Garren-Edwards Gastric Bubble Research Articles

Intragastric Balloon Therapy in the Management of Obesity

For the first time in the history of the United States, in the 21st century, there may be a decline in life expectancy, as a result of the increasing rate of obesity. It is known that even the modest reduction of 10% of excess body weight significantly reduces obesity-associated comorbidities. Conservative measures such as diet and exercise seldom give durable results in the long term. Bariatric surgery has been shown to achieve durable weight loss but is not without significant risks and complications. As a result, greater focus has turned toward minimally invasive endoscopic therapies for the management of obesity. There have been multiple reports of creative endoscopic devices and techniques in the literature, but most have only demonstrated early pilot data. By far, the most widely studied of the minimally invasive endoscopic therapies for obesity is the gastric balloon. Now obsolete, the Garren-Edwards gastric bubble was removed from the market in the United States after several sham-controlled studies showed that diet and behavior modification were equally efficacious and that the device was associated with a prohibitive number of complications. However, the concept and technique of intragastric balloon placement has evolved considerably since that time, and we now have data on nearly 3,000 patients who have undergone placement of the BioEnterics Intragastric Balloon (Carpenteria, CA) worldwide. The balloon is approved as part of a multifaceted approach to obesity in many countries and has been shown to result in at least a 10% excess weight loss durable over 1 year. However, the device is not yet approved for use in the United States. In this article, the authors review the efficacy, indications, complications, and potential uses for the intragastric balloon. The intragastric balloon might be the best start as gastroenterologists in the United States begin to play an increasing role in the treatment of the obesity pandemic.

A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity

We investigated the effect of an endoscopically placed gastric balloon, the Garren-Edwards gastric bubble (GEGB), on weight loss in obese patients. Fifty-nine obese patients were entered into a prospective double-blind study and randomized into two groups. In one group (34 patients) the GEGB was inserted, and in the other group (25 patients) a sham insertion was done. All patients participated in a standard weight loss program consisting of dietary therapy, behavior modification, and physical exercise. The bubble was removed endoscopically after 3 months from both groups. Patients were followed for an additional 9 months after bubble removal and weight loss was monitored. Weight loss was the same in both groups at 3 months (18.7 lb vs. 17.2 lb). This was true whether determined by change in pounds, percentage of body weight, or body mass index. We concluded that the GEGB was of no added benefit as compared with sham insertion, when combined with a standard weight loss program. Because of the lack of proven efficacy and the relatively high cost, we recommend that such devices be restricted to controlled studies until significant benefits are proven.

Limited Weight Losses With a Gastric Balloon

An evaluation of the Garren-Edwards gastric bubble in the treatment of obesity was done. Several clinical trials have compared the effects of behavior therapy with and without the bubble, but the effects of the bubble alone have not been previously evaluated. Ten obese women averaging 91% overweight received the bubble without adjunctive therapy during a 12-week treatment period. Frequent psychological and laboratory measures as well as weight were obtained during the study to explore the possible mechanisms of the bubble's effect and its side effects. Mean weight change was -2.5 kg, with a range of -8.8 to +1.6 kg. Four patients lost more than 3.5 kg, three lost less than 3.5 kg, and three gained weight. The Garren-Edwards gastric bubble alone does not appear to provide significant benefit to most obese patients.

Limited weight losses with a gastric balloon

An evaluation of the Garren-Edwards gastric bubble in the treatment of obesity was done. Several clinical trials have compared the effects of behavior therapy with and without the bubble, but the effects of the bubble alone have not been previously evaluated. Ten obese women averaging 91% overweight received the bubble without adjunctive therapy during a 12-week treatment period. Frequent psychological and laboratory measures as well as weight were obtained during the study to explore the possible mechanisms of the bubble's effect and its side effects. Mean weight change was -2.5 kg, with a range of -8.8 to +1.6 kg. Four patients lost more than 3.5 kg, three lost less than 3.5 kg, and three gained weight. The Garren-Edwards gastric bubble alone does not appear to provide significant benefit to most obese patients.

Small bowel obstruction and the Garren-Edwards® gastric bubble: an iatrogenic bezoar

Subsequent to its introduction as an adjunct to diet and behavioral modification in the management of exogenous obesity, the major complication of the Garren-Edwards gastric bubble (GEB) was small bowel obstruction (SBO) due to balloon deflation and obstruction in the jejunum or ileum. Seventy-two cases of patients with SBO due to the GEB requiring surgery and 15 cases of patients with SBO treated medically were reviewed in an attempt to determine risk factors predicting obstruction and to evaluate for treatment methods that might avoid the need for surgery. In these patients a deflated GEB behaved as a typical blunt foreign body. If the device is found to be in the small bowel and fails to pass or move and is associated with fever, leukocytosis, or complete SBO, surgery is required since the bowel may become ischemic, predicting the same high risk outcome seen with other blunt foreign bodies. With the introduction of other similar devices in the near future, since these devices behave as blunt foreign bodies, it cannot be assumed that they will pass uneventfully and appropriate evaluation and therapy must be initiated.

Double-Blind Controlled Trial of the Garren-Edwards Gastric Bubble: An Adjunctive Treatment for Exogenous Obesity

Since its approval by the Food and Drug Administration in September 1985, the Garren-Edwards gastric bubble has been extensively used as an adjunct to diet and behavioral modification in the treatment of exogenous obesity. In an attempt to evaluate the efficacy of the Garren-Edwards gastric bubble, a double-blind crossover study was undertaken. Ninety patients were randomized into three groups: bubble-sham, sham-bubble, and bubblebubble in two successive 12-wk periods. Sixty-one patients completed the entire 24-wk study. All groups participated in ongoing diet and behavioral modification therapy in a free-standing obesity program, the members of which were blinded to randomization arms. All patient groups lost weight during this study. The mean cumulative weight loss in pounds at 12 wk was as follows: bubble-sham = 19, sham-bubble = 12, and bubble-bubble = 8; and at 24 wk: bubble-sham = 23, sham-bubble =16, and bubble-bubble = 18. The mean cumulative change in body mass index (kg/m2) at 12 wk was as follows: bubble-sham = -3.1, sham-bubble = -2.3, and bubble-bubble -2.9; and at 24 wk: bubble-sham = -3.1, sham-bubble = -3.0, and bubble-bubble = -3.3. Although weight loss occurred more consistently in patients with a Garren-Edwards gastric bubble, there were no significant differences between any of the three groups at 12 or 24 wk with respect to weight loss or change in body mass index. The major part of the weight loss noted during this study occurred during the first 12-wk period, irrespective of therapy (bubble or sham). Side effects observed during this study included gastric erosions (26%), gastric ulcers (14%), small bowel obstruction (2%), Mallory-Weiss tears (11%), and esophageal laceration (1%). We conclude that, in this study, the use of a Garren-Edwards gastric bubble did not result in significantly more weight loss than diet and behavioral modification alone in the management of exogenous obesity, and it may result in significant morbidity.

An evaluation of the Garren-Edwards diet and behavior modification program

This study evaluated the efficacy of the Garren-Edwards Behavior Modification Program, which uses the Garren-Edwards Gastric Bubble as an adjunct to treatment. Group therapy sessions were conducted with 23 morbidly obese subjects for 6 months on a biweekly basis. Each therapy session used a five-stage problem-solving sequence designed to facilitate adaptive behavioral alternatives. In evaluating weight change, a multivariate analysis of variance was conducted along with two preplanned orthogonal comparisons. Patients lost significant amounts of weight between initial to 3-month (p<.0001) and 3- to 6-month intervals (p<0001). A similar treatment effect was noted in an additional sample of 24 morbidly obese subjects following 3 months of treatment (p<0005). The findings support the value of longer goal-oriented programs in promoting continued weight loss. Implications for treatment process and therapist interventions prompted by this new format are discussed.

Effect of Gastric Bubble as a Weight Reduction Device: A Controlled, Crossover Study

In spite of the widespread use of the GarrenEdwards gastric bubble as an adjuvant device in weight reduction, its efficacy has not been established. Therefore, our purpose was to conduct a randomized, double-blind, crossover study of this device in the management of exogenous obesity. The study group consisted of 23 patients, 21 women and 2 men, ranging in age from 21 to 53 yr. Patients were 25%–111% above their ideal body weight. They were studied for 24 wk, consisting of two separate 12-wk evaluation periods. Patients were randomly assigned either to receive the gastric bubble or to have a sham procedure. After the first 12-wk evaluation period, the gastric bubble and sham were administered in crossover fashion, so that those who had received the gastric bubble initially received the sham later and vice versa. The study coordinator remained blind to the kind of treatment, weighed each patient biweekly, enforced dietary counseling, and provided behavior modification. Those who had passed or were found to have a deflated bubble at the end of the treatment period were excluded from the study. Mean weight reduction in the two evaluation periods did not differ significantly. Patients lost 5.4 ± 1.7 kg (mean ± SE) during the gastric bubble period and 5.20 ± 0.8 kg during the sham period. The order of administration of the gastric bubble and sham did not significantly affect the result. The time-course of mean biweekly values, however, revealed that with the gastric bubble, weight loss was significantly greater only during first (p < 0.005) and second (p < 0.025) 2-wk evaluation periods. This difference, however, disappeared after the initial 4 wk of treatment. These observations suggest that although gastric bubble implantation reduced weight significantly more than the sham procedure initially, the mean weight loss during 12 wk of evaluation was not different between the two periods. In our opinion, the gastric bubble is of no value as an adjuvant device in weight reduction.

The effect of the Garren-Edwards Gastric Bubble on solid and liquid gastric emptying.

To determine the effect of the Garren-Edwards Gastric Bubble (GEGB) on gastric emptying, radionuclide solid and liquid gastric emptying in 12 obese patients prior to insertion of the GEGB was studied. Four were restudied at one and seven days and ten patients were restudied at twelve weeks with the GEGB in place. There were no significant differences in liquid gastric emptying at one and seven days nor in solid and liquid gastric emptying at twelve weeks. Solid gastric emptying was significantly decreased from a mean of 63% to 31% after one day (P less than 0.05) and returned to preplacement baseline by seven days. These results indicate that gastric emptying is not significantly changed after twelve weeks with the GEGB in place. Therefore, the mechanism of action for weight reduction with the GEGB is not likely to be mediated by an effect on gastric emptying. However, the solid food-induced dyspeptic symptoms commonly noted 1-3 days after placement of the GEGB, which resolve within seven days, are probably explained by transiently delayed solid gastric emptying.

Obesity and the gastric balloon: a comprehensive workshop

a Reproduced with permission of the American Edwards Laboratories. Table 1. Complications in 20,000 gastric bubbles: customer experience reports (11/85-12/86)· physical and psychological contraindications, insertion/retrieval procedures, patient management issues with respect to adjunctive drug therapy and the need for appropriate patient education on nutrition, exercise and behavior modification, were included. The authors of this summary developed the program content, format, and workshop makeup. The conference included plenary sessions on physiological principles, clinical data, aspects of patient management, relationship to surgery, balloon insertion/retrieval techniques, complications associated with the use of gastric balloons, the design and experience with alternative intragastric balloons, and possible mechanisms of acThe concept of an intragastric balloon represents a unique, innovative, and possibly efficacious approach to the short-term management of obesity. The placement of an intragastric balloon as a temporary adjunct to behavior modification and diet has been recommended to produce weight loss in a selected group of obese patients.8 Widespread clinical utilization of the procedure occurred following FDA approval of the Garren-Edwards balloon, a cylindrical air-containing bubble made of polyurethane. Controversy concerning indications, utilization, efficacy, and safety prompted the manufacturers of the Garren-Edwards balloon to provide an educational grant to address these and related issues. A scientific conference entitled Obesity and the Gastric Balloon: A Comprehensive Workshop was held in Tarpon Springs, Florida, March 19-21, 1987. Seventy-five international experts from the fields of gastroenterology, surgery, obesity, nutrition, and behavior medicine attended the conference to examine current research and clinical experience with the Garren-Edwards gastric bubble, other gastric balloons under study in the United States, and gastric balloons available for use in other countries. Representatives from the different medical disciplines necessary to examine all aspects of patient treatment with gastric balloons, i.e., patient selection with attention to both

Office insertion of Garren-Edwards gastric bubble and comprehensive weight reduction program

Office insertion of Garren-Edwards gastric bubble and comprehensive weight reduction program

A new method for gastric bubble removal

The usual method for removal of the Garren-Edwards gastric bubble as described by Garren is to grasp the edge of the bubble with a rat-tooth forceps and produce a laceration. l Unfortunately, this has proven technically difficult since numerous graspings of the bubble's edge are required to effect the laceration as the bubble moves about freely. In addition, it is difficult to judge whether a true laceration has been performed because the construction of the bubble may not allow its walls to collapse when has occurred. We describe a simple method for deflation and extraction of the gastric bubble.