FDA Approves Balloon Weight-Loss Device

The FDA approved a balloon device intended to help obese adult patients lose weight without invasive surgery.

The FDA today approved a balloon device intended to help obese adult patients lose weight without invasive surgery.

The ReShape Integrated Dual Balloon System is placed into a patient’s stomach via a minimally invasive endoscopic procedure, and once inserted, it can trigger feelings of fullness. The balloon is inflated with a sterile solution to take up more space in the stomach.

In addition to the device, patients will be instructed to follow a supervised diet and exercise plan to help them lose weight and keep pounds off. After 6 months, the device is removed.

A clinical trial involved 326 obese patients aged 22 to 60 years, and the 187 individuals who had the device implanted lost around 14 pounds on average after 6 months. Meanwhile, the control group lost about 7 pounds.

Patients may experience adverse side effects such as headache, muscle pain, and nausea. The device may also cause vomiting, abdominal pain, and gastric ulcers when the device has been placed in the stomach.

The device is not meant to treat 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.

“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, in a press 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.”

The integrated dual balloon system is intended for patients with a body mass index of 30 to 40 kg/m2.