Balloon System for Obesity Treatment gets Green Signal from FDA

On Tuesday, the Food and Drug Administration has given green signal to an inflatable medical balloon manufactured by Reshape Medical for the treatment of obesity in adults. The balloon helps patients lose weight by filling up space in stomach.

Using an endoscopy, the balloon is inserted into patient's stomach and then filled with saline solution. FDA said that the procedure that takes not even half an hour requires person to be sedated. Earlier also, there was a balloon device, but it was withdrawn in 1992 because it had ruptured and blocked patients' arteries.

FDA spokeswoman Deborah Kotz said that the new design aims to address the shortcomings of the earlier device. Over a third of US adults are obese, the ones having a body mass index of 30 or higher. Weight loss surgery is recommended to those who have BMI of 40 more and the ones having BMI of 35 and having other risk factors like heart disease.

The balloon has been approved for obese adults having BMI between 30 and 40 and has at least one complicated condition. It is also the condition that they were unable to reduce weight through other measures like diet and exercise alone.

In the trials, patients treated with the balloon were able to lose around 7% of their total body weight in six months in comparison to the ones with 3.3% weight loss among patients who did not get the balloon. After the device was removed, the patients regained more than two-thirds of their weight that they had lost.