Update on contraindication and cautionary statements in the device labelling of laparoscopic power morcellator devices intended for use in gynaecology

HSA would like to update healthcare professionals on the inclusion of contraindication and cautionary statements on the risk of spreading unsuspected uterine sarcoma in the device labelling of locally registered laparoscopic power morcellators (LPMs) used in gynaecological procedures. This regulatory decision was made in consultation with HSA’s Expert Panel on LPMs and the Medical Device Advisory Committee (MDAC), following HSA’s assessment of the available scientific data on the associated risk. Healthcare professionals are advised to take the new contraindication and cautionary statements into consideration when undertaking laparoscopic morcellation in gynaecological procedures, and share the necessary information related to the potential risk of spreading unsuspected uterine cancer with their patients.

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.