Background: The policy reviews regulatory approvals and safety communications for implantable bariatric devices. It lists FDA premarket approvals and clearances for specific intragastric balloon systems and other implantable devices, including the Obalon intragastric balloon system (PMA Sept 2016; labeled for adults with BMI 30 to 40 kg/m2, maximum placement time 6 months), the AspireAssist System (PMA Jun 2016; labeled for adults age >22 years with BMI 35.0 to 55.0 kg/m2), and the ORBERA intragastric balloon system (PMA Aug 2015; labeled for adults with BMI 30 to 40 kg/m2, maximum placement time 6 months). The policy also documents FDA approvals/clearances for other devices (eg, ReShape Integrated Dual Balloon System, TransPyloric Shuttle) and endoscopic suturing systems.
Safety communications: The policy cites FDA safety communications concerning intragastric balloons, including FDA letters reporting spontaneous balloon inflation, cases of pancreatitis, and multiple unanticipated deaths (5 deaths reported in 2016–2017 and a total of 12 deaths worldwide reported through June 2018), and continued FDA recommendations for close patient monitoring and counseling about potentially life-threatening complications (eg, balloon deflation, gastrointestinal obstruction, perforation, acute pancreatitis, spontaneous hyperinflation).
Policy determination: Despite device-specific regulatory approvals, the policy concludes that the listed surgical and minimally invasive procedures (including intragastric balloons, gastrointestinal liners, endoscopic sleeve gastroplasty, duodenal-jejunal sleeves, and others) are considered investigational for treatment of obesity because overall evidence quality is low and long-term efficacy and safety data from large well-designed trials are insufficient to demonstrate a net health benefit.