© FD-Communications Inc. Obesity Surgery, 15, 2005 1161 Obesity Surgery, 15, 1161-1164 Background: The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increas- ing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities. Methods: Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling (~1000 Kcal) and medical therapy.The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidi- ties were evaluated. Results: From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9±14.7, range 12-71; mean BMI 44.4±7.8 kg/m 2 ; range 28.0-79.1; and mean excess weight 59.5±29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treat- ment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of pep- tic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4±11.8 kg/m 2 (range 24-73) and %EWL was 33.9±18.7 (range 0-87). BMI loss was 4.9±12.7 kg/m 2 (range 0-25). Conclusions: BIB is an effective procedure with sat- isfactory weight loss and improvement in co-morbidi- ties after 6 months. Previous gastric surgery is a con- traindication to BIB placement. Key words: Obesity, intragastric balloon, weight loss, com- plications, co-morbidity Introduction The BioEnterics Intragastric Balloon (BIB) is an endoscopic device for temporary treatment of obe- sity. 1,2 Intragastric balloon positioning is potentially attractive to health-care practitioners who have experienced poor results with dietary programs, medications and behavioral therapy. Moreover, it has been recommended as a weight reduction adju- vant before bariatric surgery and before all kinds of planned surgery in the morbidly obese, to reduce life-threatening co-morbidities and lessen surgical risk. 2-4 The aim of this study is the retrospective evaluation in a large population of the efficacy of the BIB in terms of weight loss and its influence on co-morbidities. BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients A. Genco; T. Bruni; S. B. Doldi; P. Forestieri; M. Marino; L. Busetto; C. Giardiello; L. Angrisani; L. Pecchioli; P. Stornelli; F. Puglisi; M. Alkilani; A. Nigri; N. Di Lorenzo; F. Furbetta; A. Cascardo; M. Cipriano; M. Lorenzo; N. Basso Italian Group for Lap-Band ® , Fondazione IDIS - Città della Scienza, Naples, Italy Reprint requests to: Michele Lorenzo MD, PhD, Italian Group for Lap-Band ® – GILB, c/o Fondazione IDIS, Città della Scienza, via Coroglio 156, 80124 Naples, Italy. Fax: + 39 081 2301044; e-mail: info@iglb.it THI S MATERI AL MAY BE PROTECTED BY COPYRI GHT LAW (17 USC)