Is LASIK Surgery Not as Safe as We Thought?

By Anastacia Mott Austin

David Shell had the laser eye procedure LASIK (laser assisted in situ keratomileusis) in 1998, hoping to improve his vision after hearing miraculous stories of suddenly perfect sight.

Unfortunately for Shell, his was one of the rare cases where the surgery did not prove to be a miracle. After his surgery, he saw shadowy halos around everything, and experienced dry eyes and double vision, something that cannot be corrected by glasses.

An angry Shell asked an FDA panel this month, "I see multiple moons. Anybody want to have Lasik now?"

At a hearing before the FDA’s Ophthalmic Devices Panel, patients whose vision had noticeably worsened after the laser eye surgery lobbied for better warnings and patient screenings before the popular procedure. "Too many Americans have been harmed by this procedure and it’s about time this message was heard," said Shell to the panel.

In fact, the great majority of LASIK patients, 95%, report improved vision and no drastic side effects following their surgeries.

Dr. Christopher Starr, co-director of the Cornea, Cataract and Refractive Surgery at New York’s Presbyterian Hospital, thinks that LASIK produces an overwhelmingly positive outcome for the vast majority of patients, but agrees that the FDA panel’s recommendation to explore better warnings of possible negative side effects is a good thing. Dr. Starr told reporters that in ensuring better screening, more patients who are good candidates will receive the life-changing procedure, and fewer people with potential risks will decide to get it.

"This is ground-breaking. It's the first time anything like this has happened around refractory, or LASIK, eye surgery," said Dr. Starr to reporters. "I think it's a good thing, because I know that the surgery, when done on the right patients, is a great, great surgery with phenomenally good outcomes."

But the negative side effects can be just as life-changing as the positive, say sufferers. David Shell told the panel that he has "not experienced a moment of crisp, good quality vision since" receiving the surgery. Adding to the troubles of those experiencing problems after surgery, very few of the negative side effects, like excessively dry eyes, double vision, shadows or halos, decreased night vision, and a "starburst" effect of oncoming headlights, are correctable.

At least before the surgery, said the unhappy victims, corrective glasses could remedy their worst vision problems. Now, there is nothing they can do.

One man who’d had severe vision problems since his LASIK surgery went so far as to take his own life. Colin Dorrian was a law student in 2001 when he sought a doctor’s advice for his vision problems. The doctor told Dorrian he was not a good candidate for the procedure – he already had dry eyes and large pupils, both indicators of an unsuccessful result – but he insisted on getting the surgery anyway. Almost immediately, Dorrian began experiencing blurred vision and eye pain, and his father Gerard says it was partly due to his eye problems that his son later committed suicide. Gerard Dorrian read from his son’s suicide note at the panel hearing. "As soon as my eyes went bad, I fell into a deeper depression than I'd ever experienced, and I couldn't get out…I can't and won't continue facing this horror."

The procedure itself involves the cutting of a thin flap of the cornea with a laser. Once the flap is lifted, the eye surgeon uses a second laser to reshape the eye, thus correcting the vision, before the flap is returned to place. It can be used to correct either near- or farsightedness.

However, some people are not ideal candidates for the surgery. Anyone with dry eyes prior to the procedure faces a risk of worsening the condition. Also, folks with very thin corneas, large pupils, early-stage cataracts, or autoimmune disorders should not have the surgery. Some sources report that as many as one in four people seeking LASIK are not good candidates. Those speaking before the panel claim that the procedure’s overwhelmingly positive press has painted it as a low-risk surgery with a guaranteed outcome, and they want the risks to be more well known.

Matt Kotsovolos had the procedure done in 2006, and is angry that he was grouped into the category of successful outcomes because his vision is now 20/20. But Kotsovolos has experienced extreme negative side effects since then, and he wants the risks to be better known. "For the last two years, I have suffered debilitating and unremitting eye pain," said Kotsovolos to the FDA panel. "Patients do not want to continue to exist as helpless victims with no voice."

The panel appears to have listened to this small but vocal minority, and has decided to recommend that more extensive warnings be included with information about the LASIK procedure.

They recommended including photographs of what one’s vision might be like if negative side effects are experienced, as well as information about how often both minor and major side effects occur. The panel also recommended that conditions precluding successful outcomes be explained in more detail.

For the most part, doctors and eye surgeons have overwhelmingly said they’d follow the recommendations, saying they only want good health and successful outcomes for their patients.

"No matter how uncommon, when complications occur, they can be distressing," said Dr. Peter McDonnell of Johns Hopkins University to reporters. McDonnell is a representative of the American Academy of Ophthalmologists. Added McDonell, "We're dedicated to doing everything in our power to make the Lasik procedure even better for all our patients."