GAITHERSBURG, Maryland (Reuters) - Patients unhappy with their
laser eye surgery urged U.S. health regulators to do more to
limit poor results, saying complications from the LASIK
procedure have taken a toll on their sight and emotions.
Blurred vision, dry eyes, glare and double-vision have led to
depression and in some cases suicide, several patients told a
U.S. Food and Drug Administration advisory panel.
"Since LASIK, I am visually handicapped," said patient David
Shell, adding that he has near constant eye pain and depression.
"My eyes never feel comfortable... 10 years have passed and I
still suffer from this problem."
Millions of Americans have had successfully undergone LASIK, or
laser-assisted in-situ keratomileusis, which uses a laser to
reshape the eye's cornea, making them less dependent on glasses
or contact lenses.
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Surgeons and other industry representatives told the FDA's
outside advisers most LASIK patients are satisfied with their
vision. They noted depression is a complex condition and that no
studies show a direct link to laser eye surgery.
Still, the FDA is taking another look at the surgery after
receiving 140 reports of side effects and device malfunctions
between 1998 and 2006.
The FDA wants its panelists' advice on what information it would
add to its website or product labeling to help those considering
"Most of the patients who are having these procedures are fairly
satisfied and are doing well. Clearly there is a group who are
not satisfied and do not get the kind of results they expect,"
Daniel Schultz, head of the FDA's device center, told reporters
on Thursday ahead of the meeting.
Several unhappy patients at the advisory meeting faulted
their surgeon for not ruling them out as a poor candidates
for LASIK, or for failing to stress the severity of possible
The FDA, which has said the surgery is safe and effective
regulates LASIK devices but not the surgeons or clinics that
offer the procedure.
Stock analysts have said the FDA focus on the procedure
could further hurt LASIK companies, which have already seen
the softening U.S. economy dampen demand for the elective
surgery that is usually not covered by health insurance.
is also planning to begin a study on LASIK patient satisfaction
in 2009 along with the National Eye Institute and two industry
groups: the American Society of Cataract and Refractive Surgery
and the American Academy of Ophthalmology.
Patient and consumer advocates at Friday's meeting objected to
the groups' involvement with the study, citing conflicts of
interest. Industry representatives said it would help them
understand why some patients are unhappy with their LASIK