International multicenter study of safety and effectiveness of Swedish Adjustable Gastric Band in 1-, 3-, and 5-year follow-up cohorts

Abstract Background No long-term, international, multicenter studies of the effectiveness and safety of the SAGB in morbid obesity have been previously published. The objective of this study was to assess the effectiveness and safety of the Swedish Adjustable Gastric Band (SAGB) at 6 bariatric centers in Australia, Europe, and Brazil, with ≤5 years of follow-up; the effect on patient covariates; and changes in co-morbidity. Methods A 2-phase study design was used, involving both retrospective and prospective data. SAGB was implanted by way of the pars flaccida 1, 3, and 5 years previously. The retrospective phase entailed a review of the records. The prospective phase included a subset of eligible patients who agreed to undergo additional clinical assessments. The percentage of excess weight loss (%EWL), patient level predictors, change in co-morbidities, and complications were analyzed. Results A total of 481 patients in 3 mutually exclusive follow-up cohorts (1 yr, n = 200; 3 yr, n = 184; 5 yr, n = 97) participated in the present study. Of these 481 patients, 339 (1 yr, n = 139; 3 yr, n = 131; 5 yr, n = 69) underwent prospective evaluations. The mean %EWL was 43.5% ± 21.8%, 57.7% ± 25.9%, and 49.8% ± 27.6% and the mean change in body mass index was −7.64, −10.75, and −9.52 in the 1-, 3-, and 5-year cohorts, respectively ( P