The U.S. Food and Drug Administration (FDA) on Tuesday approved the first intergastric balloon device for obesity treatment available in the United States. The Integrated Dual Balloon System is minimally invasive, reversible and appropriate for patients with a body mass index (BMI) between 30 and 40 kg/m2 who do not qualify for bariatric surgery. However, while early studies look promising, experts urge caution until there is data to support the effectiveness of the device long-term.
The device works by occupying space within the stomach, which makes the patient feel full without changing the stomach’s anatomy. Using an endoscopic procedure, a clinician inserts the balloons into the stomach and, once they are in place, inflates the balloons with a sterile saline solution. According to an FDA press release, the device may trigger other mechanisms that are not yet fully understood. The…
