Lasik Surgery Dangers

Posted at: 02/25/2010 6:03 PM | Updated at: 02/25/2010 6:12 PM
By: Sandy Drag

There are a number of patients who say that, after getting LASIK surgery, they suffer from starbursts, double-vision and night blindness.

(sot) 17:41 Abby Ellin: "I was not a success because I had dry eyes and halos and everything else. That is not a success," said Abby Ellin.  After reporting the problems to her doctor, "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."

Now, the man who headed the branch of the FDA that reviewed all LASIK applications, remembers the agency was focused on eyesight improvement, and not subjective side effects that were hard to quantify and appeared to be temporary.  "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," said Morris Waxler.  He retired from the FDA a decade ago, but in the past year, angry and upset patients tracked him down to tell their stories.

Waxler now believes the FDA messed up in not requiring tougher standards for LASIK.  "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," said Waxler.

In a statement, the FDA said it "considers LASIK lasers to be reasonably safe and effective when used as intended," but the agency is launching a major two-year study to take a closer look at the side effects.  The FDA disagreed with Waxler's claim that they "ignored problems with LASIK when it was approved."

Dr. Penny Asbell. of the Mount Sinai School of Medicine, is a LASIK pioneer.  She says studies show 95% of LASIK patients are satisfied with the results, but she says not everyone is a good candidate.

 

 

 

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