Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
The U.S. Food & Drug Administration
Breast implants and Anaplastic Large Cell Lymphoma (ALCL)
Medicines and Healthcare Regulatory Agency
The TGA has published Allergan’s independent decision to initiate a Medical Device Recall and Implant Hazard Alert, regarding its macro-textured breast implants and tissue expanders. Read the update.
Breast implants are gel or fluid-filled pouches inserted in the breast area. People may get breast implants for many reasons, including cosmetic enhancement or reconstruction after breast surgery.
Breast implants differ in their size, shape, filling and surface characteristics. Most implants are either round or teardrop-shaped. They may be filled with saline (sterile salt water) or with silicone gel. The surface of the implant may be smooth or rough (textured) and different implants may vary in the amount of irregularity of the texture.
Breast implants are not lifetime devices and need to be replaced after 10 to 15 years.
If you are considering breast implants, read our page that covers things you should know before undergoing the procedure.
Breast implant associated cancer, which is also known as 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. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.
BIA-ALCL has been known to occur as soon as one year after the operation and as late as 37 years after the operation. The average time to diagnosis is within 8 years of the operation.
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.
All reported cases of breast implant associated cancer in Australia involve patients who have had a textured implant at some point in their life. 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 associated cancer is rare. Between one in 1000 and one in 10,000 people with breast implants are diagnosed with the condition. Breast implant associated cancer can occur after both cosmetic and reconstruction surgery, with 95% of cases occurring between three and 14 years after the insertion of an 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 fluid is present it will be removed and sent to the laboratory for analysis. Most fluid collections are not due to BIA-ALCL, but the laboratory test will be able to tell for sure.
If confirmed, your specialist may also order an MRI scan or CT scan to assess the extent of local growth or distant spread of the cancer. Other tests such as a PET scan may be also used to assess spread.
A mammogram will check for breast cancer, but is not useful for detecting BIA-ALCL.
It is usual that care is provided by a multi-disciplinary team. A treatment plan may be developed with advice from a blood disease specialist with experience in lymphoma, a cancer specialist, and a surgeon with breast implant experience.
In about 80% of cases, the disease is detected in the early stage, with cancer cells found only in the fluid surrounding the implant. Most of these cases are cured by removal of the implant and surrounding capsule. Over the last 10 years, four Australian women have died from breast implant-associated lymphoma.
Usually, both implants are removed even if breast implant-associated ALCL has only occurred in one breast. This is because there is a small but real risk that breast implant-associated ALCL can develop in the opposite breast. If there is a solid lump or the cancer has spread, the patient may require additional treatment such as chemotherapy, radiotherapy or additional surgery. Follow up monitoring may require additional CT scans.
It is important to know the symptoms of breast implant associated cancer. The most common symptom is swelling of a breast caused by fluid build-up around the implant, but in some cases it may appear as a lump in the breast or armpit.
As this is a rare disease, changes in your breast are unlikely to be breast implant associated cancer. For example, swelling immediately after your breast implant surgery is normal. But you should raise all concerns with your surgeon, including the possibility of breast implant associated cancer. If the surgeon or clinic which performed your original implant operation is no longer available, you should see your GP for referral to another surgeon.
Get to know the normal look and feel of your breasts. Self-examine your breasts regularly, such as in the bath or shower, and include your armpits and up to your collarbone.
If you think there are any changes, or if you have any concerns, see your doctor.
Discuss with your surgeon whether in your case there should be any longer term monitoring.
Generally, breast implants are not lifetime devices, regardless of breast implant associated cancer. Typically they are removed after 10-15 years. The longer you have the implant, the more likely it will need to be removed. Common reasons for removal are contracture (hard or painful implants) or movement of the implant.
Breast implant associated cancer is rare, but the risk is higher with certain types of breast implants. If you do not remember whether your implants are smooth or textured, or what brand they are, your surgeon or the clinic that holds your operation record should be able to advise you on these details.
It is best to discuss with your surgeon what they would recommend in their clinical opinion given the type of implant you have and the benefits versus risks of removal of implants in a healthy person with no symptoms. You can seek a second opinion to help you decide on options, or if you are unsure or concerned about the advice you receive from your surgeon.
Even if your breast implants may have been inserted for purely cosmetic purposes and so the implantation surgery did not attract a Medicare benefit at the time, services for investigation and treatment of breast implant associated cancer, as with any other cancer, are eligible for payment of Medicare benefits. In addition to benefits for diagnostic imaging and pathology services, there is also a Medicare benefit specific for magnetic resonance imaging (MRI) investigation of patients diagnosed with BIA-ALCL (MBS item 63547).
A Medicare benefit is payable under MBS item 45551 for removal of each breast implant and its surrounding capsule. Other MBS items are available for lymph node procedures and for other types of breast surgery if required. Your surgeon will choose the appropriate items depending on the procedure that is clinically necessary for you.
The TGA strongly encourages you to report all problems associated with medical devices, including breast implants. Your report helps us to monitor the performance and safety of medical devices. We investigate safety concerns, and if there is a problem, we take action to notify and protect the community.
Visit the reporting problems page to complete the online form and share any problems you may be experiencing. Please include as much information as you can, including implant/explant dates, model and serial numbers.