The US Food and Drug Administration approved the ReShape Integrated Dual Balloon System (ReShape Dual Balloon) to treat obesity without invasive surgery. It is meant to be temporary and should be removed 6 months after it is inserted.
The ReShape Dual Balloon likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.
It is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach. The device does not change or alter the stomach’s natural anatomy.
Patients are advised to follow a medically supervised diet and exercise plan to augment their weight-loss efforts while using the ReShape Dual Balloon, and to maintain their weight loss following its removal.
The ReShape Dual Balloon is indicated for weight reduction in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2. The device is limited to patients with one or more obesity-related conditions such as high blood pressure, high cholesterol, and diabetes. It is intended for patients who have failed previous attempts at weight loss through diet and exercise alone.
There are currently three other FDA-approved devices to treat morbid obesity: the Allergan LAP-Band, the Ethicon Endo-Surgery Realize Adjustable Gastric Band, and the Maestro Rechargeable System.
In the study leading to device approval, 187 individuals randomly selected to receive the ReShape Dual Balloon lost 14.3 pounds on average (6.8% of their total body weight) when the device was removed at 6 months, while the control group (who underwent an endoscopic procedure but were not given the device) lost an average of 7.2 pounds (3.3% of their total body weight).
Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9.9 pounds of the 14.3 pounds they lost.
Potential side effects include headache, muscle pain, and nausea from the sedation and procedure. In rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.
This device should not be used in patients who have had previous gastrointestinal or bariatric surgery or who have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying, or active H. Pylori infection. Those who are pregnant or use aspirin daily should also avoid the device.
The ReShape Dual Balloon is manufactured by ReShape Medical Inc in San Clemente, Calif.