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FDA approves intragastric weight-loss balloons

A diagram shows how intragastric balloons are inserted

A diagram shows how intragastric balloons are inserted through the mouth and into the stomach, then filled with saline. The limited space in the stomach helps obese patients lose weight. Photo Credit: Rod Eyer

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.

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.

The arrival of weight-loss balloons reflects a broader shift in attitudes about people who struggle with their weight. For so long, overweight people have dealt with the guilt and shame of those extra pounds, in addition to health problems like diabetes. That's why weight loss is such a big business.

But it's a business built around self-treatment, leading to the rise of Weight Watchers and other diet companies, weight-loss supplements, health clubs and diet books. The questionable results from the commercial options have begun to change the widespread perception that obesity is simply the result of eating too much or exercising too little.

Obesity as a disease

The medical community took a major step toward reducing the stigma of obesity when the American Medical Association in 2013 officially recognized it as a disease.

With that classification, the pharmaceutical and medical device industry has started investing more in possible treatments. The FDA has approved three weight-loss drugs since 2012. Apollo Endosurgery and ReShape Medical submitted balloons for FDA review last year.

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.

"People still fear surgery," said Dr. Rami Lutfi at Presence St. Joseph Hospital in Chicago. "The advantage of the balloon is there's no cutting."

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 approval of Apollo's Orbera, patients lost an average 21.8 pounds (10.2 percent of their body weight) after six months, better than the 7-pound loss in patients who tried only 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 average weight-loss

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 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 gastric balloon is not a new idea. 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 a track record of safety overseas. The device has been used in more than 200,000 patients in about 80 countries, he said.

However, some remain skeptical of the balloons' potential for long-term weight management. A 2007 study found that "compared with conventional management, intragastric balloon did not show convincing evidence of a greater weight loss." Morton is optimistic that the balloons will fare better than their predecessor from 30 years ago. He views the balloon as a bridge between weight-loss drugs and surgery, similar to a cardiac stent to treat heart disease.

"I can't say it's for everyone," Morton said, "but for the motivated patient it can work."


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