WASHINGTON, April 25, 2008

Eye Surgery Patients Describe Woes To Feds

Lasik Eye Surgery Patients Suffered From Myriad Eye Problems - Some Even Driven To Suicide

    • David Shell shows a chart of his vision after having Lasik surgery while speaking at a Food and Drug Administration (FDA) hearing in Gaithersburg, Md., Friday, April 25, 2008.

      David Shell shows a chart of his vision after having Lasik surgery while speaking at a Food and Drug Administration (FDA) hearing in Gaithersburg, Md., Friday, April 25, 2008.  (AP Photo/Luis M. Alvarez)

    • In this Nov. 1, 2005 file photo, Dr. Colman Kraff docks the femtosecond laser, flattening the cornea, of patient Steve Parker as the initial step in creating the Lasik flap during Parker's eye surgery at Kraff's offices in Chicago. A decade after Lasik eye surgery hit the market, patients left with fuzzy instead of clear vision are airing their grievances before federal health officials.

      In this Nov. 1, 2005 file photo, Dr. Colman Kraff docks the femtosecond laser, flattening the cornea, of patient Steve Parker as the initial step in creating the Lasik flap during Parker's eye surgery at Kraff's offices in Chicago. A decade after Lasik eye surgery hit the market, patients left with fuzzy instead of clear vision are airing their grievances before federal health officials.  (AP Photo/Charles Rex Arbogast)

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(AP)  In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son's suicide. The advisers recommended that the government warn more clearly about the risks of the hugely popular operations.

About 700,000 Americans a year undergo the elective laser surgery. Like golf star and famed Lasik recipient Tiger Woods, they're hoping to throw away their glasses, just as the ads say.

And while the vast majority benefit - most see 20-20 or even better - about one in four people who seeks Lasik is not a good candidate. A small fraction, perhaps 1 percent or fewer, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night.

"Too many Americans have been harmed by this procedure and it's about time this message was heard," David Shell of Washington told the Food and Drug Administration's scientific advisers before their recommendation that the FDA provide clearer warnings.

Shell held up large photographs that he said depict his blurred world, showing halos around objects and double vision, since his 1998 Lasik.

"I see multiple moons," he said angrily. "Anybody want to have Lasik now?"

Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye and pupil size should have disqualified Dorrian, but he received Lasik anyway - and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year.

"As soon as my eyes went bad, I fell into a deeper depression than I'd ever experienced, and I couldn't get out," Gerard Dorrian read from his son's suicide note.

Matt Kotsovolos, who worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, said doctors classify him as a success because he now has 20-20 vision. But he said, "For the last two years I have suffered debilitating and unremitting eye pain. ... Patients do not want to continue to exist as helpless victims with no voice."

The sober testimonies illustrated that a decade after Lasik hit the market, there still are questions about just how often patients suffer bad outcomes from the $2,000-per-eye procedure.

But one thing is clear, said Dr Jayne Weiss of Detroit's Kresge Eye Institute, who chairs the FDA advisory panel: "This is a referendum on the performance of Lasik by some surgeons who should be doing a better job."

The FDA advisers - a group of mostly glasses-wearing eye doctors - recommended that the agency make more clear the warnings it already provides for would-be Lasik patients:

- Add photographs that illustrate what people suffering certain side effects actually see, such as the glare that can make oncoming headlights a huge "starburst" of light.

- Clarify how often patients suffer different side effects, such as dry eye. Some eye surgeons say 31 percent of Lasik patients have some degree of dry eye before surgery, and it worsens for about 5 percent afterward. Other studies say 48 percent of Lasik recipients suffer some degree of dry eye months later.

- Make more understandable the conditions that should disqualify someone from Lasik, such as large pupils or severe nearsightedness.

- And spell out that anyone whose nearsightedness is fixed by Lasik is guaranteed to need reading glasses in middle age, something that might not be needed if they skip Lasik.

That's a big reason why Weiss, the glasses-wearing ophthalmologist, won't get Lasik even though she offers it to her patients.

"I can read without my glasses and ... operate without my glasses, and I love that," she said. "The second aspect is I would not tolerate any risk for myself. ... Does that mean Lasik is good or not good? It means Lasik is good but not for everyone."

Lasik is marketed as quick and painless: Doctors cut a flap in the cornea - the eye's clear covering - aim a laser underneath it and zap to reshape the cornea for sharper sight.

The FDA agrees with eye surgeons' studies that only about 5 percent of patients are dissatisfied with Lasik. What's not clear is exactly how many of those suffer lasting severe problems and how many just didn't get quite as clear vision as they had expected.

The most meticulous studies come from the military, where far less than 1 percent of Lasik recipients suffer serious side effects, said Dr. David Tanzer, the Navy's Medical Corps commander. That research prompted Lasik to be cleared last year both for Navy aviators and NASA astronauts.

"The word from the guys that are out there standing in harm's way, whose lives depend on their ability to see, are asking you to please not take this away," said Lt. Col. Scott Barnes, a cornea specialist at Fort Bragg who described Army troops seeking Lasik after losing their glasses in combat.

No one's actually considering restrictions on Lasik - but the FDA is pairing with eye surgeons to begin a major study next year to better understand who has bad outcomes.

"Millions of patients have benefited" from Lasik, said Dr. Peter McDonnell of Johns Hopkins University, a spokesman for the American Academy of Ophthalmologists. "No matter how uncommon, when complications occur, they can be distressing. ... We're dedicated to doing everything in our power to make the Lasik procedure even better for all our patients."


© MMVIII The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.
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by thgdriver April 27, 2008 4:10 PM EDT
Just for the record, my son had this done about 10 years ago or so. He wore glasses before starting school, then switched to contacts.

Other then a mild dry eye condition he did not have any problems at all and recommends it to any one that wants freedom from glasses/contacts.
Reply to this comment
by thgdriver April 27, 2008 4:01 PM EDT
"As soon as my eyes went bad, I fell into a deeper depression than I''d ever experienced, and I couldn''t get out," Gerard Dorrian read from his son''s suicide note.

Reading his own note it seems to me this guy suffered from depression "before" he got the surgery.
Reply to this comment
by incog-nito April 27, 2008 3:59 PM EDT
thgdriver: No, but some idiots are already blaming the "libs". Read below.
Reply to this comment
by thgdriver April 27, 2008 3:51 PM EDT
Hummmmmm, situation normal here I see, Some one is told not to have a procedure done, they have it done any how and it''s every one''s else''s fault but theirs.

If this tired thread has any history at all, It Won''t be long before some idiot is blaming Bush for this. LOL.
Reply to this comment
by thgdriver April 27, 2008 3:45 PM EDT
Hey ophthalmolog, I hope your operations go a lot better then your annoying quadra posting here.
Reply to this comment
by cberger April 26, 2008 2:39 AM EDT
I am a board certified ophthalmologist (cornea specialist) who performs LASIK and PRK. What most refractive surgeons omit telling patients is that refractive surgery changes the curvature and dynamics of the cornea.This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult.

If the preoperative,operative and postoperative information is available it can be used to better calculate the true intraocular pressure and implant power.

Most refractive surgery patients are in their 20s and 30s but glaucoma and cataracts don''t become problems for decades later. By this time the medical record is lost or unavailable.

There is only one web-based refractive surgery database (SAFEGUARDYOURSIGHT) where patients can store this information for future use.

Whether you use this database or not it is important to obtain your medical record for safekeeping. You will need it one day!
Reply to this comment
by cberger April 26, 2008 2:38 AM EDT
I am a board certified ophthalmologist (cornea specialist) who performs LASIK and PRK. What most refractive surgeons omit telling patients is that refractive surgery changes the curvature and dynamics of the cornea.This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult.

If the preoperative,operative and postoperative information is available it can be used to better calculate the true intraocular pressure and implant power.

Most refractive surgery patients are in their 20s and 30s but glaucoma and cataracts don''t become problems for decades later. By this time the medical record is lost or unavailable.

There is only one web-based refractive surgery database (SAFEGUARDYOURSIGHT) where patients can store this information for future use.

Whether you use this database or not it is important to obtain your medical record for safekeeping. You will need it one day!
Reply to this comment
by cberger April 26, 2008 2:27 AM EDT
I am a board certified ophthalmologist (cornea specialist) who performs LASIK and PRK. What most refractive surgeons omit telling patients is that refractive surgery changes the curvature and dynamics of the cornea.This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult.

If the preoperative,operative and postoperative information is available it can be used to better calculate the true intraocular pressure and implant power.

Most refractive surgery patients are in their 20s and 30s but glaucoma and cataracts don''t become problems for decades later. By this time the medical record is lost or unavailable.

There is only one web-based refractive surgery database (SAFEGUARDYOURSIGHT) where patients can store this information for future use.

Whether you use this database or not it is important to obtain your medical record for safekeeping. You will need it one day!
Reply to this comment
by cberger April 26, 2008 2:26 AM EDT
I am a board certified ophthalmologist (cornea specialist) who performs LASIK and PRK. What most refractive surgeons omit telling patients is that refractive surgery changes the curvature and dynamics of the cornea.This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult.

If the preoperative,operative and postoperative information is available it can be used to better calculate the true intraocular pressure and implant power.

Most refractive surgery patients are in their 20s and 30s but glaucoma and cataracts don''t become problems for decades later. By this time the medical record is lost or unavailable.

There is only one web-based refractive surgery database (SAFEGUARDYOURSIGHT) where patients can store this information for future use.

Whether you use this database or not it is important to obtain your medical record for safekeeping. You will need it one day!
Reply to this comment
by incog-nito April 26, 2008 2:00 AM EDT
I had Lasik 8 years ago and I can see like the day I was born. 20/15 vision in both eyes, up close and far.

Once again, the doom and gloom liberal media trying to ruin a good thing.


--------------------------------------------------------------------------------

Posted by ddhinnyc at 03:38 PM : Apr 25, 2008

Hey idiot, this news is front and center at Fox News. I guess that also means more gloom and doom from the wingnut media.
Reply to this comment
by vincan-2009 April 25, 2008 10:38 PM EDT
You are really sad if you can''t talk about lasik without saying something to blame on liberals. It doesn''t take any kind of liberalism to look at the risks of any procedure. Pathetic.
Reply to this comment
by bluestardad April 25, 2008 10:36 PM EDT
HEY HERE IS ONE FOR YOU....

HEALTH INDUSTRY CURE SOMETHING ANYTHING!

DONT TREAT PROBLEMS CURE THEM!

PROVE TO AMERICA THAT YOU ARE WORTH THE BILLIONS WE SPEND ON YOUR MONEY GRUBBING BEHINDS!

NATIONAL HEALTH CARE IS COMING SO YOU AND YOUR INSURANCE PARESITES ARE GONNA HAVE TO GET IT WHILE YOU CAN!

AMERICA STAND UP OR SHUT UP!

Reply to this comment
by estabwary April 25, 2008 8:42 PM EDT
I was nearly blind and have good vision after LASIK.
No side effects. Contacts were not an option due to dry eye. No complaints here.
Reply to this comment
by nothappyatall April 25, 2008 8:38 PM EDT
"when he was told he wasn''t a good Lasik candidate, but went ahead anyway - and his father, Gerald, described six years of eye pain and blurred vision"

So let''s see, the doctor tells you that you are NOT a good candidate for this procedure but you go ahead and do it ANYWAY, and now complain about the poor results??


"5% of 7,600,000 is 380,000 in discomfort and/or pain!
Posted by flagShip-usa"

Yes, BUT that means 7,220,000 had SUCCESSFUL procedures and improved sight.
Reply to this comment
by flagship-usa April 25, 2008 8:06 PM EDT
5% of 7,600,000.00 is 380,000.00 in discomfort and/or pain!
Reply to this comment
by rdhiers April 25, 2008 6:54 PM EDT
I had LASIK several years ago as an Administrator of an Eye Surgery Center. Minor complications during surgery left me with double vision in my right eye! I regret ever having it done.
Reply to this comment
by tmn April 25, 2008 6:24 PM EDT
This investigation is NOT about those who have had the procedure successfully: it is about those who have had the procedure unsuccessfully.

Comparison - when Vioxx was taken off the market, it was not because of those who obtained pain relief from it - it was because of those who had a heart attack because of it.
Reply to this comment
by ricardosolar April 25, 2008 4:58 PM EDT
I had the procedure a few years ago and it was the best money I have ever spent
Reply to this comment
by pared1 April 25, 2008 4:40 PM EDT
My only regret was that I didnt do this 10 years ago, and I''''ll wager 98% of the patients feel the same way.

Posted by taylor2124

I agree 100% as does my sister-in-law, my nephew and many friends. I think the worst part was wearing those protection goggles at night for a week when sleeping.
Reply to this comment
by gryphon501 April 25, 2008 4:34 PM EDT
my sister had the procedure and her vision is now 20/10! That''s right, her vision is actually better than what is normally considered perfect! No complications either.
Reply to this comment
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