New FDA push for LASIK-suicide risk data

www.chicagotribune.com/news/nationworld/chi-lasik_25feb25,0,5777703.story

chicagotribune.com
NATION
LASIK failure toll can be high
FDA to study effects of complications from eye surgery; some blame
them for depression, suicide
By Sabine Vollmer

McClatchy-Tribune newspapers

February 25, 2008

RALEIGH, N.C.

Patients who undergo vision-correcting laser eye surgery sign a
release form with an extensive list of risks, but some researchers and
former patients say a potential complication is not mentioned:
depression that can lead to suicide.

In response to patient complaints, the Food and Drug Administration
plans to convene a large, national study to examine the relationship
of LASIK complications and quality of life, including psychological
problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA's Center for Devices
and Radiological Health, wrote in an e-mail that the scant clinical
data available "failed to suggest significant problems following LASIK
surgery."

But she said the FDA wants a broad and systematic review. She wrote,
"We also noted that quality of life issues related to LASIK had not
been evaluated consistently, and there were few reports of well-
designed studies."

Frustration and sorrow can follow any unsuccessful surgery, but when
the procedure leaves a patient with unremitting eye pain or
permanently impaired vision, the emotional toll can be severe.

One who could not endure it was Colin Dorrian, 28, a patent lawyer and
aspiring medical student from suburban Philadelphia. He committed
suicide last summer, six years after LASIK surgery left him with
lasting visual distortions. The surgery was done at a LASIK center in
Canada that has since closed.

"If I cannot get my eyes fixed, I'm going to kill myself," he wrote in
a note police found.

In the note, Dorrian wrote that there had been other instances when he
felt down. "I have other problems like most people do. But this is
something else," he wrote. "As soon as my eyes went bad, I fell into a
deeper depression than I had ever experienced, and I never really came
out of it."

Laser eye surgeons who treat patients with complications say they do
come across cases of depression, but they don't think LASIK
complications are the root cause. They say patients who exhibit
depression after the procedure were likely depressed or
psychologically troubled beforehand.

"There's no cause and effect," said Dr. Steven Schallhorn, the former
head of the Navy Refractive Surgery Center in San Diego and an expert
on permanent visual distortions from LASIK.

Christine Sindt, an optometrist and associate professor of clinical
ophthalmology at the University of Iowa in Iowa City, has encountered
the psychological effects that patients experience when they have
trouble seeing.

"Depression is a problem for any patient with a chronic vision
problem," she said. But in the case of post-LASIK patients, she said,
the depression is compounded by remorse.

"It's not just that they lose vision," she said. "They paid somebody
[who] took their vision away."

Dr. Alan Carlson, a laser eye surgeon at the Duke Eye Center in
Durham, built his career on correcting the vision of patients at high
risk of complications. He said people at risk of depression or anxiety
are generally not good candidates for LASIK. He compared them to
patients who become depressed after undergoing cosmetic surgery.

"Their motivation and expectations may reflect something they're
missing in their life that they're not telling you about," he said.

In 2006, the FDA began to look into LASIK complications and quality-of-
life issues and determined more research was needed.

A task force that includes representatives of the National Eye
Institute and the National Institutes of Health has since formed to
design a large study that would be conducted by laser eye surgeons
across the country.

The FDA is also planning a public meeting to discuss experiences with
LASIK devices since their introduction to the U.S. market.

- - -

Mostly safe, successful

Since the mid-1990s, numerous studies have shown that the surgery
known as laser-assisted in-situ keratomileusis, or LASIK, is safe and
successful in most cases and has become more so with new technology.
Most of the 1.3 million Americans who undergo the surgery every year
are happy with the results. The American Society of Cataract and
Refractive Surgery, which represents about 9,000 ophthalmologists
specializing in laser eye surgery, suggests that only 2 percent to 3
percent of LASIK patients experience complications.

Copyright © 2008, Chicago Tribune