FDA Warns LASIK Providers: Stop Making False Claims

By Denise Mann
HealthDay Reporter

THURSDAY, Sept. 29 (HealthDay News) — The U.S. Food and Drug Administration is once again cracking down on eye care professionals who make false safety claims and promises about the popular LASIK eye surgery.

The agency’s Letter to Eye Care Professionals, issued this week, follows an earlier warning from May of 2009. In its latest salvo against deceptive, potentially harmful advertising, the FDA is now giving eye doctors 90 days to get in line and update any advertising or promotional materials that make false claims. After this time, the agency will take regulatory action, said FDA spokeswoman Erica Jefferson.

“It’s about the false claims and not adequately providing consumers with information about the risks associated with the procedure,” she said.

LASIK, a laser cornea-shaping procedure, does come with risks. Those risks are small but can include vision loss, under- or over-correction of vision, dry eye, infection, glare, halos and or double vision.

And LASIK isn’t for everyone. At this point in time, the procedure can help repair vision among people who are nearsighted, farsighted or have an astigmatism (irregular curvature of the cornea), all conditions known as refractive errors.

The FDA refrained from pointing out examples of misleading advertising by LASIK practitioners, but a 2008 guidance to eye care doctors, issued by the U.S. Federal Trade Commission (FTC), lists a few:

• Unproven claims. “A company must have a ‘reasonable basis’ for its claims before it runs an ad,” the FTC said. “For example, the statement, ‘clinical studies show that the laser used by Dr. X results in 20/20 vision 85 percent of the time,’ must be supported by clinical studies to that effect for Dr. Xs patients … Statements from satisfied customers are not sufficient to support a health or safety claim or any other claim that requires objective evaluation.”
• Important omissions. Some ads tell the truth, but not the whole truth, the FTC said. For example, a LASIK ad that claimed that nearsighted people can “‘throw away their eyeglasses’ may be deceptive without further qualification, if, after surgery, a significant number of patients require eyeglasses for best vision, for reading, or under particular circumstances, such as for night driving,” the agency said.
• Claims of complete safety. “An advertisement with express or implied representations that the procedure is ‘safe,’ or ‘clinically proven to be safe,’ for example, also should tell consumers that, like any surgery, Lasik, or other advertised refractive surgery, has risks and potential complications, and that they will be discussed during a surgical consultation prior to the procedure,” the FTC said.

Eye care professionals agreed that deceptive ads must be stamped out. Speaking on behalf of the American Society of Cataract and Refractive Surgery, Dr. Eric D. Donnenfeld said the group supports the FDA’s efforts.

LASIK is exceptionally safe when done by the right doctor on the right patient, stressed Donnenfeld, who is an ophthalmologist with offices throughout Long Island, NY. However, he said that “choosing the right doctor is the most important thing one can do.” According to Donnenfeld, LASIK surgeons should be members of the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery. LASIK surgeons should also be board-certified by the American Board of Ophthalmology.

“A lot of patients make a decision based on an ad in a magazine or an audio clip on radio,” Donnenfeld said. This may not be the smartest approach, he said, because “there are a lot of very good doctors who advertise, but it doesn’t mean a doctor is good because he advertises or offers group discounts.”

“We have to go beyond the advertising or Groupons and have to treat [LASIK] as a surgical procedure,” he said.

Not everyone is a good candidate for LASIK, either, Donnenfeld added. People with thin or irregular corneas and other eye diseases such as dry eye, glaucoma (increased pressure in the eye) or cataract (cloudy areas in the lens) might be advised against the procedure, for example.

Donnenfeld’s advice for finding a good LASIK surgeon: ask your eye doctor who he or she would see for their own eyes.

But he also stressed that as LASIK technology has improved many risks have been minimized, if not eliminated. For example, “the risk of glare and halo have largely gone away,” Donnenfeld said.

“Dry eye is common after LASIK and it almost always goes away after three or six months,” he noted, and people who already have dry eye prior to the surgery are not candidates for LASIK.

Infection is also a risk with any surgery, Donnenfeld said, but following preoperative instructions — including taking antibiotics — can help reduce this risk. Another potential risk may be larger pupils.

“These should all be discussed during your consultation,” he said.

More information

There’s more on LASIK at the International Society of Refractive Surgery.

SOURCES: Erica Jefferson, spokeswoman, U.S. Food and Drug Administration; Eric D. Donnenfeld, M.D., ophthalmologist, Long Island, New York; Sept. 23, 2011, FDA Letter to Eye Care Professionals, U.S. Food and Drug Administration; Oct. 2008, Marketing of Refractive Eye Care Surgery:
Guidance for Eye Care Providers, U.S. Federal Trade Commission

Last Updated: Sept. 30, 2011