WASHINGTON – Patients harmed by Lasik eye surgery alternated between fury and despair Friday as they told U.S government health officials of suffering years of eye pain, blurred or double vision — even of people driven to suicide.
"Too many Americans have been harmed by this procedure and it's about time this message was heard," said David Shell, who had Lasik in 1998 and says he has "not experienced a moment of crisp, good quality vision since."
Colin Dorrian was a college student when he was told he was not a good Lasik candidate, but went ahead anyway — and his father, Gerald, described six years of eye pain and blurred vision before reading his son's suicide note to a Food and Drug Administration panel: "I can't and won't continue facing this horror."
Matt Kotsovolos actually worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, and said doctors classified him as a success because he now has 20-20 vision — something Kotsovolos charged is a deceptive industry practice.
"For the last two years I have suffered debilitating and unremitting eye pain," Kotsovolos said. "Patients do not want to continue to exist as helpless victims with no voice."
A decade after Lasik hit the market, the Food and Drug Administration is taking a new look at whether warnings about its risks are appropriate — and pairing with eye surgeons for major study to better understand who has bad outcomes and why.
Most Lasik recipients do walk away with crisper vision, and the American Society for Cataract and Refractive Surgery reviewed studies showing about 95 percent of patients say they're satisfied with their outcome.
But not everyone's a good candidate, and an unlucky fraction do suffer life-changing side effects: poor vision even with glasses, painful dry eyes, glare or inability to see or drive at night.
How big are the risks? The FDA agrees that about 5 percent of patients are dissatisfied with Lasik. How many struggle daily with side effects? How many are less harmed but unhappy that they couldn't completely ditch their glasses? The range of effects on patients' quality of life is a big unknown — and the reason the FDA help a public hearing Friday as part of its new move.
"Clearly there is a group who are not satisfied and do not get the kind of results they expect," said Dr. Daniel Schultz, the FDA medical device chief. The study should "help us predict who those patients might be before they have the procedure."
About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye (euro1,280) Lasik. Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea — the clear covering of the eye— aim a laser underneath it and zap to reshape the cornea for sharper sight.
Doctors advise against Lasik for one in four people who seek the surgery, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik's safety for the ASCRS. Their pupils may be too large or corneas too thin or they may have some other condition that can increase the risk of a poor outcome.
Solomon estimates that fewer than 1 percent of patients have severe complications that leave poor vision.
Other side effects, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That is the kind of question the FDA's new study is being designed to answer.