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FDA Taking Closer Look at Lasik

By MATTHEW PERRONE,

Posted: 2008-04-24 08:10:53

Filed Under: Business News, Health News

WASHINGTON (April 23) - A decade after it first approved devices for laser eye-correcting surgery, the Food and Drug Administration is taking a closer look at grievances from patients, including blurred vision and dry eyes.

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The government should issue clearer warnings about the potential risks of Lasik eye surgery, advisers to the Food and Drug Administration said Friday. The recommendation came after dissatisfied patients testified they suffered severe eye pain, blurred vision and other problems after undergoing Lasik.

An estimated 6 million Americans have undergone Lasik surgery, which permanently reshapes the cornea, a clear layer covering the eye. There are no guarantees of 20/20 vision and the long-term safety of the procedure is still unknown.

But the society of eye surgeons who perform Lasik says 95 percent of patients are satisfied with their results. The group is expected to tell regulators later this week that most side effects from Lasik surgery are rare and temporary.

FDA will hear from Lasik eye surgeons as well as disgruntled patients at a meeting Friday of its outside panel of eye experts.

The agency will ask the expert panel whether educational materials given to patients considering Lasik need to be changed or updated, according to documents posted to the agency's Web site Wednesday.

Regulators agreed to hold the meeting after years of complaints from a small group of patients who say their eyesight has been irreparably damaged by the surgery. The agency received 140 reports of Lasik-related problems between 1998 and 2006, according to an agency spokeswoman.

Dean Kantis, who is scheduled to speak Friday, says his vision has suffered since his Lasik surgery in 1998.

"My life is a blur," Kantis said. "When I look at a computer screen I see two pages; when I look up at the moon, I see three of them."

Double vision, night-vision disturbances and dry eye are among the side effects outlined in literature given to Lasik patients, but Kantis and others say physicians often gloss over the risks.

"Just before the procedure they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," Kantis said.

An FDA spokeswoman pointed out the agency has no authority over how physicians handle patients. Regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' quality of life after surgery.

Investors will be watching Friday's meeting to gauge what impact concerns could have on Lasik laser manufacturers, which include Advanced Medical Optics Inc., Alcon Inc., and Bausch and Lomb.

Analysts already expect Lasik procedures to decline 5 to 15 percent this year as economic conditions make the procedure, which costs between $1,500 and $5,000, less financially feasible for many consumers.

The industry's largest player, Advanced Medical Optics, cut its 2008 earnings outlook earlier this year on the expectation of fewer procedures.

But Wachovia analyst Larry Biegelsen said Friday's FDA meeting could prove beneficial for the industry if it shows patient outcomes are relatively positive.

In a note earlier this month, Biegelsen wrote that a new analysis of 2,200 Lasik patients should provide "a good defense" for companies and physicians. The results, which eye doctors will present Friday, show 95 percent of patients across 19 studies were satisfied with their vision following surgery.

Biegelsen rates Advanced Medical Optics "market perform."

Shares of Advanced Medical Optics Inc. fell 28 cents, or 1.4 percent, Wednesday to $20 while Alcon Inc. rose 49 cents to $152.05.

Copyright 2008 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.

2008-04-23 14:39:39

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83 comments

cchambersrp 04:14:18 PM Apr 25 2008

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The medical industry in this country in full of MAYBES!!! There is not a damn thing out there that has totally positive results of any kind!!!
They will never be able to help ALL people with the many problems we all have.
I wear glasses and have for years. I would never think of having these idoits cut into my eyes because they can not gaurentee the results. Anyone that vain deserves just what they get!!!!

tommiata1 09:06:06 PM Apr 24 2008

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copteez7....I would bet the farm you are a complete jerk to 90% of people who come in contact with you. Telling someone they are a "sourpuss because they didn't have "perfect" results, get over it", when the surgery has blinded them???
If life was fair, YOU would have been one of the ones blinded.....then you could "get over it".

KikiTravels 07:30:45 PM Apr 24 2008

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I had surgery in 1998 and almost everything that could go wrong went wrong. It cost me $3k, I got SOS (sands of the sahara), epithelial cells under the flap, white blood cells rushed to the eye to fight a foreign object releasing enzymes that melt the stroma and melted my cornea so I now have a plus vision which means I can't see close up and I am only 28 today and the surgery was when I was 20ish during college. My eye was over-corrected, I couldn't see....I was blind in one eye....my eye was so foggy I looked like Arnold Swchazaniger "the frost man". If you looked at my eye it was no longer a beautiful green, instead it was white from white blood cells under the flap! My vision was like looking through a foggy mirror. Imagine after you get out of the shower and looking into your mirror...that was all I could see. I experienced headaches, stress, I had to take multiple drops including topical steriroids in my eyes EVERY 15 minutes for days! I was in the doctors office constan

M2MODON 06:52:16 PM Apr 24 2008

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I had the surgery too. Didn't "take" the first time so I had an enhancement.
2 years later, back to wearing glasses. I have cronic dry eyes now, which make wearing contacts very difficult. Also my close up vision went too. My husband also had the surgery the same day I did, his lasted a little longer than mine did but he's back to wearing glasses when he drives and watched the TV. 12 grand down the tubes. Now they want me to come back for another enhancement. I think I'd rather poke a sharp stick in my own eyes. The only advantage was that my vision was improved somewhat, but for 6 grand, I should be able to see the alarm clock 2 feet away comfortably. I don't recommend this surgery to anyone.

copteez7 06:20:26 PM Apr 24 2008

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To each their own, that is why we live where we do. I had lasik in order to be able to work, contacts and glasses were a hazard for me. I have some problems I did not have before, but I would rather have them than be legally blind. I was 20/200 and I'm now 20/15. Those that want to be a sourpuss because they didn't have "perfect" results, get over it. Life is all about risks.

Chattchat2 02:06:43 PM Apr 24 2008

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Nordicman23.......You must be really ugly otherwise you would think differently. If I were really ugly I wouldn't mind glasses either.

Chattchat2 02:05:43 PM Apr 24 2008

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Lasik was the best thing I ever did. No pain and instant results. Not everyone is a good candidate for this surgery but any good surgeon would tell you that up front.

Aftonmoon 01:00:01 PM Apr 24 2008

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Only an idiot would have eye surgery if the only reason is to avoid wearing glasses. And remember even if the procedure is 95 percent effective, of 6 milliion patients that is 300,000 with problems. I wound't risk going blind if the chance were one in a billion. Remember you are 100 percent blind if it happens to you.

Mitser Happ 12:58:34 PM Apr 24 2008

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Tell ya what. No matter how low the "theoretical" complication rate, if one happens to you, it's 100% - for the rest of your life!

Helaurin 12:57:08 PM Apr 24 2008

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I had laser surgery a few years ago. It wasn't that I minded wearing glasses, but my vision had reached a point where glasses weren't able to make some of the corrections I needed. Without the surgery, I was seeing halos, esp. driving at night, double vision with offset images and I was becoming a danger on the road. I need to drive to get to work, so just not driving wasn't an option. Plus I was getting more headaches and migraines than ever before. Fortunately, the procedure worked well for me - I have good vision now, see great for driving, and very infrequently get migraines now. It's important to check out the doctor's records, be sure you understand the risks, and if there's any problems afterwards, get back to the doctor asap so that a minor issue doesn't become a major issue.

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