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FDA Advisers Ask Agency To Update Lasik Eye Surgery Precautions

Greg Webb

Attorney
(866) 735-1102 Ext 530

Posted by Greg WebbMay 13, 2008 4:19 PM

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Patients harmed by Lasik eye surgery met with federal health advisers to complain of severe eye pain, blurred vision and even a son’s suicide. Advisers have asked the Food and Drug Administration (FDA) to warn the American public more clearly about the dangers that can arise from the popular surgery in which doctors cut a flap in the cornea, aim a laser under it and zap to reshape the cornea for sharper sight. More than 700,000 people undergo Lasik eye surgery annually. While most benefit by gaining 20-20 vision or better, about one percent or less suffer serious, life-changing side effects: severe dry eye, glare, the inability to drive at night, and worse vision. In one case, the results of a botched Lasik eye surgery, which should never have happened because the patient did not qualify for the surgery, led the patient to commit suicide.

The FDA advisers have asked the agency to make the warnings about Lasik clearer by adding four items. First, they want the agency to add photographs depicting what people suffering from certain side effects might see, such as the glare that makes headlights look like bursts of light. Second, they want the warning to clarify how often patients suffer side effects, like dry eye, since some surgeons say there is a 48 percent chance of it happening, while others say there is a 31 percent chance. Third, the advisers want it to be made clearer the conditions that disqualify people from getting Lasik. Fourth, and finally, they would like it to be known that if nearsightedness is fixed by the surgery, it is proven that the patient will need to wear reading glasses in middle age, something that could be possibly avoided by not participating in the surgery. While no one is considering restrictions on Lasik, the FDA is joining major surgeons for a major study next year to better understand which patients have bad outcomes from the surgery. http://seattlepi.nwsource.com/national/360757_lasik26.html?source=mypi

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Michie Hamlett Lowry Rasmussen and Tweel 866-735-1102 x 530 www.michiehamlett.com/

Greg Webb
(866) 735-1102 Ext 530 Email Greg

Bryan Slaughter
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Paul Thomson
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