Abstract
A 49-year-old woman presented as an acute admission with persistent vomiting and an inability to tolerate both solids and liquids. Five weeks prior to the admission she had an Elipse swallowable intragastric balloon placed into her stomach as an aid to weight loss. This type of balloon stays inflated inside the stomach for 16 weeks before disintegrating and passing through the gastrointestinal tract. Observations and blood parameters were unremarkable but abdominal radiograph indicated that the balloon had undergone spontaneous hyperinflation—a rare complication. At gastroscopy, the balloon was found to fill the entire stomach volume causing dysphagia. The balloon was punctured endoscopically, contents suctioned and remnants retrieved through the gastroscope. The patient commenced oral intake the following day and was discharged home with no further symptoms at 12-week follow-up.
Keywords: stomach and duodenum, gastrointestinal surgery, endoscopy, obesity (public health), general surgery
Background
Intragastric balloons (IGBs) were introduced in the 1980s as an endoscopic treatment for patients with obesity (body mass index (BMI) >30 kg/m2). The balloon acts as a space-occupying device which reduces available stomach volume leading to earlier satiety, decreased intake and weight loss.1 IGBs have a more favourable risk profile than bariatric surgery but the need for endoscopy can be associated with complications in this higher risk cohort. Therefore, swallowable intragastric balloons (SIGBs) were developed, such as the Elipse device, which do not require endoscopy during insertion or removal. SIGBs have a similar efficacy as the endoscopically inserted balloons with a mean weight reduction of 13 kg at 4 months.2
The patient swallows a capsule containing the uninflated Elipse balloon, which is attached to a removeable catheter. The capsule coating disintegrates on contact with stomach acid and the balloon is inflated with 550 mL of fluid via the catheter. Plain radiography confirms balloon position before the catheter is removed. After 4 months, a resorbable material in the balloon degrades opening a release valve. The fluid is expelled, and balloon remnants are excreted through the gastrointestinal (GI) tract. Patients are discharged on the day of insertion and followed up in outpatient clinics.
Initial studies showed the device to be safe, effective and free from serious complications.2 However, adverse events can occur and patients may present to local hospitals rather than the specialist bariatric units where the devices are typically inserted. Therefore, it is useful for non-bariatric clinicians to be aware of possible complications and how to manage them successfully.
We present a case of dysphagia secondary to spontaneous hyperinflation of the Elipse IGB presenting 5 weeks after successful insertion.
Case presentation
A 49-year-old woman presented to her local emergency department with a 2-week history of persistent vomiting and a progressive inability to tolerate solids and then liquids. She was not in overt pain. On examination, the abdomen was soft, non-tender with no signs of peritonism. There was no abdominal distension but there was mild fullness in the epigastric region which was tympanic on percussion. Normal bowel sounds were present.
She had a medical history of chronic cluster headaches but no other medical conditions, no history of GI disorders or previous abdominal surgery. Five weeks prior to the presentation, she had an Elipse SIGB inserted at a specialist bariatric centre located in a separate hospital. We consulted the specialists who examined the medical records and confirmed the balloon had been inserted in accordance with manufacturer’s protocol, including the correct volume of fluid, and its position confirmed by radiograph.
Initially, she was well after the balloon insertion and began to lose weight as expected. However, 3 weeks after insertion she developed intermittent vomiting and regurgitation of undigested solid foods. This progressed to an inability to tolerate liquids and excessive weight loss (table 1). The symptoms became intolerable which prompted her emergency presentation.
Table 1.
Patient measurements prior to balloon insertion, 5 weeks later at emergency presentation and at 12-week follow-up after balloon removal
| Prior to balloon insertion | Emergency presentation | 12-week follow-up | |
| Height (m) | 1.70 | 1.70 | 1.70 |
| Weight (kg) | 95.3 | 69.9 | 75.9 |
| BMI (kg/m2) | 33.0 | 24.2 | 26.3 |
| Excess body weight (kg) | 23.0 | −2.35 | 3.65 |
| Excess body weight (%) | 24.1 | −3.36 | 4.81 |
BMI, body mass index.
Investigations
On admission, observations were normal and blood tests were unremarkable with no sign of infection or metabolic abnormality.
A plain abdominal radiograph (figure 1) identified an IGB present in the stomach which appeared hyperinflated. Usually, an abdominal CT scan would be arranged to confirm the diagnosis and rule out alternative diagnoses, such as intestinal obstruction or perforation. However, the specialist bariatric centre was consulted, and it was decided that in the absence of clinical signs, progression directly to oesophago-gastro-duodenoscopy (OGD) was justified given the probability of the diagnosis. This would enable prompt treatment and relief of symptoms as well as avoidance of a dose of radiation.
Figure 1.
Plain chest and abdominal radiographs showed that the balloon was still in the stomach and appeared hyperinflated. Device pictured is a battery pack for a deep brain stimulator for chronic cluster headaches.
Differential diagnosis
The differential diagnoses needed to consider complications associated with IGBs as well as other gastro-oesophageal pathology.
Migration of IGBs to the distal oesophagus can lead to progressive dysphagia. This can be caused by incorrect balloon placement during insertion or migration after insertion due to partial deflation. However, the radiograph showed the balloon present in the stomach.
The IGB reduces available stomach volume but must leave enough space to allow adequate oral intake and gastric emptying. Balloon hyperinflation would not allow this and cause progressive dysphagia. The enlarged appearance of the balloon on radiograph indicated hyperinflation as the most likely cause of symptoms.
However, other pathology needed to be considered. Motility disorders, such as achalasia, can lead to regurgitation of food with dysphagia to solids and liquids. Oesophageal strictures also commonly present with dysphagia and could be benign or malignant in nature. Endoscopic visualisation would allow assessment of gastro-oesophageal pathology.
Treatment
Urgent gastroscopy was performed and showed the SIGB occupying the entire stomach (figure 2). The SIGB was pierced with forceps and the balloon contents suctioned. The balloon remnants were retrieved with a grasper through the gastroscope. OGD showed healthy gastric mucosa with no abnormalities in the oesophagus or duodenum (figure 3).
Figure 2.
Gastroscopy images showing the intragastric balloon present in the upper body of the stomach and taking up the stomach volume.
Figure 3.
OGD showed no abnormalities in oesophagus (A), middle body of stomach (B) or duodenum mucosa (C) after balloon removal. OGD, oesophago-gastro-duodenoscopy.
Postprocedure recovery was uneventful. The patient commenced oral intake the following day and was discharged home.
Outcome and follow-up
Due to the COVID-19 pandemic and limitations on clinical practice, this patient was followed up via telephone consultation. Four weeks after balloon removal, she had recovered well with no further abdominal discomfort or dysphagia and had gained 2 kg. At 12-week follow-up, she was asymptomatic and had gained a further 4 kg (table 1). When routine OGDs are available again, follow-up will be arranged to exclude any residual damage to the oesophagus and stomach.
Discussion
Initial data from a large prospective study showed the Elipse device to be safe, effective and free from serious complications.3 Patient selection criteria were established in this study to minimise the possibility of adverse events. Contraindications included any GI tract pathology that can interfere with insertion, deflation and excretion of the balloon including abnormal swallowing mechanisms, previous abdominal or pelvic surgery, or GI tract disease. Our patient did not have any contra-indications to Elipse insertion.
Another prospective study identified low rates of adverse events such as intolerance requiring endoscopic removal (2.9%), balloon emesis (0.6%), early deflation (0.6%), small bowel obstruction (0.17%) and spontaneous balloon hyperinflation (0.2%).4 The four patients that developed hyperinflation presented with mild-moderate intolerance symptoms and underwent with endoscopic balloon removal without complications. In contrast, our patient developed more severe symptoms of progressive dysphagia.
Spontaneous balloon hyperinflation is a rare but known occurrence in fluid-filled IGBs. It may be caused by the introduction of pathogens, fungal or bacterial, during insertion. Growth of these organisms can lead to gas production resulting in an increased balloon volume and the development of obstructive symptoms.5
Management of published cases of spontaneous hyperinflation is summarised in table 2. In most cases, endoscopic balloon puncture and removal has been used.6–9 However, in cases involving adjustable IGBs there are reports of clinicians performing endoscopic evacuation of balloon fluid and re-filling with the addition of an antimicrobial.5 10 11 Their approach was to control the local infection enabling the balloon to remain until the designated time for removal. Hyperinflation recurred in one of these cases.11 Currently there are no randomised studies to confirm the effectiveness of antimicrobial prophylaxis or treatment for fungal or bacterial contamination.
Table 2.
Management of published cases of spontaneous hyperinflation in intragastric balloons
| Author of case report | Type of balloon | Management |
| Barola et al6 | Non-adjustable (Orbera) | Endoscopic balloon puncture and removal |
| de Quadros et al7 | Non-adjustable (Orbera) | Endoscopic balloon puncture and removal |
| Basile et al8 | Non-adjustable (Orbera) | Endoscopic balloon puncture and removal |
| Quarta and Popov9 | Non-adjustable (not specified) | Endoscopic balloon puncture and removal |
| Marques et al10 | Adjustable (not specified) | Balloon fluid removed, refilled with addition of nystatin |
| de Souza et al5 | Adjustable (not specified) | Balloon fluid removed, refilled with addition of nystatin |
| Usuy et al11 | Adjustable (Spatz3) Adjustable (Spatz3) |
Balloon fluid removed, refilled with addition of amoxicillin Balloon fluid removed, refilled with addition of ceftriaxone |
In a case of balloon migration to the small bowel causing obstruction, where the balloon cannot easily be reached by endoscopy, ultrasound-guided percutaneous fine needle aspiration was used to deflate the balloon and then allow the remnants to pass naturally in the stool within a few days.12 Although this technique has been described in the literature, it is controversial as carries a risk of haematoma and intestinal leak. In addition, there are no reports of this technique being used for balloons that require removal from the stomach. However, it could be considered as an option if the patient was deemed too high-risk to undergo endoscopic removal.
The Elipse balloon is non-adjustable so content evacuation and antimicrobial treatment was not an option. Endoscopic removal was used in our case as the patient was happy to undergo endoscopy, and retrieval meant that there was no chance of complications associated with balloon transit through the bowel. The balloon remnants and fluid contents were not sent for culture on this occasion as they were completely removed, and no drug treatment was required. However, in cases where the balloons were refilled with antimicrobial solution, culture of balloon fluid was used confirm microbial sensitivity and inform management.
Serious complications with IGBs are rare but need to be managed quickly and effectively to prevent further clinical deterioration. Spontaneous balloon hyperinflation should be considered as a potential cause of dysphagia in patients that have recently undergone IGB insertion. This case shows it can be treated successfully with endoscopy. As intragastric balloon treatment becomes more widespread, further studies on spontaneous hyperinflation would be beneficial to inform prevention and treatment strategies in this area.
Learning points.
Swallowable intragastric balloon (IGB) treatment is a therapeutic option for patients with obesity to avoid endoscopy and surgery.
Spontaneous hyperinflation of an IGB is a rare complication but should be considered in patients presenting with increasing dysphagia in the weeks after insertion.
Patients can present to non-bariatric clinicians who need to be aware of possible IGB complications and how to manage them successfully.
In this case, plain radiograph gave the likely diagnosis without the radiation risks posed by CT. However, CT imaging is useful to exclude non-balloon related pathology such as bowel obstruction and perforation.
Footnotes
Contributors: RF identified and managed the case and revised the case report. He is the guarantor. EAG drafted and revised the case report.
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.
Competing interests: None declared.
Provenance and peer review: Not commissioned; externally peer reviewed.
Ethics statements
Patient consent for publication
Obtained.
References
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