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Experts Advise New Warnings for LASIK

Patients Tell FDA Panel About Serious Side Effects From Corrective Eye Surgery
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Debate Over LASIK continued...

"It is really a referendum on the performance of LASIK by some surgeons who should really be doing a better job," said Weiss, a professor of ophthalmology at Wayne State University in Detroit.

Experts also recommended that both patient information and FDA's LASIK web site contain photos of potential vision problems.

"We do want something that people will read and see if they have the opportunity to," Weiss said.

Experts also urged the agency to include more warnings about the potential risks of LASIK in women using hormone replacement therapy since the drugs can alter the cornea. And they called for more warnings for doctors who evaluate which patients may not be candidates for the procedure.

Some advocacy groups have said the FDA's national study lacked independence because it was being run in part by ASCRS, the group representing doctors performing LASIK and other procedures.

"The FDA will objectively evaluate the information collected," said Eva Rorer, MD, the chief of FDA's ophthalmic division.

Still, some experts said Friday they had difficulty knowing what new warnings to recommend for LASIK patients.

"I think there are many aspects of risk related to LASIK that we have yet to find out," said David C. Musch, MD, a professor of ophthalmology at the University of Michigan and a member of the advisory panel.

Peter McDonnell, MD, professor of ophthalmology at Johns Hopkins University School of Medicine, says the surgery has been studied extensively. According to a news release about the FDA meeting by the American Academy of Ophthalmology, McDonnell says, "LASIK is the most studied elective procedure. ...I believe it is safe to say that no elective ophthalmic surgical procedure has been as fully studied as has this procedure. But, as with any surgical procedure, there are complications that may occur after LASIK. Fortunately these are uncommon. No matter how uncommon, however, when complications occur they can be quite distressing to both patients and surgeons."

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