FDA Approves Non-Surgical ReShape Dual Balloon System for Weight Loss

A new non-surgical weight loss procedure offers hope for mild to moderately obese people unsuccessful at losing weight through diet and exercise alone, who either may not want, cannot afford or do not qualify for bariatric surgery.

The ReShape Integrated Dual Balloon System, approved by the U.S. Food and Drug Administration on July 28, 2015, uses two attached balloons filled with sterile saline solution (salt water) to occupy space in the stomach and trigger a feeling of fullness. In contrast to bariatric surgery that permanently alters anatomy, this device offers a minimally invasive weight loss option that is temporary and does not change the anatomy of the stomach.

National Center for Health Statistics show more than one-third of adults in the U.S. are obese.

“Many Americans who face the risk and consequences of obesity have struggled with a lack of effective weight loss options when their BMI is in the 30-40 range,” said John Morton, MD, MPH, president of the American Society for Metabolic and Bariatric Surgery. “Options like ReShape address a significant gap that exists between diet and exercise, weight loss medications and surgery, offering a minimally invasive, reversible option which we hope will promote long-term healthy habits.”

The ReShape Integrated Dual Balloon System is only for use in adults with a body mass index (BMI) of 30-40kg/m² with one or more obesity related health condition such as high blood pressure, high cholesterol or diabetes whose attempts at weight loss through diet and exercise alone have failed.

During an outpatient procedure lasting about 30 minutes and requiring only mild sedation, a physician places the ReShape Dual Balloon System into the stomach through the mouth using an endoscopic procedure. The separate balloons, connected by a flexible shaft, are then inflated with a blue saline solution. A similar endoscopic procedure is used to remove the balloons after six months. If a balloon accidentally deflates, the blue dye will cause the patient’s urine to temporarily turn blue and the remaining inflated balloon prevents migration of the device from the stomach into the intestines.

In addition to the ReShape Dual Balloon device, the ReShape system utilizes medically supervised coaching to teach a healthy lifestyle and track weight loss progress.

According to the FDA, a clinical trial of ReShape Integrated Dual Balloon System found patients who received the device and associated coaching lost about twice as much weight as those who received only the coaching.

“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, M.D., M.P.H., 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 non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

Photo and video courtesy of ReShape Medical Inc.