Article Text

Download PDFPDF

Complications resulting from an intragastric balloon in a patient without follow-up and monitoring
  1. Rodolfo Romero1,
  2. Lore Biliauws2,
  3. Joel Roussel1 and
  4. Jean-Marc Catheline1
  1. 1Department of Digestive Surgery, Centre Hospitalier de Saint Denis, Saint Denis, France
  2. 2Gastroenterology MICI Nutrition Assistance, APHP, Clichy, France
  1. Correspondence to Professor Jean-Marc Catheline; jmcatheline{at}orange.fr

Abstract

The intragastric balloon (IGB) is recognised as a minimally invasive intervention for the treatment of obesity. Here, we detail a rare and life-threatening complication stemming from this procedure. A female patient in her 40s, who had an IGB in situ for 14 months, presented at the emergency department with septic shock characterised by abdominal guarding and emesis. These symptoms were a direct result of IGB-induced bowel obstruction. We emphasise that the patient missed the recommended 6-month removal window, which in our opinion is the decisive cause leading to deflated balloon migration and subsequent complications. In the course of managing multiple critical events, the patient required multiple operations related to the bowel obstruction, numerous nutritional and psychological challenges. Currently, the patient is living with short bowel syndrome, secondary to the chronic intestinal failure, necessitating the administration of parenteral nutrition 6 days per week.

  • Nutrition
  • Endoscopy
  • Obesity (nutrition)
  • Parenteral / enteral feeding
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Background

The intragastric balloon (IGB) is recognised as a minimally invasive intervention for the management of morbid obesity, first used in Europe in 1991.1 It is deemed an effective treatment across various obesity levels, although typically resulting in temporary and limited weight reduction.1 IGBs function as restrictive devices within the gastric space, slowing gastric emptying and inducing weight loss through hormonal and neuronal modifications. This endoscopically introduced system is designed for short-term use, requiring removal within 6 months postplacement, with the possibility of replacement with another balloon at the end of this period. On average, IGBs facilitate a body mass index (BMI) reduction of 2.13 kg/m2, surpassing the efficacy of lifestyle interventions in the overweight and obese adult population.1 2 Nonetheless, IGBs are not devoid of risk, with a considerable incidence of adverse events reported. Approximately 91% of patients experience gastrointestinal symptoms after implementation.2 3 Compared with laparoscopic bariatric surgery, balloon therapy is associated with a higher rate of adverse events and a mortality rate that has been reported to reach 0.05% in some studies.4 5 Critical abdominal complications (table 1) include life-threatening conditions such as visceral perforation and bowel obstruction leading to peritonitis, all of which may necessitate emergent surgical intervention. A 2019 review highlighted 26 documented cases of bowel obstruction as a complication of IGB.6 Here, we present an additional case report detailing bowel obstruction accompanied by several adverse events.

Table 1

Complication secondary to the procedure

Case presentation

A female patient in her 40s, with a medical history including an ectopic pregnancy, abdominoplasty and bilateral breast reduction, was admitted to the emergency department exhibiting symptoms of septic shock, manifesting as abdominal guarding and vomiting. Previously, a Spatz-ABS (Spatz, Fort Lauderdale, Florida, USA) IGB, inflated with a coloured saline solution, had been placed by a gastroenterologist at a separate facility in 2014, with an initial BMI of 36 kg/m2 and a weight of 89 kg and height of 1.58 m. Over a year later (441 days), she presented with systemic symptoms of fever, chills, diffuse abdominal pain, uncontrollable vomiting and diarrhoea. A CT scan demonstrated a foreign body within the terminal ileum (figure 1). The clinical presentation and imaging results enabled us to diagnose small bowel obstruction and recommend surgery. Crucially, the IGB was not removed within the recommended 6-month window, which is in our opinion the primary cause of subsequent complications. It is imperative to acknowledge that relying solely on the patient’s own account, in this context, introduced a limitation to the available information. Her weight decreased to 74 kg. An exploratory laparotomy was conducted, during which the IGB was extracted, and the ileal loop with perforation was resected (figure 2), followed by the formation of an ileostomy in the right iliac fossa. A drop in blood pressure and oliguria were observed during the procedure, necessitating the use of catecholamines, which subsequently led to an ischaemic appearance of the small intestine. In the subsequent days, the patient required multiple bowel resections and extensive antibiotic therapy to manage several episodes of septic shock, resulting in multisystem organ failures. Surgical interventions included the creation of a proximal jejunostomy 70 cm distal to the Treitz ligament, involving an intermediate bowel segment of approximately 60 cm and 25 cm of terminal ileum (total length of small intestine remaining: 155 cm). All these complications are related to ischaemic bowel obstruction caused by a foreign body, which is this deflated balloon obstructing the small intestine.

Figure 1

Coronal and axial CT images show diffuse small bowel distension with intraperitoneal fluid effusion and extraluminal gas collection, secondary to an intraluminal foreign body at the penultimate ileal loop.

Figure 2

Per operative view of intragastric balloon (IGB), the ileal resection and IGB view.

Outcome and follow-up

Approximately a decade following the initial treatment, the patient endured a complex series of medical challenges. Her case has necessitated ten abdominal operations as well as the management of over 20 episodes of sepsis, which were treated with multiple courses of antibiotics. She has suffered from numerous life-threatening septic shocks, culminating in a diagnosis of short bowel syndrome accompanied by chronic intestinal failure and severe gastroparesis. Subsequently, the patient experienced a significant weight reduction of 22 kg from her baseline weight. Additionally, her medical journey included an extended hospitalisation totalling 3 years across various departments: intensive care, surgery, nutrition and rehabilitation. During this period, she encountered several other complications, such as pulmonary embolism, nutritional deficits, psychological distress and dermatological issues. To date, the patient continues to experience unresolved complete intolerance, and because of frequent vomiting, a gastrostomy is being considered. She is currently on complete parenteral nutrition and see timeline of clinical care (figure 3).

Figure 3

Timeline of first 2 years of inpatient care (A) and the following 9 years (B). Figure 3 is done by Regis Cohen. *Results from bacterial cultures. AS, abdominal surgeries; ER, emergency room; FS, foot surgeries; G-POEM, gastric peroral endoscopic myotomy; GS, gastric stimulator; ICU, intensive care unit; IGB, intragastric balloon; m, months; PE, pulmonary embolism; SD, surgery department; ×3, three times.

Discussion

In this case report, we detail the exceptional array of serious adverse effects following an IGB insertion which was not removed within the recommended time frame. Although fatalities have been documented secondary to IGB placement, our focus was on averting life-threatening visceral complications.

IGB therapy has been established as a safe and well-tolerated, minimally invasive option for obesity management. It bridges the treatment gap between various conventional measures and bariatric surgery. Serious adverse events from IGB, such as gastric perforation, balloon migration and mortality, remain uncommon. Pooled data on Orbera (Apollo Endosurgery, Austin, Texas, USA) IGB risks have identified gastric perforation rates at approximately 0.1%, balloon migration at 1.4%, small bowel obstruction at 0.3% and mortality at 0.08%.7 Consequently, IGB insertion requires a multidisciplinary approach and adherence to contraindications including a history of bariatric or gastric surgery, the presence of a large hiatus hernia, inflammatory diseases of the gastrointestinal tract, increased risk for upper gastrointestinal bleeding, pregnancy and certain psychiatric illnesses or substance abuse.8

Bowel obstruction is a specific complication that can be mitigated by adhering to the recommended 6-month lifespan of the intragastric device. One precautionary measure includes dyeing the saline within the balloons blue, serving as an indicator of rupture by causing the urine to change colour, thus alerting the patient to potential balloon rupture and ensuing possibility of small bowel obstruction. In our case, the patient did not observe any blue or green discolouration in her urine and did not recall being informed that a change in urine colour could occur if the balloon was perforated. The literature prior to 2019 reports approximately 30 cases of bowel obstruction attributable to IGB deflation or partial deflation.6 9 Most incidents were due to patient non-compliance with timely balloon removal, with obstructions occurring from 1 to 48 months postinsertion, ranging from the duodenum to the sigmoid colon.6 Our case report emphasises the importance and responsibility of the practitioner to follow up and remove the IGB at the 6-month interval, and if necessary, replace it with a new balloon. Fewer cases were linked to valve dysfunction or balloons not found during the 6-month endoscopic removal. Bowel obstruction related to the Spatz-ABS model, as in our case, represented a significant portion of these instances, although other models exhibited similar adverse effects. The Spatz-ABS IGB is less commonly used by many medical professionals due to the reported incidents. Most cases of bowel obstruction necessitated laparoscopic or open surgical intervention, with a minority managed through percutaneous deflation or conservative treatment.10 11 Notably, balloon deflation alone did not always lead to obstruction; it was reported that 49 of 176 balloons (27.8%) were unexpectedly expelled spontaneously, with vomiting precipitating the event in four patients and natural expulsion in the stools for 45 in the initial IGB models.12

Diagnosis of these complications (table 1) commonly occurs in an emergency context, with CT imaging providing valuable assistance. In our case, the patient’s symptom duration was 4 days. This sequence of severe complications underscores the necessity for thorough multidisciplinary consultation and robust patient education and engagement in the therapeutic plan.

Learning points

  • The intragastric balloon (IGB) is no longer considered a viable therapeutic option for patients with obesity, as it has fallen out of favour due to weight regain after removal. In today’s medical landscape, true bariatric surgeries and GLP-1 agents offer more effective and sustainable weight management strategies.

  • A multidisciplinary approach is imperative for the decision-making process regarding IGB placement, ensuring comprehensive evaluation and risk assessment.

  • Both patients and healthcare providers must be well informed about the potential for severe complications associated with IGB therapy and the critical need for stringent postprocedure monitoring.

  • Prompt CT imaging is essential in the evaluation of patients presenting with abdominal pain or symptoms suggestive of obstruction and should be readily available in emergency settings for timely diagnosis and management.

  • It is essential for practitioners to follow up and remove the IGB at the 6-month interval and, if necessary, replace it with a new balloon.

Ethics statements

Patient consent for publication

References

Footnotes

  • Contributors The following authors were responsible for drafting of the text, sourcing and editing of clinical images, investigation results, drawing original diagrams and algorithms, and critical revision for important intellectual content: J-MC, RR and LB identified and managed the case and revised the case report. J-MC is the guarantor. JR drafted and revised the case report. The following authors gave final approval of the manuscript: RR, LB, JR and J-MC.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Case reports provide a valuable learning resource for the scientific community and can indicate areas of interest for future research. They should not be used in isolation to guide treatment choices or public health policy.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.