The FDA has approved a new balloon device — the ReShape Integrated Dual Balloon System — to treat obesity by facilitating weight loss without invasive surgery, according to a press release from the agency.
The device, which is delivered into the stomach through the mouth using a minimally endoscopic outpatient procedure that usually takes less than 30 minutes with mild sedation, likely works by occupying the stomach. This may lead to fullness, although the balloon may also work by other mechanisms that are not yet understood, the release states.
The ReShape Dual Balloon is intended for temporary use and should be removed 6 months after insertion. Patients are urged to follow a medically supervised diet and exercise plan to enhance their weight loss efforts.
The device is currently indicated for patients with a BMI of 30 to 40 with at least one obesity-related comorbidity, like hypertension, high cholesterol or diabetes, who have failed to lose weight with diet and exercise alone.
“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the release.
“This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent and can be easily removed.”
In a clinical trial involving 326 obese participants with at least one obesity-related comorbidity aged 22 to 60 years, the 187 who were randomly assigned treatment with the ReShape Dual Balloon lost an average of 14.3 lb (6.8% of total body weight) after 6 months with the device vs. 7.2 lb (3.3% of total body weight) among those who underwent an endoscopic procedure but did not receive the device.
Six months after removal of the ReShape Dual Balloon, those who received the device managed to keep off 9.9 lb of the 14.3 lb that they initially lost, according to the release.
Potential side effects include headache, muscle pain and nausea from the sedation and the procedure. Rare cases of severe allergic reaction, heart attack, esophageal tear, infection and breathing difficulties can also occur.
After placement of the balloon, patients may also experience vomiting, nausea, abdominal pain, gastric ulcers and feelings of indigestion.
The ReShape Dual Balloon should not be used in patients who had have 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. Additionally, it should not be used in patients who are pregnant or use aspirin daily.
Currently, there are three other devices approved by the FDA to treat morbid obesity: the Allergan LAP- Band, the Ethicon Endo-Surgery Realize Adjustable Gastric Band and the Maestro Rechargeable System.