Updates to Instructions for Use of SpaceOAR™ and SpaceOAR Vue™ Systems to mitigate the risk of embolism

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific to inform healthcare professionals of upcoming updates to the Instructions for Use (IFU) for the SpaceOAR^™ and SpaceOAR Vue^™ Systems to provide new information to help mitigate the known risk of embolism. Recently, Boston Scientific had received three reports of embolism that occurred outside of the pelvis due to inadvertent placement of SpaceOAR gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis. The reported embolism events included both venous and arterial embolism in blood vessels to organs in the gastrointestinal tract and lower extremities. Consequently, the IFU will be updated to reinforce and expand on current content to reduce inadvertent hydrogel misplacements and raise the awareness of the remote possibility that embolisms may present outside of the pelvis in the venous or arterial systems. Healthcare professionals are advised to review the upcoming IFU updates attached with this letter to help mitigate the risk of embolism. 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.