Marketing of Refractive Eye Care Surgery: Guidance for Eye Care Providers

The Federal Trade Commission (FTC) has prepared this guidance on marketing Lasik and alternative laser refractive procedures, known as “surface ablation techniques,” for eye care providers. It explains the requirements of Section 5 of the FTC Act that apply to the promotion of these procedures. The FDA has approved excimer laser systems for Lasik and surface ablation techniques, and millions of people have undergone these procedures in search of better vision.

Requirements for Advertising Under the FTC Act

The FTC enforces Section 5 of the Federal Trade Commission Act (FTC Act), which prohibits deceptive or unfair practices in or affecting commerce, and Section 12 of the FTC Act, which prohibits the dissemination of any false advertisement to induce the purchase of any food, drug, device, or service.

An ad is deceptive under Section 5 of the FTC Act if it has a statement – or omits information – that:

  • is likely to mislead consumers acting reasonably under the circumstances; and
  • is “material” – that is, important to a consumer’s decision to buy or use the product.

An ad or business practice is unfair if:

  • it causes or is likely to cause substantial consumer injury that a consumer could not reasonably avoid; and
  • the injury is not outweighed by any benefit the practice provides to consumers or competition.

The FTC looks at an ad from the point of view of the “reasonable consumer” – the typical person looking at the ad. Rather than focusing on certain words or phrases, the FTC looks at an ad’s entire context – words, phrases, and pictures – to determine what it conveys to consumers.

Both “express” and “implied” claims are important to the FTC. An express claim is one that is made literally in the ad. For example, a claim that “more of our [ABC Lasik Center] patients achieve 20/20 vision than those of our competitors” is an express claim that ABC’s patients achieve better results. An implied claim is made indirectly or by inference. For example, the representation made by a patient in a testimonial that “the procedure was easy” implies that there are no complications or side effects for most of ABC Lasik Center’s patients. Under the law, advertisers must have proof to back up any claim that consumers reasonably take from an ad.

The FTC also looks at what the ad does not say – that is, if omitting information leaves consumers with a misimpression about the product or service. For example, a representation that ABC Lasik Center “provides a free consultation” may mislead consumers if it doesn’t say that a non-refundable deposit is required before their candidacy for the surgery is determined by a healthcare professional, if that is the case.

Whether a claim would be “material” – that is, important to a consumer’s decision to buy or use the product or service also is a key factor for the FTC. Examples of material claims are representations about a product or service’s performance, features, safety, price, or effectiveness.

Finally, a company must have a “reasonable basis” for its claims before it runs an ad. A “reasonable basis” means objective evidence that supports the claim. The kind of evidence depends on the claim. At a minimum, an advertiser must have the level of evidence that it says it has. 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. X’s patients. If the ad isn’t specific, the FTC looks at several factors to determine what level of proof is necessary, including what experts in the field think is needed to support the claim. In most cases, ads that make health or safety claims must be supported by “competent and reliable scientific evidence,” which means tests, studies, or other scientific evidence that has been evaluated by qualified people. In addition, any tests or studies must be conducted using methods that experts in the field accept as accurate. Statements from satisfied customers are not sufficient to support a health or safety claim or any other claim that requires objective evaluation.

Under FTC law, ads, promotional brochures, informational tapes, seminars and other forms of marketing of Lasik or any other refractive surgery to consumers should not have express or implied claims that are false or unsubstantiated, or that omit material information. In particular, claims that convey an inaccurate impression about the safety, efficacy, success or other benefits of any form of refractive surgery would raise concerns about deception. For example, a claim for Lasik or surface ablation procedures suggesting that patients who are nearsighted, with no other refractive vision deficiencies, 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.

Claims about success rates, long-term stability, or predictability of outcome must be substantiated by competent and reliable scientific evidence. Keep in mind that FDA approval of the excimer laser for use in Lasik is not, by itself, adequate substantiation for all specific claims about the success of the procedure.

In addition, representations about the safety or efficacy of Lasik or any other refractive surgery sometimes may require disclosures of key information about health risks or limitations associated with the surgery to prevent charges of deception. 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.

For further guidance on FTC requirements for advertising, see the FTC Policy Statement on Deception and the FTC Policy Statement on Unfairness.

For more information contact the FTC’s Division of Advertising Practices, Bureau of Consumer Protection.

October 2008