The Therapeutic Goods Administration (TGA)’s breast implant expert working group met on Monday to discuss whether Australia follows France and Canada in banning textured implants. The TGA have been monitoring the link between breast implants and breast implant associated anaplastic large cell lymphoma (BIA-ALCL) since 2011 with the expert working group established in 2016, and convened the meeting in response to the decision by regulators in France and Canada to take several textured implants off their market.
However, the TGA joined other countries’ regulators including several in Europe and the United States FDA in deferring a definitive decision until further data is available. The group identified gaps in the information currently available in Australia on textured implants and BIA-ALCL so have taken several steps to rectify this including a formal request for all Australian suppliers of textured breast implants to provide dates and numbers of how many have been supplied to the Australian market. The group are also concerned with the different grades of texture on the implants and have asked suppliers to also provide samples of several of their products. Australian breast implant suppliers have 10 working days to respond to the requests.
While BIA-ALCL is rare, as of 8 April 2019 there have been 76 reports of BIA-ALCL in Australian women – all of them had textured implants. While this is a small percentage compared to the number of breast implant procedures in Australia which is estimated to be between 13,000 and 17,000 each year, the TGA says they take the potential risk to women’s health very seriously. In fact, it was Australian Plastic Surgeon Dr Anand Deva’s research on women with textured implants that contributed to France’s decision to ban textured implants.
Dr Deva’s research estimated that the risk of developing BIA-ALCL is 1 in 2,800, however the TGA’s official position on their website is that between one in 1,000 and one in 10,000 patients with textured breast implants are diagnosed with the condition.
The Flip Side – Benefits to Textured Implants
The working group also discussed the benefits of textured implants. It has long been recognised that textured implants are less likely to move around in the patient’s body compared with smooth or teardrop implants. However, obviously patient safety is paramount and once the relevant information is received the TGA say they will consider whether or not to suspend or completely cancel particular textured implants from the Australian Register of Therapeutic Goods. It was also identified there is a need to update the TGA website with the most up-to-date information about both the benefits and risks of any implant, including the signs and symptoms of BIA-ALCL (the most common being swelling or a lump in the breast). The TGA have also confirmed the introduction of a new requirement for Patient Information Leaflets to increase patient access to information.
In the meantime patients with textured implants need to recognise that BIA-ALCL is a VERY rare disease. In fact, one of the reasons why it’s taken so long to compile data is that such a large number of women have them and are completely fine. If you have any symptoms and are concerned at all, contact your surgeon or doctor. To read more about BIA-ALCL check out the blog below: