May 6, 2010 -- Gastric balloons offer a reversible, incision-free approach to weight loss in overweight and obese people, according to two separate reports from Brazil.
In one study, 81 overweight and obese people lost an average of 20 pounds over five to seven months. In the second study, 19 obese people shed an average of 29 pounds in six months.
During the procedure, a deflated silicone balloon is inserted via the mouth and into the stomach, where it is filled with saline or air to about the size of an orange. This reduces the amount of food the stomach can hold, causing the patient to feel fuller faster and to eat less.
In the U.S., the procedure is not available outside of clinical trial settings. But it's catching on in Brazil and other countries, the researchers say.
Gastric Balloons May Help Pre-obese People Lose Weight
Paula P. Elia, MD, of Gastroendo Endoscopia Especializada in Rio de Janeiro, Brazil, says she recommends balloons for overweight and obese patients who can't shed pounds with diet and exercise alone and who aren't eligible for or who don’t want to undergo gastric bypass or Lap-Band surgery.
In the U.S., the National Institutes of Health (NIH) requires that otherwise healthy people have a body mass index (BMI) of 40 or higher to be eligible for weight loss surgery. People with a BMI of 35 or higher with co-existing conditions such as diabetes and sleep apnea are also considered candidates by the NIH. In Elia's study, some of the patients had BMIs of less than 30.
"We are using this in the pre-obese as well as the obese," she tells WebMD.
Christopher Thompson, MD, of Brigham and Women's Hospital in Boston, who moderated a news conference at Digestive Disease Week where the studies were presented, says the balloon approach might also be useful as a temporary bridge for obese patients needing non-emergency surgery.
By helping a person reach a safer weight before undergoing surgery, the procedure may help to lower the risk of complications, thereby cutting costs in the long run, he tells WebMD.
"But if it can gain FDA approval, the real role may be in the pre-obese," says Thompson, who has served as a consultant for several companies involved with weight loss surgery.
Elia says that refinements in design since gastric balloons were first introduced in the 1980s have eliminated or lowered the risk of complications such as perforation, making them more appropriate for the pre-obese.
Saline-Filled Gastric Balloon Aids Weight Loss
Another advantage of the gastric balloon is that no hospital stay is required, says Elia's colleague, Gregorio Feldman, MD.
"You can usually go home three hours after the balloon is inserted and inflated," he tells WebMD. "And it can also be reinflated in place if necessary.”
Elia and Feldman studied 84 patients using a saline-filled balloon. The balloons deflated spontaneously in two patients. Another patient, who Elia says hid chronic alcoholism from the researchers, suffered a gastric laceration.
In the remaining 81 patients, the average weight dropped from 220 pounds at the start of the study to an average of 200 pounds when the balloons were removed five to seven months later. Their mean BMI dropped from 36 to 32.6.
Overall, patients lost an average of 9.18% of their initial weight.
Fourteen "pre-obese" patients with BMIs of between 27.6 and 30 at the start of the study lost an average of 7.6% of their body weight. In the U.S., people with BMIs of 25 to 29.9 are considered overweight and people with BMIs of 30 or greater are obese.
The 17 patients with starting BMIs of 40 or more lost 12.2% of body weight, Elia says.
About 10% of patients failed to follow dietary and exercise recommendations and therefore did not do very well, Feldman says.
"It's a multidisciplinary approach. The balloon can’t do it all," he says.
Air-Filled Gastric Balloon Aids Weight Loss
The second study involved 19 patients with an average BMI of 39.75. Their balloons were filled with air rather than saline.
At six months, their BMI had dropped an average of 4.9 points and they had lost an average of 29 pounds, reports Kyoshi Hashiba, MD, of Sirio Libanês Hospital in São Paulo, Brazil.
One patient suffered a rare complication in which the stomach twists more than 180 degrees, but there were no cases of bleeding or cutting.
Thompson says that if you overeat with a gastric balloon, you may feel extremely nauseated or vomit. In the study, nausea, vomiting, and abdominal pain were successfully treated with oral medications.
Balloons deflated in two patients during the second month, but they were replaced without any problems.
Currently, the balloons are only left in place for six months. At that point, it is hoped that the patients can continue to lose or maintain their weight with diet and exercise alone. But some may need another procedure.
Hashiba tells WebMD that the air-filled balloon may be easier than the saline-filled balloon for some patients to tolerate because it weighs less, but there are no studies comparing the two.
The treatment is not recommended for morbidly obese patients because of complications with imaging, he says. It's recommended that patients get monthly X-rays to ensure the balloon hasn't deflated.
Both the air-filled and the saline-filled balloons cost about $4,000 to $5,000 for the full procedures, Feldman says.
Lap-Band surgery and related expenses range from $15,000 to $25,000 in the United States, but weight loss is much greater -- about 50% of excess weight, on average, within the first year, according to a Lap-Band web site.