There’s a new weapon in the fight against obesity: balloons.
For many struggling with their weight, a new device has been approved that will give them another medical alternative to treatments such as prescription drugs and surgery.
It involves inserting a small balloon into the stomach through the mouth. The saline-filled balloon is meant to be a temporary measure to curb the appetite and help patients lose weight.
The federal Food and Drug Administration recently approved two intragastric balloons made by different companies in the space of two weeks. Both are aimed at adults with body mass indexes (BMI) of 30 to 40 who couldn’t lose weight through diet and exercise. One balloon, called Orbera, is made by Apollo Endosurgery, the other by ReShape Medical.
The potential marketplace is huge. An estimated 45 million to 50 million adults have BMIs of 30 to 40, said Dr. John Morton, president of the American Society for Metabolic and Bariatric Surgery.
There is a lot of enthusiasm about the balloons among some gastroenterologists because using them is less invasive than weight-loss surgery like gastric bypass. The patient is under mild sedation and the balloon is placed without surgery through a tube inserted in the mouth. The balloon should be removed after six months.
But just because there’s no cutting and stitching doesn’t mean the balloon is risk-free. Patients can suffer severe nausea and vomiting in the first days after placement. Other potential risks include ulcers and balloon deflation.
In clinical data cited by the FDA in its Orbera approval, patients lost an average of 21.8 pounds (10.2 percent of their body weight) after six months, better than the 7-pound loss in patients who only tried diet and exercise. Some patients gained some weight after the device was removed but maintained an average of 19.4 pounds of weight loss nine months after placement.
The ReShape balloon, shaped like a dumbbell, is intended for adults who also have an obesity-related condition like diabetes, high blood pressure or high cholesterol. Patients with the device lost an average of 14.3 pounds in a clinical study.
But the devices won’t be cheap. The Orbera procedure, including a 12-month diet and exercise program, will be $6,000 to $8,000, said Dennis McWilliams, founder of Apollo Endosurgery. And at least initially, he doesn’t expect insurance to cover the cost.
The FDA first approved a weight-loss balloon in 1985. As now, there was a lot of excitement about the development. But the manufacturer stopped selling it three years later because of problems with spontaneous deflation and questions about its long-term effectiveness.
McWilliams said Orbera has been used in more than 200,000 patients in about 80 countries.