Gastric Bubble May Aid in Halting Ballooning Obesity

Three weeks ago, 34-year-old Helen Finger stepped on the bathroom scale, watching as the digital readout flashed its frightening message: 268 pounds. For her height--5 feet, 6 inches--that put her about 140 pounds over her ideal weight. And those extra pounds were threatening Finger’s life, causing problems ranging from hypertension to arthritis.

Finger, a Santa Ana resident who works as a health-care coordinator for a group of doctors, says she had “tried everything” when she read in a medical journal about something called a gastric bubble, a small plastic balloon that is inserted through the mouth and inflated in the stomach, causing the patient to feel full and decreasing the desire to eat.

So, on Nov. 6, Helen Finger became one of the first patients in the United States. to have the new device, approved by the Food and Drug Administration on Sept. 17, inserted in her stomach. In the first two weeks, Finger lost 20 pounds and went shopping for new clothes. “I feel great. I just can’t eat as much,” she said. “You actually can’t hold as much food.”

Bubble Designed by Doctors

The bubble, designed by two Delaware doctors and manufactured by an Irvine laboratory, is currently available through only 16 specially trained physicians in the United States. Of those 16, six are in California--two in Orange County and four in Northern California.

The physicians received their training in Delaware from Drs. Lloyd and Mary Garren, the husband-and-wife gastroenterologists who designed the bubble. (He is an instructor of medicine at Jefferson Medical College in Philadelphia; she is chief of gastroenterology at Union Hospital of Cecil County in Elkton, Md.)

Within weeks, American Edwards Laboratory of Irvine, which makes and markets the product for the Garrens, expects the bubble to be available nationwide through hundreds of doctors, mostly gastroenterologists (physicians who specialize in diseases of the stomach and intestines), according to Mark Cole, a representative of American Edwards.

Until then, the only two Southern California doctors trained to prescribe the device are Drs. David J. Chapman in Placentia and Davinder Singh in Santa Ana, according to American Edwards Laboratory. Both Chapman and Singh, board-certified

gastroenterologists who do not specialize in treating obese patients, became interested in the bubble and joined the first group of physicians to be trained to use it.

So far Singh’s only patient has been Helen Finger. Singh, who has a private practice in Santa Ana, says that “a couple of other obese patients” are interested in the bubble, but says he is “keeping a low profile. I have other patients who want it,” said Singh, who teaches at Martin Luther King County Hospital. “But I want to wait and see how this patient does first.”

Singh adds, however, that he does feel the bubble is “safe and simple . . . a safer procedure than gastric surgery.”

Chapman, on the staff at Placentia-Linda Community Hospital, expects to insert his first gastric bubble this week in 31-year-old Jim Switzer, a Placentia engineer, who is 120 pounds overweight. Switzer found out about the bubble through his wife, a registered nurse at the Placentia-Linda hospital.

Chapman, an associate clinical professor at USC, has been following the bubble’s development for more than two years.

“To me it (the bubble) seemed like an exciting advancement in an interesting field,” he said. Chapman describes the bubble as a “less invasive, less serious” method of treating obese patients than such radical procedures as stomach reduction, intestinal bypass surgery or gastric stapling, all of which require extended hospital stays. “All the other procedures are major surgery in people who are not good surgery candidates to begin with,” he said.

Enthusiastic About Bubble

Dr. Daniel Hollander, chief of gastroenterology at UC Irvine Medical Center, is also enthusiastic about the development of the bubble. Although Hollander has not used the bubble, he has read about its development in medical literature since 1982 and says: “Basically the problem we are dealing with is a selective group of patients having morbid obesity; that means most of these people are in the 300 to 400 pound range and unable to control their weight. And they are experiencing health problems because of this.”

Such people have had “no medical means of controlling their weight,” he said until the development of intestinal bypass surgery or stomach stapling. “But the problem with surgery,” Hollander said, “is the high rate of mortality (associated with it) and we have stopped recommending bypass surgery altogether because we are dealing with a 20 to 30% mortality rate. There is good weight loss, but the risk is quite high.”

Stapling or suturing the stomach--making the stomach smaller and reducing the amount of food it can hold--”seems to be working better,” Hollander said, “and is the method of choice until recently.”

However, Hollander views the gastric bubble as a “promising new approach.”

“It has the same effect as the gastric stapling--that is diminishing the gastric volume, and the advantage is that it can be introduced without surgery. If complications ensue, it can be removed without surgery. It certainly is an attractive proposition and the preliminary articles I have seen have been very supportive of it.”

Insertion of the bubble is performed on an outpatient basis under a mild sedative, according to David Chapman. The procedure costs about $3,000, about one-fifth as much as intestinal bypass or gastric stapling, which range from $15,000 to $20,000, he says.

Insurance Coverage

Most medical insurance does not cover such procedures as intestinal bypass surgery, unless “there are serious medical problems as a result of the obesity,” according to Susan Diaz, business office manager at Placentia-Linda Community Hospital. Because the bubble is new, Diaz and others who will be processing insurance claims do not know whether the bubble will be included in insurance coverage. Rulings will have to be made by the patients’ insurance companies on a case-by-case basis, she said.

Development of the gastric bubble took nearly 10 years and involved three years of tests in 106 patients before the device finally won the approval of the FDA, according to Dr. Lloyd Garren, whose goal was to offer obese patients a less drastic alternative than gastric bypass procedures.

The bubble was tested by four investigators, all board-certified gastroenterologists, at Brandywine Hospital near Philadelphia, Pa.; Our Lady of Lourdes Hospital in New Jersey, and Union Hospital in Elktown, Md. The 106 patients in the study had the device in for an average of eight months, according to Lloyd Garren. The weight loss ranged from .25 to 7.75 pounds per week with a mean loss of 2.09 pounds per week, he said. “One woman lost 120 pounds in the treatment period with no gain during the first year afterward. During her second year, she gained 20 pounds. We are now retreating her and she has lost most of the weight she gained,” he said.

During the study, doctors removed the bubble from 21 patients who had had it implanted from five to seven months. Most of the 21 patients either maintained their weight loss, or gained a slight amount, but gained no more than 14 pounds, according to Lloyd Garren. However, patients who had the bubble in for three months or less gained back an average of 20 pounds when the bubble was removed.

The bubble, about thumb-size in its deflated form, is inserted through the mouth with a long tube while the patient is mildly sedated. Once in the stomach, it is inflated into a free-floating cylindrical balloon about 3 1/2 inches long and 2 inches wide.

“We don’t know exactly what makes it work,” Lloyd Garren admitted. “Theories are that there are receptors in the stomach that make it feel full. But the bubble in and of itself does not cause a weight loss for the patient. It gives them a full feeling and makes them not want to eat, but there is no magic about it. The patient loses weight by taking in fewer calories or burning up more calories. So the patient has to be an active participant.”

All patients using the bubble must undergo behavior modification and nutritional counseling, according to Chapman. “The bubble merely allows people to learn new ways of eating without the distraction of constant hunger,” he said. “The ultimate objective is to get the bubble out and leave it out. It would be removed when the person reached the ideal weight and possibly sooner.”

FDA guidelines specify that the bubble be used only in those patients who are 20% over ideal weight as defined by the 1983 Metropolitan Life Insurance Table, according to David Duarte in the FDA office in Maryland.

However, UCI’s Daniel Hollander says if he were prescribing the bubble “guidelines for me would be that a patient be 100% over normal weight,” not just the 20% as required by the FDA. “And we are certainly not talking about a woman who is slightly overweight by 30 pounds,” he said.

According to FDA regulations, the device must be removed and a new one inserted every four months. Removal, according to Lloyd Garren, involves puncturing the balloon and retrieving it through the mouth by rat-toothed forceps.

A Liquid Diet

During the first five days after the bubble is placed in the stomach, the patient must adhere to a liquid diet until, as Chapman says, “the stomach has a chance to get used to having a bubble in it.” Afterward, a normal diet, limited to a maximum of 1,000 calories a day, can be resumed. “There is nothing excluded on their diet,” he said, “except that we do ask them not to drink alcoholic beverages.”

Side effects include stomach cramping and mild stomach pain in the first week, but after that most patients in the Garrens’ study did not report any discomfort, according to a summary of his findings published in Endoscopy Review.

Potential serious side effects include ulcers and intestinal blockage, but they are uncommon, according to the study. Intestinal blockage occurred in only one patient in the Garrens’ study, and that patient had had previous intestinal surgery, he noted. As a result, patients who have undergone such surgeries are excluded as candidates for the gastric bubble.

Among others excluded are persons with a history of liver disease, inflammatory bowel disease and ulcers. The bubble also is not prescribed for pregnant women, persons who are heavy drinkers and patients on certain medications.