BioEnterics Intragastric Balloon for the treatment of pathologic obesity in Prader-Willi patients

Obesity in Prader-Willi syndrome (PWS) is progressive, severe and resistant to dietary, pharmacological and behavioural treatment. A reduction in body weight is mandatory to reduce the risk of cardiorespiratory and metabolic complications. The aim of the present study was to assess the risks and benefits of the BioEnterics Intragastric Balloon (BIB) for the treatment of morbid obesity in patients with PWS. Twenty-one BIBs were positioned in 12 patients with PWS (4 male and 8 female) aged from 8.1 to 30.1 years, and were removed after 8 ± (SD) 1.4 (range 5-10) months. Auxological, clinical and nutritional evaluations were performed every 2 months. Variations in body composition were analysed by dual-energy X-ray absorptiometry (DEXA). One patient (aged 28.5 years and with a body mass index [BMI] of 59.3 kg/m2) died 22 days after BIB positioning because of gastric perforation. In another individual (26.2 years, BMI 57.6 kg/m2), the BIB was surgically removed after 25 days because of symptoms suggesting gastric perforation (which was not confirmed). The remaining 10 patients showed a significant decrease of BMI (p = 0.005) and of fat tissue as measured by DEXA (p = 0.012). No significant modifications in bone mineral density occurred, but a slight loss in lean body mass (p = 0.036) was documented. In five patients, BIB treatment was repeated more than once. This study shows that when non-invasive pharmacological therapies fail, BIB may be effective to control body weight in PWS patients with morbid obesity, particularly when treatment is started in early childhood. However, careful clinical follow-up and close collaboration with parents are crucial to avoid severe complications, which can be caused by persisting unrestrained food intake.