Gastrointest Endoscopy Clin N Am

17 (2007) 545–557

Endoscopic Bariatric Procedures

and Devices
Kiyoshi Hashiba, MD
Department of Surgery, São Paulo University Medical School, Rua Anatólia,
105, São Paulo 05471-000, Brazil

Since the discovery of a correlation between bezoars and weight loss in

the early twentieth century, the medical community has been hopeful about
the use of iatrogenic bezoars for minimally invasive weight reduction endo-
scopic treatment [1]. Only recently the presentation of other modalities
started. The devices that can be applied in the endoscopic treatment of obe-
sity may be divided now into three categories: those that occupy a space in
the gastric lumen, those that make a restriction in the stomach lumen, and
finally the devices that alter food absorption. The interest in endoscopic
treatment of obese patients is growing as a result of the technical develop-
ment of endoscopic devices and because several studies have shown that
most patients do not need the substantial weight loss afforded by bariatric
surgery procedures. This article reviews current and investigational projects
and devices not available in the market.

Gastric volume–displacing weight loss devices (GVDD)

The intragastric balloons are the most important representatives of these
kinds of devices. They are intended to make a reduction in food intake and
body weight due to early satiety.
Animal studies seem to confound the argument by positively showing ef-
ficacy in dogs and rats [2,3]. When balloons of a particular volume were
placed in these animals, a reduction in food intake caused some weight
loss, although it should be noted that this effect diminished when the
balloon volume was reduced, indicating presence of some volume threshold
below which the balloon has no physiologic effect and above which patients
report undesirable symptoms. This volume varies with population. The

E-mail address: hashiba@attglobal.net

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doi:10.1016/j.giec.2007.05.008 giendo.theclinics.com
546 HASHIBA

sensations of satiety, fullness, bloatedness, and nausea can all be induced

by different volumes; however, the correlation is not so straightforward
[4,5].
The true mechanisms triggering weight loss from volume-displacing de-
vices are inconclusive. Isolating a particular mechanism or combination of
mechanisms is difficult because of the many factors that can be attributed
to weight loss. Hypotheses for weight loss from intragastric balloons include
delayed gastric emptying, mechanical volume reduction, hormonal changes,
and neuronal effects.
The general idea is well perceived and could possibly result in weight loss
because of an increased sense of fullness for a longer period of time. Studies
conducted with large devices such as the 600-mL saline-filled Bioenterics
Intragastric Balloon (BIB) (Bioenterics Corp., Carpinteria, CA) [6] or the
500-mL air-filled Ballobes [7] report a decrease or slowing of gastric
emptying rates. However, there are studies performed with Garren-Edwards
[8–10] and Willmen gastric bubble [11] that are conflicting.
The idea of weight loss from a volume-displacing device is the occupation
of a large volume of the stomach and reduction in its capacity to store food.
With reduced capacity to store foods, one subsequently eats less because of
an early feeling of fullness. Studies conducted by Durrans and colleagues [3],
suggest that the 200 mL balloon had no significant effect in intake whereas
the 500 mL balloon reduced energy intake.
Some chemical and biochemical markers stimulate and suppress appetite
and satiety. Cholecystokinin (CCK) has been shown to be associated with
appetite suppression. The relation of the serum marker elevation to the
balloon is not clear, but one study [12] showed that CCK reduced gastric
pressure in response to increasing balloon volume.
On the neuronal effects, it seems that distending the stomach stimulates
gastric stretch receptors, thus triggering vagal discharges that activate hypo-
thalamic neurons and induce the feeling of satiety [13].
However, there are hypotheses that reject the idea that the weight loss is
device-induced and attribute the weight loss to diet modifications, behavior
changes, and placebo effects [14].
In general, the intragastric devices are not recommended in patients with
a disease of the upper digestive tract. Patients with malignancy, pregnancy,
alcoholism, and drug abuse are also excluded.
The first intragastric device to be commercialized was the Garren-
Edwards balloon. Because of issues regarding the efficacy and safety of
the concept itself, it was withdrawn from the market after few years of use.
At present, the BIB and the Heliosphere Balloon (HB) (Helioscopie SA,
Vienne Cedex, France) seem to have found a niche in the international
iatrogenic bezoar market. Both balloons are smooth and spherical. The shell
is made of inert, nontoxic silicone elastomer, impervious and resistant to
gastric acid. The HB has two layers of the same sheet. Both of them have
a valve to retain liquid (BIB) and air (HB), connected with a balloon fill
 ENDOSCOPIC BARIATRIC PROCEDURES AND DEVICES 547

tube. The balloon is inserted collapsed within a sheath of plastic (BIB) or

cloth (HB).

Balloons insertion
Both balloons can be inserted under conscious sedation. This introduc-
tion is not controlled by endoscopy or radiograph. The balloon placement
assembly is inserted a distance from the incisor teeth and calculated so as
to be located 10 cm distal to the esophagogastric junction. The procedure
is easily performed, although the collapsed HB is more rigid. In both cases
a hand maneuver is needed to help the introduction in the hypopharynx.
The BIB usually is filled with a solution of methylene-blue (Fig. 1).
The balloons when filled adequately may cause some symptoms in the
postendoscopic period. It is important to observe the patient in the hospital,
because nausea, vomiting, and abdominal cramps are common. To control
these undesirable events, it is important to start symptomatic medications (an-
tiemetics and antispasmodics) immediately after insertion. These symptoms
are expected to last 72 hours, but, in few patients, they are uncontrolled and
the balloon needs to be removed. These events are less frequent and intense
with the HB [15]. On discharge, the patients are given a balanced diet of
around 1000 to 1500 kcal per day. Physical activity is also recommended.

Balloons removal
For balloon removal, as much fluid as possible should be removed in the
first step, using a needle or one catheter. The BIB balloon can be grasped
with a snare or a forceps. Finally, the endoscope and the balloon are removed.
Usually this procedure is easily performed. The same does not occur with the

Fig. 1. The BIB in a stomach filled with colored liquid.

548 HASHIBA

HB. In this case, after the maximum aspiration of the balloon, a specific device
must be used. This device has two claws that catch the balloon in the valve
(Fig. 2). The HB always finds a resistance in the cardia and the operator has
to wait for the relaxation of the muscles of the esophagogastric junction
area. Sometimes the first maneuver is not successful and the balloon has to
be grasped again. In this case, the removal procedure conducted with snare
and basket usually results in important esophageal trauma.

Results
During the implant period, the rate of weight loss typically increases in
the first week, remains constant for 3 to 4 additional weeks, and finally de-
creases as patients presumably adapt to the device. Probably, the distended
stomach’s increased capacity might contribute to increased food intake and
therefore decrease the rate of weight loss [2]. The treatment is effective in
well-motivated patients as a method for losing around 1 kg per week.
Most published studies are on the BIB balloon. For one of them [16], pa-
tients were invited for a randomized, double-blind trial of balloon or sham
treatment of 3 months’ duration. Only patients who achieved weight loss
were given an additional 9-month treatment. Forty-three patients held an av-
erage body mass index (BMI) of 43.3. Balloon and sham groups had similar
mean weight loss during the first 3 months. Balloon/balloon patients lost
significantly less weight in months 3 to 6 than did sham/balloon patients, evi-
dencing the weight loss plateau effect. Patients who completed the study per
protocol lost 25.6 kg (20.5%) after 1 year and 14.6 kg (11.4%) after 2 years.
A double-blind, sham-controlled, randomized and crossover study con-
ducted by Genco and colleagues included 32 patients with BMI of 40 to
45 and lasted 6 months [17,18]. The balloon group had a significant

Fig. 2. The HB after the complete deflation.

 ENDOSCOPIC BARIATRIC PROCEDURES AND DEVICES 549

reduction in BMI from 43.5 to 38.0. The authors concluded that in associ-
ation with appropriate diet, the device is significantly effective in weight re-
duction as compared with sham procedure plus diet control.
At the Sı́rio Libanês Hospital (SLH) in São Paulo (Brazil), an open pro-
spective study included 41 patients who did not respond to medical therapy.
A dietitian instructed each subject to consume a diet with 1200 kcal. On the
first and second days after the insertion, the patients received liquids, 200
mL, 8 times a day. Only water was allowed in the intervals. From the third
to seventh days of the postoperative course they received 7 times, 200 mL
of a full liquid diet. Between the 8th and the 30th days the patients received
200 g or 200 mL of a soft solid diet. The patients remained in the hospital for
1 day. Antiemetic and antispasmodic medications were administered for
8 days. Acid suppressant drugs were given during all the treatment. Physical
activity was advised. There were no complications in the insertion and re-
moval procedures. The mean initial weight was 112.07 kg and the BMI,
38.7. The final results were 92.45 kg and 32.4, respectively. No balloons de-
flated during the treatment. Only three were removed early. In one case, the
patient revealed intolerance for a long time (10 days) and in the other two,
the patients lost weight strongly in a short time (1 month) and they were
afraid to get sick. The data on the HB are limited and the results seem to
be similar to the BIB [15].

Complications
The spontaneous deflation of the balloon occurs in about 2% of cases
[16]. Probably, this is the most important adverse event in the treatment.
When the deflation occurs, the device can remain in the stomach or can
migrate distally. In some cases of migration, the balloon had to be removed
surgically. However, it is important to emphasize that most balloons lost
their contents. Some studies showed that well-functioning balloons deflate
at a rate of 2 to 3 mL per day [17]. The rates of complication related to
insertion and removal are low [15,16], but unpublished data (Jermid Q
and Hashiba K, 2006) show that the HB is more difficult to remove with
the current design and it requires a special device to complete the removal
procedure after the puncture for deflation.

Other balloons
The described BIB and HB are the balloons available on the market in
some parts of the world. However, since the first well-studied attempt to
treat obesity with balloons, there were other devices and few studies with
them (Table 1).
Recently, some studies were performed with a novel balloon device. It is
the Adjustable Totally Implanted Intragastric Prosthesis (ATIIP) Endogast
[19] (Districlass Medical S.A., Corbas, France).
550 HASHIBA

Table 1
Overview of balloons
Name Material Approximate date Volume (mL) filling fluid Shape
Garren-Edwards Polyurethane Early 1980s 250 air Cylinder
Taylor Silicon 1989–1990 550 water Pear
W.Cook Polyurethane Early 1980s 300 air Pear
Ballobes Polyurethane 1980s 500 air Spherical
BIB Silicon Current 500–800 water Spherical
Heliosphere Silicon Current 900 air Spherical
Endogast Silicon Current 300–800 air Pear

This device has a tube like a gastrostomy tube that keeps the balloon in
place. There are two models, one in which the gastrostomy tube has a valve
and the second in which the tube is totally implanted subcutaneously. The
advantage is the significant migration reduction and the volume control
that can be increased or decreased by the patient.
However, the difficulties in making a gastrostomy in obese patients and
the complications of the placement of the gastrostomy opening in the
abdominal wall are well known. One open study performed in patients
with mean BMI of 48.4 showed progressive weight loss: first month,
11 kg; 3 months, 18 kg; and 6 months, 22 kg. Most of the early complica-
tions were a result of the gastrostomy procedure. No late postoperative
complications occurred [19].
The present results with BIB showed that it is not an alternative to suc-
cessful bariatric surgery and seems to be most appropriate as a temporazing
adjunct measure for bariatric surgery candidates. The ultimate goal would
be to provide adequate psychological motivation for patients to maintain
their modified diet, thus maximizing the benefits of the balloon. It seems
also to be a suitable treatment for not morbidly obese patients with comor-
bities. At present, there is now general agreement that the treatment should
focus on a sustained 10% to 15% weight loss to prevent or to reduce the risk
of cardiovascular and other obesity-related diseases [16]. Considering that
the balloon treatment is easily reversible, the balloons seem to be a very
interesting option to treat some selected obese patients. However, a strong
reliance on the placebo effect, the lack of compliance with a modified diet
and behavior, and the stigma surrounding the Garren-Edwards bubble fail-
ure prevent widespread acceptance of the concept.
A different kind of GVDD is the development of a device made with
polyethilene (Butterfly; Wilson-Cook Medical Inc., Winston Salem, North
Carolina) [20]. In the final design of the experimental phase, a 36-meter strip
was made (Fig. 3). This long strip was 75 m thick and 3 cm wide, folded in
the middle. The strip was divided into loops of 40 cm that are put together in
bundles of seven loops so as to facilitate the insertion (Fig. 4). The loop has
a hole, each 20 cm, to allow the passing of a thread to close the device be-
tween two drags in the thread ends. A 36-cm long, 1.6-cm diameter overtube
 ENDOSCOPIC BARIATRIC PROCEDURES AND DEVICES 551

Fig. 3. Early design of the Butterfly device.

was used in all procedures. Canola oil was used as lubricant. The insertion
was performed in a left-side position and under general anesthesia. Intrave-
nous (IV) antibiotics were given immediately after the procedure.
The device is easily inserted and removed from the gastric lumen. Some
trauma always occurs during the insertion in the posterior wall, near the car-
dia, but it can be reduced if the stomach is kept distended. When the clinical
study started, it was difficult to compress the loops to obtain a compact
device. So, some distal loops released from the block and migrated distally
to the duodenum.
To have a compact plastic device, a 3-m long polyethylene flexible tube 75
m was used. This tube was compressed over a plastic tube used as a guide
and pusher. The compressed plastic tube has a plastic ring at every segment
of 15 cm (Fig. 4). The pusher holds the ring to insert the polyethylene tube in
a continuous movement, without the need to return to the mouth, as in the
previous design. To deploy this later generation device, it needs to come
back 15 cm to take the other segment to push. As the device has a drag

Fig. 4. Current Butterfly ready to be inserted.

552 HASHIBA

in the distal end of the central thread, when the insertion finishes, another
drag is placed in the proximal end and closes the device after a suitable com-
pression (Figs. 5 and 6).
This device seems to have some advantages over the balloons, because it
does not need to be inflated or to change in any shape to work and allows
for different sizes as needed. It does not have valves to keep fluids and the
migration seems to be limited. The mechanisms of action resulting in weight
loss can also differ from those of the balloons. While the ideal position for
the balloons in the stomach is the fundus/body, the described plastic device
can move in the gastric lumen and probably distend the stomach due to its
volume and the emptying delay. However, this action can be the same as the
majority of balloons, because most of them lose their contents during the
treatment [17].
Further studies will show the real usefulness of the device to treat obese
patients.

Gastric lumen restriction with suture

The development of endoscopic suturing devices has enabled the
endoscopist to attempt an endoscopic version of the vertical gastroplasty.
One initial study [21] was performed in a postmortem specimen of porcine
stomach using the endoscopic suturing device available in the US market
(Endocinch, C.R. Bard, Inc., Murray Hill, New Jersey) to treat GERD
(Gastroesophageal Reflux Disease). With this sewing machine, mounted
in the distal end of a flexible upper gastrointestinal endoscope, a tunnel
was created by suturing together the anterior and posterior walls of the
stomach near the cardia and the side of the lesser curvature. In the distal
part of this restricted area a plastic flexible ring, 3 cm in diameter, was su-
tured to the stomach. The authors suggested that the purpose of the outlet
ring was to secure the gastroplasty.

Fig. 5. The shape of the present Butterfly after the insertion maneuvers.
 ENDOSCOPIC BARIATRIC PROCEDURES AND DEVICES 553

Fig. 6. Endoscopic view of Butterfly into the stomach.

Gastric reduction has also been performed in live animals using another
endoscopic suturing device [22]. The 2-0 stitches were placed in the gastric
fundus, 5 cm below the gastroesophageal junction. Differently, the suture
was closed using extracorporeal knots. The authors needed 10 to 12 stitches
to obtain a gastric pouch with 30 mL at the end of the procedure. There was
no follow-up in this study.
Certainly, there are many reasons why this procedure has not become
more widely attempted. One of them is that the experience with endoscopic
sutures in GERD treatment showed that most patients (83%) lost the
stitches after 18 months [23]. Moreover, in cases of the open vertical-banded
gastroplasty, in the late postoperative course, a staple-line disruption
occurred in 30% of cases, allowing an abnormal communication between
the ‘‘stomachs’’ and subsequent weight gain [24]. Moreover, the studies
performed in Hospital Novo Atibaia Experimental Surgery Center (São
Paulo, Brazil) on vertical gastroplasty in pigs with a transmural device
[25] showed a suture disruption 1 month later.
Nevertheless, a recent published report [26] on 10 patients, showed weight
loss between 15 to 49 kg after endoscopic vertical gastroplasty. The Bard
Endocinch was used in this study (Figs. 7 and 8). The BMI of patients
ranged between 25 and 35. Only one plication had to be repeated after 9
months because of rupture of the suture. All patients complained of sore
throats for 2 days. No complications occurred in any procedures performed
under general anesthesia. Laboratory tests demonstrated clinical significant
reductions in cholesterol and triglycerides.
Thus, it appears that endoscopic gastric reduction is technically feasible.
With the development of new endoscopic suturing devices, more preclinical
554 HASHIBA

Fig. 7. Endoscopic view of the gastric restriction with Endocinch. (Courtesy of Dr. Roberto
Fogel, Caracas, Venezuela.)

research and new clinical studies will evaluate whether an endoscopic proce-
dure can achieve long-lasting results and determine its clinical impact.

Endoscopic devices to alter food absorption

Recently, investigators have attempted to perform an endoscopic bypass
using a sleeve in the duodenum and proximal jejunum. It consists of a very
thin polyethylene flexible tube, impermeable, attached to an autoexpandable
metal stent in the proximal end [27] (GI Sleeve, GIDinamics Inc.,

Fig. 8. Radiographic study of the stomach after the Endocinch suture. (Courtesy of Dr. Rob-
erto Fogel, Caracas, Venezuela.)
 ENDOSCOPIC BARIATRIC PROCEDURES AND DEVICES 555

Fig. 9. GISleeve placed into the duodenum. The arrows show the sleeve. (Courtesy of Dr. Man-
oel Galvão Neto, São Paulo, Brazil.)

Watertown, Massachusetts). This stent has a special design to keep the

sleeve in place. Thus, food would not have contact with the mucosa for
a variable length between 180 and 360 cm. For the same reason, the bilio-
pancreatic secretions are not in contact with ingested foods throughout
the same distance (Fig. 9).
After experimental studies, a feasibility and safety clinical study was per-
formed in Chile. Ten patients received the device and then 7 had it removed.
There were no complications of insertion or removal. After 90 days, the pa-
tients showed weight loss around 20% of the baseline weight. The patients’
overall health improved during the treatment period.
There have been other attempts to treat obesity through endoscopy, like
the botulinum toxin antral injection [28]. However, poor results due to lack
of alteration of appetite and minimal weight loss suggest only a limited pos-
sibility with further data required.

Summary
The development of endoscopic treatments for obesity offers gastroenter-
ologists, surgeons, and endoscopists an exciting and highly desirable less-
invasive therapeutic modality as compared with bariatric surgery. At
present, preliminary results cannot compare with those offered by surgical
treatment, but in selected patients, all endoscopic procedures have afforded
important improvements in patient health by reducing the comorbidities as-
sociated with morbid obesity. With the development of new techniques, the
possibility of a combined procedure can offer an interesting therapeutic
556 HASHIBA

alternative. Most modalities of endoscopic treatment of obesity are still at

a very early stage and clearly much work remains to be done. However,
the results reported in studies such as the ones discussed here should encour-
age further research and development of the techniques described.

Acknowledgments
I thank Mr. Vihar Surti for helping me with the preparation of the text
and Ms. Alvamar H.C.A. Lamparelli for helping me with the manuscript
revision.

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