Safety and Effectiveness of the Intragastric Balloon for Obesity. A Meta-Analysis



Intragastric balloons have been used since 1985 to treat obesity, but an evidence-based systematic review had not been previously performed. The objective of this study is to determine the safety, efficacy, and effectiveness of the most widely used balloon, BioEnterics Intragastric Balloon (BIB®), to treat obesity.


Systematic literature review of Medline, Embase, and other information sources from inception to March 2006. The quality of selected studies was assessed. Meta-analysis of weighted mean difference was made using the inverse variance method.


We pooled 15 articles (3,608 patients) to estimate BIBs® effectiveness. The estimates for weight lost at balloon removal for BIB® were the following: 14.7 kg, 12.2% of initial weight, 5.7 kg/m2, and 32.1% of excess weight. However, data were scant after balloon removal. Yet, efficacy at balloon removal was estimated with a meta-analysis of two randomized controlled trials (75 patients) that compared balloon versus placebo, indicating the balloon group lost more weight than the placebo group. These differences in weight lost were 6.7 kg, 1.5% of initial weight, 3.2 kg/m2, and 17.6% of excess weight. Regarding BIB® safety, the majority of complications were mild and the early removal rate was 4.2%.


The use of the BIB®, within a multidisciplinary weight management program, is a short-term effective treatment to lose weight, but it is not yet possible to verify its capacity to maintain the weight lost over a long period of time.

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  1. 1.

    Fernandes M, Atallah AN, Soares BGO, et al. Baloes Intragástricos para pessoas com obesidade. Cochrane Library. Oxford: Update Software Ltd.; 2006.

    Google Scholar 

  2. 2.

    National Institutes of Health, National Heart Lung and Blood Institute, North American Association for the Study of Obesity. Practical Guide to the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. NIH Publication no. 00-4084. Bethesda: NIH; 2000. p. 94.

    Google Scholar 

  3. 3.

    Meshkinpour H, Hsu D, Farivar S. Effect of gastric bubble as a weight reduction device: a controlled, crossover study. Gastroenterology. 1988;95:589–92.

    PubMed  CAS  Google Scholar 

  4. 4.

    Schapiro M, Benjamin S, Blackburn G, et al. Obesity and the gastric balloon: a comprehensive workshop. Tarpon Springs, Florida, March 19–21, 1987. Gastrointest Endosc. 1987;33:323–7.

    PubMed  Article  CAS  Google Scholar 

  5. 5.

    Allison C. Intragastric balloons: a temporary treatment for obesity. Issues in emerging health technologies, no. 79. Canadian Coordinating Office for Health Technology Assessment, Ottawa; 2006.

  6. 6.

    Forestieri P, De Palma GD, Formato A, et al. Heliosphere(R) bag in the treatment of severe obesity: preliminary experience. Obes Surg. 2006;16:635–7.

    PubMed  Article  CAS  Google Scholar 

  7. 7.

    Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. 4.2.6. In: The Cochrane Library. Issue 4, ed. Chichester, UK: John Wiley and Sons, Ltd.; 2006.

  8. 8.

    Jadad AR. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.

    PubMed  Article  CAS  Google Scholar 

  9. 9.

    Khan KS, Riet G, Glanville J, et al. Undertaking systematic reviews of research on effectiveness. CRD’s guidance for those carrying out or commissioning reviews. no. 4. York: NHS Center for Reviews and Dissemination, University of York; 2001.

    Google Scholar 

  10. 10.

    Oxford Centre for Evidence-based Medicine. Quality filters [On line]. Web of the centre for evidence-based medicine, 23-10-2006.

  11. 11.

    Schwartz D. Métodos estadísticos para médicos y biólogos. Barcelona: Editorial Herder; 1991. p. 385.

    Google Scholar 

  12. 12.

    Furukawa TA, Barbui C, Cipriani A, et al. Imputing missing standard deviations in meta-analyses can provide accurate results. J Clin Epidemiol. 2006;59:7–10.

    PubMed  Article  Google Scholar 

  13. 13.

    Angrisani L, Lorenzo M, Borrelli V, et al. Is bariatric surgery necessary after intragastric balloon treatment. Obes Surg. 2006;16:1135–7.

    PubMed  Article  Google Scholar 

  14. 14.

    Busetto L, Segato G, De Luca M, et al. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg. 2004;14:671–6.

    PubMed  Article  Google Scholar 

  15. 15.

    Busetto L, Enzi G, Inelmen EM, et al. Obstructive sleep apnea syndrome in morbid obesity: effects of intragastric balloon. Chest. 2005;128:618–23.

    PubMed  Article  Google Scholar 

  16. 16.

    Doldi SB, Micheletto G, Perrini MN, et al. Intragastric balloon: another option for treatment of obesity and morbid obesity. Hepatogastroenterology. 2004;51:294–7.

    PubMed  CAS  Google Scholar 

  17. 17.

    Francica G, Giardiello C, Iodice G, et al. Ultrasound as the imaging method of choice for monitoring the intragastric balloon in obese patients: normal findings, pitfalls and diagnosis of complications. Obes Surg. 2004;14:833–7.

    PubMed  Article  Google Scholar 

  18. 18.

    Galloro G, De Palma GD, Catanzano C, et al. Preliminary endoscopic technical report of a new silicone intragastric balloon in the treatment of morbid obesity. Obes Surg. 1999;9:68–71.

    PubMed  Article  CAS  Google Scholar 

  19. 19.

    Mathus-Vliegen EM, Tytgat GN. Gastro-oesophageal reflux in obese subjects: influence of overweight, weight loss and chronic gastric balloon distension. Scand J Gastroenterol. 2002;37:1246–52.

    PubMed  Article  CAS  Google Scholar 

  20. 20.

    Krakamp B, Leidig P, Gehmlich D, et al. Der Magenvolumen-Reduzierungsballon zur Gewichtsreduktion: Welche Berechtigung hat diese umstrittene Methode? Zentralbl Chir. 1997;122:349–56.

    PubMed  CAS  Google Scholar 

  21. 21.

    Rydzewska G, Milewski J. Balony dozoladkowe-nowa nadzieja w leczeniu otylosci? Pol Merkuriusz Lek. 2004;17 Suppl 1:114–6.

    Google Scholar 

  22. 22.

    Bonazzi P, Petrelli MD, Lorenzini I, et al. Gastric emptying and intragastric balloon in obese patients. Eur Rev Med Pharmacol Sci. 2005;9:15–21.

    PubMed  CAS  Google Scholar 

  23. 23.

    Alfalah H, Philippe B, Ghazal F, et al. Intragastric balloon for preoperative weight reduction in candidates for laparoscopic gastric bypass with massive obesity. Obes Surg. 2006;16:147–50.

    PubMed  Article  Google Scholar 

  24. 24.

    Al Momen A, El Mogy I. Intragastric balloon for obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg. 2005;15:101–5.

    PubMed  Article  Google Scholar 

  25. 25.

    Carbonelli MG, Fusco MA, Cannistra F, et al. Body composition modification in obese patients treated with intragastric balloon. Acta Diabetol. 2003;40 Suppl 1:S261–2.

    PubMed  Article  CAS  Google Scholar 

  26. 26.

    Evans JD, Scott MH. Intragastric balloon in the treatment of patients with morbid obesity. Br J Surg. 2001;88:1245–8.

    PubMed  Article  CAS  Google Scholar 

  27. 27.

    Genco A, Bruni T, Doldi SB, et al. BioEnterics intragastric balloon: the italian experience with 2,515 patients. Obes Surg. 2005;15:1161–4.

    PubMed  Article  CAS  Google Scholar 

  28. 28.

    Herve J, Wahlen CH, Schaeken A, et al. What becomes of patients one year after the intragastric balloon has been removed? Obes Surg. 2005;15:864–70.

    PubMed  Article  CAS  Google Scholar 

  29. 29.

    Hodson RM, Zacharoulis D, Goutzamani E, et al. Management of obesity with the new intragastric balloon. Obes Surg. 2001;11:327–9.

    PubMed  Article  CAS  Google Scholar 

  30. 30.

    Loffredo A, Cappuccio M, De Luca M, et al. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg. 2001;11:3.

    Article  Google Scholar 

  31. 31.

    Mion F, Napoleon B, Roman S, et al. Effects of intragastric balloon on gastric emptying and plasma ghrelin levels in non-morbid obese patients. Obes Surg. 2005;15:510–6.

    PubMed  Article  Google Scholar 

  32. 32.

    Roman S, Napoleon B, Mion F, et al. Intragastric balloon for “non-morbid” obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg. 2004;14:539–44.

    PubMed  Article  Google Scholar 

  33. 33.

    Sallet JA, Marchesini JB, Paiva DS, et al. Brazilian multicenter study of the intragastric balloon. Obes Surg. 2004;14:991–8.

    PubMed  Article  Google Scholar 

  34. 34.

    Sánchez B, Espinós J, Turró J, et al. Tratamiento y seguimiento nutricional en pacientes con balón intragástrico. Revista Española de Nutrición Comunitaria. 2005;11:152–5.

    Google Scholar 

  35. 35.

    Totté E, Hendrickx L, Pauwels M, et al. Weight reduction by means of intragastric device: experience with the bioenterics intragastric balloon. Obes Surg. 2001;11:519–23.

    PubMed  Article  Google Scholar 

  36. 36.

    Weiner R, Gutberlet H, Bockhorn H. Preparation of extremely obese patients for laparoscopic gastric banding by gastric-balloon therapy. Obes Surg. 1999;9:261–4.

    PubMed  Article  CAS  Google Scholar 

  37. 37.

    Genco A, Cipriano M, Bacci V, et al. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes. 2006;30:129–33.

    Article  CAS  Google Scholar 

  38. 38.

    Mathus-Vliegen EM, Tytgat GN. Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up. Gastrointest Endosc. 2005;61:19–27.

    PubMed  Article  Google Scholar 

  39. 39.

    Maggard MA, Shugarman LR, Suttorp M, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005;142:547–59.

    PubMed  Google Scholar 

  40. 40.

    Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992;16:397–415.

    PubMed  CAS  Google Scholar 

  41. 41.

    Li Z, Maglione M, Tu W, et al. Meta-analysis: pharmacologic treatment of obesity. Ann Intern Med. 2005;142:532–46.

    PubMed  CAS  Google Scholar 

  42. 42.

    McTigue KM, Hess R, Ziouras J. Obesity in older adults: a systematic review of the evidence for diagnosis and treatment. Obesity. 2006;14:1485–97.

    PubMed  Article  Google Scholar 

  43. 43.

    Tosetti C, Corinaldesi R, Stanghellini V, et al. Gastric emptying of solids in morbid obesity. Int J Obes Relat Metab Disord. 1996;20:200–5.

    PubMed  CAS  Google Scholar 

  44. 44.

    Geliebter A, Melton PM, McCray RS, et al. Clinical trial of silicone-rubber gastric balloon to treat obesity. Int J Obes. 1991;15:259–66.

    PubMed  CAS  Google Scholar 

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We thank David Peck for his structural review of this manuscript.

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Correspondence to Iñaki Imaz.

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Imaz, I., Martínez-Cervell, C., García-Álvarez, E.E. et al. Safety and Effectiveness of the Intragastric Balloon for Obesity. A Meta-Analysis. OBES SURG 18, 841 (2008).

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  • Intragastric balloon
  • BIB
  • Obesity
  • Meta-analysis
  • Systematic review