A retrospective analysis of weight loss associated with the Orbera intragastric balloon at a single bariatric center

Retrospective Study: An assessment of weight loss and safety profile of ORBERA Intragastric Balloon System (IBS). Background: Lifestyle modification and dietary management have proven to be ineffective in the treatment of obesity. ORBERA Intragastric Balloon (IGB) system, a treatment modality approved by the US Food and Drug Administration has recently become available commercially for the treatment of refractory obesity in patients with Body Mass Index (BMI) of 35-40. Setting: A private clinic based in the United States. Objectives: Data on the effectiveness and accommodative adverse effect of ORBERA IGB are currently limited. The objective of this study is to measure the effect of IGB on weight loss, assess the accommodative adverse event safety profile and examine factors associated with accommodative symptoms such as nausea and vomiting. Methods: A review of records of 22 patients treated using ORBERA in a private clinic from September 2016 to January 2018 was conducted. The balloons were filled with 400-600 mL of saline solution. The IGB was placed and removed endoscopically over a treatment period of 6 months. Results: The sample size comprised of 18 (81.82%) females and 4 (18.18%) males with a mean age of 49.23 (range 21-76 years). The most common comorbidities in this population were gastroparesis (4, 20%), hiatal hernia (6%29%), diabetes mellitus (3%-15%), and cholecystitis (2%-10%). The baseline mean weight was 239.26 lb (range 158 lb-323 lb), baseline mean BMI was 39.48 (range 29.85-48.90).The mean end of treatment weight was 182.2lb (range 134 lb-279 lb) with a mean weight loss of 32.2 lb (range 16 lb-48 lb) and a mean BMI 30.79 (range 25.3- 40.2) at end of the 6 months treatment period. No serious adverse events were observed during the endoscopic placement and removal of the system. The most frequent accommodative adverse events were nausea 13 (65%), vomiting 12 (60%), reflux/Gastroesophageal reflux disease 8 (40%). No significant characteristics associated with the accommodative side effects (e.g. nausea and vomiting) were discernible. Conclusion: The findings suggest that ORBERA IGB is an effective, safe and reasonably well-tolerated management option for obesity as significant weight loss was found consistently in the study population. However, further study is recommended for a better understanding of the accommodative symptoms associated with the IGB system.