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FDA Panel Urges Stronger Warnings for LASIK Surgery
Washington Post ^ | April 25, 2008 | Amanda Gardner

Posted on 04/26/2008 10:28:40 AM PDT by Anti-Bubba182

FRIDAY, April 25 (HealthDay News) -- Golf great Tiger Woods lauds vision-correcting LASIK surgery as "life changing." NASA now allows astronauts to undergo the procedure, and the U.S. military says it has been performed on 112,500 military personnel, including pilots.

But are some of the risks and complications of this elective surgery being lost in this laudatory celebration?

The U.S. Food and Drug Administration's Ophthalmic Devices Panel convened Friday to discuss post-LASIK quality-of-life issues. Its recommendation at day's end: That the FDA warn more clearly about the risks of the increasingly popular surgery, theAssociated Pressreported.

"This is ground-breaking. It's the first time anything like this has happened around refractory, or LASIK, eye surgery," said Dr. Christopher Starr, co-director of Cornea, Cataract and Refractive Surgery at New York-Presbyterian Hospital/Weill Cornell Medical College in New York City. "I think it's a good thing, because I know that the surgery, when done on the right patients, is a great, great surgery with phenomenally good outcomes."

According to the LASIK Study Task Force, formed in 2007, studies indicate a 95.4 percent satisfaction rate among patients worldwide. The Task Force consists of the FDA, the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, and the U.S. National Eye Institute.

But of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA......."

(Excerpt) Read more at washingtonpost.com ...


TOPICS: Culture/Society; Miscellaneous; News/Current Events
KEYWORDS: eyesight; lasik
It looks like a small percentage of patients have serious problems.
1 posted on 04/26/2008 10:28:41 AM PDT by Anti-Bubba182
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To: Anti-Bubba182

It’s a surgical procedure, there are always going to be a statistically small amount of patients who suffer complications or for whom the surgery is ineffective. No surgical procedure has a 100% success rate.


2 posted on 04/26/2008 10:31:47 AM PDT by infantrywhooah
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To: Anti-Bubba182
Yep. If you don't have severe long distance vision problems, the surgery could make matters worse. A good pair of contact lenses or prescription eyeglasses will satisfactorily correct the problem in the vast majority of cases.

"Show me just what Mohammed brought that was new, and there you will find things only evil and inhuman, such as his command to spread by the sword the faith he preached." - Manuel II Palelologus

3 posted on 04/26/2008 10:33:25 AM PDT by goldstategop (In Memory Of A Dearly Beloved Friend Who Lives In My Heart Forever)
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To: Anti-Bubba182

Six years ago.
LIFE CHANGING, even at age 36.
Not one problem.

If I’d hade it before basic training, Airborne and Ranger School, it would definitely have been easier.


4 posted on 04/26/2008 10:34:06 AM PDT by SJSAMPLE
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To: Anti-Bubba182

Got to have a great Doctor. Best thing I have ever done for myself.


5 posted on 04/26/2008 10:34:16 AM PDT by Shady (The Fairness Doctrine is ANYTHING but fair!!!!)
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To: infantrywhooah

Either the History or Discovery channel did a special called 20-10 in 2010.

Says they will have perfected eye surgery by then. I can wait.


6 posted on 04/26/2008 10:36:01 AM PDT by edcoil
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To: Anti-Bubba182
But of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA......."

.00182%

With a percentage of complaints that high, I think the government should create a special oversight committee to investigate, and then set up a Lasik Surgery Complaint dept. to handle all of national outrage. Of course this will need new taxes to fund it. (/sar)

7 posted on 04/26/2008 10:36:03 AM PDT by uptoolate (I don't fear the election - my God is there already - and bigger than them all.)
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To: Shady

Of course we’ll have millions of blind people in 40 years when the side effects come to fruition.....but I digress....


8 posted on 04/26/2008 10:41:51 AM PDT by stravinskyrules (Why is it that whenever I hear a piece of music I don't like, it's always by Villa-Lobos?)
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To: goldstategop
... and making clearer the conditions that should disqualify someone from LASIK, such as large pupils or severe nearsightedness

With severe myopia and the need for prisms, I would never consider this surgery. I can see well enough with glasses and I would be terrified to take the chance of irreversible damage.
9 posted on 04/26/2008 10:45:30 AM PDT by Not gonna take it anymore
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To: uptoolate

I had the surgery about 6 years ago. I was at the limit for the surgery -11.00 diopters. I chose a good doctor who had done thousands of surgeries including many who were almost as nearsighted as I. The results were very good although not perfect. But at 52 I was able to end the restriction on my driver’s license that I had for 36 years. 20/40 in one eye;
20/80 in the other. I wear glasses for night driving.
It was one of the best things I have done for me.


10 posted on 04/26/2008 10:46:44 AM PDT by Maine Mariner
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To: Anti-Bubba182
But of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA.

Now the FDA has followed up on those complaints.


140 out of 7.6 million calls for a 1.2 million dollar study?

Colin Dorrian was a law school student from suburban Philadelphia when he was told he wasn't a good candidate for LASIK, but got the surgery anyway..blah,blah,blah... suicide...

and it's the surgery's fault ?
11 posted on 04/26/2008 10:52:34 AM PDT by stylin19a
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To: Anti-Bubba182
95.4 percent satisfaction rate

What medical procedures have a higher rate? Ear wax removal? Toe nail trimming?

12 posted on 04/26/2008 10:54:48 AM PDT by Right Wing Assault ("..this administration is planning a 'Right Wing Assault' on values and ideals.." - John Kerry)
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To: Maine Mariner

Wife needs the surgery real bad. Waiting to save up some cash to get it done. Her original estimate about a year and a half ago was $2500.00. Does that sound about right?


13 posted on 04/26/2008 10:56:21 AM PDT by uptoolate (I don't fear the election - my God is there already - and bigger than them all.)
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To: edcoil

I have worn contacts for over 30 years with no problems. But the thought of someone slicing my eye, with a knife or laser, gives me the creeps. As much as I would love to have my 20-20 back, I don’t know if I am willing to take the risk.


14 posted on 04/26/2008 10:58:38 AM PDT by infantrywhooah
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To: infantrywhooah

I am the same however, even with the surgery I would need to wear reading glasses. Seems pointless to spend that kind of money and still wear glasses.


15 posted on 04/26/2008 11:01:29 AM PDT by edcoil
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To: Anti-Bubba182
I had it done five years ago, and couldn't be happier. There was no pain, and I was able to see instantly after the procedure.

The screening process was very thorough, and I would hope that any reputable ophthalmic surgeon would refuse to perform it on someone with inherent problems.

16 posted on 04/26/2008 11:03:33 AM PDT by Inspectorette
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To: Anti-Bubba182

It seems that a lot of those who had complaints had the procedures done ten years ago, before the technology had improved to the extent it has.

I wonder what exactly causes the chronic eye pain some unsuccessful patients have?

I’d love to have Lasik because I hate getting dust in my contact lenses when I ride my horse, but I’m scared to death of the procedure. The idea of lying there with my eyes open while a laser beam descends on me—AAAAUUUGGHHH! < OTTBmare jumps up off table and runs screaming out of the operative suite>


17 posted on 04/26/2008 11:03:33 AM PDT by ottbmare
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To: ottbmare
The actual time the laser is being used is approximately 15-25 seconds per eye. Plus, they do give you a little "relaxer" before.

My daughter and her husband both had it done before I did - I was a big chicken. Now I wish I'd had it done sooner.

18 posted on 04/26/2008 11:05:39 AM PDT by Inspectorette
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To: Anti-Bubba182

Had it done 5 years ago. No problems. Took a few weeks to fully adjust at 20/15. Waited until laser slicing worked and went to a doctor with lots of experience.


19 posted on 04/26/2008 11:10:47 AM PDT by Number_Cruncher
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I am an artist, and the thought of losing my eyesight is more terrifying than the thought of losing my life-BY FAR.( Yes, I'm serious.) But in 2003, I forced myself to lay there while the laser came closer and closer-totally conscious. I could feel something being done to my eyes, but it was at most mild discomfort-not painful.

Afterward, my vision had improved from 20/950 to 20/15. Or to put it another way , from legally blind or very near-so to better than perfect vision.

I regret only that I hadn't had it done years earlier. My vision went bad when I was 7 or 8 years old, BTW, so you can imagine what a change this was for me.

No problems with my eyes thus far...Prior to the surgery, I wore :

Eyeglasses (1973-2003)

Hard contacts (1979-1990)

Gas permeable contacts (1990-1997)

Soft contacts (1997-2003)

Anyone mulling over the surgery will have to make up his/her own mind, and with all surgery there's always a risk, however slight-but as I said , I only regret I didn't do it years earlier.

BTW, I believe there's a new lasik coming out soon, that not only corrects vision but corrects presbyopia-that's the bad vision that gets even people who had 20/20 all their life, once they hit 45-50 or thereabouts. I hope I'll be a candidate for a second round of lasik, once it's needed .

20 posted on 04/26/2008 11:11:18 AM PDT by Verloona Ti
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To: infantrywhooah; Anti-Bubba182
It’s a surgical procedure, there are always going to be a statistically small amount of patients who suffer complications or for whom the surgery is ineffective. No surgical procedure has a 100% success rate.

But eyesight is extremely important. I would hate to give up the quality of my corrected vision just to not have to wear glasses or contacts.

21 posted on 04/26/2008 11:11:19 AM PDT by Paleo Conservative
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Comment #22 Removed by Moderator

To: Not gonna take it anymore
If you have severe myopia, you are not a candidate for LASIK anyhow.

I had my surgery 20 years ago, when it was still a pilot program. I would not qualify for the surgery today, because I had 13.25 diopters of myopia in my left eye, and 9.85 in my right.

Now THAT is severe myopia, boys and girls.

I did not tolerate daytime contact lenses well, because of my crazy athletic activies - horseback riding in dusty conditions, kayaking, etc. - and glasses weren't practical for the same reason.

But what made the decision for me, so to speak, was when we moved from the house where we had lived for almost 20 years. Severe myopia becomes far worse in dim light. I discovered that I had been finding my way around our old house in the night by memory, and I realized that in an emergency or a fire I was functionally blind.

So I signed up for the experimental program. The surgery went well, and I had no complications except that a slight astigmatism in one eye became glaringly obvious and I had followup surgery for that.

My myopia has slightly and slowly returned in 20 years, I am probably 20/30 in my good eye and 20/40 in my bad eye now. I wear CRT (sleep-in) contacts to return my vision to 20/10 so that I don't have to wear contacts or glasses in the daytime.

It's a bit of a pain, but it beats being totally dependent on being able to find my glasses in the middle of the night!

23 posted on 04/26/2008 11:13:55 AM PDT by AnAmericanMother (Ministrix of Ye Chase, TTGC Ladies' Auxiliary (recess appointment))
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To: uptoolate
Waiting to save up some cash to get it done. Her original estimate about a year and a half ago was $2500.00. Does that sound about right?

I had mine done in Toronto by a real pro; total cost was about $1500. That was in 2003.

24 posted on 04/26/2008 11:15:33 AM PDT by xjcsa (Has anyone seen my cornballer?)
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To: ottbmare
See post 23.

I know what it's like to (1) lose a contact in the hunting field when you're 8-10 miles from civilization; (2) have your glasses fog up in the middle of a jumping course on a chilly day!

25 posted on 04/26/2008 11:16:36 AM PDT by AnAmericanMother (Ministrix of Ye Chase, TTGC Ladies' Auxiliary (recess appointment))
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To: edcoil

I agree, see post 14


26 posted on 04/26/2008 11:18:14 AM PDT by infantrywhooah
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To: Anti-Bubba182

It seems some who had problems were told they were poor candidates but went ahead anyway. This is one area where you must get the BEST doctor, not the cheapest. Even if a very small number of LASIKS go wrong, it is someone’s EYESIGHT we are talking about. A bad result can be life changing in a tragic way.


27 posted on 04/26/2008 11:19:11 AM PDT by informavoracious (God BLESS America)
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To: Anti-Bubba182

I had LASIK done in 2003 in Toronto. My prescription before LASIK was in the -3.5 range for each eye, plus astigmatism of about -1.5 in each eye. I was a bit borderline because my pupils are “huge” (their word), but I had enough corneal tissue for their scanning-spot laser (a Bausch & Lomb Technolas 217C) to treat a large-enough area to do the job. They used a B&L zero compression keratome to cut the flap; it has a very low rate of complications and less pain/quicker recovery than the all-laser procedures.

The place I had it done (Lasik MD) is a large, multi-site operation with several surgeons and a veritable army of optometrists. It has a bit of an assembly-line feel; you don’t get the personal attention from the surgeon that you might get at a US clinic.

But the optometrist staff (which handles the pre-op and post-op exams) impressed me a great deal. They were real pros, and extraordinarily thorough. I had never had an eye exam anything like it - they checked every parameter two or three times, using multiple methods: corneal mapping, corneal ultrasound, auto-refraction, wavefront topology, etc. They were the best.

I only saw the surgeon for the 10 minutes or so I was in the laser room. He looked over the chart and noticed a small inconsistency in the “axis” of the astigmatism in one of my eyes and sent me out to the optometrists for another test to confirm it, after which I went back to the laser room for the surgery.

The surgeon had done over 20,000 LASIK procedures and was the president of the Canadian Society of Refractive Surgeons (or something like that) at the time; he was one of the founders of the clinic chain.

After the ten minutes in the laser room (a process I found fascinating), they sat me in the semi-darkened recovery room for about 45 minutes and then did a quick post-op exam. The next morning I returned for a more thorough post-op, after which I caught a flight home.

My results were excellent. No appreciable side effects after the recovery period (occasional minor ghosting at night, nothing major). I can read the 20/12 line on an eye chart consistently, and on a good day I can read the 20/10 line. There are days when I’m still stunned at the clarity of my vision these days; noticably better even than with contacts or glasses before the surgery.

In another 10 or 15 years I’ll need reading glasses to counter presbyopia, but I’m hopeful that there will be a mature, reliable surgical procedure for that too by the time I need it.

Overall, I can’t recommend the surgery highly enough for people deemed to be good candidates. I also highly recommend the people at Lasik MD in Toronto and their other locations; they did a great job. It’s one of the segments of their health care system that is *not* part of the socialist system up there; if anything it’s more free-market than our own, and their technology tends to be a bit ahead of ours due to the FDA being a bit slow on approvals.

If people have questions I’d be happy to answer them.


28 posted on 04/26/2008 11:29:00 AM PDT by xjcsa (Has anyone seen my cornballer?)
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To: Paleo Conservative
I would hate to give up the quality of my corrected vision just to not have to wear glasses or contacts.

If you're a good candidate and go to a reputable clinic, the odds of losing the quality of your corrected vision is essentially zero these days.

29 posted on 04/26/2008 11:32:46 AM PDT by xjcsa (Has anyone seen my cornballer?)
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To: Anti-Bubba182

I had it done six years ago. It was scary, and looking back, I can’t believe I did it! But it worked out well. I went from “blind as a bat” to 20/30 vision. I can do without glasses 95% of the time. (Not everybody can “throw their glasses away,” but Lasik will at least reduce your dependence on glasses.)

I think some of the problems are caused by people who wear their contact lenses too close to the surgery date. I stopped wearing my contacts a full month before having the procedure. The Lasik people were very happy that I did that. Contacts change the shape of your eyes, and it’s important that your eyes are their true shape when you have Lasik done.


30 posted on 04/26/2008 11:37:34 AM PDT by Nea Wood (I'm not a bad Christian because I refuse to join you in giving other people's stuff away.)
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To: xjcsa
If you're a good candidate and go to a reputable clinic, the odds of losing the quality of your corrected vision is essentially zero these days.

I can see well enough to safely walk or go jogging without any vision correction. I can't legally drive without correction, and I wouldn't want to ride a bicycle in traffic without correction. I can read without any glasses. My biggest problem now is that I need bifocals. If I corrected my distance vision with LASIK, I would need to carry around reading glasses to do all sorts of tasks involving reading and signing documents. I'd rather wear bifocals all the time than have to constantly be putting on and taking off reading glasses.

31 posted on 04/26/2008 11:56:00 AM PDT by Paleo Conservative
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To: Maine Mariner

I had lasik done last October at age 61. I won’t tell anyone that it’s a walk in the park (my husband thought it was, so that was his experience with is surgery five years ago). Six months later, I can still tell that I’m not out of the healing process completely; eyes are dryer than they were, but not too awful. “Floaters” are worse now, but I had floaters before, so can’t blame this entirely. I CAN see, though, 20/20 in one eye and 20/15 in the other. I still reach for my (nonexistent) glasses lots of mornings, then realize “Oh, don’t need those, I can see a bump on a gnat’s bottom.”

For anyone contemplating it, if my glasses didn’t bother me too much, I wouldn’t do it. I’d just keep a nice shaped pair of glasses and “fergit it” - especially if I was over 60 - just too much physical “stuff” to deal with at this age to risk anything or to have to go through surgery. . and it IS surgery with a definite recovery time. The halos and sunbursts are better now after dark then they were at first. They were so bad at first I was SKEERED! - Oh, and taking a six-month sabbatical from the computer monitor would have been the best thing for me, too.


32 posted on 04/26/2008 11:58:59 AM PDT by Twinkie (TWO WRONGS DON'T MAKE A RIGHT !!!)
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To: SJSAMPLE
I’d hade it before basic training, Airborne and Ranger School, it would definitely have been easier.

My thinking, exactly (see my tagline)

33 posted on 04/26/2008 12:00:02 PM PDT by don-o (My son, Ben, reports to Parris Island on June 30.)
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To: Not gonna take it anymore
and making clearer the conditions that should disqualify someone from LASIK, such as large pupils or severe nearsightedness

News to me. I had severe nearsightedness until I had LASIK almost ten years ago in Canada. Since then I've enjoyed 20/20 vision and zero problems. It has been a blessing not to have to put on thick-lens eyeglasses just so I could see the alarm clock in the morning.

34 posted on 04/26/2008 12:18:58 PM PDT by hinckley buzzard
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To: AnAmericanMother
If you have severe myopia, you are not a candidate for LASIK anyhow.

Are you an ophthalmologist?

35 posted on 04/26/2008 12:50:57 PM PDT by A.A. Cunningham
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To: Anti-Bubba182

After listening to my optometrist explain why I should have Lasik to correct my myopia, I asked him why he wears glasses?


36 posted on 04/26/2008 12:56:54 PM PDT by fso301
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To: fso301
After listening to my optometrist explain why I should have Lasik to correct my myopia, I asked him why he wears glasses?

My optometrist did have the surgery done. She was very pleased with it, but her good results only lasted about 3 years before she was back to wearing glasses.

Before too many years pass, glasses wearers will be as thin on the ground as smokers are now. I'll be very visible, wearing my glasses AND smoking. I don't care much for change, I guess.

37 posted on 04/26/2008 1:01:26 PM PDT by Dianna
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To: A.A. Cunningham
No, but that's what my ophthalmologist told me, and he's the best one in Atlanta!

I think 11-12 diopters is about the limit.

38 posted on 04/26/2008 1:07:30 PM PDT by AnAmericanMother (Ministrix of Ye Chase, TTGC Ladies' Auxiliary (recess appointment))
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To: Anti-Bubba182

The problem is not the procedure as much as those who perform it. My wife had LASIK done with great success. However she went to an ophthalmologist who was part of the original LASIK clinical trials in the US and has probably done more procedures than anyone else in the country. Her doctor rigorously screens his patients and rejects about 5% who he feels are not ideal candidates for the procedure. Contrast that to having your LASIK done at a strip mall clinic by some hastily trained by seminar physician who rejects virtually no one for the procedure. Our sister in law had her procedure done at that kind of facility with less than satisfactory results.


39 posted on 04/26/2008 1:08:18 PM PDT by The Great RJ ("Mir we bleiwen wat mir sin" or "We want to remain what we are." ..Luxembourg motto)
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