The U.S. Food and Drug Administration (FDA) is interested in a patient engagement activity (listening session) seeking feedback from patients who have used any of the following FDA approved medical devices for weight loss:

• ReShape vBloc (formerly Maestro Rechargeable System) – Approved in 2015
• ReShape Integrated Dual Balloon System – Approved in 2015
• ORBERA Intragastric Balloon System – Approved in 2015
• AspireAssist – Approved in 2016
• Obalon Balloon System – Approved in 2016

The listening session will be a collaborative conversation between regulators and weight loss device users regarding the patients’ expectations for these devices and treatment decision-making process, the impact on their quality of life, and input on patient resources. The meeting is scheduled for Thursday, June 28, 2018 from 10:00a-12:00p at the FDA White Oak Campus in Silver Spring, MD. There will be an available call-in option for remote access.

Please distribute this information and attached flyer to patients who might be interested in attending. This meeting is not open to the public, therefore interested participants should contact Laura Gottschalk by June 22, 2018 for more information.

Email: laura.gottschalk@fda.hhs.gov
Phone: (301) 796-0798