Weight-Loss and Weight-Management Devices

The FDA issued two draft guidances for medical devices with indications associated with weight loss:

• Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations
• Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations

The draft guidances, when finalized, are intended to provide:

• Recommendations for the non-clinical testing to support premarket submissions for these devices.
• Recommendations about clinical study design for these devices.
• Discussion on how the FDA considers the benefit-risk analysis to support such indications.

FDA-regulated medical devices can help patients lose or manage their weight. The FDA categorizes devices as weight-loss or weight-management devices based on the amount of weight a person is expected to lose.

On this page:

• Overweight and Obesity
• Weight-Loss Devices
• Weight-Management Devices
• Factors to Consider Before Use of Weight-Loss or Weight-Management Devices
• How to Report a Problem
• Reports of Problems
• Additional Resources

Overweight and Obesity

Overweight and obesity are defined as excessive fat accumulation that presents a risk to health. 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 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. A person is considered overweight with a BMI of 25.0 - 29.9 kg/m². Being overweight may increase the risk for many of the same health problems that are associated with obesity.

Therapies for weight-loss or weight-management range from healthy eating and exercise to prescription medicine, medical devices and surgery. Healthy eating and exercise are typically recommended to help a person who is overweight lose excess weight.

Weight-Loss Devices

Currently, there are three types of FDA-regulated devices intended for weight-loss:

• 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
  • ORBERA Intragastric Balloon System
  • Obalon Balloon System
  • TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
  • Spatz3 Adjustable Balloon System
  • Apollo Endoscopic Sleeve Gastroplasty and Revise Systems

  Weight-Management Devices

  Currently, there are two types of FDA-regulated devices intended to aid in weight management:

  • Oral Removable Palatal Space Occupying Device - worn during meals to limit bite size
    • Sensor Monitored Alimentary Restriction Therapy (SMART) Device
    • Plenity

    Factors to Consider Before Use of Weight-Loss or Weight-Management Devices

    Before prescribing medicine or recommending devices or surgery, most doctors will request their patients demonstrate healthy lifestyles that include better nutrition and increased physical activity. Even after prescription medicine, device, or surgical treatments, patients will need to maintain a healthy lifestyle for the rest of their lives. Despite treatments and lifestyle changes, some patients may not be able to lose weight or maintain weight-loss.

    For some weight-loss devices, patients should be evaluated and treated for eating disorders before considering device use as part of their obesity treatment. An undiagnosed and untreated eating disorder can have serious health consequences for patients. Some devices are not for (contraindicated in) patients that have a history of eating disorders. Medical professionals may also find it appropriate to closely monitor patients with certain weight-loss devices during treatment for evidence of an eating disorder.

    How to Report a Problem

    If you experience an injury or problem when using a weight-loss or weight-management 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.

    Reports of Problems

    In February 2017, August 2017, June 2018, and April 2020, the FDA issued letters to health care providers based on reports of patient problems related to liquid-filled gastric balloon systems, including death. Other problems included a hole in the stomach (gastric perforation); sudden inflammation of the pancreas, which typically causes a sudden and severe stomach ache (acute pancreatitis); and balloons filling with air and enlarging, causing discomfort (spontaneous hyperinflation).

    The FDA continues to monitor these problems and recommends health care providers closely monitor patients who have liquid-filled gastric balloons for complications. The FDA also recommends health care providers instruct patients on symptoms that could be signs of serious or even life-threatening problems—and explain to patients what to do if these symptoms happen.

    Additional Resources

    • UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers (April 27, 2020 - Archived)
    • National Library of Medicine - Weight-loss Surgery
    • CDC - About BMI for Adults
    • National Institute of Mental Health - Eating Disorders
    • FDA Consumer Update - Medical Devices for Weight Loss and Weight Management: What to Know
    • FDA Activities: Weight-Loss and Weight-Management Devices
    • National Eating Disorders Association - Binge Eating