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FDA Issues Warning Letters for Misleading Advertising of Lap-Band
Date:12/13/2011

s index (BMI) of 30-40, with one or more obesity-related medical conditions (such as type II diabetes and hypertension), or in patients with a BMI of 40 or over with or without an obesity-related medical condition.  Gastric banding is used when non-surgical weight loss methods (such as supervised diet, exercise and behavior modification) have not been successful. Patients considering gastric banding must be willing to make major changes in their eating habits and lifestyle.

"The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider," said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA's Center for Devices and Radiological Health. "It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient."

The Lap-Band has not been approved for use in children younger than 18. Only those who are able and willing to follow dietary and other health and lifestyle recommendations should consider the procedure. It's important that patients and their physicians are aware of and understand the limitations of gastric banding.

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.

If you suspect a problem with a gastric banding device, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events ca
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SOURCE U.S. Food and Drug Administration
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