Medical Devices

FDA Approved Obesity Treatment Devices

Currently, there are two FDA-approved devices on the market designed to treat obesity: Lap-Band Gastric Banding System and Realize Gastric Band.

Lap-Band Gastric Banding System

Lap-Band Gastric Banding System showing the device on the stomach and a diagram of the device showing the gastric band, access port, and connection tubing.
Figure 1: Lap-Band System

The Lap-Band System (Figure 1) is a surgically implanted device that helps adults who are at least 18 years old eat less and lose weight. The Lap-Band consists of a silicone band, tubing, and an access port. The inner surface of the silicone band is inflatable and is connected by the tubing to the access port. The band limits the amount of food that can be eaten at one time and increases the time it takes for food to be digested, helping people to eat less.

The FDA approved the Lap-Band System for use in obese patients with a Body Mass Index (BMI) of at least 40. It is also approved for patients with a BMI of 30-40 with one or more obesity-related medical conditions, such as high blood pressure, heart disease, diabetes or sleep apnea. This device is indicated for use only in adult patients who have failed non-surgical weight-loss alternatives, such as supervised diet, exercise and behavior modification programs.

Realize Gastric Band

Realize Gastric Band diagram showing the band, balloon, tubing, injection port, and septum.

Figure 2: Realize Gastric Band

The Realize Band (Figure 2) is a surgically implanted device used to help adults (18 years of age or older) lose weight. The Realize Band consists of a silicone band, tubing, and an injection port. The band helps a person eat less by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested.

The FDA approved the Realize Band for patients who are morbidly obese, with a BMI of at least 40. It is also approved for patients with a BMI of at least 35 with one or more obesity-related medical conditions. The Band is indicated for use only in adult patients who have failed non-surgical weight-loss alternatives, such as supervised diet, exercise and behavior modification programs.

Page Last Updated: 07/08/2014
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