FTC, AAO combine on tips for LASIK surgery patients

The two groups collaborated to create a set guidelines for LASIK consumers to read before committing themselves to surgery.

WASHINGTON — Perhaps sensing what a minefield promotion of laser vision surgery could become, the American Academy of Ophthalmology and the Federal Trade Commission worked together last year to draft “Basik Lasik: Tips on Laser Eye Surgery” for potential refractive surgery patients. The guide is now displayed on the Web sites of both organizations.

The tip sheet for consumers can trace its roots to a set of guidelines released by the FTC in December 1997, after they had been besieged by “numerous inquiries concerning potentially misleading promotions and advertising for radial keratotomy (RK), photorefractive keratectomy (PRK), and laser assisted in-situ keratomileusis (LASIK).”

The concern of the FTC was that, despite the existing guidelines, laser refractive surgery companies and individual eye care practitioners were not telling the whole story in their advertisements promoting the advantages of refractive laser surgery.

Careful marketing guidelines

The professional guidelines, called “Marketing of Refractive Eye Care Surgery: Guidance for Eye Care Providers,” were released by the FTC in 1997. In that document the FTC explained that under Section 5 of the Federal Trade Commission Act, an advertisement is deceptive and therefore unlawful if it contains a representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances, and the representation or omission is material — that is, likely to affect a consumer’s choice or use of a product or service.

The FTC also noted that advertisers are responsible for claims that are reasonably inferred from their advertisements, as well as claims that are expressly stated. These requirements apply to all objective claims, including those made through the use of consumer testimonials.

Also the FTC advised that advertisers must have substantiation for all objective claims about a product or service before the claims are disseminated. In the context of claims about the safety, efficacy, success or other benefits of RK, PRK or LASIK, substantiation would usually require competent and reliable scientific evidence sufficient to support the claim that is made.

The FTC specifically stated that anecdotal evidence and consumer testimonials are not considered competent and reliable scientific evidence of efficacy.

An example of poorly worded advertising was cited in the 1997 report: “[A claim] made for any of these surgeries, suggesting only that patients … can ‘throw away their eyeglasses’ may also 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.”

Safety of the surgery also needs to be substantiated if the ads for surgery mention its safety. For example, an advertisement containing express or implied representations that the surgery is safe may also need to contain information about any significant risks associated with the surgery, and, for PRK or LASIK, with the particular laser in use.

Basik Lasik guide for consumers, available on the AAO and FTC’s
Web sites, gives eye surgery consumers a well-balanced look at the benefits
and possible bad outcomes that can occur following laser vision surgery.

‘Basik Lasik’ tips

With the 1997 FTC recommendations for professionals out there but not always closely followed by some laser vision correction companies and individual doctors, the AAO and the FTC felt the need to address refractive surgery consumers as well. They decided to combine efforts to create the Basik Lasik guide for consumers.

The guide, available on both organizations’ Web sites, gives eye surgery consumers a well-balanced look at the benefits and possible bad outcomes that can occur following laser vision surgery.

Among the tips listed on the Web site:

• LASIK is surgery to a very delicate part of the eye.
• Hundreds of thousands of people have had LASIK, most very successfully.
• As with any surgery, there are risks and possible complications.
• LASIK may not give you perfect vision. The AAO reports that seven out of 10 patients achieve 20/20 vision, but 20/20 does not always mean perfect vision.
• If you have LASIK to correct your distance vision, you’ll still need reading glasses around age 45.
• LASIK surgery is too new to know if there are any long-term ill effects beyond 5 years after surgery.
• LASIK surgery cannot be reversed.
• Most insurance does not cover the surgery.
• You may need additional surgery — called “enhancements” — to get the best possible vision after LASIK.

The sites also give in layman’s term some details about the eye and what actually takes place during the surgery.

Risks vs. rewards

The Basik Lasik sites also give an example of who would benefit best from LASIK surgery. The guide states that candidates should generally be 18 or older, not pregnant or nursing, not on certain prescription drugs, with stable refractions and in good general health. Patients should also have reasonable expectations of the surgery, understand the risks and rewards and ask their doctors about the possibility of monovision, the guide advises.

Among the lists of risks and possible complications, the guide has these explanations:

• Over- or under-correction. These problems can often be improved with glasses, contact lenses and enhancements.
• Corneal scarring, irregular astigmatism (permanent warping of the cornea), and an inability to wear contact lenses.
• Corneal infection.
• “Loss of best corrected visual acuity” — that is, you would not be able to see as well after surgery, even with glasses or contacts, as you did with glasses or contacts before surgery.
• A decrease in contrast sensitivity, “crispness” or sharpness. That means that even though you may have 20/20 vision, objects may appear fuzzy or grayish.
• Problems with night driving that may require glasses.
• Flap problems, including irregular flaps, incomplete flaps, flaps cut off entirely and ingrowth of cells under the flap.

The guide advises people interested in laser surgery to contact the AAO’s “Find an Eye MD” web site at www.eyenet.org or the International Society of Refractive Surgery Web site www.LocateAnEyeDoc.com.

For Your Information:

• The Federal Trade Commission can be reached at CRC-240 Washington, DC 20580; (877) 382-4357; Web site: www.ftc.gov.
• The American Academy of Ophthalmology can be reached at P.O. Box 7424, San Francisco, CA 94120; (415) 561-8500; fax: (415) 561-8633; Web site: www.eyenet.org. The FTC “Marketing of Refractive Eye Care Surgery: Guidance for Eye Care Providers” guidelines can be found online at www.ftc.gov/bcp/guides/eyecare2.htm. The FTC and AAO ”Basik Lasik: Tips on Lasik Eye Surgery” can be found online at the FTC’s Web site, www.ftc.gov/bcp/conline/pubs/health/lasik.htm and on the AAO’s Web site, www.eyenet.org/member/whats_new/basik_lasik.htm.