BioEnterics (R) Intragastric Balloon (BIB (R)). Single Ambulatory Center Spanish Experience with 714 Consecutive Patients Treated with One or Two Consecutive Balloons

Background The BioEnterics (R) Intragastric Balloon (BIB (R)) 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 (R) results in terms of weight loss and comorbidity change. Methods BIB (R) 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 (R) 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 (R) 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.