Both gastric balloon manufacturers in the US asked the FDA for approval to use their device in patients with a BMI of 30-40. In August 2016 the FDA granted approval for their request. Most likely in the future, data will be submitted to the FDA and requests will be made to increase the BMI limit.
- Your BMI is over 40, which lies outside this initial range of approval. You may still be a candidate for a balloon, however it would be considered off-label use of the device.
- Patients who have a BMI over 40, or who need to lose more than 50 lbs may be better off with a surgical weight loss option.