August 5, 2011 10:59 am

This Week on 16:9 – May 28 – 20/20 Hindsight

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It’s marketed as ten minutes that will change your life. A quick laser blast to the eyes and you can get rid of your glasses. But is Lasik eye surgery really the low-risk vision miracle some clinics claim?

Lasik eye surgery is one of the most popular elective procedures on the planet. A quick cut on the outer surface of the eye with a tiny precision blade or a laser, followed by another laser to reshape the cornea. Minutes later, if everything goes as advertised, the patient walks away with 20/20 vision.

Canadian Opthamological Society representative Dr. Guillermo Rocha has been performing Lasik surgery for more than a decade. He told 16:9 The Bigger Picture it almost never goes wrong.

“It has been incredible in terms of the amount of precision, the safety, the efficacy that we have seen over the past 15, 16 years,” Dr. Rocha said.

But a high-ranking American whistleblower told 16:9 he’s concerned about the dangers of Lasik surgery.

Morris Waxler was one of the people responsible for approving Lasik in the United States 15 years ago. Now he’s saying they got it wrong.

“We said that the adverse event rate [for the surgery] should be no greater than 1%. That was the goal that we said to everybody,” Waxler told 16:9. “That was clear in the guidance document, it was clear in all of our communications.”

But Waxler doesn’t think that’s the reality. He told 16:9 he thinks the percentage of patients who have problems after Lasik surgery is actually closer to 20% or 30%. That’s at least 20 times higher than the 1% the industry claimed in order to get the procedure approved.

When Waxler took his findings to his former FDA colleagues, certain the government organization would investigate, he told 16:9 he wasn’t received the way he expected.

“They were unresponsive to me,” he said. “I contacted them in emails and letters and they were unresponsive about this matter. ”

Waxler told 16:9 he doesn’t think the Lasik industry is willing to admit the real risks of cutting the cornea.

“You are not cutting a piece of plastic you are cutting a live tissue. You are essentially destabilizing the cornea,” he told 16:9. “So no matter how you cut it, you’re cutting it. The re-growth of those cells or those nerves is unpredictable.”

But Jay Herman, president of Sigmacon, the company that sells the latest generation of lasers used in Canada, told 16:9 he doesn’t agree.

“These days with the modern technology it’s really about the pre-op,” Herman said. “In normal healthy eyes there is very little that can go wrong related to the procedure itself.”

Herman believes Waxler’s science is flawed. He told 16:9 the 20% rate Waxler quotes is based on studies done with obsolete lasers.

“You could say it’s not valid because that is a 1st, 2nd generation laser – it’s not manufactured anymore. It’s not used certainly anywhere in Canada, “he told 16:9. “It’s not even the worst case scenario. It’s a scenario that hasn’t existed in a decade. “

Waxler, however, told 16:9 his numbers are based on all lasers, new and old.

“I used every table I could lay my eyes on for all the lasers that are approved,” he said. “The most recent ones and the ones that were first approved.”

And in January 2011, Waxler took an extraordinary step: he filed a petition to ban the procedure he helped approve. He’s even calling for a criminal investigation. When it comes down to it, he says his message to the Lasik industry is simple.

“The question is,” he said, “How many eyes are you willing to ruin to make a living?”

For more on this story, including the personal stories of former Lasik surgery patients who say they still suffer crippling aftereffects and an undercover investigation into what Lasik clinics are telling patients about the risks of the surgeries they perform, watch 16:9 The Bigger Picture this Saturday on Global.

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