Medical Devices

Obesity Treatment Devices


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 also help treat obesity. Currently, there are four types of FDA-approved devices on the market designed to treat obesity:

  • Gastric Bands - bands are placed around the top portion of the stomach leaving only a small portion available for food.
  • Electrical Stimulation Systems - electrical stimulator is placed in the abdomen to block nerve activity between the brain and stomach.
  • Gastric Balloon Systems - inflatable balloons are placed in the stomach to take up space.
  • Gastric Emptying Systems - a tube is inserted between the stomach and outside of abdomen to drain food after eating.

Prior to prescribing medicine or recommending surgery, doctors will probably want their patients to demonstrate healthy lifestyles that include better nutrition and increased physical activity. Even after 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 FDA-approved obesity treatment devices, FDA activities related to obesity treatment devices, and how to report a problem with an obesity treatment device.

Page Last Updated: 08/26/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English