Is LASIK Eye Surgery Safe? FDA Scientist Regrets Saying 'Yes'

Politics Daily ^ | 2/12/11 | Bonnie Goldstein

[Nachum]

In Washington, D.C., a culture that embraces regulatory oversight and rule-making and where bureaucracies are everywhere, no federal agency is more warren-like than the Food and Drug Administration, which regulates the safety and efficacy of food, pharmaceuticals, cosmetics and medical devices.

The health and well-being of every American depends on the FDA's rigorous collecting, sifting and interpreting of data to approve products ranging from those that cure nail fungus to devices that electronically zap the brain to relieve anxiety. FDA regulators are scientist bureaucrats who tirelessly navigate the tedious but essential world between reports and medicine in a poorly lit building with very narrow hallways. They do important work, but FDA scientists don't always get it right.

This is a story about one scientist haunted by what, he fears, was a bad decision. Between 1996 and 2000, the scientist, Dr. Morris Waxler, was chief of the FDA's Diagnostic and Surgical Devices Branch and in charge of approving the LASIK medical device to restore visual acuity. And now, Waxler thinks that the FDA's standards were not tough enough. In 2008, an FDA advisory panel was urged by unhappy patients to re-evaluate the long-term effects of LASIK surgery and around the same time, patients began contacting him personally to report bad outcomes, including blurred and double vision.

[freedumb2003]

>>I got LASIK six years ago. No regrets, whatsoever.<<

Check back with us in 20 years. Or, use your voice interface to do so, anyway.

[Bronzy]

I want to add that I think its big success is with near sighted patients. If you have presbyopia, then I would ask if if would help. In presbyopia, they may do one eye like the contact lens treatment - one lens for near and one lens for far sight. If Lasix can treat presbyopia, I am for it.

[A.A. Cunningham]

Publicly demonstrating how ignorant you are isn’t a character trait to be proud of.

[Dawggie]

I agree. I have one set of eyes and I do not want to screw them up. I will keep my glasses thank you.

[freedumb2003]

>>Publicly demonstrating how ignorant you are isn’t a character trait to be proud of.<<

Healthy skepticism that prolongs sight is always to be lauded.

Trust me, in 20 years the demand for audio interfaces for the newly blind will be much in demand.

[Wissa]

Check back with us in 20 years. Or, use your voice interface to do so, anyway.

The Wiki article on LASIK says the risk of significant loss of vision with LASIK is 1 in 10,000. Risk of significant loss of vision with contact lenses is 5 times as high. People have been getting the surgery for over 20 years now, and I'm not aware of any studies reporting the bad longterm outcomes you're warning people about.

Is there some particular reason that you seem so determined to frighten people away from getting a medical procedure done that might make them happier?

[freedumb2003]

>>The Wiki article on LASIK says the risk of significant loss of vision with LASIK is 1 in 10,000. <<

Ah, Wiki. A good source for information about pop culture. I am sure its background on Donny Osmond is quite exhaustive.

Anyone who uses Wiki as a source should bear the results of their own research.

>>Is there some particular reason that you seem so determined to frighten people away from getting a medical procedure done that might make them happier?<<

Yes — they should be concerned about long-term blindness. Except in extreme cases this operation makes no sense.

As I said, eyes cannot be replaced. It might be worth the risk to some. Not to me.

[catnipman]

“Thanks. I’ve wondered about that”

One of the dirty little secrets of LASIK is that it doesn’t really help presbyopia. All it does is change when you need classes. If you happen to be like me and are near-sighted, then you wouldn’t need glasses for distance usage, but would have to use them for close work, which I can do fine now without glasses at all.

To overcome this, they try to convince you to surgically set one eye with a close focal length and one eye with a far focal length, sort of like having one eye set to macro vision and one set to telephoto vision. I simulated this with contacts and felt I had sub par vision all the time, so was smart enough to not go through with the surgery.

[Varsity Flight]

All this bureau nonsense should/could have been avoided by requiring EVERY H.S. graduate, trained in any school system from age 5 on, to be prepared to be licensed in the ability to argue their own cases before a verdict box of 12, the way it is supposed to be.

We would know public information, probably much sooner, if this were the case. Furthermore, the incentive for govt. protected fascism would be curtailed. And frivolous plaintiff costs absorbed by the loser.

[boatbums]

I had Lasik surgery in 2001 and went from 20/400 vision to 20/15,20/20. After the surgery I experienced dry eyes that I resolved by using a good moisturizing eye drop. There was also some double vision and a halo effect around lights especially at night, However, after two or three months these side effects completely cleared up and I have not had even one problem in over ten years. It was one of the best things I have ever spent money for ($4500 at that time). My doctor was an expert in the field, he had been one of the pioneers for the Eximer laser, he taught seminars and only he ever touched the machine for the procedures. He provided one year of follow up visits after the surgery. I was thrilled with the results and would do it again.

Anyone who is thinking of doing this MUST be well screened because not everyone should have it done. Also, I would highly suggest NOT bargain hunting - it's your eyesight!!! Make sure your doctor is well known and has readily available references from patients. I can't begin to tell you how great it is to be totally free from glasses or contacts. I do not regret it one bit.

[catnipman]

They actually cut the cornea with a microkeratome:

http://www.lasik1.com/LASIK_Detailed.html

I'm sure that makes you feel much better!

[Wissa]

Ah, Wiki.

If you have a contradictory source to refute it, I'm open to reading it.

As I said, eyes cannot be replaced. It might be worth the risk to some. Not to me.

That's your choice, and feeling that way, you definitely shouldn't have it done. But you're not just saying what YOU'D do. You're warning people about dangers with zero evidence to support your contentions. I know a lot of people that have had the surgery, and every one of us would do it again in a heartbeat. It's improved our lives that much.

[RowdyFFC]

In February of 2003 I was looking for a job and worked temporarily for a company transcribing medical conference recordings. One of the company’s we did work for was Alcon, who manufactures artificial tears. I transcribed a conference that was held in Madrid with international opthalmologists that was assisting Alcon with development of a better formula for their product. It sems the preservatives in their current recipe for artificial tears was causing scarring tissue on patient’s eyes because of the chemical reaction when the artificial tears dropped onto the eyeball. They KNEW this was happening. Didn’t bother them, they were still placing it on the shelves anyway until they could develop a new formula that ‘hopefully’ would not have the same chemical reaction or sans preservatives.

At this conference it was rather amazing to hear them describe all the side effects of LASIK, one such being their ooops slips when they managed to damage the patients tear ducts, and go ohhhhh my I just whacked off your natural ability to produce tears that lubricate your eyes’!!!! Oh myyyy, well, NOW, you’re forever going to have to use artificial tears...that leave SCARS on your eyeballs! NO PROBLEMO!

WOW! They had just invented a new disease for eye patients—dry eye syndrome—that just created a nice new cash cow for their practice! And they were ‘joking’ about it!

Hopefully by now they have developed a new product that is not leaving scar tissue on people’s eyeballs!

So, there went my desire for LASIK surgery. I’ll stick with my monthly contact lenses, thank you very much! I have NO problem at all pulling them out and keeping them clean...and I haven’t spent nearly $4200 yet on them. Plus, I barely know they’re in my eye.

[Polynikes]

I had my eyes done about 2002. I was near sighted with 20/150 and 20/300 and some astigmatism. I was corrected to be far sighted and the astigmatism was corrected. I am still 20/20 in both eyes but only use cheapy reading glasses for close up work.

The ability to hold your eyes absolutely still during the procedure is vital as is the post-op treatment with various eyes drops. My optometrist was obsessive about the post-op care. You also have to be evaluated prior to the procedure to see if your are a good candidate. I have no regrets and it was some of the best money I ever spent.

[Hildy]

I had Lasik in 1997 before anyone else I knew had it. It was great then and yes, there were some things that weren’t so good...like my night vision isn’t very good..but I had 20/20 vision for the first time in my life. Almost 15 years later I wear glasses and contacts some times. It doesn’t stop the natural aging process. I would do it again in a heartbeat.

[aliquando]

I think it depends on what you pay. My wife had it done for about $4,000 6 years ago. No more headaches or glasses. It was from a very reputable Dr. in Atlanta. Stay away from those $800 dollar offers.

[AnotherUnixGeek]

This is a story about one scientist haunted by what, he fears, was a bad decision. Between 1996 and 2000, the scientist, Dr. Morris Waxler, was chief of the FDA's Diagnostic and Surgical Devices Branch and in charge of approving the LASIK medical device to restore visual acuity. And now, Waxler thinks that the FDA's standards were not tough enough.

I had LASIK done in 1996 - in another country which used the most modern equipment, since the FDA's standards at that time had only approved a single laser for experimental, off-brand use in LASIK - a laser that was originally made to etch circuit boards. It's one of the best things I've ever done for myself - my vision is still amazing almost 15 years later.

The FDA has gone far beyond legitimate regulation to prevent fraud and abuse - these days they're an intrusive nanny pre-empting the ability of Americans to make their own informed choices on health care.

[Billthedrill]

I had it done in '03. Found a brilliant surgeon in Vancouver BC, one of the originals. I had severe astigmatism in one eye - 20/300 - moderate in the other. One month later I was delighted to have 20/20 in one eye, 20/30 in the other.

It wasn't good enough. He gave me a free re-treat in the "bad" eye and when he was done it was 20/15 in both eyes together. I think I was told maybe 20 times, "Hey, you're over 40, so even when we get done you're going to need reading glasses, you realize that?" Yeah, Doc. 10-dollar cheaters instead of 300-dollar trifocals. It isn't a problem.

Some dry-eye issues afterward, nothing severe. Had a few rings night-driving but then I did with glasses too. Now that's gone away. I can now shoot at 500 meters, iron sights, what I couldn't even see at 200 when I was 30.

Some advice: find somebody who's done it a lot and who has a very good record of success. It isn't for everybody, so make sure you get screened by somebody in a position to tell you you're not a candidate if you don't have sufficient corneal tissue to spare. Make sure it's what you really want to do, and then do it fearlessly.

In my case it was a life-changing success. It isn't for everyone - at the time of my surgery there was a 15% chance of a neutral or negative outcome. I was one of the 85% and I'm absolutely delighted.

[Cyman]

FDA? Aren’t they the ones that decided after 40 years and hundreds of millions of doses that propoxyphene( Darvon, Darvocet)should not be on the market because it was not effective or safe?

[UnwashedPeasant]

Who was your LASIK doctor?

(The ones I hear ads for are all named something like Mohammad.)