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Voluntary worldwide recall of BIOCELL® textured breast implants and BIOCELL® textured tissue expanders

A Dear Healthcare Professional Letter has been issued by Allergan Singapore Pte Ltd to notify healthcare professionals on the voluntary worldwide recall of Natrelle BIOCELL® textured breast implants and Natrelle BIOCELL® textured tissue expanders. Allergan is taking this global action as a precaution after being notified of the recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).  Locally, Health Sciences Authority (HSA) has disallowed the sale of the Allergan Natrelle breast implant, since April 2019. A HSA Dear Healthcare Professional Letter has also been issued in May 2019 to update healthcare professionals on the risk of BIA-ALCL. Since 2017, HSA has required cautionary statements regarding the risk to be included in the package inserts of breast implants. Healthcare professionals are advised to cease implanting the affected devices and return any unused devices to Allergan Singapore Pte Ltd. It is important to note that the HSA, FDA and other global health authorities, do not recommend the removal or replacement of textured breast implants or textured tissue expanders in asymptomatic patients. Please refer to the letter for details.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.