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Health Sciences Authority
Dear Healthcare Professional Letters

Labelling and Patient Booklet Updates for BIB™/ Orbera™/ Orbera365™ Intragastric Balloon Systems

Audiences

Healthcare professional

Industry member

Product type

Medical devices

13 September 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Emergo Singapore Consulting Pvt. Ltd on behalf of Apollo Endosurgery to inform healthcare professionals of labelling changes for the BIB™/ Orbera™/ Orbera365™ Intragastric Balloon Systems. As a condition of the US Food and Drug Administration (FDA) approval, Apollo Endosurgery conducted a post-approval study to collect further information on the safety and effectiveness of its intragastric balloons. While no new risks were identified, this study highlighted the known risk of balloon hyperinflation, which is believed to be possibly related to the presence of microorganisms entering the balloon during placement. Consequently, the Directions for Use (DFUs) for the intragastric balloon systems have been updated to indicate that the balloon filling procedure should be performed using aseptic technique (e.g. use of clean or sterile gloves, sterile syringe, etc). The contraindications, warnings and precautions have been revised to improve clarity and consistency. A patient booklet to provide patient education on intragastric balloon therapy and the importance of communicating symptoms of balloon intolerance to their healthcare provider, is also expected to be available online in October 2021. Healthcare professionals are advised to review the changes reflected in the DFUs highlighted in the letter. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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