by Lori Andrews

What has Tiger Woods got that you don't have?  Ads for LASIK surgery capitalize on his golf swing, his charisma, his fortune–with the subtle implication that you, too, could be a Tiger if only you underwent surgery for nearsightedness.

Over a million people a year undergo LASIK.  But not everyone who submits to the procedure enjoys Tiger's success.  The surgery, laser-assisted in-situ keratomileusis, can pose risks. Some patients who have undergone LASIK complain of double vision, blurriness, and depression.  Last year, the FDA held hearings on the risks, including a report of suicide by a man who had an unsuccessful procedure.

The Federal Trade Commission took action by creating a checklist of questions that consumers should ask before undergoing the procedure.  But now the Food and Drug Administration has gone one step further.  On Friday, May 23, the FDA advised doctors and clinics that their LASIK ads must contain information about the risks as well as benefits.

Consumer groups suggest that the FDA has not gone far enough.  At the very least, suggests Diana Zuckerman, president of National Research Center for Women & Families, the agency should take note of the fact that certain people won't be benefited by the surgery and require that doctors provide a brochure describing all possible risks.  Legal scholars, such as ISLAT guest blogger Bruce Patsner, M.D., J.D., see this controversy as part of a larger issue, which he has addressed in an article in the Food, Drug, and Law Journal.  The FDA's main strength is in regulating drugs, with little experience in regulating ads about devices and procedures. As the Obama appointees reinvigorate the agency, procedures like LASIK and the devices that enable it, will command an increasing amount of the FDA's attention.