ReShape Lifesciences Update

June 4, 2018 Update to FDA Health Care Professional Letter

As you may know, on June 4, 2018, the United States Food and Drug Administration (FDA) posted a Letter to Health Care Providers on their website that updates the Agency’s August 10, 2017, letter, regarding the potential risks of death associated with liquid-filled intragastric balloons manufactured by Apollo Endosurgery and ReShape Lifesciences™ that can be found here.

Below you will find a number of materials that are available to help educate the medical community and patients about the ReShape Balloon™

Available Support Materials

ReShape Lifesciences Response to FDA’s Letter to Health Care Providers (HCPs)
Updated Instructions for Use (IFU)
Updated Patient Information Guide

At ReShape Lifesciences, our highest priority is patient safety. As always, we encourage you to please continue to report any of these incidences or any other complication that you may have with any of our products via our complaint handling process. If you have any questions, please don’t hesitate to call our Customer Service Department at 1-844-937-7374.