The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The Therapeutic Goods Administration (TGA) monitors the performance and safety of medical devices such as breast implants.
The TGA is currently monitoring the association between breast implants and anaplastic large cell lymphoma (ALCL), a rare cancer of the immune system. This cancer is often called BIA-ALCL, or breast implant associated anaplastic large cell lymphoma.
All Australian reported cases of BIA-ALCL involve a textured implant having been implanted at some point in the patient's life. To date in most cases the removal of the implants and the tissue capsule that forms around the implant is all that is necessary to treat the cancer. The factors that cause the cancer are unknown, and further research is being undertaken in Australia and overseas.
If you have breast implants but do not notice changes to your body, there is no reason to worry. Any changes are unlikely to be BIA-ALCL, but if you have breast implants you should be aware of the symptoms so you can consult a doctor.
Georgia's story explains how to spot the warning signs for this cancer, and how it can be diagnosed and treated.
Georgia's Story
Georgia was 25 when she had her second child.
A year after giving birth Georgia had returned to her pre-pregnancy weight, but she was unhappy with some of the changes in her body. She wanted her pre-pregnancy body back.
Georgia decided to get cosmetic breast implants to restore her breasts to their pre-pregnancy shape. She consulted her General Practitioner (GP) who recommended a surgeon with experience in breast augmentation. The surgeon inserted textured silicone gel breast implants.
Three years later, Georgia noticed an unusual and painful swelling in one of her breasts.
Georgia visited her GP who referred her back to the surgeon who inserted the breast implants. The surgeon ordered an ultrasound. The scan identified a build-up of fluid near the implant, and a sample of the fluid was analysed.
Georgia was diagnosed with a rare cancer of the immune system, BIA-ALCL.
What is BIA-ALCL?
BIA-ALCL is a cancer associated with breast implants. BIA-ALCL is not breast cancer, where a cancer forms from cells in the breast. Instead, it is a cancer of the body's disease-fighting lymphatic system and will usually grow in the fluid and internal scar tissue that develops around the breast implant.
The most common symptom of BIA-ALCL is swelling of a breast caused by fluid build-up, although in some cases it may present as a lump in the breast or the armpit.
So far, BIA-ALCL has been seen in association with both saline and silicone filled implants, and implants with a textured surface, not smooth. People with smooth implants may still develop the cancer if they have previously had a textured implant inserted.
How common is BIA-ALCL?
BIA-ALCL is a rare cancer, and it is estimated that 1 in 1,000 to 10,000 people with breast implants will be diagnosed. The cancer occurs in breasts that have implants inserted for both cosmetic or breast reconstruction reasons, and 95% of cases occur between 3 and 14 years after the insertion of the latest implant.
How is BIA-ALCL diagnosed?
In Georgia's case, an ultrasound determined that the breast was swelling because of a fluid build-up, and further analysis of the fluid confirmed this was caused by BIA-ALCL. However, most breast implant related fluid build-up is not caused by BIA-ALCL.
The surgeon also ordered a CT scan to assess whether the cancer had spread to other parts of Georgia's body. Tests such as an MRI or a PET scan may be used to assess the growth of a cancer. In Georgia's case the cancer was still confined to the breast area.
A mammogram will check for breast cancer, but does not detect BIA-ALCL.
How is BIA-ALCL treated?
Georgia's treatment plan was developed with advice from a blood disease specialist with experience in lymphoma, a cancer specialist, and a surgeon with breast implant experience.
In 85% of cases, cancer cells are only found in the fluid, and the only treatment required is the removal of the implants and the tissue capsule surrounding the implants. Usually, both implants are removed. If there is a physical growth or the cancer has spread, the patient may require additional treatment such as chemotherapy, radiotherapy or additional surgery.
Georgia's BIA-ALCL was treated by the surgical removal of both of her breast implants and the tissue capsule around the implant.
For two years after the removal of the implants, Georgia's doctor scheduled CT scans to check for return of the cancer. Georgia's scans have all been normal with no signs of a recurrence of BIA-ALCL.
What should I do if I have breast implants?
Experts do not recommend removal of the implant in a healthy person with no symptoms, and because the cancer is rare there is no need for regular screening for BIA-ALCL. If your surgeon recommends you have your implants removed despite not having any symptoms, we recommend you get a second opinion.
If you have a breast implant and detect any change in the breast or armpit such as swelling, a lump or pain you should consult your doctor and raise the possibility of BIA-ALCL.
If you do not remember whether your implants are smooth or textured, or what brand they are, your surgeon will be able to advise you on these details.
How can I find out more?
The Therapeutic Goods Administration (TGA) monitors medical devices after sale to ensure they continue to be as safe as possible, perform to appropriate standards, and comply with regulations.
As part of the ongoing monitoring of breast implant health risks, in 2016 the TGA assembled an expert advisory panel to provide guidance on BIA-ALCL. The TGA has published this panel's advice for consumers and health professionals.
Research into BIA-ALCL is ongoing. People with breast implants are advised to monitor their body, and to consult their doctor if they have any health concerns.
