Experts Advise New Warnings for LASIK
Patients Tell FDA Panel About Serious Side Effects From Corrective Eye Surgery
By
Todd Zwillich
WebMD Health News
Reviewed By
Louise Chang, MD
April 25, 2008 — The FDA should do more to warn patients about the risks of
popular laser vision corrective surgery, an expert panel has concluded.
The recommendations came after more than a dozen
LASIK patients or their family members testified Friday about severe
reactions to the surgery. Most said their doctors did not adequately warn them
that vision loss or eye dryness could persist, in some cases, for years.
"For a small minority, their regret is profound," said Todd Krouner,
a New York attorney who represents about half a dozen LASIK patients, including
the wife of a former police officer who Krouner said blamed a botched LASIK
surgery for his suicide.
"It is not about the 20 minutes in surgery, it's about what came before
it and what has come after it. It's about a lack of solution for them,"
said Rebecca Petris, a former LASIK patient who now runs a network of
dissatisfied patients.
The FDA has launched a new national study of patient outcomes, along with
the National Eye Institute and the American Society of Cataract and Refractive
Surgery (ASCRS) to try to compile more information on the rate of poor LASIK
results.
The study is likely to take years to complete. In the meantime, experts said
information given to patients considering LASIK surgery should warn more
clearly of the possibility of long-term vision disruptions, including
"halos," "starbursts," blurriness, and multiple vision.
The FDA has become increasingly concerned about reports of severe
complications but has acknowledged that it does not have enough studies to know
how often severe reactions occur. Those reports, which include debilitating eye
dryness, blurred vision, and other vision disruptions, could suggest doctors
are not doing enough to inform patients about the potential risks, the agency
said.
Debate Over LASIK
LASIK (which stands for laser-assisted in situ keratomileusis) is performed
in more than 700,000 U.S. patients each year. One study published last month by
a trade group representing LASIK surgeons suggested about 95% of all patients
are satisfied with their procedure.
"Even with the stats we have, we have info that the vast majority of
patients who have LASIK do very well," said Jayne S. Weiss, MD, who chaired
the advisory panel.
"It is really a referendum on the performance of LASIK by some surgeons
who should really be doing a better job," said Weiss, a professor of
ophthalmology at Wayne State University in Detroit.
Experts also recommended that both patient information and FDA's LASIK web
site contain photos of potential vision problems.
"We do want something that people will read and see if they have the
opportunity to," Weiss said.
Experts also urged the agency to include more warnings about the potential
risks of LASIK in women using hormone replacement therapy since the drugs can alter the cornea. And they called for more
warnings for doctors who evaluate which patients may not be candidates for the
procedure.
Some advocacy groups have said the FDA's national study lacked independence
because it was being run in part by ASCRS, the group representing doctors
performing LASIK and other procedures.
"The FDA will objectively evaluate the information collected," said
Eva Rorer, MD, the chief of FDA's ophthalmic division.
Still, some experts said Friday they had difficulty knowing what new
warnings to recommend for LASIK patients.
"I think there are many aspects of risk related to LASIK that we have
yet to find out," said David C. Musch, MD, a professor of ophthalmology at
the University of Michigan and a member of the advisory panel.
Peter McDonnell, MD, professor of ophthalmology at Johns Hopkins University
School of Medicine, says the surgery has been studied extensively. According to
a news release about the FDA meeting by the American Academy of
Ophthalmology, McDonnell says, "LASIK is the most studied elective
procedure ... I believe it is safe to say that no elective ophthalmic surgical
procedure has been as fully studied as has this procedure. But, as with any
surgical procedure, there are complications that may occur after LASIK.
Fortunately these are uncommon. No matter how uncommon, however, when
complications occur they can be quite distressing to both patients and
surgeons."
SOURCES: Jayne S. Weiss, professor of ophthalmology, Wayne State University,
Detroit. Todd Krouner, attorney, Chappaqua, N.Y. Rebecca Petris, founder, lasermyeye.com. Eva Rorer, MD, chief ophthalmic medical officer, FDA. David C. Musch, MD, professor of ophthalmology, University of Michigan;
member, FDA advisory panel. LASIK: A Global Perspective on Patient Satisfaction, American Society of
Cataract and Refractive Surgery (ASCRS), March 5, 2008. News release, American Academy of Ophthalmology.
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