Problems with LASIK surgery

I had LASIK on both eyes some years back. I still wear glasses and, because of the resulting correction, my glasses now require a “slab-off” on one lens so that the bifocals will work. That’s a problem primarily because it means I can no longer wear progressive lenses, which had solved the distance problem: by tilting one’s head, one gets a good correction for all the distances between “distant” and “reading”—specifically, for me, the computer screen. So now I have special computer glasses along with bifocals (the latter for reading and for distance).

But still: I can see pretty well even without glasses, which was definitely untrue before: my uncorrected vision before LASIK was on the order of 20/900. Still, this article should give anyone pause:

How are your eyes?

That’s all anyone ever wants to know these days: How my eyes are doing after my collision with Lasik almost three years ago. Are they still dry? Do they still hurt when exposed to sunlight? Is my vision still blurred? And what about glasses — am I still wearing them?

The answer: Yes, yes, yes and yes. Emphatically, resoundingly, blindingly yes. My eyes sting. They burn. I look at neon signs and the colors bleed into a fluorescent Rorschach test. I have difficulty deciphering black lettering on white boards; I have personally helped elevate the stock of Allergan, which manufactures Refresh Plus, the drops that allegedly help dry eye.

Clearly, this is all very annoying, but at this point, I’m used to it. It’s just one of the things I live with, like PMS and hangnails. And in the grand scheme of things, it’s not so bad. According to Market Scope, LLC, an ophthalmic industry research firm, nearly 15 million procedures have been performed in the U.S. over the last decade, with a 95.4 percent patient satisfaction rate. Lasik is also a $1.6 billion industry — which, as Michael Lewis points out in “The Big Short,” was initially created to replace the revenue stream lost to declining cataract surgery reimbursement rates.

Ninety-five percent satisfaction is not awful (although of course it depends on what your definition of “is” is). It’s the other 5 percent that worries me. I’ve interviewed people who’ve had corneal transplants because of botched Lasik, who’ve lost their jobs because they can’t see — like Los Angeles Dodger Jay Gibbons, who reportedly stopped playing winter ball in Venezuela because of blurred vision he acquired after Lasik surgery earlier in the season, the L.A. Times reported.

So all in all, I’m pretty lucky. But I think it’s fair to say that I’m angry. Not just about my situation, but because this is an industry where it’s almost impossible to find a reputable refractive surgeon to speak out on behalf of patients. If you’ve got a problem, it’s your fault. I went to a dry eye specialist in New York City, a guy who wrote a book on the subject. He acknowledged that Lasik causes dry eye and that it’s a major surgical side effect.

“Would you ever say that on the record?” I asked.

He shook his head somewhat sheepishly. “We do Lasik here,” he explained. Aha! Talk about a smart businessman. He’s got the problem and the solution under one roof.

Attorneys also have trouble finding doctors to testify for patients. On June 2, 2009, Todd Krouner, a lawyer in Chappaqua, N.Y., who has won millions of dollars for injured Lasik patients, cross-examined a Dr. Wing Chu in a case involving a patient with post-Lasik ectasia, a bulging of the cornea. Dr. Chu is medical director of the Eye-Bank for Sight Restoration, and an associate clinical professor of ophthalmology at Columbia University, among other appointments. He was hired by the defense to conduct an independent medical examination of the patient. Here’s how that conversation went:

Krouner: “Is your version of the Hippocratic oath “first do no harm” translated “first do no harm to any ophthalmologist,” is that your interpretation of the Hippocratic oath?”

Chu: “That’s a part of it.”

Oh. Good to know.

The hero here is a man named Morris Waxler, whom I wrote about last year for Salon. Waxler is a Ph.D. and a former branch chief of the FDA’s Center for Devices and Radiological Health from 1995 to 1999. He was, in effect, the man responsible for approving Lasik vision enhancement lasers in 1997. Since that time, he has become rabidly anti-Lasik, publicly admitting that the FDA “screwed up” when it approved it.

Now he’s taken his activism a step further. Last month, he filed a petition calling for the FDA to withdraw approval “for all Lasik devices and issue a Public Health Advisory with a voluntary recall of Lasik devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for Lasik eye surgery.”

In his petition, Waxler maintains that the initial approval was based on data that was “dominated by Lasik surgeons working hand-in-glove with Lasik manufacturers. Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of Lasik devices were the device manufacturers and its collaborators.” Consequently, he says, the FDA was deprived of knowledge of the full extent of Lasik injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of Lasik devices.

He adds that — contrary to the FDA’s own device-approval standard, which limits adverse events to 1 percent — published scientific data shows that Lasik devices induce an average adverse event rate of about 22 percent “that persists beyond six months to five or more years.”

Lastly, he says, the published data show that . . .

Continue reading.