FDA to study risks of Lasik

The Baltimore Sun

WASHINGTON -- A decade after approving the Lasik laser eye procedure for vision correction, federal health officials moved yesterday to explore potential risks in what's become one of the country's most popular surgeries.

Almost 8 million Americans have had the procedure, and most ended up discarding their eyeglasses or contact lenses without long-term complications, according to doctors and health officials. But a small fraction complain of serious side effects that have left their eyes painfully dry and their vision marred by ghostly shadows or starbursts of color. Some say their sight is so poor they can't watch a movie or drive at night.

In light of the complaints, the Food and Drug Administration plans to launch a national study assessing the rate of side effects among Lasik patients.

Agency officials, who held an all-day hearing yesterday as a first step to examining the problem, also intend to look into whether interested patients need more and better information about the risks.

"The technology has evolved, it's gotten better, it's safer, but we still have a percentage of patients who are having unsatisfactory results," said Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health.

"Now it's a question of whether there are concrete steps the FDA can take to minimize the number of people who are having these bad experiences."

Americans have flocked to Lasik in ever-growing numbers since its approval in 1998. Patients, who pay from several hundred to several thousand dollars a surgery, spend $2.5 billion a year, according to Market Scope, an industry analyst.

Customers are attracted to the quick recovery times and the prospect of experiencing little pain afterward.

But the surgery isn't for everyone, and there can be complications like impaired night vision. Angry patients like Barbara D. Berney say their surgeons glossed over the risks, leaving them seeing the world through a permanent lens of "wrinkled up, dirty wax paper."

Berney, of Rockford, Ill., underwent the surgery in 2001 hoping it would fix nearsightedness that was so severe she had trouble reading at night. Bifocals wouldn't fix the problem. Berney said the Lasik procedure left her eyes so dry she had to add drops every hour, and her vision was impaired by glare and images of halos and starbursts. At her son's college graduation, the hall was too dark for Berney, 54, to see the festivities.

"Looking through the trash that my vision is, it's hard to sort out what is there," said Berney, who argues that the government not only needs to conduct an impartial study and require better warnings, but also recognize her symptoms as a medical condition.

From 1998 to 2006, the FDA received 140 reports of serious side effects. Early this year, the American Society of Cataract and Refractive Surgery, which represents Lasik physicians, reviewed almost 3,000 journal articles on Lasik and found that 95 percent of patients reported satisfaction with the outcome of their surgery.

Dr. Kerry Solomon, a Charleston, S.C., eye surgeon who led the association review, expressed support for a national study, but he said there was no need to rewrite the warning information since doctors are already careful to fully inform patients about potential problems.

In his practice at the Medical University of South Carolina's Storm Eye Institute, Solomon said, he spends two hours briefing a prospective patient on the risks from surgery and testing their eyes to make sure the operation has a high chance of success. Based on the results, Solomon said, he turns away every fourth patient. After surgery, he makes sure to follow up to ease their minds.

"The key is steering patients right," said Solomon. On the rare occasions "when they are dissatisfied, we shouldn't write them off, but spend the time and address their concerns."

Dr. Walter J. Stark, director of cataract and cornea services at Johns Hopkins' Wilmer Eye Institute, agrees that doctors must take time to make sure patients have realistic expectations.

Chances for night glare and other side effects have been reduced by improvements to the laser and tweaks to the procedure, he said, but he still stresses that there's a 1 percent risk of serious side effects.

While doctors need to do a better job reporting cases of adverse events, Stark said, the most important step the government and medical profession could take is to curb marketing hype. "It is important that doctors not trivialize the procedure. Sometimes, advertisements trivialize it. They say it's bladeless, it's not really cutting, but it's still a cut in the eye," he said.

The FDA's Schultz said in an interview that some Lasik promotions were misleading. "Frankly, some of the marketing that has been done with respect to Lasik makes it sound like you go to the grocery store and you come out and see perfectly. That's not good. This is real surgery," he said. Schultz said some unhappy patients may not appreciate that they had an operation, with risks.

The procedure itself takes 40 minutes.

A surgeon cuts a flap in a patient's cornea covering the eye, a laser reshapes the cornea to improve vision and finally, the surgeon puts back the flap.

Kenneth Hausmann of Austin, Texas, said his doctor made it sound as if the surgery was guaranteed to restore his vision to 20/20, but it only worsened. Now, 10 years after the surgery, he wishes the surgeon had fully informed him of the risks.

Hausmann, 50, must wear both contacts and reading glasses to peruse the newspaper, and he needs to ask fellow golfers to tell him where his ball landed.

"I look at the moon, and I see four of them."


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