LASIK Should Be Banned, Claims Former FDA Advisor

Every now and again, a news story will come out that makes you physically cringe. If the article involves your eyeballs, it’s even more likely to have this effect. (Yes — we’re thinking of the woman who ended up with black masses embedded in her eyelids after not removing her mascara properly.) Well buckle up, because we have another upsetting eye-related story for you today.  

A former Food and Drug Administration adviser who voted to approve LASIK eye surgery 20 years ago says he now thinks it should be banned, CBS News reports. Morris Waxler, Ph.D., who helped evaluate the technique, is back-pedaling based on what he says is now known about the long-term health effects of the procedure.

"Essentially we ignored the data on vision distortions that persisted for years," Waxler told CBS. “I re-examined the documentation … and I said, ‘Wow this is not good.’” 

LASIK stands for laser-assisted in-situ keratomileusis, and an estimated 20 million Americans have had it to correct their vision issues, CBS notes. During the minimally invasive procedure, lasers are used to reshape a tiny part of the cornea. Many people who have it end up with 20/25 vision (or better), according to the Mayo Clinic. However, it comes with some side effects, such as dry eyes. And many people who’ve had the procedure need glasses for driving at night or reading as they age. In extreme but rare cases, patients will even lose their vision in a way that can’t be corrected, the FDA notes. Still, it's a popular procedure. Kylie Jenner reportedly even threw a party to celebrate getting the surgery.

Waxler says that he did independent analyzation of LASIK in the last few years, and says he saw a “vision complication rate” of up to 30 percent. He’s petitioned the FDA to have the entire procedure nixed and recalled, but they denied his request.

When Refinery29 asked about Waxler's comments, an FDA spokesperson pointed to a study the FDA took part in called Patient-Reported Outcomes with LASIK (PROWL), which showed that "fewer than 1 percent of patients had symptoms that gave them a lot of difficulty with or prevented from doing their usual activities." They also noted that the FDA has a "significant amount of consumer-focused information available on its website about the benefits, risks and expected outcomes associated with LASIK."

"The FDA continues to monitor the safety of devices after they are marketed, such as by monitoring adverse event reports and following up on adverse events, including those related to LASIK," the FDA spokesperson noted in an email.

This is not the first time Waxler has spoken out against LASIK. In March 2011, American Society of Cataract and Refractive Surgery's magazine EyeWorld published a letter from the serving ASCRS president R. Doyle Stulting, MD, PhD, to Waxler in response to the latter's criticisms. In the portion of the letter that was published, Stulting calls Waxler's views on LASIK "misinformed, unsupported by evidence, and lacking in balance and perspective."

Although the FDA says research found that more than 95 percent of participants who'd had the surgery were satisfied with their vision, Waxler maintains that it should “absolutely” be banned. 

The bottom line, according to Waxler, is that people who have the surgery won't suffer or die without it, so why take the risk? “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.”