Bariatric (obesity) surgery has proven to be effective for the treatment of obesity; however, the invasive procedure comes with a risk of adverse effects, even death. On July 28, the Food and Drug Administration (FDA) announced that it had approved a new noninvasive device to treat obesity.
The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is proposed to aid weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood. The device is delivered into the stomach via the mouth by 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 space in the stomach.
The device does not alter the stomach’s natural anatomy in any way. Recipients of the device are advised to follow a medically supervised diet and exercise plan to supplement their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is a temporary device that should be removed six months after insertion.
“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,” explained William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. He added, “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.”
The ReShape Dual Balloon is suitable for weight reduction in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2. It is limited to patients with one or more obesity-related conditions such as high blood pressure, high cholesterol, and/or diabetes. In addition, it is intended for patients who have failed previous attempts at weight loss through diet and exercise alone. The FDA notes that 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.
The ReShape Dual Balloon was evaluated in a clinical trial comprised of 326 obese individuals aged 22 to 60 (with a BMI of 30 kg/m2 to 40 kg/m2) who had at least one obesity-related health condition. In the study, 187 participants who were randomly selected to receive the ReShape Dual Balloon lost an average 14.3 pounds (6.8%t of their total body weight) when the device was removed at six months; 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). This is likely due that the monitoring of one’s weight provided motivation to lose it.
A problem with many weight loss programs is that not uncommonly, after completing a weight loss program, the individual gains back the weight. Thus, it is encouraging that 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 for the procedure 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.
The FDA cautions that the 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. In addition, individuals 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, California.