Home About Qualtech NEWS SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants – June, 2019
SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants – June, 2019

June 11, 2019

Called as a cancer of the immune system, BIA-ALCL is diagnosed by swelling around the implants on patients. Reports showed that this can manifest as early as 1 year to as late as 37 years after the breast implant surgery. If diagnosed early, BIA-ALCL is treatable via surgery, chemotherapy and targeted immunotherapy.

HSA took precautionary measures as the cases of BIA-ALCL rose in 2017 by requiring manufacturers of breast implants to include cautionary statements regarding BIA-ALCL risk in the package inserts of the products being sold in Singapore. Recent growing global concerns on BIA-ALCL prompt HSA experts to reexamine the local situation of the product in Singapore. The expert panel concluded that textured surface implants are associated with the disease. With this decision, HSA has disallowed the sale of Allergan Natrelle Breast Implant, which is a textured implant, in Singapore since April 2019.

HSA encourages patients who are going to use or current users of the device to be vigilant for the symptoms of BIA-ALCL by reporting to proper authority.

 

References:
Risk of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), [Press Release] Risk Of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), BIA-ALCL Infographic, BIA-ALCL FAQs

Tags:
HSA Singapore, Post Market, Medical Device Safety, Product Recall

 

Follow us here and stay updated on all latest happenings in Asia medical device market and more:

Facebook iconLinkedin iconTwitter icon

 

 
Home About Qualtech NEWS SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants – June, 2019