Former FDA supervisor calls his approval of Lasik ‘a mistake’

Posted at 3:09 PM, Feb 01, 2019
and last updated 2019-02-01 15:09:55-05

The thought of ditching glasses is alluring, but a Federal Drug Administration (FDA) database holds hundreds of reports, detailing significant complications after Lasik eye surgery.

One report described post-surgery as "pain worse than child birth." Another patient claimed the procedure was the "worst decision of my life."

Nancy Burleson's son killed himself in 2016. After returning from serving in Iraq, the veteran got Lasik eye surgery, but he struggled with complications post-procedure. In his suicide note, Burleson’s son stated, "I trusted a doctor that destroyed my eyes."

In at least three cases, families say Lasik caused their loves ones to take their own lives. It's cases like those that make former FDA supervisor Morris Waxler rethink his role in approving Lasik.

"I got this call from people very upset at me because my name was on the approval documents,” Waxler says.

He says when he helped get Lasik approved, eye surgeons told him surgery offered positive outcomes nearly across the board.

"I was lied to. I trusted people I shouldn't have trusted and I didn't know a lot of things I know now," Waxler says.

Waxler, who has started his own industry consulting company in Madison, Wisconsin, decided to take on his former employer, demanding the FDA reconsider its decision.

“The problem is not so much with the surgery, but with the recovery,” he says.

Waxler says even if a surgeon does everything right, a patient could suffer problems, because we all heal differently. Sometimes the cuts in eyes don't heal, or the eye becomes weak after being cut, and other times, the nerves never reconnect properly.

“Sometimes they don't' grow back properly,” he explains. “They grow in whirly gigs and they just end on themselves and they produce uncontrivable pain.”

Dr. John Vukich, with the American Society of Cataract and Refractive Surgery, says they’re just now understanding how that can occur.

The ophthalmologist agrees healing isn't an exact science in everyone, but Dr. Vukich stresses millions of lives have been improved.

“The balance of good is so overwhelming for those individuals who have had Lasik I think we have to look at that context,” Vukich says.

Vukich says 96 percent of patients are satisfied after surgery, and he adds researchers are trying to better understand why, rarely, things go wrong.

Waxler wants the FDA to more prominently warn Lasik patients of the risks, including on the agency’s website. As to why the agency hasn’t already taken Waxler’s advice, he says, “If they make a big dramatic change in their website, the refractive surgeons are going to come down on them as glue. They are going to hit them hard.”

Waxler believes the hundreds of reports detailing things like post-surgery pain and double vision speak for themselves, and he thinks it’s enough to cause patients to rethink Lasik surgery.

Overall, Waxler believes in sticking with contacts and glasses as a safe alternative to the surgery.