LASIK (or laser-assisted in-situ keratomileusis) surgery is a procedure that corrects vision so that you’ll no longer need glasses for distance vision. Countless people opt in thinking it’s completely risk free. And I’d be lying if I told you I haven’t considered it myself…that is, until some of my patients came in with totally unexpected side effects.
And as it turns out, they’re not alone.
Unbearable pain and vision loss
Morris Waxler headed the FDA team that approved LASIK surgery back in the late nineties. Today, he’s saying it was a mistake—and that the FDA needs to be more transparent about the procedure’s risks.
He might as well be screaming into the void, though. Because apparently, he’s been in this fight for over 10 years to little or no avail.
Back in 2007—a good seven years after leaving the FDA—Waxler says he started talking with people who reported that they or their family members suffered after LASIK. That’s when he started pushing the agency to issue more aggressive warnings.
These adverse effects ranged from chronic dry eyes to unbearable pain and vision loss. And yet the FDA still hasn’t budged an inch.
In fact, this is the first time I’m even hearing of these effects—and I make it a point to keep up with medical news.
But since the FDA only seems to make a point of addressing issues that appear on TV, maybe the high-profile death of a Detroit meteorologist named Jessica Starr will finally get their attention.
Unfortunately, Starr ended her own life in December at the age of 35. She publicly shared details of her rocky recovery from a recent LASIK-type surgery called SMILE (small incision lenticule extraction) only a month prior. And while we’ll never know for sure whether the procedure played a role in her suicide, it certainly should have sounded an alarm to the FDA.
Every surgery comes with risks
Waxler, who may be my new hero, had some choice words for the FDA, accusing them of deliberately deceiving the public about the risks associated with SMILE.
The agency claimed, for example, that the rate of adverse events was less than one percent. But, Waxler contends, that’s only true within the FDA’s narrow definition of an adverse event, which only refers to vision loss. Plus, the impact of the procedure is completely underestimated as the FDA is counting each effect individually, when most patients are suffering from multiple complications at once.
This type of deception is downright unacceptable.
But naturally, the FDA sees things differently. They insist that their only job is to state the facts concerning LASIK’s safety and effectiveness—not to tell people whether or not they should have the surgery.
And, they claim, after 20 years and 20 million procedures, evidence supports LASIK surgery as a safe and effective option for vision correction.
The American Society of Cataract and Refractive Surgery, on the other hand, at least admits that the procedure isn’t for everyone. And while I’m not here to be an alarmist, I would have to agree.
Always keep in mind that along with any surgery comes potential complications.
A rate below one percent might meet the FDA’s standards for safety. But the patients unfortunate enough to fall into that one percent aren’t just numbers…they’re real people who are suffering irreversible effects from a completely elective surgery.
As for me, I decided that glasses could be a fashion statement after all.
“Man Who Led FDA Team to Approve LASIK Now Says It Was a Mistake.” Medscape Medical News, 02/12/2019. (medscape.com/viewarticle/909011)