Five More Deaths, FDA Alerts on Liquid-Filled Intragastric Balloons

By MedTech Intelligence Staff

This is the second alert the agency has issued in less than one year.

Five more deaths have been reported in patients where liquid-filled intragastric balloon systems were used to treat obesity. That brings the total number of deaths to 12 patients worldwide since 2012.

MedTech Intelligence last reported on this issue in August 2017, with the cases involving the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System.

Last week the FDA approved labeling changes that indicated deaths could be associated with the above-mentioned devices. The agency is also monitoring complications associated with device placement and use, which includes perforation of the stomach wall or esophagus, acute pancreatitis, and spontaneous hyperinflation. Healthcare providers have also been advised to monitor patients who have these balloons for complications.

Related Articles

  • Alert

    The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.

  • RQM plus logo

    Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.

  • MedTech Regulatory Intelligence Summit

    Registration is now open for the MedTech Regulatory Intelligence Summit in Washington, DC, May 16-17. Join us as we take a closer look at strategies and best practices in developing an effective and sustainable regulatory strategy for today’s global market.

  • MedTech Regulatory Intelligence Summit

    On May 16-17, device developers, regulatory affairs and regulatory intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements.

About The Author

MedTech Intelligence