title: Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients.
abstract: OBJECTIVE
  To analyze the 3-year outcomes of lower body mass index (BMI) (<35 kg/m2) adjustable gastric band (AGB) recipients across multiple sites in the French health insurance system.
  
  
  METHODS
  From prospectively collected data on a cohort of 517 morbidly obese Swedish Adjustable Gastric Band® (SAGB) patients (Clinical Trials Web database, #NCT01183975), a retrospective analysis of a subgroup of 29 low-BMI patients was conducted. Patients had a severe obesity-related comorbidity, had undergone a prior bariatric procedure requiring reintervention, or had a maximum adult BMI≥40. Safety (mortality, adverse events) and effectiveness (BMI change, excess weight loss [EWL, %], total body weight loss [%TBWL], quality of life [QoL], and comorbidities) were evaluated.
  
  
  RESULTS
  Multiple surgical teams/sites enrolled patients and performed SAGB procedures between September 2, 2007 and April 30, 2008. Of 29 low-BMI patients (mean age, 41.3±10.3 years), 89.7% were female, and obesity duration was 13.6±7.3 years. Mean BMI was 31.5±3.7; there were 37 comorbidities in 15/29 patients. At 3-year follow-up, BMI was 29.4±4.9 (mean change, -2.3±6.2; P=0.069); total cohort EWL, 7.3±74.8%; TBWL, 6.2±18.8%; BMI≥30 to <35 EWL, 38.8±48.0%; there were 7 comorbidities in 15/29 patients (P<0.031). There were 20 adverse events in 13 patients (44.8%); SAGBs were retained in 25/29 (86.2%) at 3 years.
  
  
  CONCLUSIONS
  In a retrospective analysis of a subgroup of BMI<35 kg/m2 patients, some following a prior bariatric procedure, SAGB was found to be safe and effective at 3-year follow-up.
authors.affiliation: Goran Ribaric, Director, Regional Safety Officer EMEA, Medical Devices and Diagnostics, Johnson and Johnson, Ethicon Endo Surgery (Europe) GmbH, Hummelsbütteler Steindamm 71, 22851 Norderstedt, Germany, gribaric@its.jnj.com.
authors.forename: Goran
authors.initials: G
authors.lastname: Ribaric
authors.forename: Jane
authors.initials: J
authors.lastname: Buchwald
mesh_terms: D000328:Adult; D015992:Body Mass Index; D015897:Comorbidity; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery*; D011788:Quality of Life; D012086:Reoperation; D012189:Retrospective Studies; D015431:Weight Loss