Health Problem: Obesity is a multifaceted condition, involving a combination of factors such as behavior, genetics, medication use, and dietary patterns, as well as community environment, education, and food marketing. Obesity is associated with poorer mental health outcomes, can significantly impact quality of life, and can foster conditions like diabetes, heart disease, stroke, and some cancers. Obesity is a common condition in the United States, where approximately 37.7% of adults ages 20 years and older are considered obese, as are 17.2% of youths ages 2 to 19 years.

Technology Description: Intragastric balloons (IGBs) are acid-resistant balloons that are inserted into the stomach via an endoscope and expanded with saline or air. These space-occupying devices promote weight loss by creating a feeling of fullness, which can lead to reduced consumption of food. Currently, there are 3 IGBs approved for marketing in the United States. These are indicated for patients with a body mass index (BMI) ranging from 30 to 40 kilograms per square meter (kg/m2), although they may be used outside of the United States for overweight individuals (25 to 29.9 kg/m2). The devices are intended as an adjunct to diet, exercise, and behavioral counseling for the treatment of obesity. With the patient under conscious sedation, the gastrointestinal endoscopist progresses a balloon placement catheter through the mouth and esophagus into the stomach cavity, and the catheter guidewire is removed. The balloon is filled and deployed, after which the catheter tube is disengaged and removed. An IGB is also available that is taken by mouth using a normal pill-swallowing method.

Controversy: Despite many years of research and clinical use, particularly outside of the United States, no strong benefits favoring the use of IGBs over lifestyle interventions (such as restricted diet and exercise alone) have been established. In addition the use of IGBs carries risks for adverse effects, some potentially severe. The Food and Drug Administration recently issued 2 letters to healthcare providers alerting them to serious adverse events, including deaths, associated with both ReShape and Orbera IGBs. The events have only been reported for the fluid-filled IGBs, not for the gas-filled Obalon.

Key Questions:

  • Do endoscopically placed IGBs, along with dietary modifications, more effectively promote weight loss in obese patients compared with sham, conventional treatment, or hyaluronic acid injections?
  • Are IGBs safe?
  • Do gas-filled and saline-filled IGBs differ with regard to effectiveness and safety?
  • Have definitive patient selection criteria been established for IGB use in the treatment of obesity?

If you have a Hayes login, click here to view the full report on the Knowledge Center.