Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study

Abstract

\n Background\n The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) Adjustable Gastric Band collected in this prospective, multi-center study in subjects with morbid obesity are presented. The primary objective was to determine the reoperation rate, including band revision, replacement and explant resulting from a serious adverse device-related event through years four and five. Various efficacy measures were also assessed as secondary objectives.\n \n Methods\n Nine academic and/or private institutions enrolled 303 subjects who were then assessed on an annual basis. Two hundred thirty-one subjects completed five years of follow-up. The study parameters included reoperation rates, changes in percentage of Excess Weight Loss (%EWL), Body Mass Index (BMI) as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using SF-36 and the Impact of Weight on Quality of Life (IWQOL-Lite) questionnaires.\n \n Results\n The reoperation rate due to a serious adverse event in this population at five years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage which affected 6.9% of the study population. The mean %EWL was 35.6 + 26.84 and the decrease in mean BMI was -7.01 + 5.45 at 5 years. Subjects experienced improvement in mean hemoglobin A1c and serum lipid levels in addition to improvement in the quality of life measures.\n \n Conclusion\n No new safety concerns were identified during the five years of follow up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study is consistent with the current literature.\n