Update regarding Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), (updated October 2019).
For members who have patients concerned by the recent TGA changes to the use of textured implants, please find following, a WORD version of a draft letter that you may like to tailor and send under your name and letterhead to those patients. ASAPS and ASPS have worked together to agree the content of this draft letter.
If you have any further questions please contact the ASPS or ASAPS office.
This fact sheet and an accompanying statement can be located at the following links on the TGA website:
The TGA have also updated the consumer BIA-ALCL page to include a link to the fact sheet.
Evidence from a range of sources is being assessed as the TGA forms a final decision in relation to its review of the link between BIA-ALCL and textured breast implants.
Textured breast implants and tissue expanders made by Allergan are being recalled from sale globally.
These implants have been linked to anaplastic large-cell lymphoma (ALCL), which is a rare cancer of the immune system. It is not breast cancer, but can develop adjacent to a breast implant. In most cases, removing the implant and the capsule around it cures the disease. The main symptoms patients should be aware of are an unusual swelling and/or fluid accumulation in the breast or around the implant. If any of these symptoms occur please see your Specialist Plastic Surgeon. Your surgeon knows the details of your implants and will assess you and if appropriate perform tests which may include a biopsy or draining the fluid and sending it for specific testing. A delay in diagnosis has been shown to have poorer long term outcomes.
ALCL has occurred associated with implants placed both for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer. It has also occurred in implants that are filled with silicone or saline. Whilst there are several hypotheses, why this texturing leads to cancer in some patients is not known.
The lymphoma is rare, given that millions of women have breast implants.
Women who have these implants, but no symptoms, do not need to have them removed. The recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergan.
“Patient safety is a priority for Allergan,” the company said in a statement, “and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns.”
Although several companies make textured implants, a great majority of the lymphoma cases have occurred in women with the Allergan products and the Australian Society of Plastic Surgery supports their withdrawal from the market.
On 19th May 2009 ASPS President wrote to the TGA in relation to breast implants. The same letter was sent to all members. It contains relevant references. Read more.
The Therapeutic Goods Administration (TGA) published an ALCL information page on 11 Jan 2011 (updated 28 Oct 2014).
Guide for Patients. Download the guide (updated August 2019).