SAUSALITO, CA (ASRN.ORG) -- Tammy Kwarciak, a 44-year-old nurse whose weight had been creeping up for years, was determined to lose 50 pounds. So in February, she drove from her home in Port Huron, Mich., across the border into Canada and had a small balloon-like device inserted into her stomach.

The intragastric balloon, filled with liquid and left in the stomach for up to six months, is not approved for use in the United States, though it’s available in Europe, South America and other parts of the world. Clinical trials required to win federal Food and Drug Administration approval are being initiated, but many Americans aren’t waiting.

Since the balloon’s introduction in Canada in 2006, people like Mrs. Kwarciak have been streaming north in growing numbers. Drawn by the relative ease of balloon placement, Americans account for nearly a third of patients undergoing the procedures in Canadian clinics just over the border.

“The nice thing about the balloon is that you have such a sense of satiety,” said Mrs. Kwarciak, who has lost 25 pounds since she had the procedure. “I feel full all the time. I have to remind myself at times to eat.”

But the balloon is a temporary measure, and once it is removed in a few months, she said, “I’m on my own.”

The intragastric balloon appeals to people like Mrs. Kwarciak who have a significant amount of weight to lose but are not heavy enough to qualify for bariatric surgery like gastric bypass surgery and adjustable gastric band surgery. The patient is anesthetized, and the balloon is inserted through the esophagus — a relatively noninvasive procedure. It is removed after six months or so.

The balloon may also be an option for extremely obese people who need to lose enough weight to be considered for more invasive procedures.

But just because the placement doesn’t involve surgery doesn’t mean it’s risk-free. Patients can suffer severe nausea and vomiting during the first few days or week after placement. On rare occasions, it can deflate and obstruct the intestines, or it can perforate the abdomen, which can be life-threatening.

Perhaps as significant, the weight loss that patients can expect is modest at best.

“That’s the most common complication — not losing as much weight as the patient would like,” said Dr. Sanjeev Kaila, the plastic surgeon who pioneered the intragastric balloon program in Canada. Some return for a second balloon after taking a short break, he added.

Though Mrs. Kwarciak said she lost 25 pounds in the first two months, studies say most patients experience the bulk of their weight loss during the first three to four months after the balloon’s insertion.

Studies of the balloon have reported weight loss ranging from 13 to 34 pounds on average, with some individuals losing up to 50 pounds. Patients often gain weight again after the device is removed, though long-term studies are limited.

But a scathing review by The Cochrane Collaboration in 2007 noted the possibility of serious complications and concluded that “compared with conventional management, intragastric balloon did not show convincing evidence of greater weight loss.” Another review suggested the device was a waste of money, saying that its use “only to reduce weight has no medical and economic justification.”

The combination of potential risks and little benefit is the main reason there is no intragastric balloon on the market in the United States. An earlier version called the Garren-Edwards Gastric Bubble was approved in 1985. But officials at the Food and Drug Administration soon became concerned about the severe and frequent complications associated with the device, an agency spokeswoman said.

By 1988, the manufacturer, American Edwards Laboratories, stopped selling it, voluntarily withdrawing the balloon from the market entirely in 1992. In the interim, randomized clinical trials comparing the bubble with a sham or placebo device found that diet and exercise were equally effective for weight loss.

Getting the new intragastric balloon is not cheap: In Canada, an outpatient procedure that takes less than an hour costs $8,000. The fee includes removal of the device after six months, as well as physician follow-up and support services from a nutritionist and dietitian, usually provided over the phone and online.

F.D.A. officials would not comment on the current balloons, which are made of new, sophisticated materials, but said generally that the agency “reviews medical devices to assure American patients that they are safe and effective. Many countries will approve medical devices without first having to demonstrate that the technology is effective.”

Dr. Robin Blackstone, a bariatric surgeon in Scottsdale, Ariz., and president of the American Society for Metabolic and Bariatric Surgery, who is involved in a clinical trial of a balloon in the United States, said that people who need to lose a modest amount of weight may do just as well with a more conventional approach, given the risk of complications.

“Patients who are obese are very vulnerable,” she said. “They’re desperate to find something that works, and it’s important for people not to offer things that aren’t well established.”

For those who insist on trying the procedure despite its lackluster record, some cautions are in order.

The balloon is an option only for those who have less than 50 pounds to lose — Canadian clinics may accept patients with a body mass index as low as 27, if they also have weight-related health problems — or for extremely obese people who need to lose weight to be accepted for bariatric surgery.

Potential patients should consult with a primary-care physician. The metabolic and bariatric surgery organization recommends establishing a relationship with a local gastroenterologist able to remove the balloon endoscopically should a complication occur.

The balloon, usually filled with blue liquid, can rupture. The liquid will turn patients’ urine green, which is how they are alerted to the problem. A ruptured balloon may pass through the intestines on its own or require endoscopic or surgical removal if it obstructs the intestines. The most serious complication is a rupture in the abdomen, which can be life-threatening. Other complications include infections and ulcers.

Patients should not have the balloon implanted if they are pregnant or planning a pregnancy, have a hiatus hernia or history of gastric ulcers, other gastrointestinal disease or previous abdominal surgery.

Successful weight loss with the intragastric balloon depends on lifestyle changes, including a better diet and increased physical activity, and maintaining those changes is critical to maintaining the weight loss after the balloon is removed. Many balloon programs have a team of providers, often a gastroenterologist, endocrinologist, nutritionist or dietitian, personal trainer and psychologist involved in weekly follow-up with patients.

 

 

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