Exclusive: Former FDA Regulator Says LASIK Side Effects Weren't Taken Seriously Enough

Feb. 25, 2010— -- LASIK eye surgery has provided the promise of a quick vision fix for millions of Americans, but now one of the Food and Drug Administration regulators who approved the procedure in the 1990s is publicly expressing concerns about its safety.

Some 700,000 people a year in the U.S. get LASIK surgery to correct their vision, and in the years since the procedure was approved, the majority of patients have been happy with the results.

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."

A number of patients who underwent LASIK, a procedure that uses a laser to reshape the cornea and thereby correct vision, say they now suffer from side effects such as starbursts, halos, glare double-vision and night blindness.

In some cases the side effects go away within weeks or months of the surgery, but in other cases, they appear to be permanent.

Some people experience them mildly, but others have them so bad they can't perform basic functions, such as driving, and some people have said they lost their jobs due to negative side effects from LASIK procedures.

Abby Ellin, a 42-year-old journalist from New York, underwent LASIK three years ago, but she said the side effects she experienced have still not gone away.

"I was not a success, because I had dry eyes and halos and everything else. That is not a success," Ellin said.

She reported her problems to her doctor but was unhappy with the response, she said.

"She said, 'It will go away, it will go away.' That was really pretty much it. 'It will go away.' Well, it didn't go away," Ellin said.

Waxler, who retired from the FDA 10 years ago, said the stories about patients' bad experiences have affected him.

"One of the patients asked me, 'Don't you feel bad?' and I said, 'I did the best I could with the folks that were all around us,'" he said. "But in hindsight it wasn't good enough. It wasn't good enough."

Waxler said he thinks the FDA erred in not setting tougher standards for LASIK outcomes, for not requiring fewer adverse effects. He does not believe the devices should be pulled off the market, but he does think the FDA should force manufacturers and LASIK surgeons to be more forthcoming with patients about potential side effects.

"The agency actually has a lot of power," Waxler said. "The agency could readily require that those manufacturers keep better tabs on what happens with their product."

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