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Breast implant associated cancer (or BIA-ALCL)
What are breast implants?
Breast implants are fluid-filled pouches inserted in the breast area. They are inserted for many reasons, including cosmetic enhancement and reconstruction after surgery.
These implants are usually distinguished by their contents. Saline implants are filled with sterile salt water, which will be absorbed by the body if the implant leaks. Silicone implants are filled with silicone gel.
They can also be distinguished by their shape and texture. Most implants are either round or teardrop-shaped, and they can be different sizes. The surface of an implant can be smooth, textured, or coated in foam. Foam-coated implants are considered to be textured implants.
Breast implants are not lifetime devices, and need to be replaced after ten to fifteen years.
What is breast implant associated cancer?
Breast implant associated cancer, or breast implant associated anaplastic large cell lymphoma (BIA-ALCL), is a rare cancer of the immune system. It is not breast cancer, which forms from cells in the breast, but instead a cancer that grows in the fluid and scar tissue that forms around a breast implant.
The most common symptom of breast implant associated cancer is swelling of a breast caused by fluid build-up, but in some cases it may appear as a lump in the breast or armpit.
Breast implant associated cancer will not be detected by a mammogram, and is usually tested for by analysis of a sample of the fluid around the implant. If you develop swelling of an implanted breast, your doctor will send you for an ultrasound scan to see if this is due to a fluid collection. If the ultrasound shows that fluid is present, a sample of the fluid will be removed and sent to a laboratory for analysis. Most fluid build-ups are not due to ALCL, but the laboratory test will be able to tell for sure.
Georgia's Story – a breast implant cancer case study
Three years after getting breast implants, Georgia noticed 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.
Who can get breast implant associated cancer?
All Australian reported cases of this cancer involve patients who have had a textured implant inserted at some point in their life. Patients with smooth implants may still develop this cancer if they have previously had a textured implant or tissue expander inserted. Based on current evidence, experts do not think breast implant associated cancer is related to either the contents (saline/silicone) or shape (round/teardrop) of the implant.
Breast implant cancer can occur after both cosmetic and reconstruction surgery, with 95% of cases occurring between 3 and 14 years after the insertion of an implant. The cancer is rare, with an estimated one in 1,000 to 10,000 chance of having this diagnosis.
How is breast implant associated cancer treated?
In most cases, removal of the implants and the scar tissue that forms around the implant is all that is necessary to treat the cancer. If the cancer has spread to other areas of the body, further treatment is likely to be necessary.
What should I do if I have breast implants?
Experts do not recommend removal of the implant in a healthy person with no symptoms. If your surgeon recommends removing implants despite not having any symptoms, we recommend you seek a second opinion.
Because the cancer is rare, there is no need for regular screening. People with breast implants should be aware of the symptoms of breast implant associated cancer, such as painful swelling of a breast after the initial recovery time has passed (swelling immediately after surgery is normal). Any changes are unlikely to be breast implant associated cancer, but you should raise all concerns with your doctor, and also 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.
What is the role of the TGA?
In Australia, breast implants are regulated as high risk medical devices. This means that we evaluate these products for safety, quality and performance (that they will do what they are supposed to) before they can be used in surgery. The TGA, working closely with the Australian Breast Device Registry, which also monitors breast implant products after supply, makes sure these products continue to perform as expected and remain safe to use.
We are currently monitoring the relationship between breast implants and this form of cancer, and publish updates as new information becomes available. In 2016, we assembled an expert advisory panel to guide consumers and health professionals on this relationship. The advice of this panel is published on our website.
You should report any issues to your doctor or the TGA
The TGA welcomes reports of adverse event associated with any medical device through the Incident Reporting and Investigation Scheme (IRIS). The information received through this scheme helps us gather information about the real-world performance and safety of medical devices.
You should visit the reporting problems page to let us know through the online form of any issues you may be experiencing. Please include as much information as you have available, including implant/explant dates, model and serial numbers.