Experts Advise New Warnings for LASIK
Patients Tell FDA Panel About Serious Side Effects From Corrective Eye Surgery
Debate Over LASIK continued...
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