Dangers Lurk For Some Lasik Eye Surgery
Patients, Clearer Warnings Necessary
In fury and despair, patients harmed by Lasik eye
surgery told federal health advisers of severe eye pain, blurred
vision and even a son's suicide. The advisers recommended that
the government warn more clearly about the risks of the hugely
popular operations.
Millions undergo the elective laser surgery around the world.
Like golf star and famed Lasik recipient Tiger
Woods, they're hoping to throw away their glasses, just
as the ads say.
And while the vast majority benefit most see 20-20 or
even better about one in four people who seeks Lasik is
not a good candidate. A small fraction, perhaps 1 percent or fewer,
suffer serious, life-changing side effects: worse vision, severe
dry eye, glare, inability to drive at night.
"Too many Americans have been harmed by this procedure and it's
about time this message was heard," David Shell of Washington
told the Food and
Drug Administration's scientific advisers before their
recommendation that the FDA
provide clearer warnings.
Shell held up large photographs that he said depict his blurred
world, showing halos around objects and double vision, since his
1998 Lasik.
"I see multiple moons," he said angrily. "Anybody want to have
Lasik now?"
Colin Dorrian was in law school when dry eye made his contact
lenses so intolerable that he sought Lasik, even though a doctor
noted his pupils were pretty large. Both the dry eye and pupil
size should have disqualified Dorrian, but he received Lasik anyway
and his father described six years of eye pain and fuzzy
vision before the suburban Philadelphia man killed himself last
year.
"As soon as my eyes went bad, I fell into a deeper depression
than I'd ever experienced, and I couldn't get out," Gerard Dorrian
read from his son's suicide note.
Matt Kotsovolos, who worked for the Duke
Eye Center when he had a more sophisticated Lasik procedure
in 2006, said doctors classify him as a success because he now
has 20-20 vision. But he said, "For the last two years I have
suffered debilitating and unremitting eye pain. ... Patients do
not want to continue to exist as helpless victims with no voice."
The sober testimonies illustrated that a decade after Lasik hit
the market, there still are questions about just how often patients
suffer bad outcomes from the $2,000-per-eye procedure.
But one thing is clear, said Dr Jayne Weiss of Detroit's
Kresge Eye Institute,
who chairs the FDA advisory panel: "This is a referendum on the
performance of Lasik by some surgeons who should be doing a better
job."
The FDA advisers
a group of mostly glasses-wearing eye doctors recommended
that the agency make more clear the warnings it already provides
for would-be Lasik patients:
• Add photographs that illustrate what people suffering
certain side effects actually see, such as the glare that can
make oncoming headlights a huge "starburst" of light.
• Clarify how often patients suffer different side effects,
such as dry eye. Some eye surgeons say 31 percent of Lasik patients
have some degree of dry eye before surgery, and it worsens for
about 5 percent afterward. Other studies say 48 percent of Lasik
recipients suffer some degree of dry eye months later.
• Make more understandable the conditions that should disqualify
someone from Lasik, such as large pupils or severe nearsightedness.
• And spell out that anyone whose nearsightedness is fixed
by Lasik is guaranteed to need reading glasses in middle age,
something that might not be needed if they skip Lasik.
That's a big reason why Weiss, the glasses-wearing ophthalmologist,
won't get Lasik even though she offers it to her patients.
"I can read without my glasses and ... operate without my glasses,
and I love that," she said. "The second aspect is I would not
tolerate any risk for myself. ... Does that mean Lasik is good
or not good? It means Lasik is good but not for everyone."
Lasik is marketed as quick and painless: Doctors cut a flap
in the cornea the eye's clear covering aim a laser
underneath it and zap to reshape the cornea for sharper sight.
The FDA
agrees with eye surgeons' studies that only about 5 percent of
patients are dissatisfied with Lasik. What's not clear is exactly
how many of those suffer lasting severe problems and how many
just didn't get quite as clear vision as they had expected.
The most meticulous studies come from the military, where far
less than 1 percent of Lasik recipients suffer serious side effects,
said Dr. David Tanzer, the Navy's Medical Corps commander. That
research prompted Lasik to be cleared last year both for Navy
aviators and NASA astronauts.
"The word from the guys that are out there standing in harm's
way, whose lives depend on their ability to see, are asking you
to please not take this away," said Lt. Col. Scott Barnes, a cornea
specialist at Fort Bragg who described Army troops seeking Lasik
after losing their glasses in combat.
No one's actually considering restrictions on Lasik but
the FDA is pairing with eye surgeons to begin a major study next
year to better understand who has bad outcomes.
"Millions of patients have benefited" from Lasik, said Dr. Peter
McDonnell of Johns
Hopkins University, a spokesman for the American Academy
of Ophthalmologists. "No matter how uncommon, when complications
occur, they can be distressing. ... We're dedicated to doing everything
in our power to make the Lasik procedure even better for all our
patients."
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