Background: Since March 1998, 143 BioEnterics(R) Intragastric Balloons (BIB
) were placed in 132 obese and morbidly obese patients, to study the clinic
al possibilities of a new system, both from the point of view of the materi
als used and the application method.
Methods: 36 patients were male and 96 female; mean age was 43 years (21-70)
; mean weight was 115.4 kg (67-229), and mean BMI was 41.0 (29-81). 8 patie
nts were affected by severe respiratory insufficiency. We placed and remove
d the balloon endoscopically under conscious sedation or general anesthesia
. BIB was removed in the majority of patients 4 months after insertion. The
patients were given a balanced diet of 800-1000 kcal/day; follow-up involv
ed a monthly check-up (routine blood tests, weight control) and a visit eve
ry 15 days with the dietitian.
Results: Mean weight loss was 14.4 kg; mean reduction in BMI was 5.2. Weigh
t loss was much better in males. The weight loss produced an improvement of
the complications associated with the obesity. Complications observed were
: balloon intolerance (9 early removals), 1 balloon deflated and passed, 2
cases of gastric ulcer at balloon removal.
Conclusions: The most correct indications for BIB should be: extremely obes
e patients (BMI>40) in preparation for a bariatric operation; obese patient
s with BMI 30-35 with a chronic disease otherwise unresolved; patients with
BMI < 30 in a multidisciplinary approach.