Orbera is a non-surgical intragastric balloon device that has been used for weight loss outside of the United States for over 20 years. It is now FDA approved to be used in the United States. The device is indicated for weight reduction in obese patients with a BMI of 30 to 40 kg/m2 who have been unable to lose weight with diet and exercise.
The non-surgical procedure takes about 30 minutes in which the patient is mildly sedated. The balloon is placed inside the stomach through the mouth via an endoscopic procedure. Once the device is inside the stomach, it is filled with 500 cc of saline causing it to expand to induce a feeling of satiety. The device is removed after six months.
Data on the use of Orbera included 125 individuals with a BMI of 30 to 40 kg/m2. The participants lost an average of 22 pounds (10% of their body weight) after the six months of treatment with Orbera. Three months after the balloon was removed, the participants maintained 19 pounds of that weight loss. Participants who only received a 12-month behavior-modification program only lost an average of 7 pounds (3% of their body weight). Nausea, vomiting, and abdominal pain were occasionally reported, but were manageable and no deaths occurred.
- The procedure takes about 30 minutes.
- The participants lost an average of 22 pounds (10% of their body weight) after the 6 months of treatment with Orbera. Three months after the balloon was removed, participants maintained 19 pounds of that weight loss.
- Orbera has been available outside the United States for over 20 years.
Tucker, Miriam. “FDA Approved Another Balloon Device for Weight Loss.” The US Food and Drug Administration has approved the Orbera Intragastric Balloon System (Apollo Endosurgery) as a weight-loss device.