One former FDA adviser who voted to approve laser eye surgery now views the procedure differently.
The minimally invasive surgery, commonly known as LASIK, aims to correct vision in just minutes, using lasers rather than blades to make incisions that reshape a small portion of the cornea. Since its approval by the Food & Drug Administration more than 20 years ago, an estimated 20 million people in the U.S. have undergone the operation.
Today, Morris Waxler — one of the experts who was consulted on LASIK approval by the FDA and voted to okay it — is walking back on that decision, due to what is now known about the surgery’s potential long-term health effects. He believes LASIK should “absolutely” be taken off the medical market altogether.
“Essentially we ignored the data on vision distortions that persisted for years,” Waxler told CBS News, calling his vote a mistake. “I re-examined the documentation … and I said, ‘Wow this is not good.’ “
In recent years, Waxler has analyzed data independently and observed a vision complication rate of up to 30 percent, and he has petitioned for a LASIK recall. The FDA told CBS News it denied the suggestion because it “has not found any new safety concerns associated with LASIK devices.”
“There’s nothing wrong with a person’s eyes who goes to get LASIK,” Waxler said. “They have healthy eyes. They could go and get a pair of glasses.”
According to the Mayo Clinic, common side effects of laser eye surgery include dry eyes and temporary vision disturbances, with some patients more rarely affected by under- or over-corrections, astigmatisms and even potential loss of eyesight.
LASIK was first performed in the U.S. in 1991, and FDA approval came in 1996, says the Eye Doctor Network, which is led by a community of private practicing optometrists.
The eye doctors’ resource recommends patients who undergo the procedure schedule follow-up appointments one day, one week, one month, three months and one year afterward to track any changes to vision, positive or negative.
While more than 95 percent of patients say they’re satisfied with the results of the procedure — which typically costs an average of $2,200 per eye — others report suffering painful and disruptive complications.
“For the patients who have pain, it’s absolutely a condition that requires treatment and attention,” Dr. John Vukich, chair of the Refractive Surgery Clinical Committee for the American Society of Cataract and Refractive Surgery, previously told PEOPLE. “But the risk of [winding up with chronic pain] is very low.”
To avoid complications, the FDA recommends talking to your doctor about whether LASIK is right for you and assessing potential risks. Anyone considering LASIK should ask a doctor to examine their eyes for corneal conditions that could lead to problems post-operation.
“There are patients who are turned away — as many as 10 to 20 percent of patients may have some corneal finding or some other condition that would make them a less-than-ideal candidate, but most patients are counseled and redirected to some other way to correct their vision,” Vukich said.
Complaints over LASIK were the focus of an FDA panel in 2008 as well as a 2017 survey of more than 500 patients, who described their vision experience before LASIK and three and six months after surgery. Just 2 percent of patients reported complications. Vukich says it’s important to know that for those who are experiencing problems after surgery, things will improve.
“We know that for [most] individuals who have dry eye and other conditions, it almost always gets better within three to six months,” Vukich said. “… There are going to be very rare cases of individuals who may have difficulty that can be attributed to the surgery, but I think that’s true of any kind of procedure.”