Intragastric Balloon for Obesity Treatment: Safety, Tolerance, and Efficacy

Abstract

Background:
Obesity is an increasing worldwide problem associated with a vast number of comorbidities. Decreasing body weight by only 5-10% has been shown to slow and even prevent the onset of obesity-related comorbidities. Between pharmacological therapy and bariatric surgery a great variety of endoscopic techniques are available, the most common being intragastric balloon (IGB). The purpose of this study was to assess the safety, tolerance, and kinetics of IGBs in weight loss. The kinetics of weight loss were evaluated in 2 different contexts and phases: after the IGB's removal and after follow-up that varied between 6 and 12 months. Successful weight loss was defined as ≥10% weight loss after 6-12 months.

Methods:
The study included 51 patients who had undergone Orbera® IGB placement between September 2014 and February 2016. Inclusion criteria were age between 18 and 65 years; body mass index (BMI) 28-35 with severe obesity-related disorders; or BMI 35-40. The IGB was removed 6 months later. All patients were followed for a minimum period of 6-12 months.

Results:
Of 51 patients, 16 were excluded (7 due to intolerance) and 35 patients entered the study, of which 83% were followed for more than 6-12 months. The average weight loss (WL) and % excess WL (%EWL) after 6 months of treatment were 11.94 kg and 42.16%, respectively. At 6-12 months, after removal of the IGB, the mean WL was 8.25 kg and %EWL was 30.27%. Nineteen patients attained a WL of ≥10% the baseline value at IGB removal and 12 maintained their weight below this threshold during the 6-12 following months.

Conclusions:
After temporary IGB implantation in overweight or obese individuals, a WL that was ≥10% of weight at baseline was achieved in 54.3% and sustained at 6-12 months in 41.4% of participants. IGBs are an attractive intermediate option between diet and exercise programs and bariatric surgery. In general, IGB placement is a safe and well-tolerated procedure.

Full text

E-Mail karger@karger.com
Original Article
GE Port J Gastroenterol
DOI: 10.1159/000485428
Intragastric Balloon for Obesity
Treatment: Safety, Tolerance, and
Efficacy
Joana Ribeiro da Silva Luísa Proença Adélia Rodrigues Rolando Pinho
Ana Ponte Jaime Rodrigues Mafalda Sousa Rita Almeida João Carvalho
Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia , Portugal
tered the study, of which 83% were followed for more than
6–12 months. The average weight loss (WL) and % excess WL
(%EWL) after 6 months of treatment were 11.94 kg and
42.16%, respectively. At 6–12 months, after removal of the
IGB, the mean WL was 8.25 kg and %EWL was 30.27%. Nine-
teen patients attained a WL of ≥ 10% the baseline value at
IGB removal and 12 maintained their weight below this
threshold during the 6–12 following months. Conclusions:
After temporary IGB implantation in overweight or obese in-
dividuals, a WL that was ≥ 10% of weight at baseline was
achieved in 54.3% and sustained at 6–12 months in 41.4% of
participants. IGBs are an attractive intermediate option be-
tween diet and exercise programs and bariatric surgery. In
general, IGB placement is a safe and well-tolerated proce-
dure. © 2017 Sociedade Portuguesa de Gastrenterologia
Published by S. Karger AG, Basel
Balão Intragástrico no Tratamento da Obesidade:
Segurança, Tolerância e Eficácia
Palavras Chave
Balão intragástrico · Tratamento da obesidade · Orbera
®
Keywords
Intragastric balloon · Obesity treatment · Orbera
®
intragastric balloon
Abstract
Background: Obesity is an increasing worldwide problem
associated with a vast number of comorbidities. Decreasing
body weight by only 5–10% has been shown to slow and
even prevent the onset of obesity-related comorbidities. Be-
tween pharmacological therapy and bariatric surgery a great
variety of endoscopic techniques are available, the most
common being intragastric balloon (IGB). The purpose of
this study was to assess the safety, tolerance, and kinetics of
IGBs in weight loss. The kinetics of weight loss were evalu-
ated in 2 different contexts and phases: after the IGB’s re-
moval and after follow-up that varied between 6 and 12
months. Successful weight loss was defined as ≥ 10% weight
loss after 6–12 months. Methods: The study included 51 pa-
tients who had undergone Orbera
® IGB placement between
September 2014 and February 2016. Inclusion criteria were
age between 18 and 65 years; body mass index (BMI) 28–35
with severe obesity-related disorders; or BMI 35–40. The IGB
was removed 6 months later. All patients were followed for
a minimum period of 6–12 months. Results: Of 51 patients,
16 were excluded (7 due to intolerance) and 35 patients en-
Received: August 3, 2017
Accepted after revision: November 14, 2017
Published online: December 21, 2017
Dr. Joana Ribeiro da Silva
Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho
Rua Conceição Fernandes
PT–4434-502 Vila Nova de Gaia (Portugal)
E-Mail joanasilva67  @  hotmail.com
© 2017 Sociedade Portuguesa de Gastrenterologia
Published by S. Karger AG, Basel
www.karger.com/pjg  is article is licensed under the Creative Commons Attribution-
NonCommercial-NoDerivatives 4.0 International License (CC BY-
NC-ND) (http://www.karger.com/Services/OpenAccessLicense).
Usage and distribution for commercial purposes as well as any dis-
tribution of modi ed material requires written permission.
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Ponte/Rodrigues/Sousa/Almeida/Carvalho
GE Port J Gastroenterol
DOI: 10.1159/000485428
2
Resumo
Introdução: A obesidade, problema crescente, está asso-
ciada a um grande número de comorbilidades. A redução
do peso corporal em apenas 5–10% mostrou-se eficaz na
melhoria e até na prevenção do aparecimento de comor-
bilidades relacionadas com a obesidade. Entre a terapia
farmacológica e a cirurgia bariátrica, temos disponiveis
uma grande variedade de técnicas endoscópicas, sendo a
mais comum a colocação de balão intragástrico (BIG). O
objectivo do estudo foi avaliar a segurança, tolerância e
cinética da perda de peso do BIG. A cinética da perda de
peso foi avaliada em dois momentos e contextos distin-
tos: após a remoção do balão e depois do periódo de
follow-up (PFU), que variou entre 6–12 meses. Eficácia de-
finida como perda de peso 10% após PFU de 6–12 meses.
Métodos: O estudo incluiu 51 pacientes que colocaram
Orbera
® BIG entre setembro de 2014 e fevereiro de 2016.
Os critérios de inclusão foram: idade entre 18–65 anos,
IMC 28–35 com comorbilidades relacionadas com obesi-
dade e IMC 35–40. O BIG foi removido passados 6 meses.
Todos os doentes foram acompanhados por um período
minino de 6–12 meses (PFU). Resultados: Dos 51 doentes
considerados, 16 foram excluidos (7 por intolerancia) e 35
entraram no estudo, dos quais 83% foram seguidos du-
rante PFU. A perda de peso média (PPM) e % de excesso
de peso perdido (EPP) na altura de remoção do BIG foi de
11.94 kg e 42.16%, respetivamente; após PFU, a PPM foi
de 8.25 kg e o EPP foi 30.27%. Dezanove alcançaram uma
perda de peso na altura de remoção de BIG e 12 mantive-
ram o seu peso abaixo deste limiar após o PFU. Conclu-
sões: Após a colocação temporaria do BIG em pacientes
com excesso de peso ou obesidade, foi alcançado uma
perda de peso superior a 10 em 54.3% na altura de remo-
ção do BIG e sustentada após periodo de follow-up de
6–12 meses em 41.4% dos doentes. Os BIG são uma alter-
nativa intermédia atractiva entre dieta/exercicio fisico e
cirurgia bariátrica. Em geral é um procedimento seguro e
bem tolerado. © 2017 Sociedade Portuguesa de Gastrenterologia
Publicado por S. Karger AG, Basel
Introduction
Obesity is an increasing worldwide problem with dev-
astating health consequences [1] . Worldwide, more than
1.4 billion adults are overweight or obese and face an in-
creased risk of numerous, potentially disabling conditions
[2] . Obesity is associated with a vast number of comor-
bidities, including coronary heart disease, type 2 diabetes
mellitus, stroke, sleep apnea, musculoskeletal disease, and
an increase in the prevalence of certain cancers [3] .
The health benefits of weight reduction are well estab-
lished. Decreasing body weight by only 5–10% has been
shown to slow and even prevent the onset of obesity-re-
lated comorbidities [4, 5] . However, permanent weight
loss is frequently difficult to achieve [6] , and the availabil-
ity of safe and effective weight loss therapies is limited [2] .
The conventional treatments, such as a calorie-restricted
diet, regular physical activity, and behavioral modifica-
tion, are frustrating procedures which take a long time
before any significant result can be observed [7, 8] .
Pharmacological therapy is indicated for patients with
a body mass index (BMI) ≥ 30 or ≥ 27 if obesity-related
risk factors or diseases are present [5] . Pharmacotherapy
is less invasive and less costly for the management of obe-
sity but results in a limited weight loss and may have sig-
nificant side effects [9] .
Bariatric surgery is the most effective weight loss inter-
vention [10] , resulting in long-term sustained weight loss
[10] and long-term resolution of comorbidities [11] . It is,
however, restricted to patients with morbid obesity (BMI
>40) [12] . Despite all of its advantages, bariatric surgery
is still extremely invasive and costly and is likely to cause
a vast number of complications that may prove to be fatal
[13] . However, there is an intermediate group of patients
who do not respond to medical therapy and who do not
qualify for the bariatric procedure.
In recent years, new endoscopic techniques have
emerged, thus providing less invasive and more cost-ef-
fective options for the treatment of obesity. Endoscopic
modalities in the treatment of obesity can be categorized
into the following: space-occupying devices (intragastric
balloon [IGB], transpyloric shuttle), gastric restrictive
methods (transoral gastroplasty, transoral endoscopic re-
strictive implant system), malabsorptive endoscopic pro-
cedures (duodenal-jejunal bypass liner, satiSphere), regu-
lating gastric emptying (intragastric botulinum toxin in-
jections, gastric electrical stimulation), and other therapies
(aspiration therapy) [14–16] . Of these methods, the most
commonly employed is IGB placement.
The first generation of IGBs date back to 1985 [2] .
These balloons, filled with 220 mL of air, were endoscop-
ically placed and left in the stomach for 3 months, then
being removed endoscopically. This procedure was with-
drawn from the market, not only because of severe pro-
cedure-related complications but also due to lack of effi-
cacy. Since then, different balloons have been tested, re-
sulting only in short-term results or being associated with
technical problems [2] .
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Intragastric Balloon for Obesity
Treatment
GE Port J Gastroenterol
DOI: 10.1159/000485428
3
Safer and more effective IGBs were subsequently de-
veloped over the next 2 decades that were more effective
at promoting weight loss [2] . Nowadays, the most com-
monly used IGB worldwide is the Orbera
® IGB (former-
ly the Bioenterics IGB). These balloons, which are filled
with saline solution, are placed endoscopically in the
stomach, remaining there for 6 months, and are then re-
moved in a subsequent endoscopy. The IGB decreases
preprandial hunger, increases postprandial satiety, and
promotes weight loss in the short term [12] .
The IGB is an attractive intermediate option between
prescription drugs and bariatric surgery for overweight
and obese patients hoping to lose a significant amount of
weight without the invasiveness of surgery or the sys-
temic side effects of pharmacotherapy. The minimal in-
vasiveness and temporary nature of the IGB is attractive,
but the duration of implantation, during which the pa-
tient is closely followed, is short. Whether this short-
term follow-up is sufficient to change the patients’ life-
style and eating practices and to maintain their weight
reduction after IGB removal is still a subject of contro-
versy [17] .
We have prospectively followed a cohort of patients
treated with the IGB to induce weight loss. The aim of this
study was to assess the safety, tolerance, and kinetics of
weight loss during and after IGB therapy, with a mini-
mum follow-up of 6 months after IGB implantation. On
the other hand, we sought to evaluate changes in the met-
abolic parameters associated with weight reduction.
Materials and Methods
Patients and Design of the Study
A prospective single-center study was conducted on 51 patients
who had undergone the Orbera
® IGB procedure between Septem-
ber 2014 and February 2016. All patients were screened for major
endocrine disorders before admission to the study. All procedures
were performed by 2 of the authors, who have extensive experience
in IGB therapy. Informed consent was obtained from all patients
before the procedure.
Inclusion criteria were the following: (1) age between 18 and 65
years; (2) BMI >28 and <35 with severe obesity-related disorders
who had failed to achieve weight loss with an adequate weight loss
program for 3 years; (3) BMI ≥ 35 and ≤ 40. Exclusion criteria were
a history of malignancy within the previous 5 years, previous bar-
iatric or gastrointestinal surgery, alcohol or drug abuse, hormonal
or genetic causes of obesity, women referred from the infertility
clinic, use of anticoagulants or nonsteroidal anti-inflammatory
drugs, pregnancy, gastric or esophageal varices, large hiatus hernia
(>5 cm in length), reflux esophagitis grade C or D on the Los An-
geles classification, duodenal or gastric ulcer, and other lesions
considered to be high risk for bleeding.
Procedure
The IGB was placed with the patient under anesthesiologist-
administered propofol sedation. A complete upper gastrointesti-
nal endoscopy was previously performed to exclude abnormalities.
The balloon was inserted blindly into the gastric body collapsed
within a specially designed sheath, as presented in the commer-
cially available pack. Then, the endoscope was reinserted, and the
balloon was inflated under direct endoscopic vision with saline
(600 mL) and methylene blue (5 mL) solution. After the procedure,
the patients were kept in the recovery room for 2 h for observation
and for symptom control. Once they could tolerate a liquid diet,
they were discharged medicated with proton pump inhibitors,
which they were indicated to maintain until removal of the IGB,
and with antiemetic agents for 1 week.
The patients were advised to follow a fully liquid diet for the
first 4 weeks, and a soft diet was gradually introduced thereafter.
During the 6 months of treatment, a balanced diet with 1,100 kcal/
day and 20% protein was prescribed by the nutritionist to all pa-
tients (regardless of the BMI).
Patients were followed twice a week for the first week, then at
the end of the first month, and finally at 3 and 6 months. During
the follow-up visits with the nutritionist, the nutrition plan and the
weight control were evaluated, and nutritional education was re-
inforced.
The IGB was removed 6 months later under endoscopic control
using the IGB removal kit. Then, all patients were followed on an
outpatient basis by the nutritionist for a period of 6–12 months
after placement of the IGB.
Parameters
The patients underwent complete physical examination, an-
thropometry (body weight, BMI, percentage of body weight loss,
and fat mass), blood pressure measurement, and determination of
serum triglycerides, high-density lipoprotein (HDL) and low-den-
sity lipoprotein (LDL) cholesterol, glucose, and liver enzymes
(ALT, GGT) at baseline, 6 months (time of IGB removal), and 6–12
months after IGB removal.
The Anthropometric evaluation was performed using bio-
impedance (Tanita TBF-300
® ). Successful weight loss was defined
as ≥ 10% weight loss after 6–12 months.
Statistical Analysis
Discrete variables are presented as proportions, and continu-
ous variables are presented using the mean and standard distribu-
tion. The normal distribution of continuous variables was con-
firmed using the Kolmogorov-Smirnov test. Continuous variables
were compared across 2 time periods using the paired-samples t
test. Results were considered as statistically significant if p < 0.05.
The Statistical Package for the Social Sciences (SPSS 20.0) was used
for data entry and data analysis.
Results
Sample Characteristics
The IGB was placed in 51 consecutive patients be-
tween September 2014 and February 2016. Of these 51
patients, 8 did not meet the inclusion criteria and 1 was
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DOI: 10.1159/000485428
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excluded before the placement of the IGB due to a large
hiatal hernia. Considering the 42 patients who received
the IGB, 7 did not tolerate it ( Fig.1 ). In total, 35 patients
entered the study, of which 29 (83%) were followed for
more than 6–12 months.
The baseline characteristics are presented in Table1 .
All 35 patients completed a 6-month period with the IGB,
31 of which were female and 4 male. The mean age was
41.3 ± 9.6 years; the mean weight was 94.6 ± 11.9 kg, the
mean BMI was 35.8 ± 4.0, and the mean initial excess
weight was 28.7 ± 8.9 kg.
Regarding comorbidities, 8.6% of the patients suffered
from arterial hypertension, 11.4% from hyperlipidemia,
2.8% from diabetes, and 28.6% from chronic depression.
During the examination, we observed 1 case with esoph-
agitis and 1 case with peptic ulcers.
All endoscopic placements were successfully per-
formed in 10 ± 4 min, and 600 mL of saline were injected
in every patient. There were no serious complications, ex-
cept for nausea and vomiting, and the average recovery
period was 2 ± 1 h.
IGB Removal
The average weight loss and % excess weight loss
(%EWL) after 6 months of treatment were 11.94 kg and
42.16%, respectively. Upon IGB removal, in patients with
a baseline BMI <30 ( n = 2), the mean weight loss was 13
kg and the mean %EWL was 67.15%; in patients with a
baseline BMI 30–35 ( n = 15), the mean weight loss was
8.3 kg and the mean %EWL was 36.5%; in patients with a
baseline BMI 35–40 ( n = 18), the mean weight loss was
21.1 kg and the mean %EWL was 49.7% ( Table2 ).
Compared to baseline values, the patients experienced
significant reductions in weight (93.8 ± 11.0 to 81.9 ± 10.4
kg, p < 0.001), BMI (35.8 ± 3.9 to 31.8 ± 2.6, p < 0.001),
and fat mass (42.7 ± 7.1 to 31.8 ± 7.4 kg, p < 0.001). Com-
pared to baseline values, a significant improvement in tri-
glyceride level and insulin, but not in HDL cholesterol,
total cholesterol, LDL cholesterol, and glucose levels, was
seen ( Table3 ).
Follow-Up after IGB Removal
Patients who completed 6–12 months of follow-up af-
ter IGB removal followed no structured weight mainte-
nance program, and they attended 1 visit with a nutrition-
ist. Six patients were lost to follow-up.
At 6–12 months after removal of the IGB, the mean
weight loss was 8.25 kg and the mean %EWL was 30.27%
for the group as a whole; 18.9 kg and 64.7% for patients
with a BMI <30 ( n = 1); 4.6 kg and 26.9% for patients
with a BMI 30–35 ( n = 11); and 12.7 kg and 27.4% for
patients with a BMI 35–40 ( n = 17), respectively ( Ta-
ble 2 ). Compared to baseline values, patients showed
significant reductions in weight (93.8 ± 11.0 to 86.9 ±
13.4 kg, p < 0.001), BMI (35.8 ± 3.9 to 33.5 ± 4.3, p <
0.001), and fat mass (42.7 ± 7.1 to 36.2 ± 9.9 kg, p <
0.001).
Regarding weight loss results, a generally accepted cri-
terion used in clinical treatments was used: the method
has failed if %EWL is <20%. According to this criterion,
we compared %EWL at 2 time points ( Table4 ): immedi-
51 patients
42 patients
Excluded
 8 without inclusion criteria
 1 large hiatal hernia
35 patients
Excluded
 7 intolerants
Fig. 1. Study design.
Table 1. Baseline characteristics (n = 35)
Age, years 41.3 ± 9.6
Female sex 31
Body weight, kg 94.6 ± 11.9
BMI 35.8 ± 4.0
Excess weight, kg 28.7 ± 8.9
Comorbidities
Dyslipidemia 4
Arterial hypertension 3
Diabetes mellitus 1
Depression 10
Values are means ± standard deviations or n. BMI, body mass
index.
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Intragastric Balloon for Obesity
Treatment
GE Port J Gastroenterol
DOI: 10.1159/000485428
5
ately after IGB removal and 6–12 months later. Just after
IGB removal, there were 8 patients with a %EWL <20%
(unsatisfactory results) and 27 patients with a %EWL
>20% (good results). At 6–12 months after the IGB had
been removed, there were 23 patients with a %EWL
<20% (unsatisfactory results) and 6 patients with a
%EWL >20% (good results). On the other hand, 19 pa-
tients attained a weight loss of ≥ 10% the baseline value
at IGB removal and 12 maintained their weight below
this threshold during the 6–12 following months, while
7 regained weight above this threshold. Compared to
IGB removal values, a significant improvement in HDL
cholesterol, but not in insulin, triglycerides, total choles-
terol, LDL cholesterol, and glucose levels, was seen ( Ta-
ble3 ).
Complications
Complications were observed in 7 patients. These con-
sisted of abdominal pain, nausea, and vomiting (food in-
tolerance, n = 5) and spontaneous IGB deflation ( n = 1).
All complications resolved with IGB removal, either un-
expectedly through vomiting after spontaneous deflation
( n = 1) or endoscopic extraction ( n = 6). Additionally,
unexpected pregnancy led to the extraction of 1 IGB at 3.7
months after implantation (without complications at
birth). Gastroscopy during the removal procedure was
normal in 32 patients and revealed esophagitis in 1 pa-
tient and peptic ulcers in 2 patients.
Table 2. Weight loss results
Group At removal 6 – 12 months after IGB removal
nmean weight
loss, kg
mean
%EWL
mean %
weight loss
n mean weight
loss, kg
mean
%EWL
mean %
weight loss
All patients 35 11.94 42.16 11.83 29 8.25 30.27 9.3
BMI <30 213.0 67.15 14.5 118.9 64.7 20
BMI 30 – 35 15 8.3 36.5 8.8 11 4.6 26.9 7
BMI 35 – 40 18 21.1 49.7 20 17 12.7 27.4 11.6
IGB, intragastric balloon; EWL, excess weight loss; BMI, body mass index.
Table 3. Changes in blood pressure and biochemical parameters before insertion of the IGB, at its removal, and at 6 – 12 months of
follow-up
Baseline IGB removal pIGB removal 6 – 12 months
after IGB removal
p
Blood glucose, mg/dL 86.7 ± 16.8 85.7 ± 15.7 0.528 85.7 ± 15.7 88.9 ± 18.8 0.397
Insulin, U/mL 18.8 ± 11.4 12.7 ± 11.4 0.001 12.7 ± 11.4 17.6 ± 12.7 0.102
Triglycerides, mg/dL 113.8 ± 52.6 94.2 ± 41.8 0.029 94.2 ± 41.8 110.9 ± 54.5 0.056
Total cholesterol, mg/dL 193.8 ± 39.7 195.2 ± 55.5 0.663 195.2 ± 55.5 200.9 ± 36.3 0.448
HDL, mg/dL 55.9 ± 15.4 54.6 ± 14.5 0.493 54.6 ± 14.5 59.9 ± 16.2 0.032
LDL, mg/dL 115.0 ± 41.4 121.6 ± 52.8 0.513 121.6 ± 52.8 118.7 ± 39.0 0.631
Values are means ± standard deviations. Italics indicate statistical significance. IGB, intragastric balloon; HDL, high-density
lipoprotein; LDL, low-density lipoprotein.
Table 4. Comparison of %EWL immediately after versus 6 – 12
months after IGB removal
Immediately after
IGB removal
6 – 12 months after
IGB removal
%EWL <20% 8 23
%EWL >20% 27 6
EWL, excess weight loss; IGB, intragastric balloon.
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DOI: 10.1159/000485428
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Discussion
Earlier generations of IGBs had a limited volume
(200–220 mL), were filled with air, had a low resistance to
gastric acid, and the treatments lasted a maximum of 3–4
months. This may explain spontaneous balloon deflation,
passage of the balloon through the digestive tract, and in-
sufficient weight loss with air-filled IGBs. Current-gener-
ation balloons have an intragastric capacity of up to 960
mL, are filled with saline solution, and have fewer adverse
effects.
IGBs affect both the stretch receptors and the gastric
capacity and increase satiety while decreasing the residu-
al volume available for food and, therefore, could be con-
sidered a nonsurgical restrictive procedure to treat obe-
sity. Compared with surgical treatment, the IGB can be
attractive for patients. This treatment is less invasive than
surgery, can be repeated, and is completely reversible. On
the other hand, this treatment is temporary, because the
IGB can remain in the gastric cavity for only a limited pe-
riod of time. The mean duration of IGB implantation in
our series was 6 months.
The question remains whether the obese patient’s food
practices and lifestyle can be modified sufficiently during
this temporary process to cause significant weight loss.
There are contrary results from studies that assess the
long-term effectiveness of IGB: on the one hand, there are
studies that conclude that patients may recover partial or
total weight loss after the balloon has been removed; on
the other hand, in other series, the results are encourag-
ing. In these latter studies, the consistency of weight loss
achieved during IGB therapy and the amount of weight
loss sustained after IGB removal were surprisingly very
similar. Thus, Datis et al. [5] , Dogan et al. [18] , Fuller et
al. [19] , Genco et al. [20] , Herve et al. [21] , Ohta et al. [22] ,
and Sallet et al. [23] report that after extraction of the bal-
loon, the majority of patients had achieved weight loss.
In our study, mean weight loss and %EWL 6 months
after balloon placement were 11.94 kg and 42.16%, re-
spectively. Studies evaluating patients at 6 months after
removal include the following: Dogan et al. [18] noted
that the mean weight loss at the time of balloon removal
was 9.5 kg and 1 year after the removal 7.6 kg; Fuller et al.
[19] noted a weight loss of 9.4 kg, Gaur et al. [2] noted a
weight loss of 18.3 and 20.1 kg, and Sallet et al. [23] noted
a weight a loss of 17.4 kg.
After 6–12 months of follow-up, our patients showed
a mean weight loss of 8.25 kg, similar to other studies with
the IGB: Dastis et al. [5] (7.9 kg), Dogan et al. [18] (7.6
kg), Herve et al. [21] (8.6 kg) and Ohta et al. [22] (6.4 kg).
In our study, after IGB removal, there were 8 patients
with %EWL <20 and 27 patients (77.1%) with %EWL
>20%. At 6–12 months after the IGB had been removed,
there were 23 patients with %EWL <20% and 6 patients
(23%) with %EWL >20%.
Kotzampassi et al. [17] obtained better results. They
demonstrated that the percentage of patients having
EWL% of 20% was 83% at the time of balloon removal, 53
and 27% at 12 and 24 months, respectively, and 23% at
the 60-month follow-up of 195 obese patients. On the
other hand, we found that, after temporary IGB implanta-
tion in overweight or obese individuals, a weight loss that
was ≥ 10% of weight at baseline was achieved in 54.3% and
sustained at 6–12 months in 41.4% of participants.
Given the ease and reproducibility of the method,
these results are encouraging, because they are at least
equivalent to those reported with therapies recommend-
ed for weight loss or maintenance. In particular, dietetic
counseling or behavioral therapy allows 15–30% of obese
individuals to achieve ≥ 10% baseline weight loss at 1 year
[5] , compared to 65.5% at 6 months and 41.4% at 6–12
months in the present series.
Obesity plays a key role in the metabolic syndrome.
Visceral fat accumulation, above all in the liver, is associ-
ated with a cluster of metabolic alterations, i.e., type 2
diabetes, hypertension, and dyslipidemia. Patients in our
study experienced only metabolic effects. Stimac et al. [7]
also demonstrated there that there were no significant
differences in LDL and total cholesterol concentration.
The endoscopic examination performed before im-
plantation of the IGB is of primary importance. During
this examination, we observed 1 case of esophagitis, 1
peptic ulcer, and 1 large hiatal hernia. The last contrain-
dicated the placement of an IGB.
As in other studies, there was a high incidence of nau-
sea and vomiting in the first 3 days of balloon placement.
However, the prophylactic prescription of antiemetic
drugs in the first days reduced the intolerance, with only
7 patients (13.7%) demanding endoscopic removal of the
IGB. The continuous use of proton pump inhibitors is
mandatory, not only for the protection of the gastric mu-
cosa and against gastroesophageal reflux, but also to pro-
tect the balloon itself from the deleterious action of hy-
drochloric acid.
During the IGB removal procedure, we observed 1
new case of esophagitis and 2 new peptic ulcers among
the patients with a normal gastroscopy before implanta-
tion. Our study reports 1 case of balloon deflation, re-
solved by spontaneous IGB elimination through vomit-
ing.
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Intragastric Balloon for Obesity
Treatment
GE Port J Gastroenterol
DOI: 10.1159/000485428
7
This study has some limitations. The anthropometric
evaluation of the patients was limited to a bioimpedance
evaluation. Other measurements which could add detail
to the evaluation of body changes and to the impact of the
IGB on body composition were not used.
The current generation of IGBs is an attractive inter-
mediate option between diet and exercise programs and
bariatric surgery; it is a safe and effective procedure in
which about half of the patients can expect to maintain
their weight after the balloon is removed. Since IGB rep-
resents a temporary nonsurgical and nonpharmaceutical
treatment for obesity that is totally reversible and repeat-
able, it should be recommended to patients who have pre-
viously tried traditional methods of weight reduction
which have failed. Careful patient follow-up is of primary
importance to avoid complications and to support the ef-
ficacy of the treatment. One year of follow-up cannot be
considered “long-term,” but these results are encourag-
ing. Concurrent behavior modification is necessary for
durable weight loss success.
Statement of Ethics
Informed consent was obtained from all patients before the
procedure.
Disclosure Statement
The authors have no conflicts of interest to declare.
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