Lasik Surgery Patients Air Grievances to FDA

The Food and Drug Administration is seeking advice from a panel of outside experts over whether to provide more information to patients about laser eye surgery. They will also hear from Lasik customers who are not satisfied with the results of the surgery.

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Advisors to the Food and Drug Administration are set to weigh in on Lasik eye surgery today. Experts will consider whether Lasik patients are getting enough information before they opt for the laser procedure to help their vision and whether there's enough known about the reports of bad side effects.

NPR's Allison Aubrey reports.

ALLISON AUBREY: More than eight million Americans have had Lasik surgery to improve their vision since it was first approved in the 1990s. According to doctors that perform the procedure and some industry experts, the vast majority of the patients, up to 95 percent of them are satisfied with the results.

But over the years, the FDA has received a steady stream of complaints from unhappy Lasik customers. Dr. Daniel Schultz directs the FDA Center for Devices and Radiological Health.

Dr. DANIEL SCHULTZ (Director, FDA Center for Devices and Radiological Health): Clearly, there is a group who are not satisfied and do not get the kind of results that they expect.

AUBREY: Some of the reported side effects include eye infections, blurry vision and dry eyes. Schultz says no one knows for certain how many of the people who undergo laser eye surgery actually experience complications. There are lots of anecdotes, and there are some estimates based on clinical trials done by the companies that market Lasik. But Schultz says none of these really answer the question.

Dr. SCHULTZ: What we're trying to do is develop more concrete numbers so that we can quantify it.

AUBREY: Schultz says the FDA will begin a new study sometime next year to assess Lasik customers' real world experiences. The hope is that some good hard data on who's done well and who hasn't may help predict if there are certain characteristics that make some individuals better candidates for laser eye surgery than others.

Allison Aubrey, NPR News.

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