The Food and Drug Administration recently approved a promising new tool in the arsenal against obesity.
Endoscopic placement of a silicone balloon in a patient’s stomach is designed to help patients augment their more traditional weight loss efforts.
“Until now, despite the huge problem with obesity in the U.S., there were no endoscopic devices approved for weight loss,” says Johns Hopkins gastroenterologist Vivek Kumbhari. “So we’re very excited about FDA approval of the intragastric balloon.”
Kumbhari has performed the balloon insertion procedure in countries where it’s already approved. “I’ve done about 30 of these,” says the native of Australia, “and I’ve seen patients lose significant weight.”
The FDA approved two different balloon devices within a few weeks of each other. Both perform the same function, says Kumbhari, who describes the balloon insertion as a quick, simple and safe procedure.
“The patient is sedated and, using the endoscope, we go down to the stomach and inflate the balloon with 600 to 900 cubic centimeters of saline fluid,” he explains. “There’s a self-detaching mechanism, and the balloon stays in the stomach when we remove the endoscope. The procedure takes about 15 minutes, and the patient goes home.”
The balloon remains in the patient’s stomach for six months. Kumbhari says the removal is as simple as the insertion.
Patients who’ve had the balloon report feeling full earlier.
“There might be some nausea in the first week or so,” Kumbhari says. “But I’ve had patients tell me they played tennis three days after getting the balloon. You get accustomed to it very soon, and after a few days, it starts working.”
In clinical trials, patients with a body mass index between 30 and 40 lost 30 percent greater excess body weight compared with controls.
Kumbhari cautions that the balloon doesn’t work on its own. “The balloon helps change behavior, but it’s not magic. The patient definitely has to take some ownership.
“One of the good things at Johns Hopkins is that we have an integrated service, where patients work with a dietician, an exercise physiologist, a psychologist, a gastroenterologist and a surgeon. We don’t just put in a balloon. We work closely together to look at all facets of obesity.”