May 25, 2009

FDA Warns Of Deceptive LASIK Ads

The U.S. Food and Drug Administration released a letter on Friday warning providers of LASIK eye surgery to ensure their advertisements inform consumers of the possible risks of the procedure.

The FDA has been investigating patient complaints over the corrective LASIK eye surgery, and told doctors, clinics and others who perform the procedure that commercials and other promotions that do not include the necessary warnings are deceptive.

"Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading," wrote Timothy Ulatowski, who leads the Office of Compliance for agency's Center for Devices and Radiological Health.

The FDA's letter comes more than a year after the agency held a public meeting that included scores of dissatisfied patients who complained of double vision, blurriness, depression and other problems after undergoing LASIK eye surgery.

However, surgeons and other industry groups argue the procedure is safe and effective when performed properly, and that the majority of patients are satisfied with the results.

LASIK, or laser-assisted in-situ keratomileusis, surgery involves cutting a flap in the eye and then using a laser to reshape the cornea.   Since its approval in 1998, roughly 700,000 Americans have undergone the procedure, which seeks to improve patients' vision so they can avoid having to wear glasses or contact lenses.  

The FDA's letter excludes LASIK-related firms that could have been harmed by more severe action, such as device makers Bausch & Lomb, Abbott Laboratories' unit Abbott Medical Optics Inc, Alcon Inc. and clinics such as and LCA Vision Inc. and TLC Vision Corp.

A slowing U.S. economy has already weakened demand for the elective surgery, which is not covered under most health insurance plans and can cost several thousand dollars per eye.

The FDA shares oversight of LASIK advertising with the Federal Trade Commission (FTC).  If the FDA believes LASIK advertising is misleading, it can issue warning, impose fines or  even refer the cases for criminal investigation.

However,  Diana Zuckerman, president of National Research Center for Women & Families, said the FDA could have done more than issue a "vague" letter that does not help patients "in any meaningful way.

"The problem is there are certain people who are unlikely to benefit (from LASIK) and they don't know who they are," she told Reuters.

"At this point many people think LASIK is some kind of miracle ... and that's just not true."

Instead, she said, the FDA should move to require clinics and doctors to provide potential patients a simple, easy-to-understand pamphlet that details the possible risks.

Mary Long, an FDA spokeswoman, pointed to additional steps the agency has taken, such as updating its Web site to make it easier for patients to report problems.

The American Academy of Ophthalmology physicians' group said it was appreciative of the "reminder" from the FDA, and that it would distribute the letter to its members. 


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