Life-threatening visceral complications after intragastric balloon insertion: Is the device, the patient or the doctor to blame?

Abstract

Background and aim Intragastric balloon placement is established as a safe, relatively low-cost and well-tolerated minimally invasive procedure for weight loss, giving encouraging results under the strict prerequisite that the obese patient will enroll in a medically supervised weight loss program. This retrospective study reviews already published cases of severe visceral complications for the purpose of assigning responsibility to the device, the patient, or the doctor.

Methods We reviewed PubMed and Scopus archived publications describing intragastric balloon (BIB/Orbera)-related severe visceral complications, i. e. perforations and obstructions.

Results Twenty-two cases of gastric perforation, two cases of esophageal perforation and 10 cases of bowel obstruction were found. For the gastric perforation the endoscopist was responsible in nine cases, the patient in four, and the balloon itself in nine. For the two cases of esophageal perforation, the endoscopists were responsible, while for the 12 cases of bowel obstruction, the patient was responsible for seven and the device for the other five cases.

Conclusion BIB/Orbera balloon insertion remains a safe procedure, with a minimum of complications related to hollow viscera. Mandatory education and accreditation of physicians dealing with bariatric endoscopy and strict supervision of the obese individuals, while living with the balloon, will eliminate such complications.

• References

• 1 Gleysteen JJ. A history of intragastric balloons. Surg Obes Relat Dis 2016; 12: 430-435
• 2 Genco A, López-Nava G, Wahlen C. et al. Multi-centre European experience with intragastric balloon in overweight populations: 13 years of experience. Obes Surg 2013; 23: 515-521
• 3 Kotzampassi K, Grosomanidis V, Papakostas P. et al. 500 intragastric balloons: what happens 5 years thereafter?. Obes Surg 2012; 22: 896-903
• 4 Imaz I, Martinez-Cervell C, Garcia-Alvarez EE. et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg 2008; 18: 841-846
• 5 Kotzampassi K, Shrewsbury AD, Papakostas P. et al. Looking into the profile of those who succeed in losing weight with an intragastric balloon. J Laparoendosc Adv Surg Tech A 2014; 24: 295-301
• 6 Abu Dayyeh BK, Kumar N, Edmundowicz SA. et al. ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endos 2015; 82: 425-438
• 7 Laing P, Pham T, Taylor LJ. et al. Filling the Void: A Review of Intragastric Balloons for Obesity. Dig Dis Sci 2017; 62: 1399-1408
• 8 Mathus-Vliegen EM, Alders PR, Chuttani R. et al. Outcomes of intragastric balloon placements in a private practice setting. Endoscopy 2015; 47: 302-307
• 9 Tate CM, Geliebter A. Intragastric Balloon Treatment for Obesity: FDA Safety Updates. Adv Ther 2018; 35: 1-4
• 10 Totté E, Hendrickx L, Pauwels M. et al. Weight reduction by means of intragastric device: experience with the bioenterics intragastric balloon. Obes Surg 2001; 11: 519-523
• 11 Bataille L, Descamps C, Miroult L. Covered gastric perforation by the BioEnterics Intragastric Balloon. J Clin Gastroenterol 2001; 33: 344-345
• 12 Roche-Nagle G, Mulligan E, Connolly E. et al. Unusual cause of a perforated stomach. Ann R Coll Surg Engl 2003; 85: 396-397
• 13 Giardiello C, Cristiano S, Cerbone MR. et al. Gastric perforation in an obese patient with an intragastric balloon, following previous fundoplication. Obes Surg 2003; 13: 658-660
• 14 Al-Momen A, El-Mogy I. Intragastric balloon for obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg 2005; 15: 101-105
• 15 Genco A, Bruni T, Doldi SB. et al. BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients. Obes Surg 2005; 15: 1161-1164
• 16 Koutelidakis I, Dragoumis D, Papaziogas B. et al. Gastric perforation and death after the insertion of an intragastric balloon. Obes Surg 2009; 19: 393-396
• 17 Rodríguez-Hermosa JI, Roig-García J, Gironès-Vilà J. et al. Gastric necrosis: a possible complication of the use of the intragastric balloon in a patient previously submitted to Nissen fundoplication. Obes Surg 2009; 19: 1456-1459
• 18 Smigielski JA, Szewczyk T, Modzelewski B. et al. Gastric perforation as a complication after BioEnterics intragastric balloon bariatric treatment in obese patients--synergy of endoscopy and videosurgery. Obes Surg 2010; 20: 1597-1599
• 19 Knoetze R, van Mollendorff V, Wan YO. Gastric perforation as a complication of an intragastric balloon. Continuing Medical Education 2010; 28: 392
• 20 Ramia Angel JM, de la Plaza Llamas R, Veguillas Redondo P. et al. Stomach perforation in a patient with an intragastric balloon. Cir Esp 2010; 87: 397-399 [Article in Spanish]
• 21 Charalambous MP, Thompson J, Efthimiou E. Late gastric perforation after insertion of intragastric balloon for weight loss--video case report and literature review. Surg Obes Relat Dis 2012; 8: 121-123
• 22 Bekheit M, Abdelsalam WN, Sgromo B. et al. Is conservative management for gastric perforation secondary to intragastric balloon possible? Case report and review of literature. Obes Surg 2014; 24: 968-970
• 23 El Hage Chehade HH, El Khatib ZO, Abtar HK. What could happen if you insert a BioEnterics intragastric balloon after sleeve gastrectomy?. Surg Obes Relat Dis 2015; 11: e39-e41
• 24 Abou Hussein BM, Khammas AA, Al Ani AM. et al. Gastric perforation following intragastric balloon insertion: combined endoscopic and laparoscopic approach for management: case series and review of literature. Obes Surg 2016; 26: 1127-1132
• 25 Ríos A, Febrero B, Rodríguez JM. Gastric perforation by intragastric balloon in patient with Nissen fundoplication. Gastroenterol Hepatol 2018; 41: 251-253
• 26 Nijhof HW, Steenvoorde P, Tollenaar RA. Perforation of the esophagus caused by the insertion of an intragastric balloon for the treatment of obesity. Obes Surg 2006; 16: 667-670
• 27 Ruiz D, Vranas K, Robinson DA. et al. Esophageal perforation after gastric balloon extraction. Obes Surg 2009; 19: 257-260
• 28 Kim WY, Kirkpatrick UJ, Moody AP. et al. Large bowel impaction by the BioEnterics Intragastric Balloon (BIB) necessitating surgical intervention. Ann R Coll Surg Engl 2000; 82: 202-204
• 29 Vanden Eynden F, Urbain P. Small intestine gastric balloon impaction treated by laparoscopic surgery. Obes Surg 2001; 11: 646-648
• 30 Roman S, Napoléon B, Mion F. et al. Intragastric balloon for “non-morbid” obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg 2004; 14: 539-544
• 31 Sallet JA, Marchesini JB, Paiva DS. et al. Brazilian multicenter study of the intragastric balloon. Obes Surg 2004; 14: 991-998
• 32 Alnafisi BA. Small bowel obstruction caused by delayed intragastric balloon impaction. Radiol Case Rep 2015; 3: 176
• 33 Zdichavsky M, Beckert S, Kueper M. et al. Mechanical ileus induces surgical intervention due to gastric balloon: a case report and review of the literature. Obes Surg 2010; 20: 1743-1746
• 34 Mousavi Naeini SM, Sheikh M. Bowel obstruction due to migration of an intragastric balloon necessitating surgical removal before completion of the recommended 6 months. Case Rep Med 2012; 2012: 414095
• 35 Di Saverio S, Bianchini Massoni C, Boschi S. et al. Complete small-bowel obstruction from a migrated intra-gastric balloon: emergency laparoscopy for retrieval via enterotomy and intra-corporeal repair. Obes Surg 2014; 24: 1830-1832
• 36 Al Shammari NM, Alshammari AS, Alkandari MA. et al. Migration of an intragastric balloon: A case report. Int J Surg Case Rep 2016; 27: 10-12
• 37 Schapiro M, Benjamin S, Blackburn G. et al. Obesity and the gastric balloon: a comprehensive workshop. Tarpon Springs, Florida, March 19-21, 1987. Gastrointest Endosc 1987; 33: 323-327
• 38 Runkel N, Colombo-Benkmann M, Hüttl TP. et al. Evidence-based German guidelines for surgery for obesity. Int J Colorectal Dis 2011; 26: 397-404
• 39 Voelker R. Deaths reported after intragastric balloon surgery. JAMA 2017; 318: 996
• 40 Kotzampassi K, Eleftheriadis E. Not stretch, just fill. Surg Obes Relat Dis 2016; 12: 725
• 41 ORBERA Intragastric Balloon System. Apollo Endosurgery. Directions for Use. At: www.accessdata.fda.gov/cdrh_docs/pdf14/P140008c.pdf [Last accessed September 10th 2018]
• 42 https://apolloendo.com/orbera Last accessed September 10th 2018
• 43 English WJ, DeMaria EJ, Brethauer SA. et al. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis 2018; 14: 259-263
• 44 Brooks J. Intragastric balloon-induced ischemic perforation. Obes Surg 2016; 26: 161-162