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Ex-FDA Advisor Says of Lasik Eye Surgery: ‘It Should Have Never Been Approved’

242 points| bookofjoe | 6 years ago |pittsburgh.cbslocal.com

260 comments

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[+] gdebel|6 years ago|reply
Refractive surgeon here. I work in a well-known eye hospital in Paris. I operated my sister (PRK) and my best friend (LASIK). My mother underwent PRK when I was a child and I think the amount of admiration/gratefulness that she had for her surgeon afterward actually gave me interest for this surgery. We regularly operate ophthalmology residents as well, and one of the surgeons of the center underwent LASIK. However, if you consider surgery, please turn to a well-known and experienced surgeon. It is a very secure surgery that can turn really bad if errors are made during patient selection, surgery planning, surgery itself, and management of the unfrequent complications that can occur. Patient selection is especially important. So you have to choose a surgeon that really cares about his reputation, and that will not operate you whatever your examination.
[+] siffland|6 years ago|reply
I wanted LASIK so bad starting around 2010, I had worn glasses since I was 6 for my astigmatism. The reason I did not get it was because someone I worked with had a friend who they messed up one of his eyes and he was legally blind. My sister got it in 2015 and I kept putting it off. In 2018 i was turning 40 and needed readers, the eye doctor said i should get bifocals or LASIK and readers.

I got LASIK in September of 2018, I did my 1 year checkup in September of this year and am seeing 20/15. I used eye drops as instructed and now I don't need them. I still use readers for little print (or more light), but I knew I would need to going into this.

No regrets, except I should of done it years ago.

[+] cullenking|6 years ago|reply
There are a couple other mentions in this thread about PRK. I went the PRK route instead of Lasik, and don't regret it one bit. I chose PRK because it was less risky, and was more durable. Look it up yourself, but brief summary:

  - no flap, they remove top layer of cells with a scraper, then laser
  - no flap means stronger eyes. if you box, mountain bike, work in a high risk environment, it's the procedure to get
  - long recovery time, and it's pretty painful for the first week. ~ 2 weeks to reasonable vision, 4-6 weeks for 20/20 or better.
  - less chance of dry eyes (still a semi-common outcome)
My eye doctor, the casey eye institute, pushed lasik, but that was purely for what people commonly want. They were enthusiastic about PRK, considered it a better procedure for people who were OK with the recovery time, with less chance of complications.

My complications:

  - dry eyes, but nothing worse than contacts get midway through a day
  - sensitive eyes. meaning, a scratch on the eye becomes eye wateringly bad
  - slight halos at night, but again, nothing worse than contacts at the end of the day
I am happy with the results, would do it again, and am currently advising my wife to do PRK instead of lasik (she's on the fence of doing anything). I ride mountain bikes, dirt bikes, and do lots of building, so chances of complications with a flap are non-zero. If you haven't read, those complications are pretty bad - get lazik, take a stick to the eye a year later which causes the flap to dislodge, you now have potentially uncorrectable vision in that eye.

Search the rest of this discussion for PRK. If you aren't afraid of pain, discomfort, and a long recovery time, it's the procedure to get.

Also there's a HUGE difference in lasik or PRK providers. As you can imagine, it's worth spending extra. My procedure cost $4k total, which is $3k more than budget lasik providers. However, I worked with some top eye doctors that regularly perform serious eye surgery, and are at the forefront of optometry. Strip mall discount lasik has less time spent on planning, comes with less experience in recommending procedures, and has less experience working with complications. Definitely don't cheap out!

[+] vladgur|6 years ago|reply
The article links to a FDA study on outcomes [1] but is very selective at what it chooses to highlight.

Here is what article singled out: “In a recent study, the FDA found nearly half of participants who had no visual symptoms prior to the surgery reported having some complication three months after surgery.”

AND here are ALL the conclusions from the linked study results:

* Up to 46 percent of participants, who had no visual symptoms before surgery, reported at least one visual symptom at three months after surgery.

* Participants who developed new visual symptoms after surgery, most often developed halos. Up to 40 percent of participants with no halos before LASIK had halos three months following surgery.

* Up to 28 percent of participants with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery. This is consistent with previous studies. * Less than 1 percent of study participants experienced "a lot of difficulty" with or inability to do usual activities without corrective lenses because of any one visual symptom (starbursts, ghosting, halos, glare) after LASIK surgery.

* More than 95% of participants were satisfied with their vision following LASIK surgery.

* Participants were more than twice as likely to report their visual symptoms on a questionnaire than to tell them to their health care provider

So what this means is that more than 50% of participants of the study had NO visual symptoms 3 months after the surgery and including those that did have some symptoms, 95% of ALL participants were happy with the outcome.

Add me to those 95% -- I had my Lasik done a decade ago at the Stanford Eye Center and had a quick recovery with zero complications and zero side effects

[1] https://www.fda.gov/medical-devices/lasik/lasik-quality-life...

[+] lostmsu|6 years ago|reply
I suspect the halo thing is not an objective problem. People just get alert and start noticing it, or could not see it before due to blurriness. That was my impression after having several conversations with my wife who had LASIK and complained about halos.

It finally convinced her, when several consecutive days I had what she described as "halos" because I was tired and could not properly focus at late night.

Myself having a nearly perfect vision at the time never paid attention to them before she expressed her concert about that effect after surgery.

[+] daeken|6 years ago|reply
Holy observation bias, Batman! The only thing even resembling actual negative statistics in this article is the ballpark estimates by the ex-FDA advisor, and those are just guesses.

You can find negative experiences, sure, but what is the actual incidence of that? Without that data, this is utterly meaningless. It certainly isn't damning.

[+] exhilaration|6 years ago|reply
Some data here [1]:

A recent clinical trial [2] by the F.D.A. suggests that the complications experienced by Mr. Ramirez are not uncommon.

Nearly half of all people who had healthy eyes before Lasik developed visual aberrations for the first time after the procedure, the trial found. Nearly one-third developed dry eyes, a complication that can cause serious discomfort, for the first time.

The authors wrote that “patients undergoing Lasik surgery should be adequately counseled about the possibility of developing new visual symptoms after surgery before undergoing this elective procedure.”

[1] https://www.nytimes.com/2018/06/11/well/lasik-complications-...

[2] https://jamanetwork.com/journals/jamaophthalmology/fullartic...

[+] arcticfox|6 years ago|reply
Anecdotal, obviously, but the only person I know that has had Lasik now has terrible, chronic dry eyes. I took stats with her; she said it never even crossed her mind that it might actually be pretty risky.
[+] commandlinefan|6 years ago|reply
Yeah, the headline scared the heck out of me, since I had lasik done about 10 years ago, but (at least in the article) there's no way to tell if the people who are having problems wouldn't have had problems if they hadn't gotten lasik in the first place.
[+] fellowniusmonk|6 years ago|reply
Exactly. This is statistically a non-story.

MY STORY: I was recently interested in Lasik because I could no longer wear contacts. I ran into Dr. Oz's expose video right away, and realized that since at least 2013 there was a constant local/national news cycle promoting the lasikcomplications.com group.

This freaked me out quite a bit.

I read many of the negative posts, not all, but a large number said something like "Dr's told me my cornea wasn't thick enough but I had the procedure anyway."

THE NUMBERS: Google very heavily features https://lasikcomplications.com/ and its FB page when you do any basic search, their FB group https://www.facebook.com/groups/LasikComplicationsFaceBookGr... page has 6,400 members.

In the U.S. ~9 million people have had Lasik, internationally it's 30 million. There FB group has effectively no membership, their FDA petition has less than 2k signers.

The site mentions suicide rate prominently, but the baseline suicide rate from https://afsp.org/about-suicide/suicide-statistics/ is 14.0 per 100,000, and it didn't seem like that rate was higher for people who got Lasik, it seemed lower really.

Ok, so I was confident that people with real complications have an outlet, and that outlet seems to be concentrated in this single group, so english world complaints should be pretty reliably represented in this group... and there just aren't that many complaints.

so...... statistically outcomes look great.

RESULT:

I got Lasik 4 months ago, couldn't be happier with the outcome, due to my risk tolerances if I could have kept wearing contacts I wouldn't have gotten it but everything has been hunky dory. On the plus side because I can easily wear sunglasses again my light triggered migraines (transitioning to sunlight is a problem) have all but disappeared and I am back long distance cycling again because my vision isn't jostling on the bike any longer.

Also, this group definitely juices its numbers by focusing on the large percentage of people who have dry eyes and halos during the recovery period and they include those as "complications", I had those for the first month, I've since met a surprising number of people who got Lasik (they come out of the woodwork once you get it) and people have different lengths of recovery from dry eyes, the longest I've met was 7 months and they were still very happy with getting it.

[+] onfire|6 years ago|reply
Had PRK 10 years ago, which I always describe to people as the closest thing to a miracle I've ever experienced. Went from not being able to read my bedside clock to better than 20/20. Of course, I am getting older so I need readers now, but my long distance vision is still perfect. Would have done it sooner!
[+] vilhelm_s|6 years ago|reply
So in the study the article refers to, when asked after 6 months "Currently, how satisfied or dissatisfied are you with the result of your LASIK surgery?" on a 6-point scale, the responses were:

    Completely satisfied         69.9%  (151/216)
    Very satisfied               22.7%   (49/216)
    Somewhat satisfied            4.2%    (9/216)
    Somewhat dissatisfied         0.9%    (2/216)
    Very dissatisfied             0.9%    (2/216)
    Completely dissatisfied       0.9%    (2/216)
(this is from eTable 4 in the supplement here: https://jamanetwork.com/journals/jamaophthalmology/fullartic...).

If the FDA guy concludes from this that the procedure should never have been approved, I'm tempted to say that it reveals more about the risk-averseness of the FDA than about the dangers of the procedure.

[+] Freak_NL|6 years ago|reply
Three percent dissatisfaction and another four percent merely ‘meh’ is pretty high for an elective, perhaps even cosmetic, procedure that operates on something as fragile and irreplaceable as the eye.
[+] bogwog|6 years ago|reply
This is a dangerous perspective on the issue. Why should the FDA approve an elective procedure that has the possibility of ruining your life? Lots of perfectly healthy people people who had a bad outcome have committed suicide due to the unbearable pain and suffering.

If this was a life-saving procedure with a 50/50 chance of working with no alternatives, then that's different. But an elective procedure where a perfectly healthy person sees an advertisement one day, and has their life ruined the next is not something that should be acceptable.

[+] maxkwallace|6 years ago|reply
Thanks for pulling out the data! One problem is that "somewhat", "very", "completely" don't give a good picture of how dissatisfied these 2.7% of patients are. It's possible some of them developed serious dry eye which can be totally debilitating.

This doesn't mean the procedure shouldn't have been approved, it most likely means that folks need to do better patient education and qualification. Not everyone needs to be a good candidate.

It's also possible that these results vary a lot between LASIK docs. I'd expect that some qualify patients more thoroughly than others. Risk for developing side effects can be assessed beforehand, to some extent.

[+] AWildC182|6 years ago|reply
We're becoming an incredibly risk averse society. Not sure what that means for the future...
[+] jmwilson|6 years ago|reply
The FDA's mandate is to ensure safe and effective therapies, not high customer satisfaction.
[+] tomohawk|6 years ago|reply
This is like buying a car that has a .9% chance of conking out on the side of the road, a .9% chance of colliding with another vehicle with no injuries, and a .9% chance of blowing up when you turn the key.

Or, you could stick with your reliable car that has some scratches and dents and needs a quart of oil when you fill up.

[+] mcguire|6 years ago|reply
From that study:

"Results A total of 262 participants were enrolled in the PROWL-1 study (mean [SD] age, 29.1 [6.1] years), and a total of 312 participants were enrolled in the PROWL-2 study (mean [SD] age, 31.5 [7.3] years). Visual symptoms and dissatisfaction with vision were common preoperatively. Overall, the prevalence of visual symptoms and dry eye symptoms decreased, although a substantial percentage of participants reported new visual symptoms after surgery (43% [95% CI, 31%-55%] from the PROWL-1 study and 46% [95% CI, 33%-58%] from the PROWL-2 study at 3 months). The percentages of participants in the PROWL-1 study with normal Ocular Surface Disease Index scores were 55% (95% CI, 48%-61%) at baseline, 66% (95% CI, 59%-72%) at 3 months, and 73% (95% CI, 67%-79%) at 6 months. The percentages of participants in the PROWL-2 study with normal Ocular Surface Disease Index scores were 44% (95% CI, 38%-50%) at baseline and 65% (95% CI, 59%-71%) at 3 months. Of those participants who had normal scores at baseline in both the PROWL-1 and -2 studies, about 28% (95% CI, 19%-37%) had mild, moderate, or severe dry eye symptoms at 3 months. While most participants were satisfied, the rates of dissatisfaction with vision ranged from 1% (95% CI, 0%-4%) to 4% (95% CI, 2%-7%), and the rates of dissatisfaction with surgery ranged from 1% (95% CI, 0%-4%) to 2% (95% CI, 1%-5%)."

I would really like someone to explaine these figures to me:

https://cdn.jamanetwork.com/ama/content_public/journal/ophth...

[+] lern_too_spel|6 years ago|reply
The suicides aren't going to take the survey, which skews the survey results in a favorable direction but are of interest to the FDA.
[+] ebiester|6 years ago|reply
Isn't the real question "how satisfied are you after a decade" when discussing the claims in the article?
[+] aiyodev|6 years ago|reply
Even a 1% failure rate is extremely high. This is incredibly bad.
[+] ars|6 years ago|reply
216 responses is not enough to gain data on the few people who were dissatisfied.
[+] CharlesColeman|6 years ago|reply
I had laser eye surgery, but I went with PRK. Less invasive, more durable, far less wasteful of cornea, and its end results are just as good as LASIK's. The only downside is it's a little less convenient because each eye takes a few weeks to heal, so people usually do one eye at a time.

The LASIK procedure is just utterly insane in comparison, especially given its extremely limited advantages.

https://en.wikipedia.org/wiki/Photorefractive_keratectomy

[+] schnide05095|6 years ago|reply
This is a bit disturbing of a headline to see, literally a couple hours before I'm scheduled for a Lasik procedure.

But after reading the article, I don't know how much weight there is to this. Seems to be a small sample and that report is heavily highlighting a couple negative items out of a largely happy pool of patients.

Was there any connection to the doctor or clinic? Did some clinics or equipment have a higher rate of complications? I'm getting mine performed at a well reviewed practice in San Jose.

This article isn't enough for me to cancel the procedure, but it was enough of a scare to put me on the edge for a second. Sensationalism? Maybe not quite, but it'd be great if these reports would work to remove their bias.

[+] deminature|6 years ago|reply
LASIK in the 90s versus LASIK in 2019 is almost an entirely different procedure. Modern LASIK procedures involve mapping the eye on a microscopic level, evaluating vision acuity at hundreds of points on the eye surface, and then allowing an automated laser to perform the procedure. This is known as a wavefront-guided LASIK procedure and produces outstanding results.

LASIK in the 90s involved physically cutting the surface of the eye with a keratome (blade) and relied on the precision of the surgeon's hand.

[+] jcranberry|6 years ago|reply
Here are some relevant quotes from the FDA study for you.

In each of the PROWL studies, less than 1 percent of patients experienced difficulty performing their usual activities following LASIK surgery due to any one symptom.

...

* Up to 46 percent of participants, who had no visual symptoms before surgery, reported at least one visual symptom at three months after surgery.

* Participants who developed new visual symptoms after surgery, most often developed halos. Up to 40 percent of participants with no halos before LASIK had halos three months following surgery.

* Up to 28 percent of participants with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery. This is consistent with previous studies.

* Less than 1 percent of study participants experienced "a lot of difficulty" with or inability to do usual activities without corrective lenses because of any one visual symptom (starbursts, ghosting, halos, glare) after LASIK surgery.

* More than 95% of participants were satisfied with their vision following LASIK surgery. Participants were more than twice as likely to report their visual symptoms on a questionnaire than to tell them to their health care provider

https://www.fda.gov/medical-devices/lasik/lasik-quality-life...

[+] RantyDave|6 years ago|reply
These risks are not bullshit. On high contrast images I see not just 'halos' but more like blobs. Things it ruins: stars - looking at the night sky is ruined forever; good quality cinema - white letters on a black background are toast. Etc etc. I regret the almighty shit out of Lasik, but most people don't.
[+] at_a_remove|6 years ago|reply
A few years back I was getting a little eye surgery done, under local, a quasi-regular thing with me. Because I like hearing about people's jobs, I asked my surgeon what he thought of LASIK. He has a very dry presentation. He paused and then began, "You'll notice I'm wearing glasses ..."

I filed that one away.

[+] nominated1|6 years ago|reply
Dry eyes and halos, many I speak to say they have these issues. Followed by “I don’t regret it, best thing ever”. I walk away mostly confused.

Watching my sister, who had it done ~10 years ago, struggle to stay between the lines on the freeway at night due to halos I wrote it off completely. Even with these issues she’s perfectly happy with the results. Again, I don’t get it.

[+] krapht|6 years ago|reply
I have halos, very occasional dry eyes. Was worth it.

I was myopic (20/350) that got corrected to 20/15. Things I can do now: * Being able to lay in bed and look around the room and see things in focus. * Being able to lay in bed and look at my significant other and it not be a out-of-focus blurry mess. * Being able to get up in the middle of the night to go to the bathroom without hunting for glasses. * Being able to go swimming without goggles. * Avoiding the discomfort of contact lens wear and cleaning. * Being able to do read while laying on the couch without bending my frames. * Avoiding possibility of eye infection due to dirty contact lenses. * Avoiding the need to clean and wash glasses due to dirt. * Avoiding the painful removal of contact lenses after falling asleep with them in due to tiredness.

etc, etc etc

[+] loh|6 years ago|reply
Am I one of the lucky ones? I see quite a few negative comments about dry eyes, halos, etc., but for me that really only lasted about a week or two. It healed so quickly that I actually don't even remember now how long it took, exactly. With that said, I made sure to go to a surgeon with a lot of experience, using the latest proven tech. I spent $4500 on it and I feel it was worth every penny.
[+] RedDeckWins|6 years ago|reply
My wife is an ophthalmologist and would never get LASIK. The benefit of potentially not having to put contacts in every morning just does not outweigh the possible complications.
[+] JohnFen|6 years ago|reply
Yes, this is why I was never willing to get the procedure done. The risk/reward ratio is too unfavorable. Even if the percentage of people who have problems is very low, those problems are permanent. To take the risk of permanent injury just to avoid the inconvenience of wearing glasses never made sense to me.
[+] ggreer|6 years ago|reply
Isn't the cumulative risk of complications from contacts similar to the risks of LASIK? Contacts increase the rate of eye infections and corneal ulcers. In some cases these issues lead to permanent damage, even blindness.
[+] buboard|6 years ago|reply
Sounds like she s overly cautious. I hated all kinds of glasses and contacts, and even some dryness sometimes and some glare at night is incomparably better than having to rely on those. Then again, i m lucky that i only had to do it in one eye, so i can compare vision with the intact one. Still, would recommend 100%.
[+] keldaris|6 years ago|reply
What does she think about phakic intraocular lens implantation as an alternative to LASIK/PRK?
[+] PhasmaFelis|6 years ago|reply
I didn't know it was this bad, but I decided not to get LASIK for a different reason. It'd fix my near-sightedness, but also normalize my superior close-up vision. I can easily read ultra-fine print that most people need a magnifying glass for, and LASIK would destroy that. Absolutely not worth the small benefit of getting rid of my glasses.
[+] artificialLimbs|6 years ago|reply
Ha! I thought I was the only one that loved being able to see any swimmers in my water bottle. I guess that's more of a drawback, but being able to have magnifying vision is pretty awesome. I use contacts sparingly when working, and glasses the rest of the time, and the maintenance thereof is not really a big deal.
[+] rhinoceraptor|6 years ago|reply
I didn't even realize people with normal eyes couldn't see as closely as I could. Is it really true that normal eyes have a near point of almost 10 inches?
[+] llsf|6 years ago|reply
My husband is an Optometrist, and it did not do LASIK for his own eyes. Actually, I do not think I know one Optometrist in our circle of friends who did LASIK. They pretty much all wear either contact or glasses. It does not seem like we should ban LASIK, but LASIK is not for everyone. And here in US, LASIK is a lucrative business. I would not be surprised that some LASIK have been done on people who were not good candidate at the first place. And now those people are disappointed, after spending several thousand dollars.
[+] smogcutter|6 years ago|reply
Interesting side note about LASIK, it’s caused problems for the navy: it’s getting harder and harder to fill submarine crews. It used to be that for top-qualified recruits, the ones with perfect vision became pilots and the rest got stuffed into subs. Then the military started providing LASIK, and suddenly no one’s dq’ed from flying because of their vision. The submarine force is a tough sell to begin with, but when the alternative is Top Gun forget about it.
[+] gamblor956|6 years ago|reply
Not sure where you heard that. Submarine duty is considered prestigious in the US Navy and most people who serve aboard a submarine wouldn't be rated for (or even interested in) pilot duty.
[+] melling|6 years ago|reply
How many pilots does the Navy have?

I’m pretty sure it’s a small percentage of people in the Navy.

[+] diveanon|6 years ago|reply
I am a happy lasik success story. The procedure changed my life and allowed me to start diving again, it is the best money I have ever spent.

I think it is unfair to blame suicides on the procedure, as they warn you about the risks beforehand and are clear that you may have some halos/blurriness for a few months.

Blame the suicide on mental illness, because that is where the problem actually lies. Anything else seems like an emotional play to get money from a lawsuit.

[+] consultutah|6 years ago|reply
There has been nothing I’ve spent money on that has been as useful and valuable to me as getting lasik 15 years ago. If I had known ho much it would change my life I would pay 10 times as much.
[+] Vysero|6 years ago|reply
I was considering LASIK but why risk it? Glasses aren't so bad and I could always get contacts if I really wanted. Even without my glasses I can see okay, not great but okay.
[+] dreamcompiler|6 years ago|reply
Most people I know who have had it are happy. But I'll never do it. I have a fantastic microscope available just by taking off my glasses and I don't want to lose that.