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LASIK eye surgery should be taken off market, former FDA adviser says

Cross-Posted from CBS News

LASIK eye surgery has been popular for more than 20 years, with an estimated 20 million Americans undergoing the procedure to correct nearsightedness and improve distance vision. But some patients say the surgery has ruined their eyesight.

The quick, minimally-invasive surgery uses a laser to cut a flap to reshape the cornea at the front of the eye. Now an expert who once backed LASIK is campaigning to get it off the market.

Abraham Rutner said LASIK surgery damaged his vision and nearly ruined his life. “It’s a devastation that I can’t even explain,” Rutner told CBS News medical contributor Dr. Tara Narula.

“Things would appear double. Around the lights were like having starbursts,” he added.

After months of not being able to drive or do his job, the Brooklyn electrician finally found help in Miami where optometrist Edward Boshnick fitted him with special contact lenses. 

“His cornea is very distorted as a result of his LASIK surgery,” Boshnick said.

Boshnick estimates he’s treated thousands of patients with LASIK complications.

Paula Cofer had surgery 19 years ago, “and from day one my vision was an absolute train wreck and it still is today,” she said.

She started a LASIK complications support group on Facebook and quickly found she was not alone. “You really have to understand you’re risking your only pair of eyes,” Cofer said. 

Since 1998, an estimated 20 million LASIK procedures have been performed, and according to an FDA patient survey, more than 95% of patients were satisfied with their vision after surgery.

Still, the FDA’s own website is filled with stories of serious complications. Patients reported “relentless eye pain,” dizziness and detached retinas, and told the agency: “LASIK ended my life” and “this procedure needs to stop.”  

“Essentially we ignored the data on vision distortions that persisted for years,” said Morris Waxler, a retired FDA adviser who voted to approve LASIK. He now says that vote was a mistake.

“I re-examined the documentation … and I said, ‘Wow this is not good,'” Waxler said.

Waxler said his own analysis of industry data shows complication rates between 10 and 30%. In 2011, he petitioned the FDA to issue a voluntary recall of LASIK. Three years later, the agency denied that request and now tells CBS News it “has not found any new safety concerns associated with LASIK devices.” 

Waxler said he thinks LASIK should “absolutely” be taken off the market. “There’s nothing wrong with a person’s eyes who goes to get Lasik,” he said. “They have healthy eyes. They could go and get a pair of glasses.”
Doctors who perform LASIK surgery said risks can be minimized with pre-surgical screening.

“The most important thing is knowing who to operate on and who not to operate on and there are people who really should not have this procedure,” Dr. Jules Winokur said.
Rutner now believes he was never a good candidate.

“I was blaming myself,” he said.

Rutner estimates his vision is now about 90% improved. He tolerates the discomfort of hard contact lenses, but wishes he had known more before he had LASIK surgery. To those who are considering LASIK, Rutner said he would tell them, “First, please think it over. … It’s your eyes. It’s not something you can rectify later.”

Doctors we spoke with stress the importance of pre-surgical screening to make sure the patient is a good candidate for the surgery.

Here are FDA’s advisory on risks and how to find the right doctor for the procedure.