FDA Approved Obesity Treatment Devices
Currently, there are three FDA-approved devices on the market designed to treat obesity: Lap-Band Gastric Banding System, Realize Gastric Band, and Maestro Rechargeable System.
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.
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.
The Maestro Rechargeable System is an electrical stimulator that is surgically implanted into the abdomen to block nerve activity between the brain and the stomach. It consists of a rechargeable electrical pulse generator, wire leads and electrodes and is used to help people who are at least 18 years old lose weight.
The Maestro System works by sending intermittent electrical pulses to the vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. External controllers allow the patient to charge the device and allow health care professionals to adjust the device’s settings in order to provide optimal therapy with minimal side effects. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.
The FDA approved the Maestro Rechargeable System for use in obese patients who have failed at least one supervised weight management program within the past five years and who have either: a Body Mass Index (BMI) of 40 to 45, or a BMI of 35 to 39.9 and one or more obesity-related conditions (e.g. diabetes, high blood pressure, sleep apnea, etc.).
FDA issues Warning Letters for misleading advertising of Lap-Band[ARCHIVED]
- FDA Targets Gastric Band Weight-Loss Claims
- Device Approval - LAP-BAND® Adjustable Gastric Banding System [ARCHIVED]
- Patient Labeling - Realize Adjustable Gastric Band
- National Library of Medicine - Laparoscopic gastric banding