FDA Targets Gastric Band Weight-Loss Claims
MedSun: Newsletter #68, January 2012
FDA Consumer Update
Beware of ads that glamorize this surgery without giving the risks. 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. FDA has approved two gastric bands: Lap-Band, by Allergan Inc., and Realize Adjustable Gastric Band, by Ethicon Endo-Surgery Inc. These devices are implanted around the upper part of the stomach to create a “pouch.” The small pouch limits the amount of food that can be eaten at one time, making you feel full faster and potentially lose weight. Both bands are approved for use in adults age 18 and older who have not lost weight with non-surgical methods, such as diet, exercise or behavior modification. Health care providers who choose to promote the gastric banding procedure are required to educate patients about the risks involved, which must also be included in any advertising and promotional materials. Patients considering the surgery should read the patient information provided by their doctor and should ask any questions they have about gastric banding before having surgery.
FDA Consumer Update. FDA Targets Gastric Band Weight-Loss Claims. December 13, 2011.