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Breast implant associated cancer (or BIA-ALCL)

3 May 2019

The TGA has commenced its review and laboratory testing of samples received from the sponsors of breast implants in Australia. Read the update.

What are breast implants?

Breast implants are fluid-filled pouches inserted in the breast area. People may get breast implants for many reasons, including cosmetic enhancement and reconstruction after surgery.

Breast implants differ in their size, shape, filling and texture. 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 textured.

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.

What is breast implant associated cancer?

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.

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.

Read more of Georgia's story in our blog post

Who can get breast implant associated cancer?

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.

What is the treatment for BIA-ALCL?

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, such as chemotherapy, radiotherapy or additional surgery.

How do I spot the symptoms?

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, 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.

Breast implant associated cancer is not detected by a mammogram. If you develop swelling of an implanted breast, your doctor will send you for an ultrasound scan to see if the swelling is due to fluid build-up. If the ultrasound shows that fluid is present, a sample of the fluid will be removed and sent to a laboratory for analysis. This analysis will help identify if the fluid build-up is caused by breast implant associated cancer. Most fluid build-ups are not caused by breast implant associated cancer.

What if I have no symptoms at all?

Because breast implant associated cancer is rare, experts do not recommend removal of implants 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.

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.

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 also works closely with the Australian Breast Device Registry to monitor the ongoing safety and performance of breast implants.

We publish updates on breast implant associated cancer as new information becomes available. Since 2016, we have convened an expert advisory panel to provide consumers and health professionals with advice on breast implant associated cancer. The panel's advice is published on our website.

The TGA works closely with international regulators to monitor the safety and quality of medical devices. In the international context,on 28 May 2019, Health Canada released an update to the safety review that was being undertaken in relation to BIA-ALCL. The outcome has been the suspension of Allergan Biocell implants from the market in Canada due to the increased risk of BIA-ALCL with textured implants. The Allergan Biocell implants are the only textured implants available in Canada.

The National Institute for Public Health and the Environment (RIVM) in the Netherlands published the findings of their review of BIA-ALCL on 17 May 2019. As a result, the Minister has decided that the devices will not be subject to further regulatory action in the Netherlands, at this time.

The United States Food and Drug Administration (FDA) released a statement on 2 May 2019 detailing the steps that they will take following a public meeting held by the FDA on 25 and 26 March 2019. The meeting discussed the benefits and risks of breast implants indicated for breast augmentation and reconstruction, including:

  1. breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
  2. systemic symptoms reported in patients receiving breast implants
  3. the use of registries for breast implant surveillance
  4. magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants
  5. the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy
  6. the use of real-world data and patient perspectives in regulatory decision making
  7. best practices for informed consent discussions between patients and clinicians.

A letter was sent by the FDA to health professionals on 6 February 2019 to increase the awareness of BIA-ALCL. Read the update.

Health Canada has also announced on 4 April 2019 that Allergan Biocell implants will be suspended from their market.

The FDA has acknowledged the latest developments and will publish more information as it becomes available.

The TGA's breast implant expert working group met on 8 April 2019 to discuss the current data on BIA-ALCL rates and correlation with type of implant. This followed decisions taken by regulators in France and Canada to remove selected textured implants from their market. Read the update.

What has the TGA been doing to monitor BIA-ALCL?

The TGA has been monitoring BIA-ALCL since 2011 after receiving the first adverse event report in 2009. It established an expert working group in 2016 to seek advice on BIA-ALCL. The working group includes plastic surgeons, cosmetic surgeons, breast-cancer surgeons, cancer epidemiologists, data analysts, public -health practitioners and consumers.

The TGA has worked with this group to develop targeted information for consumers and health professionals.

Why hasn't TGA immediately banned these products?

There are a range of types of textured and smooth breast implants supplied in Australia. By compelling suppliers to provide additional information specific to the Australian market, the TGA can make well informed decisions about safety of particular types of implants. Following the latest expert working group meeting in April 2019, suppliers were given 10 working days to respond to the request for information. After receiving this information the TGA will consider action to suspend or cancel particular products.

The decision by the French regulator appears to be based on events described to them from patients and doctors as well as data published about three implants, which has been extrapolated to other products. Other regulators, including those in the US, Germany and the UK are also seeking additional evidence on the risk of BIA-ALCL, and we are working closely with these regulators.

Patients who have breast implants should expect that the regulator makes decisions based on sound scientific and medical evidence.

Textured implants of varying roughness are used in 82% of operations in Australia. They play an important role in reconstructive surgery. Smooth implants are an alternative but they may require a higher rate of replacement reoperation due to greater rates of contracture of these implant.

The international consensus is that there is no evidence supporting the removal of breast implants in the absence of properly diagnosed BIA-ALCL.

Report any problems to the TGA

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.