Impatience to Get Thin Sends Some to Canada

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.”

...   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 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.