Patients Of Botched LASIK Surgery Urge FDA To Step In

Our beloved fatherteacher Ben Popken seems just fine with his newly lasered eyes, but not everyone sees such great results, says Reuters: “Blurred vision, dry eyes, glare and double-vision have led to depression and in some cases suicide, several patients told a U.S. Food and Drug Administration advisory panel.” These patients want the FDA to take a more active role in regulating the LASIK industry (currently the FDA regulates the equipment but not the people who use it).

Several unhappy patients at the advisory meeting faulted their surgeon for not ruling them out as a poor candidates for LASIK, or for failing to stress the severity of possible side effects.

The number of complaints the FDA has received is relatively small, only 140 between 1998 and 2006. Still, that’s 140 people who didn’t benefit from LASIK, and who potentially ended up with worse vision. (This writer worked with a woman who had LASIK in the late 90s and suffered from worse vision as a result—so it does happen.)

The FDA is also planning to begin a study on LASIK patient satisfaction in 2009 along with the National Eye Institute and two industry groups: the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology.
 
Patient and consumer advocates at Friday’s meeting objected to the groups’ involvement with the study, citing conflicts of interest. Industry representatives said it would help them understand why some patients are unhappy with their LASIK results.

“Unhappy LASIK patients urge FDA to take action” [Reuters]
(Photo: gabyu)

Comments

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  1. Pro-Pain says:

    My Mom recently had this done and the Dr. botched it bad. Her vision is horrible now. Malpractice suit pending of course.

  2. KD17 says:

    Just about every time I start giving LASIK serious consideration some story comes along that makes me say I’ll wait a few more years.

  3. snobum says:

    @Pro-Pain: That sucks, I had mine done in October and it was the best thing I’ve ever had done. I also went to one of the most expensive dr., but one of the most experienced.

  4. NDub says:

    I remember seeing the advertising on a website of theirs before. The doctor showing off the procedure…. had glasses on….. yeah.

  5. thesuperpet says:

    suicide? People have killed themselves becasue thier vision got crappy when they knew they were taking a risk? My daughter was born blind and I have yet to come into her room and find her hanging by the neck on the side of her crib.

  6. rdm says:

    @thesuperpet: That is not the same as paying $4000 to get better vision, then have the doctor tell you “oh sorry, we over corrected, we can fix it again but you will lose your distance vision probably.” come on.

  7. Trai_Dep says:

    If, post-op, I can’t walk the streets in black, x-crossed spandex w/ yellow booties and have people flee in terror*, LASIK’s a failure in my book.

    * Err – in fear of optic blasts, not my uncannily large basket, ‘natch.

  8. bohemian says:

    They turned this into marketing research rather than oversight. Have some university do the study.

  9. B1663R says:

    “My eyes…so dry… can’t take it anymore!!”

    *jumps off bridge*

  10. WraithSama says:

    @B1663R:
    Hah, that actually made me chuckle.

  11. chrylis says:

    All this background is what I had in mind last year when I decided to go ahead and have laser vision correction. However, I decided to go ahead and go to some extra expense and hassle to use a top-notch surgeon (one who, while not perfect, has treated hundreds of eye surgeons and fixed two personal friends who had their surgeries botched by incompetent doctors).

    Additionally, and just as important, I decided to have PRK instead of LASIK. The recovery’s a lot less pleasant, but outcomes are statistically the same after about 4-6 months, and without a flap you don’t have the problems with dry eyes or reinjury.

    (My results: Left eye went from -7.0D with 1.25 cylinders of astigmatism to about +2.0D with less than a half-cylinder of astigmatism, which is below what contacts can treat. I may have a retreatment to improve, but the difference is life-changing. I’m in recovery on my right eye, but so far I went from -5.5D/1.5 to +.5D/0.25 with a minor amount of coma.)

  12. chrylis says:

    I had this kind of story in mind when I decided to go ahead and have surgery last year. To reduce the risk of problems, I went to some extra expense and a lot of extra hassle to use a surgeon who has both operated on hundreds of eye surgeons and fixed two personal friends who had their surgeries botched by incompetent doctors.

    I also decided to have PRK instead of LASIK. The recovery is quite uncomfortable for a few days, but the results are the same after 4-6 months, and with a flap there’s no risk of causing dry eyes or reinjuring the cornea. I had my left eye done in August and my right eye in March.

    (My results: Left eye went from -7.0D with 1.5 cylinders of astigmatism to +2.0D with less than half a cylinder, which is so minor that contacts can’t even correct it. I’ll probably have the eye retreated to get a better correction, but the difference is life-changing; sometimes I forget whether I have my contact in or not, whereas before I couldn’t read my alarm clock while lying in bed. My right eye went from -5.5D/1.25 to about +0.5D with virtually no astigmatism but some coma. It’ll still be changing for a few more weeks, though.)

  13. chrylis says:

    (Sorry. Didn’t mean to repeat myself, but the new comment-post script and Firefox apparently don’t get along well.)

  14. alexanderpink says:

    @NDub: The ophthalmologist can’t risk having the procedure, even though the risk is very small of complications, as his eyesight is his lively hood. I am a medical student, and a number of ophthalmologists who have taught us wear glasses for this reason. It has nothing to do with their skill.

  15. Trai_Dep says:

    Versus everyone else who doesn’t require sight for working, driving, living… :)

  16. dmtien says:

    I had this procedure about four years ago, and decided to find the opthamologist that people went to to repair the mistakes that the $499-per-eye hack shacks make. He also happened to be the former head of the UCLA Medical School’s eye institute and pioneered several procedures on LASIK, and seems to be the preferred surgeon of celebrities and athletes. $8000 was pretty steep, but I figured it was money well spent in assuring that I had the best chance in good outcomes.

  17. SuperJdynamite says:

    @rdm: “you will lose your distance vision probably.”

    Yes, the possibility of losing your distance vision is much worse than being blind.

  18. benjamintm says:

    I had the surgery back in 99. To this day I still get a smile on my face when I realize how good I can see. It’s a surgery I recommend to all my poorly sighted friends.

    That said, I went under the laser 3 times. Once in 97, which resulted in near perfect vision in the right eye and an improved, but headache inducing, vision in the left. I went in again in 03 for the left and came out slightly worse. Then I went in again in 05 for a “final try” and came out darn close to perfect. The last two times were free because of the surgeons guarantee.

    Ultimately it is the responsibility of the optometrist to inform the patient of the possible complications. It’s also the responsibility of the patient to do research on an elective surgery and the surgeon.

    Ben

  19. GinaLouise says:

    I’m very glad Lasik issues are being publicized. My 50-something mother got it done a few years ago, and she sort of regrets it.

    She had been near-sighted, and after the surgery she became completely far-sighted. She’s useless at reading menus or doing anything close-up without her reading glasses. She sees great otherwise, but her doctor didn’t adequately warn her about the possibility.

    More importantly, she has terrible, painful dry-eye. She’s been to several doctors and tried every eye-drop on the market, but finally had to start taking a prescription.

    I’m not saying Lasik’s a bad idea, but I’d want to see what the long-term prognosis is before getting it done. Who knows how these patients will be doing 40 years down the line?

  20. TechnoDestructo says:

    @SuperJdynamite:

    And losing something that you had, and which was very important to you, is not the same as never having had it to begin with.

    Poor people don’t kill themselves when markets crash.

  21. StevieD says:

    I will be happy to have the procedure done…. from the Dr that performed the procedure on the Dr recommeding the proceedure.

    My eye Dr wasn’t real impressed by my comment.

  22. EskimoDave says:

    Apparently the doctor who did my LASIK did the Spice Girls and a bunch of Pro Golfers. And the hot girl who works there says hes the best of them all.
    Regardless, it is the best investment I’ve made so far.

  23. Trai_Dep says:

    Although, it’d be SO much cooler if it was the Spice Girls and a befuddled pro golfer that did your surgery. Simply so you could boast about it to your bar buddies. :D

  24. chutch says:

    @Trai_Dep: There are actual possibilities there. I haven’t seen the Spice Girls in years. They’ve got to be up to something. $499 Spice Girl Lasik anyone?

  25. Audiyoda says:

    This is what happens when you see a ad for something so outrageously low it obviously too good to be true. Dear Gawds…these are your eyes we’re talking about. You don’t get a second pair. Why the hell would you go to have this procedure done at a place in a strip mall – or worse, a cheap eyeglass retailer that has a big RV out back with the laser on-board.

    I’ve been in optics for over 16 years (optician) and I’ve seen so many people run off to get Lasik (or RK, PRK, LTK or Intacs) and not do their research. Just amazing that people will research the hell out of a flat panel HDTV but they’ll fall hook, line and sinker for cheap vision correction surgery. You get what you pay for.

  26. outsdr says:

    I spent almost $600 on a pair of glasses this year that don’t properly correct my vision. There is no way I’m letting any surgeon near my eyes; it’s too great of a gamble.

  27. beatofhawaii.com says:

    I’ve been getting so much pressure from my ophthalmologist to do this. Then I read this week that the number of surgeries is really down this year, so obviously the doctor is hurting. But really.

    So I talked with a friend who is an 80 year old retired opthalmic surgeon who said that I’d be an idiot to get the surgery since I don’t mind my glasses, and don’t have any vision problems. I was told that there was still about a 4% chance of serious complications.

    The idea that the ophthalmologist who I went to for my regular eye exam is pushing lasik so hard, and stands to make so much money from it is a clear-cut conflict of interest.

  28. P_Smith says:

    @B1663R:

    Are you always so lacking in common decency? Or do you find depression and suicide caused by blindness to be funny?

  29. P_Smith says:

    If laser surgery had a 75 year track record without regular problems, I might be willing to try. But since I expect to live at least another 50 years and it has been around less than that length of time, I’m not taking the risk. Shortsightedness is the only eye problem that has ever happened in my family, not glaucoma or diabetes induced blindness.

    I’ve never understood the desire to have surgery on one’s eyes except as a last resort. If the person is blind or will eventually go blind without surgery, that I can understand. But having someone cutting open my eyes just because I don’t want to wear my +2.5/+2.5 glasses doesn’t make any sense.

  30. Watcher95 says:

    Had mine done for free as part of my military service, changed my life.

  31. whatevernever says:

    I’ve thought about getting it done for a long time but couldn’t because my eye doctor said my vision had to stabilize. It’s been stabilized for the past 2 years now but I’m scared to have anyone touch my eyes.

    Who in their right mind would go to a doctor who advertises $499 per eye LASIK???

    I agree with the person who said people do so much research on buying a tv but don’t take the time to do research on a doctor.

  32. psyop63b says:

    It sounds like it’s more the human factor than the procedure itself that’s to blame. Even the best equipment is useless in the hands of an incompetent doctor.

  33. Mike_Hawk says:

    “. Even the best equipment is useless in the hands of an incompetent doctor.”

    If you find a doctor, that has botched dozens of these procedures, than I will agree with you that there is it is these so called “incompetent” doctors. However, all medical procedures, no matter how trivial carry a risk, and human beings are complex animals. Sometimes stuff just doesn’t work and sometimes people get unlucky. it’s unfortunate, but it happens. Even routine procedures can result in fatalities regardless of operator skill and experience. Throw in the occasional random and unpredictable drug reaction and it becomes impossible to be 100% sure that nothing bad is going to happen. Also, sometimes people are whiny little brats that want a free ride in life and I would group most* of these cases in that later category.

    We live in a country where you can sue for “mental anguish” because somebody called you fat.

    * “most” does not equal “all”

  34. Trai_Dep says:

    Okay, just for kicks, how WOULD one find a good doctor, besides word of mouth, which seems too random? Don’t the various AMA boards keep consumer-friendly data from being available?

    My HR rep told me to find a doctor that is listed in one of the better hospitals in my area, since it’s sort of a vouch. Then call their office (if they’re on my list).

    It’d be nice if there was a resource available. Or a Consumerist feature (hint hint) on how to find a good doctor.

  35. sburnap42 says:

    I had my eyes zapped about a year ago. It was the best thing I ever did. There were no complications and on my last visit to the eye doctor, I could read three out of five letters correctly on the 20/10 line. I see better now than I ever did with glasses.

    Of course, I didn’t go to the Lasik mills. I spent $4400 on a real doctor. He was recommended by my eye doctor, and my eye doctor’s assistant raved about the job he’d done on her eyes.

  36. reznicek111 says:

    @P_Smith: Exactly. Undergoing a procedure that carries (even a small) risk of leaving you with worse vision than before is simply not worth the risk to me. If my contacts were causing chronic problems, or prevented me from engaging in some important activity, maybe I’d feel differently.

    Though each case is different, given that my daily eye care regimen (thank goodness) takes less time and effort that brushing my teeth in the morning, and I’m happy with my vision correction (-6.75/-5.25 without contacts, but 20/20 vision with), I see no need to have the surgery.

    That said, a 50-something relative had LASIK several years ago, performed by a highly recommended surgeon in a hospital setting. He had some complications (dry eye, lasting blurriness) and even after two corrective surgeries still needs to wear reading glasses, use moisturizing drops, and still sees “haloes” around lights at night. His case may not be typical, but just the thought that this could happen is enough to make me forswear eye surgery.

  37. hubris says:

    @reznicek111: Then he went to a doctor expecting unrealistic results. EVERYONE needs reading glasses, and no surgery can fix that; it’s a simple wearing down of the muscles, not the structure of the eye. So even though I got LASEK now, at 29, I will eventually need reading glass, probably in my 40′s.

    But getting LASEK surgery (which is about halfway between LASIK and PRK and doesn’t create a flap) was the *best* decision of my life. Wearing contacts and glasses every day of my life was SUCH a pain in the ass; my eyes always got tired wearing contacts and wearing glasses while sweating was a huge pain in the butt.

    Now, a month and a half after the surgery, I can see 20/10 in both eyes, I no longer have astigmatism and it’s *amazing*. My eyes are still a little dry, and they’re more sensitive to light, but both of those should heal. Even if they don’t, I’d take the problems I have now, which are minor, with the improved vision.

  38. pigeonpenelope says:

    if one doesn’t do their own research on the severity of the procedure, they’re idiots. if a bad surgery leads to depression, they had mental issues before going in. people really need to own up and get rid of this victim mentality.

    that being said, PRO-PAIN, it does sound like your mom really does have a legit malpractice issue (without knowing both sides). i’m not saying that doctors don’t screw up, i am saying that there are pros and cons to everything and that we are required to be responsible for our own selves.

  39. pigeonpenelope says:

    @GinaLouise: my mom has the same experience your mom did. the dry eye my mom experiences isn’t painful but uncomfortable. she is far sighted now but she says she’d rather use the reading glasses over the bottles for glasses she used to use… my mom still thinks lasik was a good idea and a good investment. personally i’m too wussy and the thought of having my eyes messed with bugs me. besides, i think glasses are cute.

  40. rellog says:

    @benjamintm: I agree. I had mine done almost 10 years ago, and am glad I did. I too had the free “touch up” guaranty, but never needed to make use of it. I do get a slight star-burst effect at night occasionally, but I never remembered NOT having that…

    I also went to a reputable place, but price-matched the bargain eye doctor. I was rather surreal, and almost seemed as if I were at a used car lot… :) At one point, the sales person said “let me talk to my manager” and got up and left the room…. So I got both eyes done for $1000, plus the guaranty. I never once regretted having it done. Of course YMMV…

  41. ImmaterialGirl says:

    A good friend of mine had the surgery a couple of years ago and had less-than-desirable results. Her eyes got infected immediately after the surgery, then became re-infected a month or so later. In her words, she had to go back to the doctor to have him “lift the flap and scoop out a bunch of pus and goop.” Gross.

    She’s only 26 and can’t drive after sunset anymore because the surgery ruined her night vision. She’s a smart, savvy girl, so I highly doubt she went to a hack shack.

    I am highly myopic (-9.5) and her prescription was about the same as mine. Interestingly, my eye doctor said he’d never recommend LASIK for someone so myopic. I believe he said lens implantation would be a more appropriate procedure.

    Knowing all of this, I think I’ll stick with wearing contacts. I’ve been fortunate enough to be completely comfortable when wearing them, so why press my luck?

  42. Rusted says:

    I did Lasik. Don’t. A lot of people will lie about how good it was. My contrast was bad for two years. Dry eye for ten months. And I’m one of the lucky ones. If one did do it without doing research (as I did), then important to take really good care of the eyes.

    @B1663R: I had dry eye for ten months. Sucked. Painful, lotsa eye drops. Bridge would look good if water under.

    @thesuperpet:It can be scary and depressing to lose vision. I had a hyphema recently. I was pretty close to wearing an eye-patch. Thank all the odd and even gods for one really good doctor.

  43. Pro-Pain says:

    My Mother’s doctor is 73 years old and had NO REASON still doing these surgeries. I wish I would have known so I could have intervened before it was to late. Very sad indeed.

  44. hubris says:

    @Pro-Pain: To be fair, there isn’t really a lot the doc does; they’re mainly there in case something goes wrong. The laser does everything on its own, as well as shutting off if the eye moves too far.

  45. razremytuxbuddy says:

    One option is to only get one eye Lasik’ed, which is what I did about 5 yrs ago. It gave me the monovision effect, with one eye for up close vision such as reading, and one eye is 20/20 for distance. It’s totally awesome; I don’t need glasses for near or distance sight or for driving, and it’s really cool that I only had to pay for one eye.

    When I was considering Lasik, I checked out a $399 offer, but consulted my eye doc first, and he instead sent me out of state to TLC (the chain that did Tiger Woods’ eyes). My cousin had both eyes done locally (Xmas gift from her husband), and she has the dry eye problem and now a couple years later, needs reading glasses.

    This is not a commercial for TLC; I’m just reporting my unique success story. I feel just plain lucky after hearing more and more stories about the pain and vision problems others have endured.

  46. dragonvpm says:

    I had LASIK done recently and so far I’m thrilled with how it turned out. Almost no dry eye, very fast healing and amazingly improved vision (better than I could get with my glasses).

    As with all medical procedures, it seems important to remember that no matter how great they are, they will always suck, a lot, for the 1%-5% who may not get good results and you have to be prepared for that. In the end of the day, it is an “elective” procedure and everyone considering it should look at potential benefits and make sure they outweigh the potential negatives (which I had zero trouble finding, in great detail, before this all hit the news this weekend).

    All this news coverage sounds an awful lot like much ado about nothing from people who are upset because they weren’t spoon fed information on the various ways that the surgery can go wrong, and as others have noted, these are your eyes, people should put at least as much thought and research into messing with them as they do into buying a car, or buying their new home theatre.

    Next thing you know smokers will be suing tobacco companies for not telling them that the black gunk they were coughing up (and the various other problems they had) were a sign that the cigarettes might be a little bad for them… oh wait.

  47. Audiyoda says:

    @omerhi: Not entirely true about always needing reading glasses. There is a procedure called PRELEX (presbyopic refractive lens exchange) – it’s a bit radical for my blood but has many years of research behind it and is very similar to cataract replacement surgery. As someone who’s been in optics for over 16 years, I’d rather have Prelex than and laser correction. Then again, I don’t have issues wearing glasses and know that my vision with glasses will always be better than if I had any form of laser correction.

  48. Audiyoda says:

    @Trai_Dep: The single best way of finding a good OMD to do laser correction is to talk with your Optometrist. Any decent OD will have a referral network that they are comfortable with. But you still need to ask questions – biggest one being ‘why do you prefer Dr. _________ over Dr. ________?’ Some ODs won’t refer out to some other doctors over fairly petty things (I know, I used to work for one) – so you need to read between the lines a bit.

  49. kyle4 says:

    I’m 18 and I was told by my optometrist a few years ago that my eyes would get continually worse as I age. My eyes do seem to be getting worse, in fact I can’t see without my glasses on. Everything is just blurry no matter how long I leave them off. Not knowing the testing of Lasik surgery for the long run, I would not be sure how safe it is to do. Who knows if in 40 or 50 years it makes you go blind, it’s just unknown at this point.

    I’ve always thought I damaged my eyes because one day in grade 8 I was walking home from school and I wasn’t thinking and stared at the sun too long. For about 5 minutes I saw black patches and my left eye was blurry. After 15 minutes it went back to normal, but it was grade 9 in which I was told I needed glasses.

    Who knows if Lasik surgery could do to my eyes what the sun did (or didn’t do). It’s possible.

  50. Squot says:

    @kylo4: Well, it’s just natural that your eyes get worse as you age. From what my optometrist says, it should level out some right when you hit your mid twenties, but right now I get new glasses about every 2 years, because I can’t read the street signs (I’m almost 24).

    While the sun may or may not have damaged your eyes, the worsening of your eyes likely has to do with continued use, not continued deterioration from the sun.

  51. PinkBox says:

    @NDub: Also notice that most of the surgeons are older. I was told when I had my Lasik surgery that after the age of 40, there is still a huge chance of needing glasses because your vision can still naturally decline.

    It has almost been a year since I had Lasik done, and I don’t regret it at all. No real complications, and I still have 20/20 vision.

    My doctor was one of the “best” ones, wasn’t cheap, and I have a friend who went to the same guy ten years ago and still has 20/20 vision himself.

    My “vision” also came with a guarantee, which is nice.

  52. taka2k7 says:

    I had PRK a couple of years ago. No real issues, although my eyes are kind of dry when I first wake up– a couple of blinks and it’s back to normal. No issues during the day and at night. Best of all, it cost me nothing… military picked up the tab.(thanks taxpayers…)

  53. hi says:

    @B1663R: funny :D