Safety and Effectiveness of REALIZEâ„¢ Adjustable Gastric Band: 5-year Prospective Study

Phillips, Edward; Ponce, Jaime; Bhoyrul, Sunil; Cunneen, Scott A.; Gomez, Eddie; Jacobs, Moises; Kipnes, Mark; Marema, Robert T.; Schwiers, Michael; Waggoner, Jason R.; DeMarchi, Janet

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.