Brazilian multicenter study of the intragastric balloon.
BACKGROUND
Intragastric balloons have been used in obese patients to provide early satiety and thereby induce weight loss. Several studies have reported promising results with a new balloon (BIB((R))) designed to overcome some of the technical pitfalls of earlier devices. We assessed both safety and effectiveness of the BIB((R)).


METHODS
From November 2000 to February 2004, 483 overweight and obese patients were treated with the BIB((R)). 323 patients completed a 6-month follow-up, and 85 of them completed a 1-year follow-up. All patients took part in a multidisciplinary program involving clinical, psychiatric, physical training, and dietary approaches.


RESULTS
Compared to baseline values, after a 6-month follow-up subjects showed significant reductions in weight (15.2 +/- 10.5 kg), percent excess weight loss (48.3 +/- 28.1), and BMI (-5.3 +/- 3.4 kg/m(2)) (P < 0.000). At 1-year follow-up, 85 patients have maintained more than 90% of their BMI reduction. The main side-effects were nausea/vomiting (40%), and epigastric pain (20%), requiring removal of the BIB (R) in 11 patients (3.4%). Minor complications were reflux esophagitis (12%) and symptomatic gastric stasis (9%). Balloon impaction occurred in 2 cases (0.6%), and in 1 patient (0.3%) there was spontaneous deflation of the balloon leading to a small-bowel obstruction solved by a surgical approach.


CONCLUSIONS
The BIB((R)) has been effective to temporarily control obesity, inducing an excess weight loss of approximately 48%. It was not associated with mortality and showed minimal risk of major complications.
Coordinator of the Brazilian Intragastric Balloon Protocol, Interdisciplinary Obesity Treatment Group, Sallet Clinic, São Paulo. acsallet@sti.com.br
José A
JA
Sallet
João B
JB
Marchesini
Dyker S
DS
Paiva
Keila
K
Komoto
Carlos E
CE
Pizani
Maurélio L B
ML
Ribeiro
Pablo
P
Miguel
Alvaro M
AM
Ferraz
Paulo C
PC
Sallet
D000328:Adult; D015992:Body Mass Index; D020878:Device Removal; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects; D006801:Humans; D008297:Male; D009765:Obesity / Q000628:therapy*; D009767:Obesity, Morbid / Q000628:therapy; D015431:Weight Loss