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CLINICAL RESEARCH
BioEnterics® Intragastric Balloon (BIB®). Single
Ambulatory Center Spanish Experience with 714
Consecutive Patients Treated with One or Two
Consecutive Balloons
Gontrand Lopez-Nava &Miguel Angel Rubio &
Susana Prados &Gabriela Pastor &
Mar Rodriguez Cruz &Ena Companioni &Andres Lopez
Received: 28 January 2009 /Accepted: 28 January 2010
#Springer Science+Business Media, LLC 2010
Abstract
Background The BioEnterics® Intragastric Balloon (BIB®)
is a well-established device for temporary treatment in
morbidly obese patients. The aim of this study is the
evaluation, in a population of 714 consecutive outpatient
setting cases, BIB® results in terms of weight loss and
comorbidity change.
Methods BIB® was positioned in all cases after diagnostic
endoscopy. The device was inflated under direct endoscopic
vision with saline solution (600–700 ml) and methylene
blue (10 ml). Intubation was carried out in patients with
body mass index (BMI)>40 kg/m
2
affected by sleep apnea
or chronic obstructive pulmonary disease. After 6 months,
balloon removal was carried out, and patients were
discharged with drug therapy and 1,000 kcal diet. More
than 100 patients underwent a second consecutive balloon
positioning. One month from the removal of the first BIB,
patients were given a second BIB. Patients were followed
up weekly. Mortality, complications and their treatment,
postplacement symptoms, comorbidities, BMI, percentage
of excess BMI loss (%EBL), and percentage of excess
weight loss (%EWL) were considered. Data are expressed
as mean±standard deviation.
Results From June 1, 2005, to May 31, 2007, 714 patients
underwent BIB® placement (143 males/571 females; mean
age, 38.4±16.1; mean BMI, 37.6± 5.7 kg/m
2
; mean EW,
56.3± 27.1 kg). After 6 months, mean BMI was 31.1±7.2,
mean %EWL was 41.6±21.8, mean BMI loss was 6.5±12.7,
and mean %EBL was 44.5±22.6. Of 714 patients, 112
underwent a second BIB placement. At the time of the second
balloon placement, mean BMI was 32.9±6.7 kg/m
2
;range
was 31–51. After the second balloon removal, mean BMI
was 30.3±7.2.
Conclusions BIB® treatment is a safe and effective
procedure for weight reduction, without mortality and with
very low morbidity rates even in nonhospitalized patients.
A second balloon can also be positioned without difficulties,
achieving good results after 12 months of treatment.
Keywords Obesity .BIB® .Weight loss .Complications .
Comorbidity
Introduction
The BioEnterics® Intragastric Balloon (BIB®) is a well-
established device for temporary treatment in morbidly
obese patients [1–3]. The BIB® is potentially attractive to
health care practitioners who have experienced poor results
with dietary programs, drug treatment, and behavioral
therapy [4]. Moreover, it has been recommended as a
weight reduction adjuvant therapy before bariatric surgery
and before all kinds of planned surgery in the morbidly
G. Lopez-Nava (*):S. Prados :G. Pastor :M. R. Cruz
Department of Digestive and Endoscopy,
Madrid Sanchinarro University Hospital,
C/Padre Arrupe 89, Chalet,
28050 Madrid, Spain
e-mail: clinicalwriter@ymail.com
M. A. Rubio
Department of Endocrinology,
Madrid Sanchinarro University Hospital,
Madrid, Spain
E. Companioni :A. Lopez
Department of Anesthesiology,
Madrid Sanchinarro University Hospital,
Madrid, Spain
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DOI 10.1007/s11695-010-0093-3
obese to reduce life-threatening comorbidities and lessen
surgical risk [1–4]. The aim of this study is the evaluation, in
a population of 714 consecutive outpatient setting cases,
BIB® results in terms of weight loss and comorbidity change.
Patients and Methods
The BIB® (Allergan, Irvine, CA, USA) was positioned in
all cases. Patients were selected according to National
Institutes of Health criteria and guidelines for obesity surgery
[5] and were independently evaluated by members of the
bariatric staff: internists, dieticians, and psychologists. More
in detail indications for BIB use may be summarized as the
following: (1) preoperatory weight loss in a patient candidate
to bariatric surgery with high anesthesiological risk, (2)
temporary weight loss treatment in a patient with body mass
index (BMI) in the range of bariatric surgery (>35) who
refuse surgery or has possible low compliance to surgery or
in case of very long waiting list, and (3) temporary weight
loss treatment for a patient with no indications to surgery in
the context of an integrate medical approach to obesity
(BMI< 35). Exclusion criteria were all conditions precluding
safe endoscopy, esophagitis, large hiatal hernia (>5 cm),
chronic therapy with steroids or nonsteroidal drugs, active
peptic ulcer or its previous complications, previous gastric
surgery, lesions considered at risk for bleeding or anticoagu-
lant therapy, pregnancy, and physical inability to maintain
regular follow-up. The patient was positioned in a lateral
decubitus position, and diagnostic endoscopy was performed.
BIB® placement was performed under unconscious sedation
(propofol, 2 mg/kg) and was inflated under direct endoscopic
vision with saline solution (600–700 ml) and methylene blue
(10 ml). Intubation was carried out in patients with BMI>
40 kg/m
2
affected by sleep apnea or chronic obstructive
pulmonary disease (COPD), as a preanesthesia protocol.
After 6 months of placement, endoscopy was performed, and
balloon removal was carried out using a dedicated instru-
ment following complete deflation of the device. All patients
were discharged after 3 h. On the first postoperative day,
isotonic liquids with rabeprazole (20 mg/day), ondansetron
(8 mg/day), and butylscopolamine bromide (20 mg× 3/day)
were given to all patients. After the fifth postoperative day,
they began a progressive solid 1,000 kcal diet. More than 100
patients underwent a second consecutive balloon positioning.
In these cases, after the removal of the first BIB, patients were
given 1 month of medical therapy, followed by a second BIB
positioned according to the same protocol as the first
positioning and removed after 6 months. Patients were
followed up weekly. Mortality, complications and their
treatment, postplacement symptoms, comorbidities, BMI,
percentage of excess BMI loss (%EBL), and percentage of
excess weight loss (%EWL) were considered (EW was
calculated according to Lorenz formula). Data are expressed
as mean± standard deviation, except as otherwise indicated.
Statistical analysis was done by means of Student’sttest for
numerical variables and χ
2
test or Fisher’s exact test for
categorical variables. p<0.05 was considered significant.
Results
From June 1, 2005 to May 31, 2007, 714 patients
underwent BIB® placement (143 males/571 females; mean
age, 38.4± 16.1; range, 15–66; mean weight, 106.3±
21.5 kg; range, 68–190; mean BMI, 37.6 ± 5.7 kg/m
2
;
range, 31–57; mean EW, 56.3±27.1; range, 16–205 kg).
Mortality, Complications, and Early Removal
Endoscopic and postpositioning mortality was absent.
Balloon positioning was uncomplicated in all cases. Of 714
patients, 31 (4.3%) underwent BIB® removal at between 24 h
and 6 weeks after positioning, mainly due to psychological
intolerance or gastroparesis (n=6/31; 19.3%). In patients with
balloon positioning under general anesthesia (27/714; 3.8%),
complications were absent. Overall complication rate was
29/714 (4.1%). Gastroduodenal ulcer, gastric perforation,
and gastric and intestinal obstructions were absent. Balloon
rupture was absent, while partial balloon deflation was
observed in three cases (0.4%). In one patient, the balloon
was not found at the time of removal and probably was lost
with stools after deflation. Esophagitis (n=7; 0.9%) and
acute mucosal gastroduodenal lesions (n=22, 3.1%) were
Symptoms and complications Patient (n, %) Symptoms duration
mean±SD (range)
Therapy
Vomiting 140 (19.6) 4.7±3.7 (1–28) Medical
Epigastric pain 137 (19.1) 5.4±6.3 (1–51) Medical
Gastroparesis 6 (0.8%) 3±3.1 (1–21) Balloon removal
Gastroduodenitis 22 (3.1) Medical
Esophagitis 7 (0.9) Medical
Psychological intolerance 25 (3.5) Balloon removal
Table 1 Postpositioning
symptoms and complications
in 714 patients underwent
BioEnterics® Intragastric
Balloon
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treated conservatively by doubling drug doses for all the
remaining treatment time.
Of 714 patients, 32 were readmitted in ambulatory after
4.7±3.1 (range, 1–12) days from BIB positioning for
untreatable vomiting. They represent the 32/140 (26.6%)
patients affected by this complication. Postpositioning
symptoms or complications and their treatment are reported
in Tables 1and 2.
Comorbidities
One or more preoperative comorbidities were diagnosed in
162/714 (22.7%) patients: hypertension (22/162; 13.6%),
type II diabetes (16/162; 9.8%), respiratory disorders (31/162;
19.1%), osteoarthropathy (14/162; 8.6%), and others (79/162;
46.9%). Comorbidities were resolved in 64/162 (39.5%) and
improved (lower pharmacological dosage or shift to other
therapy) in 76/162 (46.9%) patients. In 22/162 (13.6%)
patients, the weight loss has not been associated with changes
in comorbidities. In the subgroup of patients treated with a
second BIB, 25/112 (12.3%) comorbidities were diagnosed.
After the first intragastric balloon, comorbidities were
resolved, improved, or unchanged in 10/112 (8.9%), 11/112
(9.8%), and 4/112 (3.4%) patients, respectively (Table 3).
After the second BIB, these results were without significant
change (p=NS; Table 4).
Weight Loss
In all treated patients, after 6 months, mean weight was
94.7±22 (range, 52–160 kg); mean BMI was 31.1± 7.2
(range, 24–48 kg/m
2
), mean %EWL was 41.6±21.8 (range,
0–77), mean weight loss was 18.8±9 (range, 0–45 kg);
mean BMI loss was 6.5±12.7 (range, 0–21 kg/m
2
); and
mean %EBL was 44.5±22.6 (range, 0–81). Results according
the initial BMI are reported in Table 5. Of 714 patients, 112
underwent a second BIB placement. At the time of the
second balloon placement, mean weight was 98±25.1
(range, 58–160 kg); mean BMI was 32.9±6.7 kg/m
2
(range,
31–51); and mean EW was 41.7±21.1 (range, 6–127 kg).
After the second balloon removal, mean BMI was 30.3±7.2
(range, 24–40 kg/m
2
;Fig.1); mean %EWL was 31.5 ± 23.2
(range, 0–100); mean BMI loss was 2.5±18.2 (range,
0–20 kg/m
2
); and mean %EBL was 59.9±24.6 (range,
0–100). In 148 patients, the balloon was not followed by any
bariatric or other surgical procedure. Their initial mean BMI
was 35.1±8.3 kg/m
2
. After BIB removal, their mean BMI
was 28.7± 5.1 kg/m
2
. After 24 months of follow-up, 22 (%)
patients regained the pre-BIB weight, 61 (%) regained the
45–50% of their pre-BIB weight, and 45 remain at the
weight level after BIB removal ±2 kg.
Discussion
The use of intragastric devices to promote weight reduction
is not novel [6,7]. Several authors, over the years, have
tried different types of balloon devices as they were thought
to be promising and less invasive than surgery for the
treatment of morbid obesity [7–12]. By the end of the
1990s, several prospective and controlled studies reported
that devices, such as Ballobes and Garren–Edwards gastric
bubbles, had no significant adjuvant effects for weight
reduction in morbidly obese patients [7–12]. Reasons for
this were considered to be the small volume of the balloon
(220 ml for Garren–Edwards and 400 ml for Ballobes); the
air filling having no weight effect on stomach walls, and the
cylinder shape of these devices. In addition, these devices
had high rates of complications (gastric erosion, 26%;
gastric ulcer, 14%; Mallory–Weiss tears, 11%; complete
deflations, migrations, and intestinal obstructions) [7–12].
The latest version of the BIB®, according to Tarpon
Springs meeting suggestions, has a spherical shape, high
Table 2 Postpositioning symptoms and complications in 112 patients
underwent a second BioEnterics® Intragastric Balloon
Symptoms and
complications
Patient
(n,%)
Symptoms duration
mean± SD (range)
Therapy
Vomiting 20 (17.8) 4.3± 2.1 (1–18) Medical
Epigastric pain 20 (17.8) 4.7± 3.1 (3–25) Medical
Table 3 Comorbidities and their outcome according to resolution criteria
Comorbidity Incidence (n, %) Resolution criteria Resolution (n, %) Improvement (n, %) No change (n,%)
Respiratory disorders 31 (19.1) Absence of symptoms 17 (54.8) 13 (41.9) 1 (3.2)
Hypertension 22 (13.6) Systolic, <120–130 mmHg 7 (31.8) 11 (50) 4 (18.1)
Diabetes mellitus type II 16 (9.8) Fasting glycemia, <110 mg/dl 4 (25) 10 (62.5) 2 (12.5)
HbA1c, <6%
Osteoarthropathy 14 (8.6) Pain absence without drugs 3 (21.4) 7 (50) 4 (28.5)
Others 79 (46.9) 33 (41.7) 35 (44.3) 11 (13.9)
Total 162 64 (39.5) 76 (46.9) 22 (13.6)
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volume capacity (400–700 ml), and uses saline solution as
filling [13]. Prospective studies and extensive clinical
experience have shown that complication rates are very
low [14–19]. In the present study, BIB placement was also
safe and feasible in an outpatient setting (no hospital
admission) settlement. Related hospital mortality and major
complications were absent.
Intragastric balloon placement was usually performed
under conscious or unconscious sedation and local
anesthesia to avoid all the life-threatening complications
related to general anesthesia in morbidly obese patients
with one or more vascular or respiratory comorbidity.
Moreover, at the beginning of our experience, we
preferred performing intragastric balloon positioning
under general anesthesia and intubation in those patients
(27/714; 3.8%) with sleep apnea or COPD. In all these
patients, the BIB placement was without complication.
Despite almost all BIBs having been inflated with more
than 600 ml of saline, gastric or intestinal obstruction was
not observed. Only gastroparesis without obstruction was
diagnosed in 6/714 (0.8%) patients and presented with
abdominal pain and untreatable vomiting. Because of these
symptoms, the balloon was removed in all these patients.
The reasons for this complication are still unclear.
History of peptic ulcer or inflammatory disease of the
gastrointestinal tract was not considered a contraindication
for BIB® positioning, but duodenal ulcer, gastric ulcer, or
esophagitis can complicate the treatment with BIB®. Genco
observed that these patients’conservative treatment, such as
doubling H
2
proton pump inhibitor dosage, was easily
accomplished without causing particular discomfort [15]. In
the present experience, esophagitis and gastroduodenal
acute mucosal lesions were diagnosed in seven (0.9%)
and 22 (3.1%) patients, respectively, and were treated
conservatively by doubling drug doses with symptom relief
and without any kind of complication. No gastroduodenal
ulcers have been found due to rabeprazole compliance
treatment.
Large hiatal hernia was considered a contraindication for
intragastric balloon positioning, but very little is known
about small size hiatal hernia with gastroesophageal reflux
(GERD). In the present experience, 11/714 (1.5%) had
preoperative diagnosis of large hiatal hernia with GERD.
All patients were symptom-free and under drug therapy. In
all patients, the intragastric balloon was positioned and
followed without difference from the described protocol
and, during the 6-month treatment period, remained
symptom-free.
Weight loss has traditionally been the main outcome
measure in bariatric procedures. The mean BMI loss in the
presented series is 4.9±12.7 kg/m
2
and is comparable with
other results reported in the literature in patients with
different BMI at baseline (Table 6). In cases with a
Table 4 Comorbidities outcome after second intragastric balloon
Comorbidity Baseline
Incidence
(n,%)
Incidence after first
balloon (improved
+no changed)
Incidence
after second
balloon
Respiratory
disorders
7 (28) 3/7 (42.8) 2/3 (66.6)
Hypertension 5 (20) 3/5 (60) 2/3 (66.6)
Diabetes
mellitus type II
4 (16) 2/4 (50) 2/2 (100)
Osteoarthropathy 4 (16) 4/4 (100) 4/4 (100)
Others 5 (20) 3/5 (60) 3/3 (100)
Total 25 15/25 (60) 13/15 (86.6)
Table 5 Mean body mass index (BMI) at time of intragastric balloon
removal according to BMI initial range
BMI range Patients number Mean BMI at removal
<35 286 27±5.1
35< 40 223 29± 7.2
40< 45 145 37± 8.9
45< 50 39 43± 9.1
50< 21 41 ±10.9
25
30
35
40
baseline 4 months 2nd BIB 4 months
BMI
Fig. 1 Mean body mass index in 112 patients who underwent
sequential treatment with a second intragastric balloon
Table 6 Body mass index pre- and post-BioEnterics® Intragastric
Balloon placement—literature report with >50 patients
Author Patients
number
BMI at
baseline
BMI at
removal
Loffredo [3] 77 46.6 41.2
Sallet [19] 483 38.2 32.9
Melissas [25] 140 42.3 33.1
Genco [15] 2,515 44.4 35.4
Lopez-Nava 714 37.6 31.1/30.3
a
a
All patients/patients with second balloon
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consecutive treatment with a second BIB, the patients also
continue to lose weight, if not at the same rate of the first
balloon. The second BIB was usually inserted after 1 month
from the first balloon removal. This procedure was proposed
in a patient who hesitates for a definitive surgical treatment
and in cases of a long waiting list for the definitive bariatric
operation. This experience support this sequential approach in
which the patients had a continuous weight loss, also if not
significant, to avoid the patients weight regain waiting for
definitive bariatric surgery. Obviously, this outcome is not
comparable with results observed from bariatric surgery, but it
has obtained satisfactory basic results in terms of resolution of
comorbidities, since the risk of death from cardiovascular
disease, cancer, or other diseases increases throughout the
range of moderate and severe overweight [20,21]. Most
morbidly obese patients have several comorbidities that can
be life-threatening and/or have a negative influence on other
surgical treatments (i.e., orthopedic prosthesis). In the
present series, the improvement or resolution of preoperative
comorbidities has been obtained in 140/162 (86.4%)
patients. The importance of these results has also been
confirmed in a study that demonstrated the benefit of 10 kg
weight loss in terms of comorbidities (diabetes, blood
pressure, lipids, etc.) and related mortality [22–24].
This study shows that BIB® treatment is a safe and
effective procedure for weight reduction, without mortality
and with very low morbidity rates even in nonhospitalized
patients. BIB® does not represent adequate and definite
treatment of morbid obesity, but in several experiences, it
has been demonstrated to be helpful in the preoperative
treatment of morbidly obese patients undergoing bariatric
or other elective surgeries by helping to lower mortality and
morbidity risk. A second balloon can also be positioned
without difficulties, achieving good results after 12 months
of treatment. In conclusion, according to other experiences,
we believe that patient motivation and compliance are
essential, and respect for dietary and behavioral rules is
mandatory.
Acknowledgments We thank Dr. Michele Lorenzo for his precious
help.
References
1. Weiner A, Gutberlet H, Bockhorn H. Preparation of extremely
obese patients for laparoscopic gastric banding by gastric balloon
therapy. Obes Surg. 1999;9(3):261–4.
2. De Waele B, Reynaert H, Urbain D, et al. Intragastric balloons for
preoperative weight reduction. Obes Surg. 2000;10(1):58–60.
3. Loffredo A, Cappuccio M, De Luca M, et al. Three years experience
with the new intgragastric balloon, and a preoperative test for success
with restrictive surgery. Obes Surg. 2001;11:330–3.
4. Genco A, Balducci S, Bacci V, et al. Intragastric balloon or diet
alone? A retrospective evaluation. Obes Surg. 2008;18(8):989–92.
5. NIH Conference. Gastrointestinal surgery for severe obesity.
Consensus development conference panel. Ann Intern Med.
1991;115:956–61.
6. Nieben OG, Harboe H. Intragatric balloon as an artificial bezoar
for treatment of obesity. Lancet. 1982;1:198–9.
7. McFarland RJ, Grundy A, Gazet JC, et al. The intragastric ballon:
a novel idea proved ineffective. Br J Surg. 1987;74:137–9.
8. Ramhamadany EM, Fowler J, Baird IM. Effect of the gastric
balloon versus sham procedure on weight loss in obese subjects.
Gut. 1989;30:1054–7.
9. Benjamin SB, Maher KA, Cattau EL, et al. Double blind controlled
trial of the Garren-Edward gastric bubble: an adjunctive treatment for
exogenous obesity. Gastroenterology. 1988;95:581–8.
10. Mathus-Vliegen EMH, Tytgat GNJ. Intragastric balloons for
morbid obesity: results, patient tolerance and balloon life span.
Br J Surg. 1990;77(1):77–9.
11. Hogan RB, Johnston JH, Long BW, et al. A double blind,
randomised, sham controlled trial of the gastric bubble for obesity.
Gastrointest Endosc. 1989;35(5):381–5.
12. Meshkinpour H, Hsu D, Farivar S. Effect of gastric bubble as a
weight reduction device: a controlled, crossover study. Gastroen-
terology. 1988;95:589–92.
13. Schapiro M, Benjamin S, Blackburn G, et al. Obesity and the
gastric balloon: a comprehensive workshop. Tarpon springs,
Florida, March 19–21, 1987. Gatrointest Endosc. 1987;33:323–7.
14. Genco A, Cipriano M, Bacci V, et al. Bioenterics Intragastric
Balloon (BIB): a double blind, randomised, controlled, cross-over
study. Int J Obes. 2006;30:129–3.
15. Genco A, Bruni T, Doldi SB, et al. BioEnterics Intragastric
balloon: the Italian experience with 2, 515 patients. Obes Surg.
2005;15:1161–4.
16. Totté E, Hendrickx L, Pauwels M, et al. Weight reduction by
means of intragatric device: experience with the bioenterics
intragastric balloon. Obes Surg. 2001;11:519–23.
17. Hodson RM, Zacharoulis D, Goutzamani E, et al. Management
of obesity with the new intragastric balloon. Obes Surg.
2001;11:327–9.
18. Roman S, Napoleon B, Mion F, et al. Intragastric balloon for ‘non
morbid’obesity: a retrospective evaluation of tolerance and
efficacy. Obes Surg. 2004;14:539–44.
19. Sallet JA, Marchesini JB, Paiva DS, et al. Brazilian multicenter
study on the intragastric balloon. Obes Surg. 2004;14:991–8.
20. Calle EE, Thun MJ, Petrelli JM, et al. Body mass index and
mortality in a prospective cohort of U.S. adults. N Engl J Med.
1999;341:1097–115.
21. Adams KF, Schatzkin A, Harais TB, et al. Overweight, obesity,
and mortality in a large prospective cohort of persons 50 to
71 years old. N Engl J Med. 2006;355:763–78.
22. Deitel M. How much weight loss is sufficient to overcome major
co-morbidities? Obes Surg. 2001;11:659.
23. Pasulka PS, Bistrian BR, Benotti PN, et al. The risks of surgery in
obese patients. Ann Intern Med. 1986;104:540–6.
24. Pinkey JH, Sjostrom CD, Gale EA. Should surgeons treat diabetes
in severely obese people? Lancet. 2001;1:357–9.
25. Melissas J, Mouzas J, Filis D, et al. The Intragastric Balloon—
smoothing the path to bariatric surgery. Obes Surg. 2006;16:897–902.
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