April 25, 2008 — The FDA should do more to warn patients about the risks of popular laser vision corrective surgery, an expert panel has concluded.

The recommendations came after more than a dozen LASIK patients or their family members testified Friday about severe reactions to the surgery. Most said their doctors did not adequately warn them that vision loss or eye dryness could persist, in some cases, for years.

“For a small minority, their regret is profound,” said Todd Krouner, a New York attorney who represents about half a dozen LASIK patients, including the wife of a former police officer who Krouner said blamed a botched LASIK surgery for his suicide.

“It is not about the 20 minutes in surgery, it’s about what came before it and what has come after it. It’s about a lack of solution for them,” said Rebecca Petris, a former LASIK patient who now runs a network of dissatisfied patients.

The FDA has launched a new national study of patient outcomes, along with the National Eye Institute and the American Society of Cataract and Refractive Surgery (ASCRS) to try to compile more information on the rate of poor LASIK results.

The study is likely to take years to complete. In the meantime, experts said information given to patients considering LASIK surgery should warn more clearly of the possibility of long-term vision disruptions, including “halos,” “starbursts,” blurriness, and multiple vision.

The FDA has become increasingly concerned about reports of severe complications but has acknowledged that it does not have enough studies to know how often severe reactions occur. Those reports, which include debilitating eye dryness, blurred vision, and other vision disruptions, could suggest doctors are not doing enough to inform patients about the potential risks, the agency said.

Debate Over LASIK

LASIK (which stands for laser-assisted in situ keratomileusis) is performed in more than 700,000 U.S. patients each year. One study published last month by a trade group representing LASIK surgeons suggested about 95% of all patients are satisfied with their procedure.

“Even with the stats we have, we have info that the vast majority of patients who have LASIK do very well,” said Jayne S. Weiss, MD, who chaired the advisory panel.

“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.”