Friday, April 25, 2008

FDA takes closer look at complaints from Lasik customers

This should provide additional quality information about the procedure for patients as well as the ophthalmologists who perform this procedure (I don't).
Most studies I have read have demonstrated >95% satisfaction with the procedure by patients who have had it done. I am curious what prompted the FDA to get involved--what were the issues behind the scene that led the FDA to look into this particular procedure of all the surgical procedures that are performed across the board.
I personally don't at all mind wearing glasses and thus have never considered having the procedure.

WASHINGTON - 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.


Make no mistake: Most Lasik recipients do walk away with crisper vision, some better than 20/20.

But not everyone's a good candidate, and an unlucky few do suffer life-changing side effects: poor vision, painful dry eyes, glare or problems seeing at night.

How big are the risks? The Food and Drug Administration thinks about 5 percent of patients are dissatisfied with Lasik. How many struggle daily with side effects? How many are just unhappy that they couldn't completely ditch their glasses? The range of effects on patients' quality of life is a big unknown.
(..)
But doctors advise against Lasik for one in four people who seek the surgery. Their pupils may be too large or corneas too thin or they may have some other condition that can increase the risk of a poor outcome.

Solomon estimates that fewer than 1 percent of patients have severe complications that leave poor vision. Other side effects, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That's the kind of question the FDA's new study is being designed to answer.

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