FDA Approves Stomach Balloon for Weight Loss

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

The FDA has approved a balloon that helps obese patients lose weight by filling part of the stomach and triggering feelings of fullness. The ReShape Integrated Dual Balloon System is indicated for adults who have at least one obesity-related condition (e.g., diabetes, hypertension, hyperlipidemia) and for whom diet and exercise hasn't worked.

The balloon — which is inserted into the stomach via the patient's mouth and then filled with saline — is only intended to be used for up to 6 months. Patients should still adhere to a supervised diet and exercise plan during and after use of the device.

In a randomized trial of over 300 obese patients, those who received the balloon lost an average of 6.8% of their total body weight (14 pounds) in 6 months versus 3.3% (7 pounds) among those who didn't receive it.

Side effects include gastric ulcers, indigestion, abdominal pain, and vomiting. Myocardial infarction, infection, and severe allergic reactions are rare. The device shouldn't be used in patients who've had bariatric or gastrointestinal surgery.