Problems Prompt Warning on Use of Stomach Balloon in Obesity Cases
American Edwards Laboratories of Santa Ana has warned doctors to curtail use of a controversial stomach balloon treatment for obesity because the device has been associated with one patient death and about 80 serious medical complications, The Times has learned.
The restrictions come 13 months after the treatment was initially approved by the U.S. Food and Drug Administration, a move that prompted enthusiasm that the balloon was a therapeutic breakthrough and criticism that its safety and effectiveness had not been proven.
The Garren-Edwards Gastric Bubble is inserted into the stomach through the mouth as a temporary measure to curtail the appetite and help patients lose large amounts of weight. So far, 17,000 bubbles have been inserted nationwide, a company spokesman said.
Warning Mailed Oct. 27
But new labeling information mailed Oct. 27 by American Edwards to the 2,000 gastroenterologists trained to insert the device warns of new and more severe side effects than previously reported, recommends earlier removal of the balloon and limits use to the most severely overweight patients.
Despite the new warnings, a company spokesperson emphasized in an interview the product’s “very low complication rate.”
The bubble “is designed for people who are morbidly obese . . . and not for people who are somewhat overweight and want to try the latest fad and miracle cure,” said Les Jacobson of Baxter-Travenol Laboratories in Deerfield, Ill., the parent company of American Edwards.
“This is a less invasive approach than surgery,” Jacobson said. “We remain committed to its safety and effectiveness.”
The Gastric Bubble has caused perforations and ulcers of the stomach and intestinal blockages, according to the advisory mailed last Monday. Emergency surgery is sometimes required if the balloon spontaneously collapses, and “delayed removal of a deflated bubble may be associated with death,” the manufacturer added.
Notify Doctors Immediately
American Edwards also instructed doctors to tell their patients to notify them immediately upon the onset of symptoms such as abdominal pain, vomiting or increased appetite, which may indicate that the balloon must be removed.
Based on an increasing number of reported side-effects, American Edwards said the device should be a last resort, limited to patients with life-threatening morbid obesity who had failed other weight-loss therapies and who might otherwise require drastic procedures such as jaw-wiring or other surgeries. Such patients are often 100 pounds or more overweight.
Initially, the balloon had also been recommended for patients who had failed other weight reduction programs but were only 20% overweight. Such patients might be only 25 to 50 pounds overweight.
The company said the bubble should be routinely removed after three months, not four months as previously recommended, because balloons left in place more than 90 days “have a significantly increased rate of deflation.” A new bubble can be inserted if further therapy is needed.
Inserted While Deflated
The hollow plastic cylinder is inserted through the mouth in its deflated form, while a gastroenterologist uses a special lighted fiber-optic tube called an endoscope to see into the stomach and make sure that the device is properly placed.
The bubble is then inflated until it is about two inches in diameter and about 3 1/2 inches long. The patient is sedated and usually sleeps through the procedure.
The endoscope is also used to remove the balloon, which is deflated by puncturing and then pulled out through the mouth.
About 2% of the 17,000 bubbles have spontaneously deflated during the first three months of use, according to Jacobson. Some have been vomited, others have passed through the intestine or have been removed with an endoscope.
The manufacturer has received reports from doctors of 33 patients who developed ulcers, 35 who developed blocked intestines requiring surgery and 12 who developed other conditions. The company is also investigating the death in August of a Florida woman that has been associated with the device. No further details of the woman’s death were released.
By comparison, the Food and Drug Administration based its approval of the product in September, 1985, on clinical studies of 78 overweight patients, according to agency documents. Since then it has received about 75 reports of medical complications from the bubble, Dave Duarte, a FDA spokesperson, said in an interview.
FDA, Company Agree
“The agency is in agreement with the actions the company has taken,” Duarte added.
No one is certain how the device curbs the appetite, although there are theories that it helps patients follow diets by making them feel full more quickly and have less hunger between meals.
When the FDA approved the bubble, it reviewed evidence that 41 patients treated for six months lost an average of 40 pounds. But some have criticized the soundness of these studies.
“The effectiveness of a gastric balloon in promoting weight loss has not been adequately demonstrated,” The Medical Letter, an independent newsletter that evaluates drugs and medical devices, concluded in August. “The only satisfactory treatment for obesity is a life-long change in patterns of food intake and physical activity.”
In addition, Blue Shield of California, after reviewing the studies, labeled the treatment experimental and declined to approve it for its insurance plans.
Controlled Studies Under Way
Only now are gastroenterologists at several universities conducting controlled studies, in which half the overweight patients receive the bubble and the others undergo “sham” insertion procedures. All the patients, none of whom know which group they are in, receive the same intensive program of diet and behavior modification.
The results of these studies, being conducted at Albert Einstein Medical Center in Philadelphia and Georgetown University Medical Center in Washington, are not yet available.
The gastric bubble was developed over a 10-year period by Dr. Lloyd Garren, a gastroenterologist who practices in Wilmington, Del., and his wife, Dr. Mary Garren, who practices in Elkton, Md. It costs physicians about $400.
Physician charges, including insertion and removal of the bubble, may total $1,500 to $4,000 over a period of several months, according to Blue Shield of California.
