New FDA push for LASIK-suicide risk data

Discussion in 'Laser Eye Surgery' started by doctor_my_eye, Feb 25, 2008.

    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


    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

    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
    doctor_my_eye, Feb 25, 2008
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