Morgan Stanley
India | Thursday, 21 August 2008
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Federal panel seeks clearer warnings on Lasik eye surgery

By Lauran Neergaard
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Posted 26 April 2008 @ 02:34 pm GMT

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.

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, to discuss Lasik surgery
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, to discuss Lasik surgery. (AP Photo)

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.

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