FDA Approves Special Balloon for Weight Loss

The Food and Drug Administration has given its approval for a new weight loss device in the form of a balloon that can be used to treat obesity. The weight loss device is made of two silicone balloons that are connected to each other are contain salt water. The balloon is inserted into the stomach of the patient without the need of surgical procedure.

The FDA-approved balloon for weight loss is called the ReShape Integrated Dual Balloon System and it fills the space in the stomach of overweight and obese patients. According to the FDA, the device can only be used by patients who have tried other methods for losing weight and failed. Also, the device can only be used by obese patients who also suffer from high cholesterol, high blood pressure or diabetes, conditions that are related to obesity.

The balloon for weight loss was produced by ReShape Medical of San Clemente, California. According to the company’s representatives, the device is a reversible method that can help people have healthier eating habits on a long term.

The balloon is connected with a shaft that is flexible and is introduced into the stomach through the patient’s mouth using an endoscope. The patient is under anesthesia during the procedure, said the creators of the device. According to the FDA, the balloon must only be inside the patient’s stomach for six months, after that it needs to be removed.

The health officials who approved the weight loss device said some of the side effects of it can include nausea, vomiting, abdominal pain, indigestion or gastric ulcers.

Diana Zuckerman, from the National Center for Health Research, explained that some patients who have a history of autoimmune disease in their family said they have had bad reactions after silicone weight loss devices were inserted into their stomachs. However, the new balloon for weight loss does not create any of those side effects, according to its makers.

The researchers used the device on 326 obese patients to see how it works and how the subjects would react. The patients were aged between 22 and 60. According to the study’s results, the patients lost about 14 pounds when the balloon was removed from their stomach after six months. The control patients who didn’t get the device but underwent an endoscopic procedure lost about 7 pounds. Six months after the device was removed, the patients didn’t gain as much weight as before, according to the FDA officials.
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