FDA: Doctors Must Warn LASIK Patients of Risks in Ads
Advertisements placed by doctors and clinics for LASIK vision-correction surgeries must warn patients about the risks of the procedure, the Food and Drug Administration said.
In a LASIK procedure, a surgeon uses a computer-guided laser beam to cut a flap in the outer surface of the eye to smooth out the surface of the cornea and improve vision. In some cases, the surgery has been linked to blindness, reduced vision, and other eye injuries. About 700,000 people in the United States have undergone LASIK surgery since 1998, when it was approved in the U.S., officials said.
However, some ads for the procedure have failed to include necessary warnings about side effects and other essential information about the laser device used in the surgery, the FDA said.
“Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading,” the FDA said in announcing the crackdown on LASIK advertising.
In 2008, the FDA held hearings to field concerns and complaints from dozens of patients who said LASIK surgery left them with blurry vision, double-vision, and other complications. The FDA and the Federal Trade Commission share regulation of LASIK advertising. If LASIK providers are found to issue misleading ads in the future, they could face fines and criminal investigations, officials said.
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