Antibiotics to Prevent Relapse of Adjustable Gastric Balloon Hyperinflation: Feasible for Balloon Maintenance?

Abstract

The placement of an intragastric balloon (IGB) plays an increasingly important role in the treatment of obesity. The authors describe the cases of 2 female patients, 34 and 62 years old, who were submitted to the implantation of a Spatz3® IGB to treat obesity. Ten to fourteen weeks later, the patients presented complaints of epigastric pain, vomiting, and abdominal distension. A bulging of the upper abdominal wall was noticed upon physical examination. Upper gastrointestinal endoscopy confirmed the clinical suspicion of IGB hyperinflation. It was decided to remove the 500 mL of saline solution with methylene blue from inside the balloon. During the same procedure, the IGB was refilled with 500 mL of fresh saline solution, methylene blue, and empiric β-lactam antibiotic. The extracted content of the hyperinflated IGB was sent for microbiological culturing and was found to be positive for <i>Streptococcus viridans</i> in one of the cases. In the other case, the culture examination was negative, and after 8 weeks, the patient presented again with hyperinflation of the IGB. It was then decided to substitute the IGB with another balloon; the procedure was uneventful. The content of the removed IGB was sent for microbiological testing, and colonization by <i>Candida tropicalis</i>was confirmed. This is a rare but potentially serious complication of IGB placement. Randomized trials are needed to clarify the role of antibiotics and antifungals in primary and secondary prophylaxis against IGB hyperinflation.

Contamination of single fluid-filled intragastric balloons with orogastric fluid is not associated with hyperinflation: an ex-vivo study and systematic review of literature

“…A total of 10 publications (11 cases) [ 15 , 23 – 31 ] describing spontaneous IGB hyperinflation were identified in the literature despite a reported rate of approximately 2% in post-marketing studies [ 13 ]. All identified cases shared a common definition of spontaneous IGB hyperinflation which is consistent with the FDA’s statement [ 14 ].…”

“…Nonetheless, our systematic review of literature identified multiple case studies reporting asymptomatic microbial colonization of the IGB without balloon hyperinflation [ 41 , 44 , 45 ]. In contrast, others described bacterial or fungal colonization with associated symptomatic spontaneous balloon hyperinflation [ 25 , 27 – 29 , 31 ]. In combination with the results of our experiment, these observations suggest that IGB contamination and ensuing microbial fermentation may not be the sole cause of hyperinflation, and the presence of additional factors is likely involved.…”

“…Worldwide, over 200 AE reports of IGB hyperinflation were received by the FDA with few published reports in the literature [15,[23][24][25][26][27][28][29][30][31]35]. Accordingly, the FDA issued an updated letter to providers regarding the potential risk of spontaneous hyperinflation based on the post-approval study of the Orbera IGB [35,36].…”

Contamination of Single Fluid-Filled Intragastric Balloons with Orogastric Fluid is not Associated with Hyperinflation: An Ex-vivo Study and Systematic Review of Literature

“…A total of 10 publications (11 cases) [15,[23][24][25][26][27][28][29][30][31] describing spontaneous IGB hyperin ation were identi ed in the literature despite a reported rate of approximately 2% in post-marketing studies [13]. Patient baseline characteristics, type of IGB, clinical presentation and subsequent management are detailed in Table 2.…”

Spontaneous Hyperinflation of an Intragastric Balloon Causing Gastric Outlet Obstruction

“…The exact mechanism of hyperinflation, in this case, is unclear. Previous reports have found contamination of the IGB fluid with gas-forming micro-organisms like some species of Candida and Streptococcus viridans [ 11 - 12 ]. The fluid used in these balloons is sterile and so authors have proposed that the integrity of the balloon can be compromised and become permeable [ 13 ].…”