It has been an extraordinarily popular, “no glasses/no contacts” solution for decades. But now, a former advisor to the FDA says that LASIK should never have been approved, and the procedure should be taken off the market!
Since it was introduced in 1998, more than 20 million Americans have undergone the procedure to correct nearsightedness and improve distance vision. But CBS News is reporting that many 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, Morris Waxler an expert who once backed LASIK, is campaigning to get it off the market, mainly because of cases such as Abraham Rutner’s. 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. Among them, Paula Cofer. Cofer had the 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.
Despite many stories like those of Rutner and Cofer, 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 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,'”
LASIK Really Is an Unnecessary Procedure
Besides being unsafe, Waxler believes that LASIK is a purely unnecessary, vanity procedure, which is hardly worth the risk.
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.”
According to the CBS report, 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.”