A popular procedure in Europe called gastric ballooning seems like a great alternative to gastric-bypass surgery. All it takes is inserting a balloon into the stomach through the throat and then filling the balloon with liquid.
Unlike gastric-bypass surgery, gastric ballooning is a quick, relatively painless and affordable way to help obese people lose weight. But the Food and Drug Administration has not approved the gastric-ballooning procedure, and it is almost nonexistent in the United States.
Why? This international difference of opinion stems in part from a nagging sense of doubt among American bariatric surgeons and other obesity experts about the balloon's safety and effectiveness. Not a lot of clinical trials have been done, and some experts theorize that the balloon technique isn't drastic enough to reduce ghrelin, a hormone produced in the stomach that increases hunger and that gastric-bypass surgery suppresses.
It doesn't help that the history of the gastric balloon has been marred with controversy. Older intragastric balloon models tended to break down from stomach-acid corrosion, and some even passed into the intestines, where they caused life-threatening bowel obstructions, said Dr. Nicholas Bertha, a bariatric surgeon at St. Clares Health System Center for Weight Loss Surgery in New Jersey.
But Inamed Health, a manufacturer of a newer version called the BioEnterics Intragastric Balloon, states on its Web site that its balloon is made of "durable, elastic, high-quality silicone." And the balloons are left in place for only six months to prevent any corrosion.
Safety concerns aside, Dr. Mitchell Roslin, chief of obesity surgery at Lenox Hill Hospital in New York, said that the stomach eventually "learns" to compensate for the balloon's presence and the weight-loss benefit is lost.
"Long-term [clinical] trials are unlikely to show lasting weight loss for a period of time to make the investment worthwhile," Roslin said.
But, he added, the balloon could be useful for high-risk obese patients who want gastric-bypass surgery but need to lose weight first to make the procedure safer.
In Italy gastric ballooning is considered the "wave of the future" for the right patients, said Madelyn H. Fernstrom, director of the University of Pittsburgh Medical Center's Weight Management Center. Her hospital works with the medical staff at several Italian clinics near Palermo.
As with other weight-loss strategies, the balloon's success depends on the patient's willpower, Fernstrom said. "I have seen some very good outcomes."
Even if the FDA approves gastric ballooning here, it might not work as well as it does in Europe, explained Keith-Thomas Ayoob, a dietitian and associate professor in the department of pediatrics at Albert Einstein College of Medicine in New York.
Americans tend to eat in a grazing style throughout the day, meaning the stomach doesn't get as full as after a large meal, so the balloon's presence might not be as noticed nor its effects realized.
Plus, Americans tend to be emotional eaters, he said.
"If we're eating for reasons that have nothing to do with being physically hungry or full, there will be less of an effect," he said. "Ultimately, all these procedures can do is just give you a leg up on complying with a diet that's lower in calories. They don't melt pounds off by themselves.That's enough for many, but not for everyone."