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Former FDA Regulator Says LASIK Side Effects Weren’t Taken Seriously Enough. Excerpt: “But while the FDA was aware of negative side effects that would occur in some, Morris Waxler, the former head of the FDA branch responsible for reviewing the data on LASIK, told ABC News in his first television interview that, in hindsight, those side effects were not taken seriously enough… “I wouldn’t say it was pooh-poohed so much it was just sort of shoved aside as the kind of, we, we don’t know what to do with that data,” he said. “It’s right there in the record. The agencies and the refractive surgeons, people know these problems occur and there doesn’t seem to be a plan to handle some of the more difficult problems that are created.”

Technorati Tags: 2/25/2010, America, Good, Lasik, Morning, Report

It’s been a little over a year since Joseph Schnell, an elevator construction worker from Philadelphia, had LASIK eye surgery to correct his nearsighted vision. Rather than becoming clearer and sharper, though, Schnell’s vision soon was plagued by near-constant glare, halos, starbursts, and double images. The results, he says, have affected his mood–he became depressed shortly after–and he rarely sleeps through the night because of eye pain.

In response to a Food and Drug Administration public forum on LASIK last week, where Schnell and other people shared their experiences with life-altering complications following the procedure, an FDA advisory panel has recommended ways to make warnings of the risks more clear. The panel suggests that photos depicting what people with visual impairment actually see be made available to those considering the surgery, as well as information on conditions such as large pupils and severe nearsightedness, which would disqualify a person from the procedure, and statistics on side effects. The FDA and a number of organizations, including the National Eye Institute and the American Academy of Ophthalmology, have formed a task force to study quality of life post-LASIK and figure out how to minimize problems.

Experts emphasize that serious complication rates are quite rare. Patient satisfaction hovers around 95 percent, according to a worldwide analysis released in March by another task-force member, the American Society of Cataract and Refractive Surgery. Among those remaining, many are simply dissatisfied that LASIK didn’t measure up to their expectations–their vision isn’t quite 20/20, and they still need reading glasses, for example. According to the FDA, only about 1 percent of patients report worse vision and have permanent side effects like eye pain, dry eye, and poor night vision. (Lots of people experience temporary effects like dry eye, glare, and halos.)

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Technorati Tags: Considering, Lasik, news, Report, surgery, U.S., World