Your advertising for LASIK can nullify informed consent
Consumer alert warns patients about risks and complications
Do you advertise LASIK (laser-assisted in situ keratomileusis) as "laser vision correction" and tell potential patients that they can "throw away their glasses" and "20/20 vision is guaranteed"? If so, you aren’t giving patients the complete picture, which could void your informed consent, LASIK experts warn.
The "minor nuisance" complication rate is 1% to 5%, depending on the surgeon’s experience, says Richard L. Lindstrom, MD, clinical professor of ophthalmology at the University of Minnesota and managing partner in Minnesota Eye Consultants, both in Minneapolis. "The rate of significant sight threatening complication is 1 per 1,000," Lindstrom says. "If your advertising says it’s safe and easy . . . it can nullify informed consent." Problems with informed consent can translate into patient satisfaction problems or even lawsuits, LASIK experts warn.
In addition, the Federal Trade Commission (FTC) in Washington, DC, is on the offensive to warn patients about the risks and complications associated with the procedure. The FTC has issued an FTC Consumer Alert about LASIK that warns patients: "It’s not for everyone." The FTC also has a brochure on Basic Lasik: Tips on Lasik Eye Surgery available. (For a copy of the alert and tips, click here. For ordering information, see "Sources" at the end of this article.)
"We felt consumers weren’t receiving sufficient information in the advertising — print or broadcast — about potential risks and complications associated with the procedures," says Colleen P. Tressler, senior project manager in the Office of Consumer and Business Education at the FTC.
With hundreds of thousands of patients having this surgery and a complication rate estimated at about 3%, "it stands to reasons that a significant number of consumers will experience problems," Tressler says. The brochure is designed to give potential patients a full picture about LASIK so they can make an informed decision about whether to have the surgery, she says.
To avoid having patients with unrealistic expectations, consider these suggestions:
• Avoid certain wording in advertisements. "Many people have been misled by ads that say you can throw away your glasses and don’t discuss risks," says Jane Aguirre, vice president for ophthalmic practice at the American Academy of Ophthalmology in San Francisco. "Anyone who goes into surgery expecting a 100% outcome, and things don’t go that way, they’ll be disappointed," she warns. The academy cooperated with the FTC in developing the brochure.
Even if information on risks is included in advertisements, "some ads simplify, trivialize, and minimize surgical complications," says R. Doyle Stulting, MD, PhD, professor of ophthalmology at Emory University in Atlanta and chair of the Refractive Surgery Special Interest Group of the Fairfax, VA-based American Society of Cataract and Refractive Surgery. Part of the problem can be attributed to the size of the ads, Stulting says. They are relatively small and don’t provide enough information on potential complications, he says, and adds that those problem are common for all advertisements.
Matthew Daynard, staff attorney in the Division of Advertising Practices at the FTC, agrees that the size of the ads is a problem. "But one could at least identify this procedure as surgery," he says, instead of "laser vision correction."
What words should you avoid? Throw away your glasses, 20/20 vision guaranteed, painless, easy, safe, "or any other unsubstantiated claim," Lindstrom says. For example, surgeons shouldn’t say they’re the most experienced in the world or that they developed the procedure, unless those statements are true, he says. (See "Guidelines for Refractive Surgery Advertising" in this issue.)
• Determine whether the candidate is a good choice for LASIK. Not everyone is a good candidate for LASIK, Aguirre emphasizes. "The surgeon’s findings on the pre-op investigation are important."
According to the brochure, patients should meet the following qualifications:
— They should be at least 18 years old, and 21 for some lasers, "since the vision of people younger than 18 usually continues to change," it states.
— They should not be pregnant or breast-feeding "as these conditions might change the measured refraction of the eye."
— They should not be taking certain prescription drugs such as Accutane (Roche Laboratories, Nutley, NJ) or oral prednisone.
— Their eyes must be healthy and their prescription stable. "If you’re myopic, you should postpone LASIK until your refraction has stabilized, as myopia may continue to increase in some patients until their mid- to late 20s," the brochure says.
— They must be in good general health. "LASIK may not be recommended for patients with diabetes, rheumatoid arthritis, lupus, glaucoma, herpes, infections of the eye, or cataracts," the brochure adds.
The brochure also advises potential patients that if they are happy wearing contacts or glasses, they might not want to undergo the procedure.
The brochure tells patients that they should ask their physicians whether they are candidates for monovision (correcting one eye for distance vision and the other eye for near vision.) "LASIK cannot correct presbyopia so that one eye can see at both distance and near," the brochure says. "However, LASIK can be used to correct one eye for distance and the other for near." If they can adjust to this correction, it might eliminate their need for wearing glasses, the brochure states.
• Be prepared to answer questions from potential patients. The brochure advises candidates to ask their surgeons these questions:
— How long have you been doing LASIK surgery?
— How much experience do you have with the LASIK procedure?
— How do you define success? What’s your success rate? What is the chance for me (with my correction) to achieve 20/20? How many of your patients achieved 20/20 or 20/40 vision? How many patients returned for enhancements (additional surgery)? The brochure advises potential patients that, in general, 5% to 15% of patients return for enhancements.
— What laser will you be using for my surgery?
The brochure says candidates should make sure the surgeon is using a laser approved by the Food and Drug Administration (FDA). Currently, the FDA has approved lasers manufactured by VISX in Santa Clara, CA; Summit Technology in Waltham, MA; Bausch & Lomb in Dallas; Nidek in Fremont, CA; and ATC in St. Petersburg, Russia.
— What’s involved in after-surgery care?
— Who will handle after-surgery care?
— What about risks and possible complications?
The brochure lists risks and potential complications, and information on what to expect before, during, and after surgery. Candidates also are given information on alternatives to LASIK, including photorefractive keratectomy, astigmatic keratotomy, and intrastromal corneal rings.
• Ensure informed consent is complete. Make sure you understand the potential patient’s expectation, Aguirre advises. "If you’re doing someone’s eyes who’s very dependent on them for vocation or work function, he needs to understand that he might have worse vision afterward than when he started," she says.
Tell patients about the most common complications: a halo effect at night, fluctuating vision and dry eye the first few months, and possible need for a second treatment, Lindstrom advises. Also tell them about the most serious potential complications: Flap complications and an inflammation or infection that, if not properly managed, can lead to loss of the best-corrected vision.
The bottom line is a simple one, Stulting says: "When [patients] agree to have any surgical procedure, they need to know the risks, benefits, and alternatives. They need to understand their chances of having an adverse reaction."
Sources
For more information about LASIK, contact:
• Jane Aguirre, Vice President for Ophthalmic Practice, American Academy of Ophthalmology, 655 Beach St., San Francisco, CA 94109-1336. Telephone: (415) 561-8595.
• Matthew Daynard, Staff Attorney, Division of Advertising Practices, Federal Trade Commission, 600 Pennsylvania Ave. N.W., Room 40002, Washington, DC 20580. Telephone: (202) 326-3291.
• Richard L. Lindstrom, MD, Minnesota Eye Consultants, 710 E. 24th St., Suite 106, Minneapolis, MN 55404. Telephone: (612) 813-3600. Fax: (612) 813-3660. E-mail: [email protected].
• R. Doyle Stulting, MD, PhD, Professor of Ophthalmology, Emory University, Atlanta. E-mail: [email protected].
Additional copies of Basic Lasik: Tips on Lasik Eye Surgery are available from the Federal Trade Commission. Telephone: (877) 382-4357. Copies also are available on the Web site: www.ftc.gov.
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