The United States Food and Drug Administration has given its approval for an inflatable device that can help patients suffering from obesity shed their weight without any surgeries. The balloon, made by Reshape Medical, will be inserted inside the body and fill a portion of the stomach.
A minimally invasive endoscopic procedure will be performed by doctors, where in they will go in through the mouth to reach the stomach and implant the device. Typically, the procedure will take less than 30 minutes and will be performed while the patient is mildly sedated.
The balloon will trigger a feeling of fullness as it begins to fill up the space in the stomach.
This device has proven to be effective for weight loss for the short term. However, it remains to be seen if these devices will have any long term advantages for obese patients. The balloon will be used for an estimated six months. In addition to the device, the patient will follow a medically supervised diet and exercises.
The FDA stated that the inflatable device does not alter the natural anatomy of the stomach.
Dr William Maisel, acting director of the Office of Device Evaluation at the Center for Devices and Radiological Health at the FDA, said in a press release that for those patients battling with obesity, remarkable weight loss and maintaining that loss of weight most often needs a combination of solutions such as exercise habits and improved diet. The device is at present limited to patients who are suffering from one or more obesity related disorders such as high cholesterol, high blood pressure, and/or diabetes.
Over 325 people between the ages 22 and 60 participated in clinical studies evaluating the product. These people had at least one chronic obesity related health condition.