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U.S. Department of Health and Human Services

Medical Devices

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Obesity Treatment Devices

Overview

Obesity is a major public health concern in the United States and has been linked to many health problems such as heart disease, stroke, diabetes, high blood pressure, sleep disorders, and breathing problems. Obesity (an excessive amount of body fat) is defined by body mass index (BMI), which is calculated from a person’s weight and height. A BMI of 30 or more is considered obese.

Treatments for obesity range from healthy eating and exercise, to prescription medicine and surgery. FDA-regulated medical devices have also played a role in treating obesity. Currently, there are two FDA-approved devices on the market designed to treat obesity: Lap-Band Gastric Banding System and Realize Gastric Band.

However, before medicine is prescribed or surgery is recommended, doctors will probably want their patients to demonstrate a healthy lifestyle that includes healthful eating and increased physical activity. Even with medical or surgical treatments, patients will need to maintain a healthy lifestyle for the rest of their lives. And some patients, despite treatments and lifestyle changes, may not be able to lose weight or maintain weight loss.

The purpose of this webpage is to provide information about the types of obesity treatment devices, FDA-approved obesity treatment devices, FDA activities related to obesity treatment devices, and reporting obesity treatment device problems.
 

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