The device is placed through the mouth in the stomach using an endoscope. This procedure takes place in less than 30 minutes and is performed while the patient is under mild sedation.Once it is placed, the device is inflated with a sterile solution and it does not affect the natural anatomy of the stomach. Following this procedure the patients are given an exercise plan and a medically supervised diet plan that they have to follow.
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FDA has said that the people would typically use the device for less than six months. The growing numbers of obese population in US is a matter of concern as recently a study had suggested that the probability of obese people retuning back to shape is very low. The study revealed that the obese participants were able to reduce up to 5 percent of their body weight but could not keep it constant. Dr. William Maisel, the acting director of Office of Device Evaluation at the FDA’s Centre for devices and Radiological Health said,” 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.”
The ReShape Dual Balloon was approved on the basis of a study that included 326 obese people, aged between 22 and 60 and having at least one obesity-related health condition. 187 participants who used the device lost an average of 14 pounds or 6.8 per cent of their total body weight.