Like the balloon’s bariatric competitors, Reshape is only intended for patients who have had multiple failed attempts to lose weight through diet and exercise means. And, while the weight loss balloon may leave patients feeling full, and may, in fact, result in some weight loss for some people, this device does not address the multiple reasons why people have allowed their weight to get out of control, aside from simply being hungry.
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187 participants who used the belly balloon lost over 14 pounds or 6.8 percent of their bodyweight after it was removed.
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. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion. Through a minimally invasive endoscopic procedure (usually lasting less than 30 minutes), the ReShape Dual Balloon device is inserted through the mouth to the stomach and then inflated with a sterile solution. By utilizing two connected balloons, the device is able to expand more while remaining more flexible to the contours of the stomach. These included some discomfort linked to the sedation needed during the insertion procedure, and “rare cases” of severe allergic reaction, heart attack, esophageal tear, infection and breathing difficulties, the agency said. Another FDA-approved device uses electrical blocking signals that interfere with nerve activity in the abdomen.
“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”, said Dr. William Maisel of the FDA. This is to ensure that the patients will lose weight and continue to do so even after the device has been removed. Over a third of US adults are obese, the ones having a body mass index of 30 or higher.
Sheih says ultimately, the balloon may be an effective way to kick start weight loss and resize your appetite, but it won’t do the hard work for you. It is also the condition that they were unable to reduce weight through other measures like diet and exercise alone. Researchers believe that by filling up some space in your stomach with a balloon, weight loss can be achieved.
The ReShape Dual Balloon is manufactured by ReShape Medical Inc., in San Clemente, California. The blue dye that filled the balloon will turn a patient’s urine blue, letting the person know that one of the balloons has ruptured.
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Privately held ReShape has sold the device in Europe since 2011 but does not disclose financial information.
