Background: The Spatz3 Adjustable balloon system is approved for 1 year implantation and allows multiple changes in the balloon volume during the course of implantation.Other intragastric balloons are currently approved for 6 months and their balloon volumes cannot be adjusted after implantation.Aim: To determine the efficacy and safety of the Spatz3 adjustable balloon system.Methods: Seventy seven consecutive patients (66 females and 11 males) in two medical centers were implanted with the Spatz3 adjustable balloon device and were followed prospectively. The patients’ mean BMI was 37.2; the mean weight was 108.7 kg; the mean age was 41 (16-68); the mean balloon volume was 469 ml (450-500 ml). Adjustments were made for intolerance or weight loss plateau.Results: The mean weight loss at 1 year was 17.2 kg with 15.9 % weight loss and 42.9 % Excess Weight Loss (%EWL). Eighteen patients underwent balloon volume adjustments: three downward adjustments of 100 -150 cc which alleviated early intolerance; 15 upward adjustments (mean 320 ml; range 200-500) at a mean 4.1 months (range 2-5 months) yielded additional mean wt loss of 8.2 kg (range 0-25 kg) after the adjustment. Three balloons were removed before the 1 year completion date due to intolerance and three others were removed for other reasons (pregnancy, gall bladder surgery, and alcoholism). There was one episode of gastric ulceration which required endoscopic therapy and balloon removal. There were no deflations or perforations. Conclusions: The Spatz3 adjustable balloon is a safe and effective treatment for weight loss. The adjustability function can yield greater weight loss for those who show weight loss plateau and can mitigate intolerance.
One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons