage may vary.
Dry Eyes Hurt
If you are considering this procedure I suggest you ask about the consequences of DRY EYE SYNDROME, a very debilitating and expensive side effect of Lasik’s surgery. Don’t let them tell you it is a nuisance disease, because it’s MUCH more than that, let me tell you.

I have severe dry eyes, but not from Lasik surgery, to the point where I wear moisture chamber goggles and put drops in my eyes every 10 minutes, which I have been doing for 15 years. At night I use oily eye ointments several few times. It’s $2000 - $3000 a year for the OTC meds plus the cost of goggles, which can run up to $1000.

There is a website out of the USA called Dry Eye Zone, which has thousands of dry eye suffers on it discussing this issue, many former Lasik’s patients. A good place to do some research from a patient’s point of view and obtain physician’s advice.
Holly
I just had Lasik done on April 19th, 2008. I’m absolutely thrilled with the results. I’d worn glasses since I was 12 years old and I am now 28. I mainly got it done to better my quality of life as well to save in further expensive glasses. My vision was so bad that if something was 10 feet away from me I wouldn’t be able to tell if they were talking to me or something else without my glasses.

It’s only been almost a week and I’m obviously having no problem using my computer. I have some trouble reading close up but it’s improving by the day.

I agree with the person who said that the specialists at Lasik always inform it’s clients about the risks, etc. I was told that I could do the regular Lasik but the chance of regression was higher than if I used the Zyoptic version. It was more expensive but SO WORTH IT!!!

The best $3500 I ever spent.

Steve
Given a competent practitioner, it is a no-brainer. Wouldn’t you rather live as if you had a set of never-care contacts that never had to be cleaned or taken out, and were never uncomfortable? I had LASIK 7 years ago, and after a year of dry eyes at night (eyedrops at about 3 am), I am very happy with my results. Damian, satisfaction rate is more like 999/1000, not 19/20, and problems that do crop up in rare cases are mostly transitory -(ie., blindness is not a risk).

Andy
I’m fortunate in that my prescription is relatively light (-1/-2). It would be nice not to need glasses but I would far rather keep these than undergo a procedure where I have a 1/20 or even 1/40 chance of being blinded.

Perhaps if I needed a ridiculously strong prescription I would consider it a more acceptable risk. Right now I just really don’t see wearing glasses as a big deal.

Bob
I just had an eye exam last week, 10 years to the day after my Lasik was performed. I did suffer with dry eyes for quite a while after the op, but ’suffer’ is a bit of a stretch — I handled it well with drops a couple of time a day. The dryness eventually went away, and has been gone for years now. I too paid a premium - $5000 (”Acme” discount eye surgery didn’t appeal to me). But for my money I had a world class surgeon here in Moncton. BY the way: results of my last testL: 20/20 in one eye, 20/25 in the other. Exactly the same as 10 years ago. (The 20/25 was planned — to reduce the need for reading glasses).

Clear Vision
I had mine done 8 years ago by Judelson in Regina. He was awesome. No side effects.
I suggest you put your faith in a surgeon who has credentials and not these fly-by-night shops that close as quickly as they open.
It is SURGERY afterall.

Dave
I had my eyes corrected by Lasik over five years ago. What a wonderful feeling having rain on my face without the constraints of glasses. It was a decision that I have never regretted. Like most surgeries, I took a risk and was pleased with the result. It was a choice that I made and I knew I would have to live with my decision, whether the procedure worked or not.

debbie
For many people like myself who have worn glasses with a very strong prescription for years, Lasik sounds like a miracle. Several years ago, I attempted to have the procedure and ended up with the scare of my life. An inadvertent blink on my part when the surgeon made the initial cut for the flap on the first eye resulted in a flap that was too thin. The procedure could not be finished. I had good follow up care from the surgeon and was told that once the flap had healed they could attempt the procedure again. After consultation with my own optometrist, I declined. She and I both felt I had been very lucky. I have friends who have had the procedure whose results have been ok, but less than stellar. They report issues with driving at night and are once again wearing glasses for many tasks. My feeling is that this procedure is likely most optimal for people with relatively minor vision deficits. Those of us with very strong prescriptions are much less likely to have truly optimal results and should take careful note of the “fine print” about risks and possible side effects and ask lots of questions about the true benefit in our circumstance. I feel I dodged a bullet and am happy I can still see through my “coke bottle” lenses!
Ian
While I have 20/20 after Lasik it came at a cost. My night vision is severly impaired (halos, starbursts) and had I known this is what I would be left with I would have opted out. I can’t even watch tv in the dark without issues.

The clinic glossed over the potential side effects and I never fully understood what the outcome could be. I guess my pupils dilate too far into the scar area, distorting my vision. They knew this would happen and they really downplayed it. I was excited and naive and listened to the experts.

I accept my choice but the industry is not doing a good job at rejecting unsuitable candidates. Plus they are pushing this to younger audiences, who will make decisions with less foresight.

If it worked for you great, I just hope that no one else ends up where I am.

Like I tell my son now, contacts aren’t that bad and glasses are pretty styish these days.
Randy
I had the lasik surgery in 1998, I ended up with better than 20/20 however from day one following the surgery I suffered from dry eyes and halos, especially at night. I had never experienced either of these prior to the surgery and had worn hard contacts for about 30 years.

Now in 2008, I’m back wearing glasses as the surgery results did not last more than seven years. I have plugs in my tear ducts, to try and keep some moisture in my eyes and to this day I use drops throughout the day and a viscous gel at night.

I do regret having had the surgery.
Cinder
My glasses are part of who I am. I feel naked and exposed without them. They’re just, me.

But…this kind of makes me glad I never really wanted Lasik in the first place (even though my mom made me go a number of years ago and they told me I was a perfect candidate).
Bob
In response to Ian: sorry that you have negative vision in darkness.

For those considering this surgery, you need to do a lot of homework, get the BEST SURGEON AVAILABLE, and a highly competent optometrist. Ian’s problem relates to something called the ablation area. Google “ablation cornea” and you’ll find info about this. I did research regarding ablation and much more before my surgery. Regarding ablation, I made sure that the area of my cornea that was going to be lased exceeded the normal dilation of my eye in darkness. I think my doc’s machine treated 9mm, and my pupil dilation was around 8mm (normal, I think). If you get the opposite (some people’s pupils dilate more than 8mm), part of the light entering is transiting through untreated area, or scar tissue from the cut. Hence, starbursts, halos, etc. You really need to ask all of these questions, IMO. Lasik changed my life. I couldn’t see the wall 6 feet away without my glasses that I had worn since I was 7 yrs old. I would do it over again — but only after a lot of research. Good luck to all of you who have experienced problems, and to those of you considering taking the leap. Another thing: when my optometrist examined my eyes last week, she said that she could only faintly make out the flap scars, and that was because she was looking for them. An optometrist unfamiliar with my history. This is because the doc used the best quality blades (the blades are VERY expensive) and uses new blades for every patient — another thing I inquired about. I’ve heard of some cheaper procedures where the docs reuse blades! So they get dull, and tear. Also — if you get the surgery — REST your eyes as directed and use the drops faithfully. One friend of mine went to Halifax from Moncton (because it was cheaper) and drove himself home with one eye closed after the op! Nuts! He still has problems to this day.
Jean
I’d like to thank everyone who has shared their experiences, good or bad, with their Lasik eye surgeries. As someone who’s had to wear “cokebottle-bottom” glasses for many years, your comments have helped me to decide that the potential negative effects years down the road are not worth the risk. Remember folks - for many of us, our eyes physically change shape as we grow older. I’ve experienced this recently as I now need bifocal (transition) lenses. If you’re like me (there’s lots of us out there), when you’re 45 that’s bound to have an impact on the effectiveness of the eye surgery you had when you were 25.
Meghan
You absolutely must do your research. You need a doctor that insists on the same type of care for each patient - you shouldn’t be allowed to opt for insurance/warranty or not. Too-good-to-be-true prices are just that - to good to be true! I had a similar procedure done (prk) and paid top price for a top-doctor in Toronto. It was definitely worth it! You get what you pay for.
Scott
I had LASIK done in July of 2004. The very next day I could see as clear as day and I realized right there that it was one of the best investments I’d ever made. I did research the procedure and the qualification exam with my surgeon lasted over an hour. Like a few have said on here already, you get what you pay for. I paid more than most but the result as well as the post-op care was fantastic. Worth every penny.
Cass
I had LASIK in one eye (-9) and an implanted contact lens (-12) inserted in the other 10 years ago. I have not regretted it at all. It was horrible not being able to see without my glasses. If I knocked them off my night table I had to get someone to help me find them. My eyes have continued to deteriorate (as forewarned) and I’ll have to wear glasses for driving in a few years. I’m sorry that some people had bad experiences but that is an possible side effect of surgery. That risk was made clear to me by my optometrist before I even went to the Gimble Clinic.

Don’t go for the deal. This is your health!
Ryan
I had the surgery almost 7 years ago. I only experienced a couple of weeks of dry eyes/sensitive immediately after the surgery but since then I have had better than 20/20 vision. It is amazing to be able to see my kids at the swimming pool without squinting etc. This surgery was the best money I ever spent.
Jason
I had considered Lasik but after hearing that a certain percentage of people suffer from very dry eyes, I decided against it. Not worth the risk in my opinion. Contact lenses nowadays are so comfortable and easy to take care of that I don’t mind whatsoever using them.
Jackie
I had Lasik surgery 9 years ago. It was the best decision I ever made. I had a very strong prescription that made my glasses thick and heavy. I was forever getting severe headaches from the weight and pressure of the frames. I tried contact lenses but experienced severe dry eye and a problem developed with my eyes not getting enough oxygen from wearing them so often. I went to an Optometrist who had extensive experience with patients who had the Lasik procedure and went to see a surgeon in Toronto who was a Pioneer in the field. I was aware at all times of all the potential risks. As in all important decisions, research and information on your part are key.

Jagged Pill
I had lasik done almost 2 weeks ago. Best $2000 i’ve ever spent!!! Haven’t had any symptoms whatsoever! No dry eyes, no redness! I love it!! makes waking up at 5 in the morning actually good…cause I can see the clock!!

Painless surgery!! Anyone curious about it should definitly go check out a clinic…they put everything there up front; risks and all.
ance
Funny how people get so offended when you push the right buttons.

Those of you who so vehemently defend your decisions as not “vanity” but “making myself feel better” or “less self consious” etc etc etc…

guess what… THAT’S VANITY..

And BTW cosmetic surgery (breast, face lipo etc) is not the same as reconstructive surgery (for the person with the burns and disfigurment comment) and is based on valid medical needs.

those of you who admit to doing it for convenience… at least you know why you took such a chance…

to those who argue the vanity thing… you are vain fools who (hopefully) were lucky…

I stand by my comments 100%
raj
I had one eye done at a time. Once one healed, I had the other done. You take risks with any kind of surgery.

mk
I’m glad that lasik has so far worked for those of you who claim the ‘minor’ side effects are worth the risk - of course any thinking person would use a reputable surgeon. However, be aware that intraocular eye pressure cannot be correctly measured post lasik - should you need cataract surgery this would be a major issue. Also, the flap ‘heals’ to only 2% of its pre surgical strength. Retinal detachment is not unheard of - particularly for those of us with high prescriptions..I could go on - educate yourselfs - don’t take a Lasik Centres word for it.
Just wanted to add that I know several people that are ‘happy’ with their surgeries - none of them drive at night - and when pressed will admit that dry eye is a major nuisance/debilitation. Let’s face it - no one wants to admit that they are unhappy with a decision they willingly made and paid for - it’s called cognitave dissonance and many people will just suck it up and learn to adjust.

Lasik eye surgery: patients air grievances in front of U.S. Food and Drug Administration panel

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