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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Exception to the Rule

Bad experiences with LASIK have not been the norm. More common are experiences like those of patients like 38-year-old Maria Coello, a health administrator living in New York.

"I had [LASIK] when I was 37. I wish I'd done it before," she said.

In a statement the FDA said it "considers LASIK lasers to be reasonably safe and effective when used as intended" and said it disagreed with Waxler's claim that they ignored problems when the procedure was approved.

Additionally the FDA said it issued a letter to LASIK providers cracking down on false and misleading advertising and said it will follow up with providers who were found to have "inadequate adverse event reporting systems."

At the same time, the agency is now beginning a study to look more closely at side effects and quality-of-life after LASIK.

Others in the field also maintain that the procedure is safe, pointing to the fact that the vast majority of patients go through LASIK and gain improved eyesight and without permanent problem.

"Most patients are very satisfied. Very happy," said Dr. Penny Asbell, a LASIK pioneer and professor of ophthalmology at the Mount Sinai School of Medicine in New York. She said studies have shown that 95 percent of LASIK patients are satisfied with their results.

But at the same time, she said, not everyone is a good candidate to get the procedure. Prospective patients could and should be more cautious when they talk to a doctor about getting LASIK, she said.

"Sometimes, I think, instead of asking, 'How many LASIK procedures you have done?' you should actually ask the doctor, 'How many have you turned away?'" she said.

Waxler also said people considering LASIK need to be more careful before deciding to get the operation.

"Read everything you can," he said. "There's no urgency to do it, so make sure you understand the worst that can happen to your eyes and you can live with the worst."

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