Doctors Take a Harder Look at Gastric Bubble : Studies Question Safety of Weight-Loss Device While Manufacturer Issues Tighter Guidelines

After experimenting unsuccessfully with various diets, Dr. Dennis Riff, an Orange County gastroenterologist, had a plastic balloon put in his stomach to control his appetite. He was 75 pounds overweight. Eight months later, he said, he had lost 65 pounds.

In his specialty, Riff treats disorders of the digestive system. He and his colleagues at the Associated Gastroenterology Medical Group in Anaheim and Orange are so optimistic about the effectiveness of the device--the Garren-Edwards Gastric Bubble--that they have inserted them in more than 500 obese patients.

Yet while an apparent majority of the hundreds of patients who have followed the doctor’s lead are pleased with the results, the gastric bubble has come into question in studies across the country. However, most authorities still think that, if it is used correctly, the device can be effective in 75% to 80% of patients.

Riff is pleased with his results but notes the bubble is “just a tool” to be used along with dietary restriction, counseling and behavior modification.

“It’s the easiest way of losing weight that I’ve seen,” he said. “It’s been safe and effective, but if you’re not committed to it you can gain weight.”

Other doctors have been more cautious with the bubble, which the U.S. Food and Drug Administration approved for commercial use in September, 1985. Several medical schools are organizing or conducting research on the device’s effectiveness.

Moreover, the product’s manufacturer, American Edwards Laboratories of Santa Ana, last week distributed a new statement warning of possible serious complications and urging physicians to be cautious.

One Death Reported

The warning was issued in response to reports of about 80 cases of ulcers, intestinal obstructions requiring surgical removal and one death associated with the bubble.

Initially, the FDA approved the bubble’s usage in patients 20% overweight. Now the manufacturer recommends it be inserted only in morbidly obese patients--those at least 100 pounds overweight--and that it be left in the stomach only for three months, rather than four.

Morbid obesity is a condition that decreases life expectancy and can produce such complications as hypertension, diabetes, heart disease, breathing problems and stress on the skeletal system.

Since last year, American Edwards has conducted training seminars for 2,000 doctors interested in using the gastric bubble, according to Les Jacobson, spokesman for Baxter-Travenol Laboratories, American Edwards’ parent company.

To date, about 17,000 bubbles have been inserted, Jacobson said. The procedure costs $2,000 to $3,000; about half of the nation’s health insurance plans reimburse expenses.

“It’s intended for people who have a life-threatening disease and whose alternative is something much more severe,” Jacobson said.

The thin, plastic cylindrical balloon--two inches in diameter and 3 1/2 inches long--is inserted through the mouth into the stomach with an endoscope, a thin, flexible tube. Then the balloon is inflated with room-temperature air, theoretically reducing the capacity of the stomach and thus making it fill up faster. The Garren-Edwards Gastric Bubble was developed by a husband-and-wife team, Dr. Lloyd Garren, instructor of medicine at Thomas Jefferson Medical College in Philadelphia, and Dr. Mary Garren, a gastroenterologist at Union Hospital in Elkton, Md.

Seeking an Alternative

Lloyd Garren said he and his wife wanted to develop an alternative to hazardous and often unsuccessful surgical techniques used to treat morbid obesity.

Intestinal bypass surgery, common in the early 1970s, reduced the absorbent surface of the small intestine. But it eventually proved to be dangerous and some studies found a 7% mortality rate, according to Dr. Stanley Benjamin, chief of the division of gastroenterology at Georgetown University in Washington.

Eventually, surgeons found that intestinal bypass surgery was too risky to be offered at all since complications--including severe gastrointestinal disorders--were so common. Bypass patients required close medical supervision essentially for the rest of their lives.

In the late 1970s, doctors developed gastric bypass surgery, or stomach stapling, to exclude part of the stomach from the digestive tract. The operation is still performed and “has its own morbidity and fatality rate,” Benjamin said.

“There are any number of people who want the bubble because their stapling didn’t work,” said Benjamin, who will not insert the bubble in those who have gastric bypass surgery.

In February, he began a research study of the gastric bubble’s effectiveness. The 90 people participating do not know if they have a bubble in place because Benjamin inserts the bubble in some and not others--a practice essential to obtaining reliable results. One-third of the group has a bubble, one-third has a “sham” or no bubble, and one-third has a bubble half the time and “sham” half the time.

All patients are monitored at an eating disorders clinic and receive behavioral modification therapy. While Benjamin has not reached conclusions, he said he wants to determine if weight loss in his patients is due to the bubble or dietary change and behavior modification.

“I think anybody having bubbles placed should be involved (treated in a medical practice) where good data is being collected, where they receive behavioral modification and diet counseling,” he said.

Other Studies

Dr. Gary Levine, head of the division of gastroenterology and nutrition at the Albert Einstein Medical Center in Philadelphia, began a study about the same time to determine, he said, if the bubble is “as good as they say.” As in Georgetown University’s study, patients do not know if a bubble has been inserted. The Einstein group is studying 70 patients over and eight-month period.

While no conclusions have been drawn, Levine said, “There are patients who don’t have bubbles who think they do and have lost weight in short periods of time.” If that finding is confirmed, it could mean that the “placebo effect,” or the achieving of a therapeutic result when a patient only thinks he is receiving treatment, may apply.

Most doctors agree that the bubble is not a panacea. Some are more pessimistic about its effectiveness than others. The UC Irvine Medical Center doesn’t recommend the balloon because of its side effects. Also, according to Dr. Daniel Hollander, chief of gastroenterology at Irvine, doctors are not convinced that it modifies weight as much as is claimed.

“It’s not an innocuous thing, and we wish to have more information about it to justify usage,” Hollander said.

About three months ago, Hollander said, a patient came into the hospital in terrible pain--a gastric balloon had migrated into the small intestine and was causing a blockage. “We watched her and treated her and within two days she passed the balloon,” he said, adding that people who are unable to pass the balloon sometimes require surgery to remove it.

Orange County-based gastroenterologist Dr. David Chapman was one of the first doctors trained by American Edwards to insert the gastric balloon. Since last year, he has inserted balloons in 200 patients at Placentia-Linda Community Hospital in Placentia.

Chapman is also among a group of doctors at the USC Medical School in Los Angeles beginning a study of the bubble’s effectiveness. About 40 patients will be followed for a six-month period.

Dr. David Heber, chief of the division of clinical nutrition at the UCLA School of Medicine, began another study last summer to find out how or if the balloon affects the ingestion of food.

Chapman said he has completed 150 treatments and that as many as 110 of his patients have lost some weight, averaging 23 pounds over a four-month period. Eight gained weight and about 10 stayed the same, he said.

Side Effects

Some experienced side effects. In two cases, he said, the bubble passed through the stomach and lodged in the intestine. Chapman said he hospitalized them and after a couple of days the bubble passed.

Initially, Chapman said, the incidence of stomach ulcers was 15% until he began routinely giving his patients medication to prevent ulcers. The proportion is now 5%, he said.

About 8% to 10% of his patients also have experienced long-term nausea and stomach cramps as a result of the gastric bubble, he said.

“It’s not the rosy picture we had hoped it would be,” Chapman said. “The bubble is not a panacea. It’s a constant reminder (the patient’s) on a diet. Those who want to make it work will lose weight.”