A fact sheet (pdf,774kb) to support consumers following a recall of Allergan Biocell breast implants has been published today by the Therapeutic Goods Administration (TGA).
The fact sheet has been published in the wake of Allergan's decision to recall un-implanted macro-textured breast implants and tissue expanders. The decision was made on 2 August 2019 due to a rare but acknowledged risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The recall means all Allergan breast implants of the Biocell macro-textured type from the Natrelle product range have been returned to the supplier and are no longer available.
However, Allergan smooth and Allergan BRST Microcell breast implants have not been recalled and are still available.
The risk of developing BIA-ALCL is rare. For this reason, people who have the Allergan macro-textured breast implants are being advised that removal is not recommended if there are no symptoms. This recommendation takes into consideration the surgical and anaesthetic risks associated with undergoing an operation to remove the implants, which may be greater than the risk of developing BIA-ALCL.
The TGA advises, however, that people with the affected implants should see their implanting surgeon to find out how often they will need to be reviewed. They should also continue to examine themselves regularly and see their doctor urgently if symptoms occur.
BIA-ALCL is a cancer of the lymphatic system and is not breast cancer. Early detection and removal of the implant with the surrounding scar tissue can result in a cure in the majority of cases. This is why it is essential that consumers know how to recognise symptoms of BIA-ALCL and seek review by their general practitioner and treating surgeon as soon as concerns arise.
The TGA has undertaken a review of textured breast implants and tissue expanders and a decision is pending regarding what regulatory action may be taken in relation to those devices which are currently available on the Australian market. The TGA is examining the large amount of material it is continuing to receive from device manufacturers, practitioner groups and consumers. It is expected that a decision on the regulatory action will be made in September.