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 five FDA-approved devices on the market designed to treat obesity:
- Lap-Band Gastric Banding System
- Realize Gastric Band
- Maestro Rechargable System
- ReShape Integrated Dual Balloon System
- ORBERA Intragastric Balloon System
Before medicine is prescribed or surgery is recommended, doctors will probably want their patients to demonstrate healthy lifestyles that include 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 FDA-approved obesity treatment devices, FDA activities related to obesity treatment devices, and how to report a problem with an obesity treatment device.