Non-surgical balloon device to treat obesity approved by FDA

The FDA recently approved a new device to treat obesity without invasive surgery. The device, called ReShape Integrated Dual Balloon System or ReShape Dual Balloon for short, is designed to help adult patients lose weight.

The primary modus-operandi of the device seems to be to take up space in the stomach, and trigger a feeling of fullness. However, the device does not change or alter the shape and size of the stomach. Whether the device works in any other way is yet to be seen.

A simple, minimally invasive endoscopic procedure is all it takes to implant the device in the recipient’s stomach. Once in place, the ReShape Dual Balloon is inflated with a sterile solution, making it take up room in the stomach. The entire process is done under mild sedation and takes about 30 minutes from start to finish.

The balloon is a temporary device and should be removed six months after it is inserted. The recipients are advised with a medically-supervised diet and exercise plan to augment their weight loss efforts while using the balloon. They are asked to continue the diet and exercise regimen to maintain their weight loss, post-removal.

According to William Maisel, acting director at the FDA’s Center for Devices and Radiological Health, the balloon gives patients a non-surgical and temporary option that can be easily removed.

However, the ReShape balloon is not for everyone. The FDA says the balloon is for people with a BMI of 30 to 40 kilograms per meters squared and one obesity-related condition such as diabetes and high blood pressure, who have tried to lose weight through diet and exercise but failed.

The ReShape Dual Balloon was tested in a clinical trial with 326 obese participants aged 22 to 60, who had at least one obesity-related health condition. The participants were divided into two randomly selected groups. In the first group, the ReShape balloon was introduced into 187 individuals via endoscopy. The participants in the second group underwent an endoscopic procedure, but did not receive the ReShape Dual Balloon. Both the groups were given a healthy diet and exercise program.

After six months when the device was removed, researchers noted that the participants in the first group (with the device) lost 14.3 pounds. The participants in the second group (who underwent an endoscopic procedure but were not given the device) lost an average of 7.2 pounds.

Six months after the device was removed, participants who received the ReShape Dual Balloon device were able to keep off an average of 9.9 pounds of the 14.3 pounds they lost.

Potential side effects include headache, muscle pain, and nausea from the sedation and procedure. In rare cases, people can suffer from severe allergic reaction, esophageal tear, infection, and breathing difficulties.