Consumers and health professionals are advised that Allergan has elected to issue an implant hazard alert regarding already implanted macro-textured breast implants and tissue expanders, due to the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in rare cases. Un-implanted stock of these products are also being recalled from the market.
Micro textured and smooth breast implants are not affected by this sponsor initiated recall action.
BIA-ALCL usually involves a swelling of the breast, on an average of eight years after the operation to insert the device. This swelling is usually due to an accumulation of fluid around the implant over time. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit. It is a rare condition, with experts estimating the published risk of BIA-ALCL at between 1-in-1000 and 1-in-10,000.
Although fatalities have been recorded, the vast majority of BIA-ALCL cases are effectively managed by removal of the implant and the surrounding capsule.
The TGA has published a range of information regarding this issue, and others associated with breast implants, in the Breast implant hub. The TGA also recently published the preliminary outcomes of a review into all textured breast implants on the Australian market.
Information for consumers
If you have breast implants and notice swelling or a lump in your breast or armpit, or you have any other concerns with your implants, you should seek medical attention.
Because BIA-ALCL is a rare condition, experts do not recommend removal of these breast implants, where there are no current problems with the implant.