TGA and an update on BIA-ALCL
The TGA recently convened an expert panel to assess the safety of textured implants and the risk of ALCL.
Australian Society of Plastic Surgeons Professor Mark Ashton explains in this video what implants are associated with a higher incidence of ALCL and what the current recommendations are by the TGA.
- Patient needs to be genetically predisposed
- Contamination during insertion: a critical factor for ALCL is exposure by a particular bacteria to the implant during the surgical procedure
- Textured implant: ALCL is not associated with smooth implants
*Not all textured implants – Allergan and Polyeurethane have a risk of 1:2300. Between 5%-20% of all implants inserted are this kind of implant.
- Textured implants provide a legitimate role in breast surgery and their use should be considered on a case by case basis.
- Dr Tavakoli does not use Macro textured implants associated with the higher risk of ALC.
- Please see below for an extract from the TGA on BIA-ALCL
What has the TGA been doing to monitor BIA-ALCL?
- The TGA has been monitoring BIA-ALCL since 2011 after receiving the first adverse event report in 2009. It established an expert working group in 2016 to seek advice on BIA-ALCL. The working group includes plastic surgeons, cosmetic surgeons, breast-cancer surgeons, cancer epidemiologists, data analysts, public -health practitioners and consumers.
- The TGA has worked with this group to develop targeted information for consumers and health professionals.
- The introduction of a new requirement for Patient Information Leaflets for implantable devices commencing in 2018 enhances patient access to information.
Why hasn’t TGA immediately banned these products?
- There are a range of types of textured breast implants supplied in Australian. By compelling suppliers to provide additional information specific to the Australian market, the TGA can make well informed decisions about safety of particular types of implants. Suppliers have 10 working days to respond to the request for information. After receiving this information the TGA will consider action to suspend or cancel particular products.
- The decision by the French regulator appears to be based on events described to them from patients and doctors as well as data published about three implants, which has been extrapolated to other products. Other regulators, including those in the US, Germany and the UK are also seeking additional evidence on the risk of BIA-ALCL, and we are working closely with these regulators.
- Patients who have breast implants should expect that the regulator makes decisions based on sound scientific and medical evidence.
- Textured implants of varying roughness are used in 82% of operations in Australia. They play an important role in reconstructive surgery. Smooth implants are an alternative but they may require a higher rate of replacement reoperation due to greater rates of contracture of these implant.
- The international consensus is that there is no evidence supporting the removal of breast implants in the absence of properly diagnosed BIA-ALCL.