FDA Cracks Whip on Lap-Band Marketing
An industry that’s grown up around a promising way to help people caught in a web of obesity needs to make a few less promises, the FDA declares.
In July, we asked how candidates for Lap-Bands — surgically implanted belts that wrap around the stomach and can be tightened to make it smaller — should be evaluated after the U.S. Food and Drug Administration widened the window of those eligible for the weight-loss procedure. By lowering the body-mass index criteria, as many as one in seven Americans became eligible for the surgery.
Our Taylor Orr wondered if the Lap-Band wasn’t being promoted a little recklessly as a get-thin cure-all – besides Lasik, how many surgical procedures do you see offered on billboards? “In short, it’s moved from the last hope of the morbidly obese to a sort of lifestyle choice for the plump,” she wrote.
Given the relentless marketing, Orr asked if the psychological aspects of the Lap-Band should have an equal weight with the physical ones, especially for people who weren’t willing to make lifestyle changes to stay trimmer.
“After having the surgery, a lot of patients are not willing to change their life patterns,” she quoted Dr. Mafa R. Kamal, a Los Angeles psychiatrist who screens potential Lap-Band patients before they can have Lap-Band surgery. “They think that if they do the surgery, they’re going to be slim, but they discover that actually they’re not going to have new friends or a new personality. After surgery, many patients don’t want to exercise or stop eating junk food. They want to do what they want to do. The surgery is risky, and there are complications. Some patients are not going to be compliant with anything.”
On Tuesday, the FDA cracked the whip on some of the surgery mills that promoted a little-too-carefree image of Lap-Band life. Eight surgical centers and the marketing firm 1-800-GET-THIN LLC have been ordered to pull what the FDA considers misleading ads off billboards, TV, the Internet, the sides of city buses, and anywhere else they’re plastered.
“FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health, was quoted in a release from the agency. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”
Orr’s reporting found Lap-Band success stories and plenty of evidence that it was a reasonable way to fight obesity – for the right candidates. Even then, as a clinical study in the Journal of Obesity found, “the authors stressed the importance of a standardized follow-up procedure to ensure a healthy recovery, greater weight loss and fewer conditions such as diabetes or hypertension.”