Lap-Band is a device implanted via gastric banding surgery that helps adult eat less and lose weight. Like any surgery, gastric banding surgery comes with serious risks, such as death, said Herbert Lerner, MD, a general surgeon and supervisory medical officer at the FDA, in the news release.
The FDA objects to the advertising because it does not mention the serious side effects and possible complications of the procedure. By federal law, advertisements for medical procedures and implants are required to contain relevant warnings and information about precautions, side effects and the medical reasons that make a treatment inappropriate.
The letters request that the advertisements, which are on billboards, on bus placards and in newspaper advertisements, be removed and that the FDA be notified of action within 15 business days.
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