The FDA Approves A New Device For Weight Loss: Reshape Dual Balloon

The U.S. Food and Drug Administration (FDA) has just approved a new device for weight loss called the Reshape Dual Balloon. The procedure is indicated for patients with BMI ranging between 30 and 40. The balloon is placed in the stomach through the mouth using endoscopy. The balloon is inflated in the stomach thereby preventing the patient from eating large meals. It is thought that the balloon increases satiety and controls appetite thus leading to weight loss. The balloon must be removed 6 months after insertion. Otherwise, the balloon may rupture inside the stomach and pass into the intestines causing obstruction.

A randomized study of 326 patients showed 14.3 pound average weight loss in those who received the balloon versus 7.2 pounds in the control group. After balloon removal, patients gained weight. An average of 4.4 pounds over 6 months following balloon retrieval. The study did not extend beyond one year.

The American Society for Metabolic and Bariatric Surgery (ASMBS) is very pleased with the approval because “the ReShape Dual Balloon offers a bridge between medications and surgery similar to a cardiac stent in cardiac disease.”

I am not sure what the ASMBS statement really means and why would the society be pleased with such a device. The weight loss is transient and small. Obesity is a chronic disease that results from disrupted interaction between the gastrointestinal tract and ingested food. Consequently, the digestive process including gastrointestinal motility, nutrient absorption, neuro-hormonal gastrointestinal signals and other substances secreted by the digestive system like bile are not properly functioning. We barely understand this complex physiology, and in the face of the obesity epidemic we come up with “silly” devices like bands and balloons as weight loss solutions and “bridges to nowhere.”

Personally, I would recommend the balloon as a temporary cosmetic procedure for an individual interested in loosing a few pounds before a wedding or a trip to the beach. ReShape Dual Balloon is not a weight loss procedure by any stretch of the imagination. Let us stay honest and stop marketing the device as “weight loss surgery without the surgery.”