Stronger Lasik warnings considered by FDA
Published 9:58 pm Friday, April 25, 2008
WASHINGTON — 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.
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 fairly 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.
The 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.
The FDA agrees with studies that only about 5 percent of patients are dissatisfied with Lasik. What’s not clear is exactly how many of those suffer lasting problems and how many just didn’t get quite as clear vision as they had expected.
No one is considering restrictions on Lasik — but the FDA is planning a major study next year to better understand who has bad outcomes. Meanwhile, the agency is considering whether warnings about the risks are enough for a public bombarded with optimistic advertising.
