FDA to review the side effects of Lasik
A decade after approving the Lasik laser eye procedure for vision correction, federal health officials moved Friday 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.
Now 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 as a first step to examining the problem, also intend to look into whether prospective 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 since its approval in 1998. Patients, who each pay from several hundred to several thousand dollars for the surgery, spend $2.5 billion a year, according to industry analyst Market Scope. 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, such as impaired night vision.
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% 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 said there was no need to rewrite the warning information because doctors are careful to 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 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.
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, he said, but he still stresses there’s a 1% risk of serious side effects.
Although 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.
