Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization

Are We Moving in the Right Direction by Altering Gastric Motility for Weight Loss?

“…A recent registry study of over 1300 patients with gas-filled balloons demonstrated a TBWL of 10.2%. 21 This is similar to other registry data on fluidfilled balloons, which resulted in TBWL of 11.8% with the single balloon and 11.4% with the dual balloon. 7,22 Moreover, when looking at the pivotal sham control trials, the weight loss between the 2 balloons is similar: 7.1% vs 3.6% TBWL in the gas-filled balloon compared with 6.8% vs 3.3% TBWL in the fluid-filled dual balloon trial.…”

AGA Technical Review on Intragastric Balloons in the Management of Obesity

“…Furthermore, both FDA-commissioned and investigator-initiated post-marketing surveillance studies have not demonstrated a significant mortality rate associated with IGB when the therapy is administered within the context of a comprehensive obesity care program with close patient follow-up. [95][96][97] There was limited evidence from RCT data for the efficacy of IGB for the treatment of obesity comorbidities, as most of the RCTs were conducted in patients with no or mild comorbidities. However, it is well established that 5%-10% weight loss is used as a surrogate marker for improvement in comorbidities and metabolic markers.…”

Bariatric endoscopy: current primary therapies and endoscopic management of complications and other related conditions

“…The authors concluded that IGB should be used as a bridge therapy to definitive therapy [10] . Moore et al [11] evaluated the outcomes at 6 months in 1,343 patients who had one or up to three Obalon IGB placed. The majority of adverse events were mild and did not require intervention; nonetheless, two severe adverse events were reported which included balloon slippage to the pylorus and gastric perforation.…”

“…Although weight loss was achieved in the population studied, long-term data are still needed to prove its efficiency. The most common adverse events reported with the use of IGB are abdominal pain, nausea, vomiting, and balloon deflation [10][11][12] . The use of IGB should be considered as either bridge therapy to definitive bariatric surgery or in patients who need only moderate weight loss in combination with behavior modification.…”