Obesity Surgery (2018) 28:1419–1421
https://doi.org/10.1007/s11695-018-3148-5
LETTER TO THE EDITOR
Elipse Balloon: the Pitfalls of Excessive Simplicity
Luigi Angrisani 1 & Antonella Santonicola 2 & Antonio Vitiello 3 & Maria Paola Belfiore 4 & Giuseppe Belfiore 5 &
Paola Iovino 2
Published online: 26 February 2018
# Springer Science+Business Media, LLC, part of Springer Nature 2018
To the Editor,
We read with great interest the manuscript by Genco et al.
[1] describing their initial experience with 38 patients who
successfully completed the therapy with Elipse intragastric
balloon (IGB) (Allurion Technologies, Wellesley, MA,
USA). After the scheduled 16 weeks of therapy, 37 balloons
were spontaneously evacuated, and one balloon was endo-
scopically removed, without any complication. The authors
concluded that Elipse balloon is a safe device that can be
swallowed and excreted without serious adverse events,
avoiding an upper gastrointestinal (UGI) endoscopy.
Despite these interesting and encouraging results, we
report different experience with this device. A 55-year-
old man with a BMI of 33.3 kg/m2 (weight 102 kg) and
hepatic steatosis underwent insertion of Elipse balloon
under our care in October 2016. After 6 weeks, the patient
was readmitted to the hospital complaining with severe
abdominal pain, nausea, vomiting, and no bowel move-
ment since 24 h. Weight loss was about 10 kg (body
* Paola Iovino
piovino@unisa.it
1
General and Endoscopic Surgery Unit, S. Giovanni Bosco Hospital,
Department of Public Health, BFederico II^ University of Naples,
Naples, Italy
2
Gastrointestinal Unit, Department of Medicine and Surgery,
University of Salerno, Via S Allende, 84081 Baronissi, Salerno, Italy
3
Department of Medicine and Surgery, Federico II University,
Naples, Italy
4
Department of Experimental Medicine, University of Campania
BLuigi Vanvitelli^, Naples, Italy
5
Department of Radiology, BS. Anna-S. Sebastiano^ Hospital,
Caserta, Italy
weight = 92 kg; BMI = 30.06 kg/m2). Abdominal ultra-
sound was unremarkable, but x-ray examination showed
gastric dilation, air-fluid levels in the small bowel, and a
radiopaque imagine that raised the suspicion of Elipse
balloon valve in the left side of the abdomen (Fig. 1a,
b). A nasogastric tube was positioned, and intravenous
fluids and antibiotic therapy were administered.
Computed tomography (CT) confirmed small bowel ob-
struction due to the presence of a partially desufflated
balloon in the jejunal tract. The day after, another CT
demonstrated the progression of the balloon, closer to
the anterior abdominal wall allowing a guided aspiration
of 85 cm3 from the device. A small amount of liquid was
left in the lumen of device in order to allow further radio-
logical studies (Fig. 2a, b). Due to persistence of symp-
toms and deterioration of clinical conditions, a laparo-
scopic exploration was performed but the Elipse device
was not found during the small bowel inspection from
Treitz ligament to ileocecal valve. A Foley catheter was
positioned in the rectum and contrast medium was admin-
istered revealing the presence of balloon in the descend-
ing colon. So the desufflated balloon was removed by
colonoscopy. There were no perioperative complications
and the patient was discharged on the second post-
operative day. Unfortunately few months later, the patient
regained weight.
Recently, a similar episode of small bowel obstruction
due to Elipse balloon migration has been reported in a
woman with previous multiple cesarean sections. A surgi-
cal intervention was required. The authors hypothesized
that the incomplete balloon filling or the premature cath-
eter disconnection during balloon placement could have
promoted the balloon migration [2]. Previously, Machytk
et al. reported the mechanism underlying balloon
desufflation. According to their explanation, the
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Fig. 1 Abdominal X-ray. a Air-fluid levels of the small bowel. b
Radiopaque imagine suspected for balloon valve (indicated by the arrow)
absorbable material inside the balloon gradually degrades
until the release valve opens and allows the balloon to
empty spontaneously [3]. Endoluminal techniques cur-
rently represent a minority of bariatric procedures. In the
IFSO worldwide survey 2014 [4], we reported 14,725
endoluminal procedures, accounting for 2.4% of all
bariatric-metabolic interventions. More robust results are
available for Orbera intragastric balloon. For this type of
balloon, the reported migration rate is 1.4% and the prev-
alence of small bowel obstruction is 0.3% [5].
Unfortunately, the literature data of Elipse IGB treatment
are still scanty and, although all IGB procedures, especial-
ly without endoscopy, are easy to perform and appealing
for management of different obesity classes, caution is
recommended. Our patient, specifically, had no contrain-
dications to balloon placement (i.e., previous abdominal
surgery); however, the migration occurred but it was
quickly recognized and properly treated. Future advances
in device properties and procedural techniques are wel-
co m e i n o r d er to im pr o ve t h e sa f et y an d co s t -
OBES SURG (2018) 28:1419–1421
Fig. 2 Computed tomography (CT) of the abdomen. a Presence of the
partially desufflated balloon in a jejunal loop. b CT-guided aspiration of
fluid from the balloon
effectiveness of these devices, and a multidisciplinary ap-
proach is mandatory for patient’s selection and prompt
detection of complications that should be managed in an
appropriate setting only by an expert bariatric team.
Compliance with Ethical Standards
Conflict of Interest The authors declare that they have no conflict of
interest.
Ethical Approval Statement For this type of study, formal consent is not
required.
Informed Consent Statement Informed consent was obtained from the
patient.
References
1. Genco A, Ernesti I, Ienca R, et al. Safety and efficacy of a new
swallowable intragastric balloon not needing endoscopy: early
Italian experience. Obes Surg. 2017;28:405–9. https://doi.org/10.
1007/s11695-017-2877-1.
2. Al-Subaie S, Al-Barjas H, Al-Sabah S, et al. Laparoscopic manage-
ment of a small bowel obstruction secondary to Elipse intragastric
OBES SURG (2018) 28:1419–1421
balloon migration: a case report. Int J Surg Case Rep. 2017;41:287–
91. https://doi.org/10.1016/j.ijscr.2017.10.050.4.
3. Machytka E, Chuttani R, Bojkova M, et al. Elipse™, a procedureless
gastric balloon for weight loss: a proof-of-concept pilot study. Obes
Surg. 2016;26(3):512–6. https://doi.org/10.1007/s11695-015-1783-
7.
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4. Angrisani L, Santonicola A, Iovino P, et al. Bariatric surgery and
endoluminal procedures: IFSO worldwide survey 2014. Obes Surg.
2017;27(9):2279–89. https://doi.org/10.1007/s11695-017-2666-x.
5. Kim SH, Chun HJ, Choi HS, et al. Current status of intragastric
balloon for obesity treatment. World J Gastroenterol. 2016
Jun 28;22(24):5495–504. https://doi.org/10.3748/wjg.v22.i24.5495.