REVIEW ARTICLE 1421

Endoscopic Bariatric Therapy: A Guide to the

REVIEW ARTICLE
Intragastric Balloon
Fateh Bazerbachi, MD1, Eric J. Vargas, MD1 and Barham K. Abu Dayyeh, MD, MPH, FASGE1
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Intragastric balloons (IGBs) are the most widely available endoscopic bariatric therapy for class I and II obesity in the
United States. Although simple in application and reversible by nature, these devices may help patients initiate the
important first steps in weight loss maintenance, provided that parallel efforts are in motion to prevent weight recidivism.
Too often, therapeutic nihilism stems from unrealistic expectations of a given therapy. In the case of IGBs, this sentiment
may occur when these interventions are applied in a vacuum and not within the purview of a multidisciplinary program
that actively involves dieticians, endocrinologists, gastroenterologists, and surgeons. There is a clear and present need to
apply different tactics in the remissive strategy to control the obesity pandemic, more so in a struggling landscape of an
ever-widening gap in bridging interventions. With such demand, the IGB is an available tool that could be helpful when
correctly implemented. In this exposition, we summarize the current state of IGBs available worldwide, discuss their
mechanism of action, relay evidence for their short- and long-term efficacy, address safety profile concerns, and suggest
procedural considerations in the real-world quotidian application.
Am J Gastroenterol 2019;114:1421–1431. https://doi.org/10.14309/ajg.0000000000000239

BACKGROUND introduced as an attempt to bridge this gap in obesity, facilitating

It is now accepted that obesity as a chronic disease has reached
pandemic heights, with close to 40% of US adults afflicted and
more than a fifth of healthcare expenses consumed by related
comorbidities (1). Mild to moderate weight loss of 5%–10% of
initial body weight improves the substantial proportion of these
comorbidities, but restoring normal body weight in adults with
obesity with lifestyle interventions alone remains a challenge
(2,3). In general, bariatric surgery continues to be the most ef-
fective means to achieve durable weight loss and comorbidity
resolution and improve mortality and quality of life (4); however,
despite the plethora of benefits obtained from surgery, the over-
whelming majority of eligible patients do not receive it due to fear
of complications, limited access, and costs associated with these
interventions. Indeed, it is estimated that only 216,000 patients
received a bariatric intervention in 2016 (5), a striking disparity
when viewed juxtaposed with more than 15 million patients with
class III obesity in the United States (6). Similarly, patients with
class I and II obesity who do not qualify for bariatric surgery are
left with largely ineffective means to achieve the weight loss
thresholds for comorbidity improvement. Importantly, these
patients contribute significantly more to the comorbid disease
burden and mortality than those with class III obesity alone,
creating a gap in obesity management (1). Currently, both gov-
ernment agencies (the Agency for Healthcare Research and
Quality) and national societies, such as the American Gastroen-
terological Association, the American Society for Gastrointestinal
Endoscopy, and the American Society for Metabolic and Bariatric
Surgery, have recognized this management gap calling for im-
proved treatment options (8–10). As a result, less-invasive weight
loss therapies, such as intragastric balloons (IGBs), were
access and application to the larger segment of the population
with class I and II obesity and to those who benefit from pre-
operative weight loss before traditional bariatric surgery or organ
transplantation. In this exposition, we discuss the available IGBs,
outlining their mechanisms of action, efficacy, safety, and their
clinical applications.
INTRAGASTRIC BALLOONS: MECHANISMS OF ACTION
AND DESIGNS
It was observed that large ingested bezoars could lodge in the
stomach for prolonged periods of time without being associated
with any symptom other than insidious weight loss (11). This
clinical observation has led to the early application of IGB for
weight loss in the 1980s (12). Currently, there are 8 IGBs in the
world market, with 3 of them currently approved by the United
States Food and Drug Administration (FDA): (i) the Orbera
intragastric balloon (OIB) (Apollo Endosurgery, Austin, TX),
previously known as the BioEnterics Intragastric Balloon
(Allergan, Irvine, CA); (ii) the ReShape Duo (Duo) (ReShape
Medical, San Clemente, CA); and (iii) the Obalon IGB (Obalon
Therapeutics, Carlsbad, CA). Characteristics of available IGBs in
the world market are summarized in Table 1.
Gastric emptying and accommodation
The effect of IGBs on gastric emptying is one of the many pro-
cesses by which they modulate hunger and satiation (7,13).
Adapted from the gastric restriction component of multiple
bariatric procedures to date, IGBs were designed to elicit a gastric
restriction process through their space-occupying design and
produce perturbations in physiologic parameters, such as gastric

1
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA. Correspondence: Barham K. Abu Dayyeh, MD, MPH, FASGE.
E-mail: AbuDayyeh.Barham@mayo.edu.
Received October 12, 2018; accepted March 7, 2019; published online May 9, 2019

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 REVIEW ARTICLE

1422
Copyright © 2019 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited.
The American Journal of GASTROENTEROLOGY

Bazerbachi et al.
Table 1. Summary of all available IGBs in the world market

Conformité
Européenne FDA No. of
IGB type Image Material, shape, design Filling volume Dwelling time (CE) mark approval No. of users implantations Market share
Orbera (Apollo Endosurgery) Silicone; spherical; 450–700 mL 6 mo Yes Yes 1,200–1,700 277,000 since 90% of current
Orbera 360 (Apollo single, unadjustable of saline 1996 market share
Endosurgery) 12 mo Yes No

Spatz Adjustable Silicone; spherical; 400–850 mL of 12 mo Yes No 300 12,000/yr

Balloon System single, adjustable saline
(Spatz Medical)

ReShape Duo Balloon Silicone; spherical; 450 mL of saline in 6 mo Yes Yes 200 .4,000 since
(ReShape Medical) double, unadjustable each balloon (900 the FDA
mL) approval in
2015

Obalon Gastric Balloon Up to 3 balloons are 250 mL of nitrogen 6 mo from the Yes Yes
VOLUME 114 | SEPTEMBER 2019 www.amjgastro.com

(Obalon Therapeutics) swallowed over 12 wk gas in each balloon 1st balloon

Elipse balloon (Allurion No endoscopy requirement 450–550 mL of 4 mo Yes No 60 4,200 since CE

Technology) Swallowed and self-empties liquid mark
in 2015
 © 2019 by The American College of Gastroenterology

Table 1. (continued)
Copyright © 2019 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited.

Conformité
Européenne FDA No. of
IGB type Image Material, shape, design Filling volume Dwelling time (CE) mark approval No. of users implantations Market share
Heliosphere BAG Polyurethane and silicone; 550 mL of air 6 mo Yes No 10% of current
(Helioscopie, France) spherical market share

Silimed Balloon Silicone; spherical 600 mL of saline 6 mo No No

(Silimed, Brazil)

Medsil (Medsil, Silicone; spherical 400–700 mL of 6 mo No No

Russia) saline

Endalis End-Ball (Endalis Polyurethane; spherical 700 mL of liquid 6 mo Yes No

Laboratory, France) and air
The American Journal of GASTROENTEROLOGY

Easy Life Gastric Balloon Adjustable system 400–800 mL of Up to 12 mo Currently not

Endoscopic Bariatric Therapy

(Life Partners, France) liquid and air available

FDA, Food and Drug Administration; IGB, intragastric balloon.

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 1424 Bazerbachi et al.
emptying, accommodation, and gastrointestinal neurohormonal
release that alter satiety and satiation, all synergistically leading to
weight loss. These findings have mostly been elucidated from
studies using the single, fluid-filled IGB, the OIB (Apollo Endo-
REVIEW ARTICLE
surgery). The first mechanistic study was a prospective, ran-
domized clinical trial that demonstrated that the OIB produced
significant delays in gastric emptying compared with lifestyle
interventions alone. The study also revealed an association be-
tween delays in gastric emptying and positive weight loss out-
comes (7). A similar effect of the OIB on gastric emptying was also
demonstrated in 2 additional smaller studies (13,14). These
effects are yet to be demonstrated when applying the dual, fluid-
filled balloons (Duo) or the more recent gas-filled balloons. Thus,
based on the available literature, it is not clear whether IGBs with
different contents (fluid vs gas) or shape (single vs double bal-
loon) share similar or different mechanisms of action. However,
a recent meta-analysis of 44 studies and 5,549 patients examined
the relation between balloon-filling volume and % total body
weight loss (%TBWL) achieved, and found no significant corre-
lation on meta-regression (15). Moreover, another recent meta-
analysis suggests that gas-filled balloons do not significantly delay
gastric emptying, as opposed to fluid-filled balloons (16).
Despite the lack of association between balloon-filling volume and
%TBWL, our group has recently shown that increasing the balloon-
filling volume, in a study examining the adjustable Spatz3 balloon,
was associated with a further delay in gastric emptying and a further
decrease in post-adjustment patient weight (17). One hypothesis is
that the change in filling volume after homeostasis is established,
rather than a fixed, unchanging filling volume, is the impetus behind
overcoming the gastric-emptying steady state. This may suggest that
a dual, fluid-filled balloon may not have the same augmented delay in
gastric emptying, at least from a dual filling volume perspective, be-
cause the volume is predetermined at balloon insertion.
Other aspects of gastric physiology, such as gastric accom-
modation, may also be altered when IGBs are placed. Samsom
et al. (18) have demonstrated that the placement of an IGB
modifies the distribution of food, leading to distention of the
antrum and potentially invoking exaggerated fundic relaxation.
The placement of an IGB in the proximal stomach may instigate
this reflex and interrupt certain neurohormonal pathways, which
may account for the mechanism of action of certain IGBs cur-
rently unavailable in the United States (19,20).
Neurohormones: ghrelin
Following diet-induced weight loss, ghrelin levels typically rise in
response to a state of negative energy balance, whereas in sleeve
gastrectomy, ghrelin levels fall due to the surgical removal of
ghrelin-producing cells (21,22). Changes in gut neurohormones
such as ghrelin that are implicated in satiety and metabolic
control after IGBs have been conflicting. In a prospective, sham-
controlled study by Mathus-Vliegen and Eichenberger (23), no
increase in ghrelin concentrations was observed with the OIB
after 13 and 26 weeks of implantation, despite significant weight
loss. A study by Mion et al. (14) also demonstrated that plasma
ghrelin levels remained lower with the OIB, with a positive cor-
relation with weight reduction (r 5 0.668). At least one other
study, however, showed a transient increase in plasma ghrelin
levels during OIB treatment which has historically been expected
with negative energy balance (24,25). Differences in ghrelin assays
(active ghrelin vs total ghrelin) and the timing of acquisition could
potentially explain the differences across these studies. However,
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stimulation of mechanoreceptors in the body and fundus could
be responsible for the lower ghrelin levels after IGB-induced
weight loss. More investigations with IGBs are needed to con-
firm this vagal hypothesis.
EFFICACY OF IGBS
Short-term efficacy (up to 12 months)
IGBs are effective in producing anywhere from 6% to 15% TBWL
compared with the 1%–5% produced through lifestyle inter-
ventions alone. In the United States, there have been 3 pivotal trials
with the FDA-approved IGBs. The REDUCE multicenter, blinded,
sham-controlled clinical trial compared 187 patients with the Re-
Shape Duo IGB with 139 patients receiving lifestyle interventions
alone. The %TBWL at 6 months among completers in the ReShape
Duo group (n 5 167) was 7.6% 6 5.5% compared with 3.6% 6
6.3% in the control group (n 5 126) (26). The OIB underwent
a similar trial, where 125 patients obtained the balloon and 130
patients received lifestyle interventions alone. The %TBWL among
completers at 6 months in the OIB group (n 5 116) was 10.7% 6
6.8% compared with 4.7% 6 5% in the control group (n 5 99) (27).
Finally, in a pivotal, multicenter, randomized, sham-
controlled clinical trial, investigators compared 198 patients re-
ceiving up to 3 consecutive balloon capsules (the Obalon IGB)
plus lifestyle interventions with 189 patients receiving sham
capsules in addition to lifestyle interventions. The %TBWL after
swallowing 3 consecutive balloon capsules (n 5 174) was 7.1% 6
5.0% at 6 months from the first swallowed capsule compared with
3.6% 6 5.1% in the control group (n 5 176) (Figure 1) (28,29). A
recent meta-analysis of 20 randomized controlled trials (RCTs)
(N 5 1,195 patients), including only 1 of the 3 pivotal US RCTs
described previously (26), demonstrated the short-term efficacy
of IGBs as a group with higher effect size favoring fluid-filled vs
gas-filled IGBs (30). This observation was maintained in a net-
work meta-analysis restricted to RCTs comparing IGBs available
in the world market (31). Overall, the OIB has been the most
extensively used and investigated IGB in the world, with usage
dating back for more than a decade, and with a meta-analysis of
55 studies including 6,645 OIB implantations demonstrating
a pooled estimate of %TBWL at 6 months of 13.2% (95% confi-
dence interval [CI], 12.4–13.95) (32).
However, weight loss after IGB insertion usually plateaus after
the first few months (33). This phenomenon may be related to
increased stomach-accommodating volume, allowing larger
intake of food, decreases in resting energy expenditure, hormonal
Figure 1. Weight loss associated with intragastric balloons in the US pivotal,
RCTs. RCT, randomized clinical trial; TBWL, total body weight loss.
VOLUME 114 | SEPTEMBER 2019 www.amjgastro.com
 Endoscopic Bariatric Therapy 1425

adaptions, or behavioral intervention fatigue. This plateau ob- One of the strategies to combat this weight recidivism is se-
servation has been key in the conceptualization and innovation of quential therapy with another balloon. This strategy has been
adjustable IGBs (Spatz3 Adjustable Balloon; Spatz FGIA), which highlighted in the study by Dumenceau et al., where further
is currently being studied in an FDA-approved trial where the weight loss was achieved with a second balloon insertion se-

IGB volume can be increased to ameliorate weight loss when
a plateau occurs. Recent literature suggests that this volume-
altering has important clinical and physiologic significance to
augment weight loss and break through plateaus (17,33).
Whether changes in the accommodation are responsible for this
observed plateau remain to be investigated.
Weight recidivism after therapy
Although IGBs are safe and effective in managing obesity for
a short term, they are temporary measures, and weight regain is
an expected result after their removal. This aftermath can be
observed from a number of studies that evaluated patient course
after balloon removal for variable periods. In a study of 500 obese
patients who underwent 6 months of treatment with IGB, only
half of the patients maintained .20% excess weight loss at 1 year
after IGB removal and a quarter of patients kept this weight loss at
5 years (34). In a Brazilian study of 224 patients, weight regain
after IGB removal was observed in 66% of patients (35), and the
authors found that the lack of psychological counseling and nu-
trition support, in addition to a sedentary lifestyle, contributed to
the long-term weight regain after IGB removal. Similarly, a Leb-
anese group suggested that up to 79% of patients will regain
weight in the long term and more than a third will resort to other
bariatric interventions after IGB treatment is concluded (36).
However, patients remain at a lower weight than their pre-
implantation levels (37–42).
REVIEW ARTICLE
quentially after the first balloon was removed (37). Other strat-
egies to mitigate weight regain may also include the addition of
adjuvant pharmacotherapy after IGB removal, and this has been
suggested for other bariatric interventions as well (43). Ulti-
mately, it is unreasonable to expect that a reversible and tempo-
rary intervention, be it lifestyle interventions, endoscopic devices,
or antiobesity medications will result in a sustained weight loss
benefit if not supplanted by continuous management from
a multidisciplinary team, including nutritionists, primary care
providers, behavioral therapists, and gastroenterologists. Obesity
is best viewed as a treatable but not a curable condition, akin to
approaching other chronic health conditions such as diabetes or
hypertension. Phenotype-driven individualized personalization
of treatment will likely become the norm in the future so that
weight loss responses are easily achieved and readily maintained.
SAFETY OF IGBS
Despite the recent reports, IGBs remain one of the safest tem-
porary endoscopic bariatric treatments available. A recent sys-
tematic review (31) of 15 RCTs including 886 IGB implantations
showed 0% mortality and low rates of severe serious adverse
events (SAEs) (24,26–28,40,44–54) (Table 2). The rates of non-
SAEs associated with IGBs in RCTs are also summarized in
Table 3, with most being accommodative symptoms, such as ab-
dominal pain and nausea, which are usually self-limited and
expected (55). Early removal rates are the major predictor of

Table 2. Rates of SAEs associated with intragastric balloons in randomized clinical trials that included at least 30 patients in each arm

% Pulmonary
% % % % % Obstruction % Pancreatitis complications %
Author and year N Balloon SAE Perforation Bleeding Migration events events (aspiration) Mortality
Genco et al., 50 Orbera 0 0 0 0 0 0 0 0
2010 (48)
Giardiello et al., 30 Orbera 0 0 0 0 0 0 0 0
(2012) (49)
Fuller et al., 31 Orbera 22 0 0 0 0 0 0 0
2013 (25)
Genco et al., 50 Orbera 0 0 0 0 0 0 0 0
2013 (52)
Mohammed 84 Orbera 3.5 0 1.2 0 0 0 0 0
et al.,
2014 (53)
Ponce et al., 187 ReShape 16.5 0.5 0.5 0 0 0 0.53 0
2015 (26) Duo
Dargent et al., 34 Orbera 8.8 0 0 0 0 0 0 0
2015 (54)
Courcoulas 125 Orbera 9.6 0.8 0 0 0.8 0 0.8 0
et al.,
2017 (27)
FDA data Obalon 198 Obalon 0.5 0 0 0 0 0 0 0
FDA, Food and Drug Administration; SAE, serious adverse event.

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 1426 Bazerbachi et al.

decreased efficacy with IGBs, with a recent meta-analysis of 68
studies of the OIB (32) revealing a pooled 7.5% early removal rate
for intolerance. Similar intolerance data are not completely avail-
able for the other IGBs, but severe SAEs in this meta-analysis were
REVIEW ARTICLE
most of them typically occur in patients with previous gastroin-
testinal surgery, underscoring the importance of a proper eval-
uation before the placement, in addition to baseline endoscopic
assessment. Third, and more importantly, inadequate peri-

rare, with an incidence of migration, gastric perforation, and
mortality of 1.4%, 0.1%, 0.08%, respectively. Fifty percent of gastric
perforations (4 of 8) occurred in patients who had undergone
previous gastric or esophageal surgeries. Similarly, among 41,863
implantations of different IGBs in Brazil, only 3 balloon-related
mortalities were reported (gastric perforation, pulmonary aspira-
tion, and pulmonary embolism) (56). As a result, previous gastric
or esophageal surgery is a contraindication for IGB placement in
the United States.
Through medical device reporting, the FDA has recently
issued 3 alerts between February 2017 and June 2018 to educate
providers on the potential risks of acute pancreatitis and spon-
taneous balloon hyperinflation and 12 reports of unanticipated
deaths worldwide that occurred in patients with the OIB System
and the ReShape Integrated Dual Balloon System (57,58). Seven
of these 12 deaths occurred in the United States (4 with the Orbera
system and 3 with the ReShape system), with mortality rate, per
the manufacturer, of 0.036% (,4 deaths per 10,000 patients) for
the Orbera system and 0.06% (3 deaths per 5,000 patients) for the
ReShape system. As relayed previously in recent systematic
reviews and meta-analyses, the incidence of these SAEs was ex-
ceedingly rare, and thus highlighting a few important points.
First, when patients are appropriately selected and followed in
a multidisciplinary program, IGBs are safe interventions. Second,
most of these reports were related to gastric perforations, in which
Table 3. Common nonserious adverse events associated with
intragastric balloons in RCTs
procedural management of retching, nausea, and vomiting leads
to gastric perforation, re-enforcing the need for close follow-up
after IGB placement. A recent Canadian study (59) suggested that
IGBs offer lower safety profile than invasive bariatric procedures,
demonstrated by a propensity-matched analysis showing higher
nonoperative reintervention rate and a higher overall adverse
events profile (5% in IGB group vs 2.6% in bariatric surgery
group; P 5 0.2). However, nonoperative reinterventions, sec-
ondary to accommodative symptoms (e.g., nausea, vomiting,
abdominal pain), contributed to this adverse events profile. In this
limited experience, the occurrence of any of these expected
symptoms was deemed an SAE, although cumulative knowledge
about periprocedural management of IGB implantation mitigates
many, if not most, of these events (26,60).
More recently, 2 large post–FDA approval US studies in-
volving 523 patients with IGB showed no incidence of death, with
a favorable safety profile comparable with routine diagnostic
endoscopy, highlighting both the safety and efficacy of these
interventions when administered as part of a multidisciplinary
and comprehensive program (61,62). The Canadian study also
reviewed 781 IGB placements in 2016, and none were associated
with death, myocardial infarction, cerebrovascular event, or ve-
nous thromboembolism. Only 2.8% of these cases required an
early removal of the balloon due to adverse events/intolerance
(59). This is in contrast to 6.4%–16.6% early removal rates in the
US postregulatory approval studies (61,62). Thus, overall, IGBs
remain one of the safest bariatric interventions available in the
market in the appropriate clinical settings, with the inherent risks
similar to any routine endoscopy (Table 4).

Orbera Obalon BALLOON CHARACTERISTICS, FILLING VOLUMES, AND

Variable ReShape (%) (%) (%) DWELLING TIME
Vomiting 86.7 86.8 17.3 As described in Table 1, there are multiple IGBs in the market with
different shapes, filling volumes, content (fluid vs gas), materials,
Nausea 61.0 75.6 56.0
indwelling times (4–12 months), and placement/retrieval mecha-
Abdominal pain 54.5 57.5 72.6 nisms. Limited data compare these IGBs with each other. However,
Gastric ulcer 35.2 (improved to 10% after 0 0.9 a synthesis of the available literature demonstrated that fluid-filled
minor design change) IGBs are more effective than gas-filled IGBs for weight loss, but gas-
Dyspepsia 17.8 21.3 16.9 filled IGBs remain better tolerated (30,31). These differences in
outcomes and tolerance may partially be explained by the differing
Eructation 16.7 24.4 9.2
effects on gastric emptying (16). Small increments in weight loss
Abdominal 13.3 6.3 0
discomfort
Abdominal 11.0 17.5 14.6
Table 4. Mortality rate across differing procedures
distension
Erosive gastritis 9.1 0.6 7.1 Procedure Mortality rate (%)
GERD 6.8 30.0 16.9 Screening colonoscopy 0.05 (85)
Erosive esophagitis 0.4 0.6 1.8 Diagnostic EGD 0.1–0.3 (86)
Constipation 5.3 0 2.7 IGB placement 0.035–0.06
Diarrhea 3.0 13.1 8.3 Laparoscopic gastric banding 0.08
GERD, gastroesophageal reflux disease. Laparoscopic sleeve gastrectomy 0.20
Adapted from Sullivan S, Edmundowicz SA, Thompson CC. Endoscopic
Gastric bypass 0.34
bariatric and metabolic therapies: New and emerging technologies.
Gastroenterology 2017;152(7):1791–801. IGB, intragastric balloon.

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were observed when increasing the balloon volume beyond 500 mL
(Figure 2) (15). On the other hand, literature from adjustable IGBs
suggests that the ability to volume-alter balloons improves toler-
ance and overall weight loss outcomes, although these adjustable
IGBs are only currently available in clinical trials (63). Finally,
although the weight loss with IGBs is most steep within the first 3
months, balloons with longer dwelling times (12 months) are as-
sociated with better long-term weight maintenance (64).
OPERATIVE AND PERIOPERATIVE MANAGEMENT
Balloon placement
The largest body of data comes from the Brazilian Intragastric
Balloon Consensus Statement and clarifies important manage-
ment details (56). For endoscopically placed IGBs, it is recom-
mended that the procedure be performed in at least an outpatient
endoscopy center with advanced life support and the ability to
administer conscious sedation. Deeper forms of sedation for
balloon placement can be used but will require anesthesia sup-
port. In our experience, IGB placement can be safely provided
without airway protection, which is not the case for IGB removal.
The adult-size gastroscope with high-definition, white light ex-
amination is the preferred instrument to evaluate the esophagus,
stomach, and duodenum before balloon placement and monitor
the location of the balloon with inflation and after release. A good
quality preplacement EGD is mandatory and may alter thera-
peutic plans. In the postregulatory US study (61), 1% of proce-
dures were aborted because of pathology on endoscopy or
previous undisclosed GI surgery. Prophylactic use of antifungal
or antimicrobial drugs is not recommended. Triple antiemetic
therapy that includes the use of corticosteroids (intraoperatively)
is recommended. It is not clear at this point whether the use of
more potent and expensive antiemetic agents such as aprepitant
(Emend) is associated with an incremental benefit over lower-
cost alternatives to justify its routine use. Proton pump inhibitor
therapy and the avoidance of nonsteroidal anti-inflammatory
drugs are recommended during IGB therapy.
Postoperative management
After IGB placement, patients should be consuming a transitional
diet that includes an initial period of full liquids to prevent de-
hydration. Aggressive management of accommodative symptoms
(nausea, vomiting, abdominal cramps) during the first week after
IGB placement is critical to prevent dehydration or esophageal
Figure 2. Association between fluid-filled intragastric balloons filling volumes and %TBWL in clinical trials of the single, fluid-filled intragastric balloon.
TBWL, total body weight loss (Adapted from ref. 15).
© 2019 by The American College of Gastroenterology
Copyright © 2019 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited.
Endoscopic Bariatric Therapy 1427
injury from retching. Therefore, antiemetics are to be scheduled
and not prescribed on as needed basis, at least during the first 3
days. An anxiolytic at bedtime as needed is helpful to avoid an-
ticipatory symptoms of cramping, which are vigorous and pro-
REVIEW ARTICLE
nounced in the first couple of days. Aggressive management with
antispasmodics (such as hyoscyamine) is also important during
this acclimating period. Patients should be followed within 1 week
after IGB placement to monitor for complications and manage
accommodative symptoms. Monthly contact with the patient while
the IGB is in the stomach is recommended. Persistent vomiting
beyond 10–14 days after IGB placement is uncommon and war-
rants a clinical investigation for electrolyte imbalance, dehydration,
gastric outlet obstruction, dietary indiscretion, or balloon in-
tolerance with consideration for initiating prokinetic pharmaco-
therapy or early balloon removal. In addition, constipation is
a common culprit when GI symptoms, such as nausea or bloating,
occur .10–14 days after placement, and a rigorous bowel regimen
with scheduled osmotic laxative and a rescue suppository should
also be discussed with the patient.
Balloon removal
For balloon removal, it is recommended that patients be on at
least 2 days of liquid diet, followed by a 12-hour fasting period due
to the expected IGB-induced gastric-emptying delay, and that the
procedure is performed in an outpatient endoscopy center with
advanced life support and the ability to administer monitored
anesthesia care. Aspiration precautions during IGB removal
should be observed (left decubitus positioning of the patient with
elevation of the head of the bed). Anesthesia support for IGB
removal with endotracheal intubation to prevent aspiration
should be used in select patients with clinical suspicion of dietary
noncompliance, with continued symptoms of delayed gastric
emptying or gastric outlet obstruction, or when moderate to large
amount of food is found in the stomach during the removal
procedure. Administration of antibiotics or prokinetic agents
before IGB removal is not recommended. For patients who were
not on proton pump inhibitor therapy before balloon placement,
these medications should be titrated off over 4 weeks after balloon
removal to mitigate any possible rebound acid hypersecretion
(65). The specific endoscopic tools and techniques for IGBs re-
moval vary with the specific device, and we recommend that
operators carefully follow the instructions for use provided with
each device.
The American Journal of GASTROENTEROLOGY
 1428 Bazerbachi et al.
PATIENT SELECTION AND FOLLOW-UP
Patient selection
In general, IGBs should be considered in patients with class I and II
REVIEW ARTICLE
obesity (body mass index [BMI] between 30 and 40 kg/m2), who are
unsuccessful in losing or maintaining weight loss with lifestyle
interventions alone. Clinicians should initially screen all potential
candidates with a comprehensive evaluation for medical con-
ditions, comorbidities, and psychosocial or behavioral patterns that
contribute to their obesity before enrolling patients in a weight loss
program that includes IGBs. Thus, an evaluation by an obesity
medicine physician is recommended. Contraindications to place-
ment are multiple, including large hiatal hernias (.5 cm), active
peptic ulcer disease in the stomach, previous gastric or esoph-
ageal surgery, upper gastrointestinal inflammatory bowel dis-
ease, gastric neoplasms, esophageal dysphagia, dysmotility, and
eosinophilic esophagitis. Other contraindications include known
gastroparesis, coagulation disorders, variceal disease, substance
abuse, uncontrolled psychiatric disease, pregnancy, chronic use
of nonsteroidal anti-inflammatory drugs, and prohibitive medi-
cal comorbidities that increase the risk of endoscopy or anesthesia
(for endoscopically managed IGBs) (66).
Outside the above-mentioned parameters, IGBs can be used in
select patients with class III obesity (BMI . 40 kg/m2) as a bridge
to traditional bariatric surgery or to facilitate nonbariatric inter-
ventions that could not be performed safely due to weight limits
(i.e., orthopedic surgery, organ transplantation) (32,60,67–72).
If IGBs are applied before a surgical procedure that involves
gastric manipulation or resection, a waiting period of at least
30 days is recommended before undertaking the operative in-
tervention and at least 6 months before endoscopic suturing. This
recommendation stems from the fact that IGBs (at least those that
are fluid filled) have been shown to transiently increase gastric
wall thickness (73). In the literature, IGBs have been shown to
produce significant weight loss in patients with wide range of
BMIs (32,60). The use of IGBs in overweight individuals (BMI 5
27–29 kg/m2) (52), adolescents (74), sequential balloon therapy
(75), and in combination with obesity pharmacotherapy (76) is
encouraging, and further investigation is warranted.
Patient follow-up
Once placed, IGBs should be accompanied by moderate- to high-
intensity lifestyle interventions, which include dietary inter-
ventions, exercise therapy, and behavior modification. Active
patient participation in these structured weight loss programs
during both initial weight loss phase and long-term maintenance
phase is highly recommended if not required. All patients should
be followed prospectively to capture changes in weight and
weight-related comorbidities, and also all related adverse out-
comes. Poor responders, such as those who fail to achieve at least
5% TBWL by 3 months, should be identified and offered a de-
tailed evaluation and alternative therapy that includes an in-
tensified behavioral and lifestyle program and pharmacotherapy
(9). Acknowledging the limited data, it is recommended that
patients are initiated on obesity pharmacotherapy with contin-
uation of the behavioral and lifestyle program after IGB removal
by a team experienced in administering these therapies to max-
imize weight maintenance (76,77). A minimum of 6 (12 recom-
mended) visits or contacts with patients is recommended within
the 12 months after IGB implantation. However, if clinicians do
not have access to psychology or nutrition support within their
The American Journal of GASTROENTEROLOGY
Copyright © 2019 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited.
practice, early observational data suggest that electronic off-site
contracted services that offer these services to patients are ac-
ceptable alternatives for highly motivated patients (78).
IMPACT OF IGBs ON OBESITY COMORBIDITIES AND
QUALITY OF LIFE
After removal, IGBs improve obesity-related comorbidities and
markers of metabolic health in association with their weight loss,
although long-term amelioration in metabolic health cannot yet
be judged from the current body of literature.
Furthermore, the unique and sole application of the IGB
is unlikely, by itself, to result in meaningful and sustained
improvements in comorbidities and maintenance of weight
loss. It is important to note that a clinically significant and
durable improvement in metabolic parameters will generally
be translated in long-term follow-up. To date, such dedicated,
robust studies are lacking; however, the absence of evidence
should not be construed as evidence of absence. Ten RCTs and
30 observational studies including more than 5,600 subjects
were analyzed in a recent meta-analysis to investigate the impact
of IGBs on obesity comorbidities. Most studies evaluated the
impact on comorbidities in the short term with a paucity of long-
term data. There was moderate-quality evidence for improve-
ment in most metabolic parameters in patients assigned to IGB
therapy compared with those receiving lifestyle interventions
alone: fasting glucose improved by 12.7 mg/dL (95% CI: 221.5,
24), triglycerides by 19 mg/dL (95% CI: 242, 23.5), waist
circumference by 4.1 cm (95% CI: 26.9, 21.4), and diastolic
blood pressure by 2.9 mm Hg (95% CI: 24.1, 21.8) over lifestyle
intervention alone. The odds ratio for diabetes resolution after
IGB therapy was 1.4 (95% CI: 1.3, 1.6) (79,80).
In patients with nonalcoholic fatty liver disease, the impact of
IGB on nonalcoholic steatohepatitis activity and liver fibrosis
was evaluated prospectively in 20 patients who underwent
paired EUS-guided biopsies and MR elastography/spectroscopy
at the time of placement and removal after 6 months. In this
cohort, fibrosis resolution was seen in 10% of patients after 6
months of IGB therapy, with 80% achieving at least 2-point
NASH activity score (NAS) improvement on liver biopsies, and
65% had complete resolution of steatohepatitis (80). Our group
described, in a prospective trial, improvement in NAS score
which was not correlated with the degree of weight loss but
rather with improvement in mesenteric fat thickness (data not
published). This is consistent with other recent studies that
demonstrate improvement in liver stiffness after bariatric sur-
gery, independent of the degree of weight loss (81). One expla-
nation is that not all phenotypes of weight loss are equal, and it
may be the case that visceral fat loss is the actual predictive
measure of metabolic health rather than %TBWL.
Reimão et al. (82) showed that IGBs also produce favorable
changes in body composition through the reduction of body fat
mass and fat area. In 2 pivotal RCTs, where the quality of life was
assessed, IGBs improved weight-related quality of life signifi-
cantly more than lifestyle interventions alone (26,27). Last, in
a recent study, Guedes et al. (83) demonstrated that IGB treat-
ment in obese patients not only decreased central and total body
fat but also improved the quality of life and physical activity.
Thus, IGBs lead to favorable changes in metabolic markers of
cardiovascular and liver health, and also the appearance and
overall quality of life in association with the induced weight loss.
VOLUME 114 | SEPTEMBER 2019 www.amjgastro.com

CLINICAL APPLICATION, LONG-TERM WEIGHT LOSS,
CLOSING THOUGHTS
IGBs are safe and effective weight loss tools that lead to
improvements in physical and mental health. Before clinicians
introduce IGBs into their clinical practice, a comprehensive
knowledge of the indications, contraindications, risks, benefits,
and outcomes of IGBs, and also a practical knowledge of the risks
and benefits of alternative therapies for obesity such as lifestyle
interventions, pharmacotherapy, and bariatric surgery should
be obtained. Clinicians should also be credentialed and privileged
to use the device by local regulatory or institutional guidelines to
ensure that the necessary knowledge and technical skill for the
particular device are achieved before performing these proce-
dures. We also encourage gastroenterologists to work as a group
with bariatric surgeons, endocrinologists, licensed dieticians, and
behavioral psychologists to form a comprehensive obesity man-
agement team.
The paradigm for managing class I and II obesity has now
evolved to a model of chronic disease management much like that
of hypertension and diabetes, with an initial weight loss strategy
including short-term devices such as IGBs, followed by an ag-
gressive weight-maintenance phase that counteracts the physio-
logic changes that led to obesity using long-term pharmacotherapy
and lifestyle changes. The question is no longer whether IGBs
result in weight loss, but whether the combination of IGBs with
pharmacotherapies or other endoscopic bariatric and metabolic
therapies (EBTs) and the indispensable comprehensive lifestyle
and behavioral intervention programs can manage obesity as
a chronic disease in the long term. In the near future, and through
the introduction of personalized medicine including prognostic
and predictive biomarkers, clinicians will soon be able to per-
sonalize endoscopic bariatric management, maximizing effec-
tiveness and minimizing intolerance rates (84). Offering such
a step-up approach that has been successful in other chronic
disease models, such as hypertension and diabetes, will likely
minimize nonresponders and enhance the efficacy-to-risk ratio
by providing an effective and durable nonsurgical weight loss
option to this historically undertreated cohort. The future of
obesity management encompasses the full spectrum of inter-
ventions from lifestyle changes, medications, bariatric endos-
copy, and surgery in a personalized, patient-centered medical
home approach to chronic disease management.
CONFLICTS OF INTEREST
Guarantor of the article: Barham K. Abu Dayyeh, MD, MPH,
FASGE.
Specific author contributions: F.B. and E.J.V.: drafting of the
manuscript. B.K.A.D.: drafting and critical revision of the
manuscript. All authors approved the final draft submitted to
the journal.
Financial support: None.
Potential competing interests: F.B.: none. E.J.V.: none. B.K.A.D.:
consultant: Apollo Endosurgery, Boston Scientific, Metamodix,
BFKW; research support: Aspire Bariatrics, GI Dynamics, Apollo
Endosurgery, USGI, Medtronic, Spatz, and Cairns; speaker: Johnson
and Johnson and Olympus.
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