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FDA Approves Nonsurgical Temporary Balloon Device to Treat Obesity
The FDA has given the “okay’ to a new balloon device to treat obesity without the need for invasive surgery.
The ReShape Integrated Dual Balloon system (ReShape Medical Inc.) is intended to facilitate 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 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 after its removal. The device is meant to be temporary and should be removed 6 months after it is inserted.
“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,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new nonsurgical option that can be quickly implanted, is nonpermanent, and can be easily removed.”
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 hypertension, high cholesterol levels, and diabetes. It is intended for patients who have failed previous attempts at weight loss through diet and exercise alone.
Three other FDA-approved devices are currently used 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 studied in a clinical trial involving obese participants (with a BMI of 30 to 40 kg/m2) aged 22 to 60 years who had at least one obesity-related health condition. A total of 187 subjects who received the ReShape Dual Balloon lost an average of 14.3 pounds (6.8% of their total body weight) when the device was removed at 6 months, whereas 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 after the device was removed, patients kept off an average of 9.9 pounds of the 14.3 pounds they lost.
Potential adverse 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 has been placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.
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 Helicobacter pylori infection; those who are pregnant or use aspirin daily should also avoid the device.
Source: FDA; July 28, 2015.