FDA Takes Closer Look at Lasik Complaints

The Associated Press

April 25, 2008, 1:18 PM PDT

In fury and despair, people harmed by Lasik eye surgery told of severe eye pain, blurred vision and even a son's suicide, as the government began considering if the public needs more warning about the risks of the hugely popular operations.

About 700,000 Americans a year undergo the elective laser surgery. Like golf star and famed Lasik recipient Tiger Woods, they're hoping to throw away their glasses, just as the ads say.

And while the vast majority benefit - most see 20-20 or even better - about one in four people who seeks Lasik is not a good candidate, and a small fraction suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night.

"Too many Americans have been harmed by this procedure and it's about time this message was heard," David Shell of Washington told the Food and Drug Administration's scientific advisers Friday.

Shell held up large photographs that he said depict his blurred world, showing halos around objects and double vision, since his 1998 Lasik.

"I see multiple moons," he said angrily. "Anybody want to have Lasik now?"

Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye and pupil size should have disqualified Dorrian, but he received Lasik anyway - and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year.

"As soon as my eyes went bad, I fell into a deeper depression than I'd ever experienced, and I couldn't get out," Gerald Dorrian read from his son's suicide note.

Matt Kotsovolos, who worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, said doctors classify him as a success because he now has 20-20 vision. But he said, "For the last two years I have suffered debilitating and unremitting eye pain. ... Patients do not want to continue to exist as helpless victims with no voice."

The sober testimonies illustrated that a decade after Lasik hit the market, there still are questions about just how often patients suffer bad outcomes from the $2,000-per-eye procedure.

It's marketed as a quick and painless operation: Doctors cut a flap in the cornea - the eye's clear covering - aim a laser underneath it and zap to reshape the cornea for sharper sight.

The FDA agrees with eye surgeons' studies that only about 5 percent of patients are dissatisfied with Lasik. What's not clear is exactly how many of those suffer lasting severe problems and how many just didn't get quite as clear vision as they had expected.

The most meticulous studies come from the military, where far less than 1 percent of Lasik recipients suffer serious side effects, said Dr. David Tanzer, the Navy's Medical Corps commander. That research prompted Lasik to be cleared last year both for Navy aviators and NASA astronauts.

"The word from the guys that are out there standing in harm's way, whose lives depend on their ability to see, are asking you to please not take this away," said Lt. Col. Scott Barnes, a cornea specialist at Fort Bragg who described Army troops seeking Lasik after losing their glasses in combat.

"I'm grateful every day for the gift of Lasik," added Courtney Henrichs of Medford, Wis., who was unable to put on her own glasses after a skiing accident left her a quadriplegic.

No one's actually considering restrictions on Lasik - but the FDA is pairing with eye surgeons to begin a major study next year to better understand who has bad outcomes. Meanwhile, the agency is considering whether today's warnings about the risks are enough for a general public bombarded with optimistic advertising.

Every potential patient is supposed to get an FDA-written brochure outlining the risks, and the agency runs a Lasik Web site that frankly warns, "You could lose vision."

But it's not clear how many patients actually see those warnings. And FDA adviser Paula Cofer, a Lasik patient serving on the panel, said how well patients fare seems to depend largely on what surgeon they pick.

Surgeons noted that one of the most denounced side effects, dry eye, is common in the general population, making it hard to tell just how much is really caused by Lasik. One study found about 31 percent of Lasik patients had some degree of dry eye before their surgery, and about 5 percent worsened afterward, said Dr. Kerry Solomon of the Medical University of South Carolina, a spokesman for the American Society of Cataract and Refractive Surgery.

"Millions of patients have benefited" from Lasik, said Dr. Peter McDonald of Johns Hopkins University, a spokesman for the American Academy of Ophthalmologists. "No matter how uncommon, when complications occur, they can be distressing. ... We're dedicated to doing everything in our power to make the Lasik procedure even better for all our patients."