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 the outcomes from the breast implant review. 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.
A number of health professionals have shared their thoughts and advice on some common questions and concerns consumers have about BIA-ALCL. Watch the below video to learn more.
Since the TGA decision to remove a range of breast implants from the market due to safety concerns about the risk of BIA-ALCL, we are aware that the Australians with implants may have a range of concerns and questions.
We are here today with a number of health professionals to answer some of the most frequently asked questions.
What is BIA-ALCL?
So BIA-ALCL stands for Breast Implant Associated Anaplastic Large Cell Lymphoma. It's a type of cancer, but not a breast cancer. It's a cancer that is derived from the immune cells, your lymphocytes and it's been associated with breast implants. So it's a cancer surrounding a breast implant that's a cancer of your immune blood cells.
What is the risk of getting BIA-ALCL?
When we talk about implants we talk about the texture or the outer surface of the implant. The higher the texture the more stable the implant is but it comes with an increased risk of this rare condition.
So to date we don't have a case that has arisen from the smooth implant at all, so that good. And then the risk goes a little bit higher to an implant that's a grade 2 implant. Theses grade 2 implants are rough but not very rough and that carries a risk of around about one case in every 30,000 implants that go in and then the highest risk are implants that are very very rough and that risk is around 1-2, one case in every 2,000 -3,000.
What are the symptoms of BIA-ALCL?
Well the most common way of presenting often would be that the patient would notice some swelling, in one or both of their breasts. It could be anytime from one year up to many years after their surgery. Sometimes there is a mass that can be found as well on an ultrasound but swelling is the most common presentation.
I have symptoms, how should I get them followed up?
First point of call would be to see the surgeon that put the implants in, now if the surgeon is not contactable or retired then go and see your GP about seeing another surgeon and possibly getting an ultrasound.
I have implants that are no longer available in Australia and I am experiencing breast pain. I don't feel supported or protected by my surgeon. What do I do now?
The best thing to do is see your GP and they will definitely put you in the right direction to someone else that will be possibly you will feel more comfortable dealing with.
I don't know what type of implants I have; how can I find out?
Often at the time of surgery patients are given a card or some documentation. So have a look thru your paper work at home, it may be that your card is still somewhere where you can find it and that should have the implant details attached. Now if that's lost for whatever reason then and the surgeon has retired or perhaps is no longer in practice. Then the hospital where you had the implant might be a good port of call there are often records of your surgery with the details, so that's number two and the third thing is that we do have some registries so there is the Australian Breast Advice Registry (ABDR), or prior to that the Breast Implant Registry (BIR) and so it may be worth contacting them. The contact details are on the web and you can ask them if your name and implant details have been stored in the data base.
I think I may have BIA-ALCL. My surgeon has retired, where can I go to get tested?
In this instance I still think the first place to go would be your General Practitioner for an assessment to see whether or not the symptoms are correlating with ALCL.
Usually if there is a question if there is a tumor then an ultrasound is what is required. Usually after an examination ultrasound it is pretty clear whether or not you have it or not. And certainly if there is a suspicion a referral to a surgeon who knows how to treat this condition is mandatory.
What is the treatment for BIA-ALCL?
So in most cases, once the diagnosis is made, treatment is just with surgery alone. The surgery involves removal of the implant but also the capsule, which is the tissue around the implant and once that's gone in the majority of cases, around 87% of women, that's all you need, you are cured. In less common circumstances if the cancer has spread then you may need other treatments such as radiation or chemotherapy.
I have implants which have been recalled, should I have them removed?
Our recommendation is likely going to be yearly reviewed with either your GP, your surgeon or somebody running a clinic but generally unless you have symptoms we would not be advocating form removal. The reason for that is because of the risks associated with surgery.
My surgeon recommends removing the implants but not the surrounding scar tissue (capsule). Is this OK?
If there's pathology, if there's rupture and if there's capsular contracture then we should try and remove the abnormal or pathological capsule. In some instances, where the capsule is not abnormal, say the implant has moved or the patient wants a change in size, then it's not necessary to remove the entire capsule and in sometimes we actually use the capsule to stabilise the implant. So I think it depends on what the indication for removal is.
How can I be sure that my surgeon removes all the surrounding scar tissue (capsule) when my implants are removed?
To be 100% sure, what people are asking for are photos of the actual implant and also a photo demonstrating what has actually happened during the operation. With varying angles so you know you have got the upper part of the capsule and the posterial lower part of the capsule as well
I don't have symptoms, but I am worried. Should I have my implants removed?
If there are no symptoms, then the important thing to remember is that it is unlikely that you have anything wrong and certainly it is unlikely that you have ALCL. So I am not recommending that people with no symptoms at all have their implants removed.
We'll be hosting an interactive forum to give you an opportunity to ask additional questions early in 2020.
In the meantime, if you have additional questions, you can visit the TGA website or visit your treating surgeon.
We also hosted two discussion panels in Sydney on 14 February 2020, one to discuss BIA-ALCL and breast reconstructive surgery and another to discuss BIA-ALCL and breast augmentations. These were recorded and have been made available as webinars to view online. The webinars provide information for consumers on a variety of issue, including clinical guidelines, follow-up, consent processes, regulatory changes, financial issues and complications and their management.
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. The recent review by the TGA has found between one in 2,500 and one in 25,000 people with breast implants are diagnosed with the condition in Australia; based on confirmed cases of BIA-ALCL where only one brand of implant had been used. The risk of developing BIA-ALCL increases with increasing texturing of the implant. Implants which have a smooth surfaced have not been associated with BIA-ALCL. Breast implant associated cancer can occur after either reconstruction or augmentation 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 how often in your case there should be monitoring over the longer term.
Medical experts do not recommend removing your breast implants if you do not have symptoms of BIA ALCL, even if your implants are no longer supplied in Australia. This is because BIA ALCL is a rare cancer with excellent cure rates if it is detected early.
The risk of developing BIA ALCL is lower than the risks associated with an anaesthetic and surgery. The complication rate of revision surgery involving implant removal or replacement is also higher with each revision procedure.
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 also discuss a plan for regular check ups. 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.
Regardless of the brand or texture of the implant, or if you have had your implants removed, you should regularly carry out breast self-examination and seek review by your general practitioner if you have any concerns or notice any changes in your breasts.
Even if your breast implant procedure did not attract a Medicare benefit at time of implantation, 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.