The FDA has warned eight surgical centers and the marketing firm 1-800-GET-THIN LLC in California about misleading advertising of the Lap-Band—a device implanted in a surgery called gastric banding to help adults eat less and lose weight.
The “FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”
By federal law, product advertising for certain medical devices, such as the Lap-Band, must contain relevant warnings and information about precautions, side effects, and contraindications (medical reasons that make a treatment inappropriate).
FDA’s warning letters direct the California marketing firm and surgical centers to pull their misleading ads and to notify FDA within 15 working days of action taken to correct them. See the warning announcement.