ReShape Lifesciences Responds to FDA Letter to Health Care Providers
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™. ReShape Lifesciences appreciates FDA’s diligence and collaboration in working with industry, physicians and patients and their families to keep all groups informed about the risks and benefits of intragastric balloons. At ReShape Lifesciences, our highest priority is patient safety: FDA’s recent update addresses this priority and we welcome the opportunity to provide additional information that is relevant to FDA’s most recent communication.
FDA’s most recent communication updates the healthcare community regarding additional reports of deaths they have received since August 2017 and discusses the collaborative effort taken with industry to understand these occurrences and enhance product labeling accordingly. We reported to FDA that, in total, ReShape Lifesciences received three reports of death since the commercial launch of the ReShape Balloon™ in August 2015. These three deaths occurred out of more than 5000 balloons implanted around the world, including those in our clinical trial (265) and those sold commercially. The occurrence rate, expressed as a percentage of all the ReShape Balloons implanted through April 30, 2018, is 0.06%1.
Of the three patient deaths reported in association with the ReShape Balloon, one was the result of sepsis secondary to an esophageal perforation. The second event occurred following device placement and involved severe vomiting during the 24-hour post-implant period. The third event was due to a pulmonary embolization secondary to a gastric perforation.
As noted, we worked closely with FDA to review and enhance our Instructions for Use (IFU), patient information and physician training materials. These updates provide additional information regarding methods and clinical assessments to further assist physicians and patients in the safe and effective use of the ReShape Balloon. Our updated IFU also includes commercial occurrence rates for conditions that physicians track closely such as death, acute pancreatitis, spontaneous hyperinflation and perforations of the esophagus and stomach.
It is important to note that FDA’s recommendations to providers remains the same: Intragastric balloons should be carefully placed and patients should be closely monitored during the entire term of their treatment. In addition, physicians are encouraged to inform patients of the potential risks associated with the use of intragastric balloons and ensure they understand the signs and symptoms that may indicate the development of underlying serious complications. In particular, the importance of seeking immediate care in the event of acute development of severe abdominal pain or the presence of blue-green urine.
We must reiterate that patient safety is our highest priority. We designed our intragastric dual balloon system with this mind, including providing our product in a sterile form and incorporating two balloons which is intended to provide protection from migration in the event of a deflation.
We will continue to work with the FDA to mitigate patient risk and optimize outcomes of the ReShape Balloon. Our customer service department has emailed updated IFUs and patient information to all physician customers. Please feel free to contact me if you did not receive the updated labeling or if have any questions or concerns related to the FDA communication and/or the safety and effectiveness of the ReShape Balloon. We want to hear from you.
Deborah L. Schmalz
Vice President, Regulatory Affairs, Clinical Research and Compliance
1 The rate of occurrence in the United States does not differ significantly from the overall, global rate.