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If you've driven around Southern California, chances are you've seen a few 1-800-GET-THIN ads. The billboards tout the ability to lose weight with the Lap-Band. But, they say little about the potential risks of the Lap-Band surgery. The FDA has now issued a letter to the marketing company and eight affiliated surgical centers.
The FDA wants them to adequately address the risks associated with the Lap-Band. They say that the current ads are simply too misleading.
And, maybe they are. When you hear the term "Lap-Band," do you automatically know what the product is?
The Lap-Band is a silicone ring . It's implanted around a patient's stomach. The ring discourages patients from eating too much. The procedures cost between $12,000 and $20,000. It's covered by many insurance policies.
Though widely available, there are risks to the surgery. Several patients died after receiving the procedure at various surgical centers. Those centers were affiliated with the 1-800-GET-THIN campaign, reports the Los Angeles Times.
Yet, none of these risks are heavily advertised on the banner advertisements. Some billboards, reports NPR, only read: "Lose weight with the Lap-Band! Safe 1 hour, FDA approved; 1-800-GET-THIN; 1-800 953-5000; PPO insurance; free insurance verification."
The FDA calls this type of advertising misleading. It doesn't adequately inform consumers of the risks associated with the Lap-Band. "Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure," said head of regulatory compliance at FDA's device center Steven Silverman in a statement.
Under federal law, advertisements for medical devices typically need to contain relevant warnings. Warnings may include information about risks and possible side effects.
None of this information is prominently displayed on the 1-800-GET-THIN ads. This is why the FDA sent the letter about Lap-Band's risks to the marketing company. The ads do have some warnings about risks, but all in small typeface, according to the Los Angeles Times.