Weight Loss News Update: FDA Approves ReShape Dual Balloon Device for Obesity Treatment

Obesity is a global concern and with individuals looking for the best way to help them in their weight management journey, medical technology has been in constant search of how to further improve and develop weight loss treatments. Fortunately, the US Food and Drug Administration (FDA) has approved yet another method that can definitely aid obese individuals who are having difficulties in losing weight.

Last Tuesday, the FDA has approved the use of the ReShape Dual Balloon System, an temporary balloon device implant that can take up space in the stomach and provide a feeling of fullness in the individual, Philly Health reports. This device will be inside an individual for six months and will be implanted by a minimally invasive endoscope though the mouth going to the stomach. The patient will be mildly sedated and the outpatient procedure will last for about 30 minutes or less.

FDA explains that the balloon device will not alter the anatomy of the stomach and the patients will be under medical supervision during the entire process for their diet and workout plans. This is to ensure that the patients will lose weight and continue to do so even after the device has been removed.

CBS News writes that back in 1992, the FDA has already approved a similar balloon device for weight loss. However, it was withdrawn due to safety concerns as the balloons can pop while inside the body, leading to artery blockage in patients. Deborah Kotz, spokeswoman of the FDA, is hopeful that the new device will be able to address the design flaws of the initial balloon method.

The ReShape Dual Balloon has been approved for obese individuals with a BMI of 30 to 40, who are suffering from one complication like high blood or elevated blood glucose, and have previous failed attempts to lose weight. This device will be initially available through several providers who have been trained to operate and perform the outpatient procedure. Price is undisclosed as the company explains it varies per location.

The FDA relates that in a clinical trial on 326 obese subjects, 187 participants have been randomly selected to receive the balloon device while the rest have been left without the device. After six months, the controlled group has been able to lose an average of 14.3 pounds or 6.8 percent of their total body weight. The patients have also been noted to maintain 9.9 pounds of their total weight after another six months since the device has been removed.