The U.S. Food and Drug Administration on Tuesday approved a stomach balloon device that obese adults can use as an option to shed off pounds without going through invasive surgery.
The ReShape Dual Balloon facilitates weight loss by giving a feeling of fullness as it occupies space in the stomach. It is recommended only for adult obese patients with a body mass index of 30 to 40 kg/m2, particularly for those with high cholesterol, high blood pressure and diabetes, according to the FDA.
The stomach balloon device is also intended for obese patients who have tried to lose weight through diet and exercise but have failed.
"For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits," said William Maisel, acting director of the FDA's Office of Device Evaluation.
The ReShape Dual Balloon is inserted into the stomach through the mouth. When it is in place, the balloon is inflated with a sterile solution. The endoscopic procedure is only minimally invasive, requires mild sedation and takes no more than 30 minutes. The stomach balloon is to be removed six months after insertion.
"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 Maisel.
In the U.S., 34.9 percent or more than one-third of the adult population is obese, with middle-aged adults being more obese compared to younger and older adults. Because of the health risks that come with obesity, addressing its prevalence has become a public health priority, according to the Centers for Disease Control and Prevention.
The stomach balloon device helped achieve, through a clinical trial, an average weight loss of 14.3 pounds, comprising 6.8 percent of the total body weight, within a period of six months. After another six months, those who lost 14.3 pounds were able to maintain their weight loss at an average of 9.9 pounds.
Some of the potential side effects of using the ReShape Dual Balloon include nausea and vomiting, gastric ulcer, feeling of indigestion and abdominal pain. In some cases, patients undergoing the endoscopic procedure for the balloon may experience headache and nausea. Other patients may experience difficulty in breathing or may exhibit severe allergic reaction to the device.
ReShape Medical, manufacturer of ReShape Dual Balloon, said the product will be available only through certain providers who are well trained in the procedure. The cost, the company said, will vary depending on the region, Fox News reports.
