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 kg/m² or more is considered obese.
Obesity Treatment Devices
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 Band - bands are placed around the top portion of the stomach leaving only a small portion available for food.
- Lap-Band Adjustable Gastric Banding System [ARCHIVED]
- 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.
Factors to Consider Before Beginning Obesity Treatment
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.
Patients should be evaluated and treated for eating disorders before considering obesity treatment. An undiagnosed and untreated eating disorder can have serious health consequences for patients, and in fact, some devices are contraindicated for patients that have a history of eating disorders. Medical professionals may also find it appropriate to closely monitor patients that have received obesity devices during treatment for evidence of an eating disorder.
Common eating disorders include binge-eating disorder and bulimia nervosa. According to the National Eating Disorders Association, some 30 million people in the U.S. suffer from a clinically significant eating disorder at some time in their life.
How to Report a Problem
If you experience an injury or malfunction when using an obesity treatment device, we encourage you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons
- UPDATE: Potential risks with liquid-filled intragastric balloons -- Letter to Health Care Providers
- National Library of Medicine - Weight Loss Surgery
- CDC - About BMI for Adults
- National Institute of Mental Health - Eating Disorders
- FDA Consumer Update - Medical Devices that Treat Obesity: What to Know
- Press Announcement: FDA approves AspireAssist obesity device
- Binge Eating Disorder Association