BIA-ALCL is a rare subtype of T-cell lymphoma that can develop in association with textured and polyurethane breast implants.

BIA-ALCL is a rare form of cancer that has been identified as having a possible link with textured breast implants. It is not breast cancer, but instead a form of Non-Hodgkin’s Lymphoma related to an immune response in the breast tissue immediately surrounding the implant.

The condition is exceptionally rare. There have been less than 800 reported cases worldwide out of the millions who’ve received breast implants. Because of how rare the condition is, it is difficult to gauge accurate risk levels. As of January 2019, the Australian Therapeutic Goods Association (TGA) notes there has been a total of 76 cases reported, with approximately 50 patients identified in Australia and a further 10 in New Zealand. The TGA notes that risk levels can be between 1:1,000 and 1:10,000, however medical literature estimates it is even rarer, between 1:3,000 and 1:30,000.

The overwhelming majority of cases are associated with textured-surface implants only, which themselves account for a small proportion of breast implants. This suggests that there is a link between textured implants and increased risk of contracting the condition. In Australia, there is yet to be any reported cases linking this form of cancer with smooth implants.

The most common form of treatment for this condition is the complete capsulectomy – removal of the implants and fibrous capsule tissue. Approximately 80% of patients are cured completely following implant removal. Because the cancer is a form of lymphoma, unless it has spread beyond the lymph nodes in the breast, it is unlikely you will need further treatment. In the US, after three years, 93% of BIA-ALCL patients are disease-free.

The TGA (Therapeutic Goods Administration) has notified manufacturers that certain types of textured implants may be removed from the market and others suspended for 6 months for review, depending on the texturing on their surface. This comes in response to many scientific papers showing the link between the degree of texturing on an implant, and the risk of developing a BIA-ALCL. The average time from insertion of implants to development of the lymphoma is 7 to 10 years. The risk depends on the surface area of texture. High surface area texture (e.g. Allergan, Silimed) have risks of 1 in 4000-7000 patients. Lower surface area texture (e.g. Mentor) have 1 in 60’000 risk.

The TGA is in the process of making final decisions for which implants will be removed from the market, suspended or allowed for continued use.

To find out more information about the TGA’s monitoring of BIA-ALCL, you can visit their website here.

If you would like to find out more information about breast implant removal, listen to Dr Yang’s podcast.

Otherwise, you can find further information provided by the Australian Society of Plastic Surgeons and the Australasian Society of Aesthetic Plastic Surgeons about this condition below.

What is BIA-ALCL?

• Breast Implant-Associated Anaplastic Large Cell Lymphoma is a rare form of cancer linked to the presence and bodily reaction to textured breast implants.
• It typically presents itself as swelling of the breast due to an accumulation of fluid. It is known to occur most commonly between 3 to 14 years after the original breast implant surgery (augmentation mammoplasty). However, there have been cases diagnosed as early as 1 year and as late as 37 years after the operation.
• Treatment for BIA-ALCL involves removal of the implant as well as the capsule surrounding the implant.
• If you have noticed swelling or any lumps in the areas around your implant, you should consult with your doctor or surgeon as soon as possible.

What is it caused by?

• In partnership with international research organisations, Australian and New Zealand Plastic Surgeons are working proactively to be at the forefront of investigating the disease and its nature.
• Evidence suggests that it is caused by a long-term inflammatory response to bacteria that becomes present within the lymphoma and around the implants.
• There may also be genetic factors that come into play for individual women.
• The TGA and Medsafe in New Zealand continue to investigate and monitor developments in research to improve our understanding of the disease

Why is it not considered breast cancer?

• BIA-ALCL develops in the fluid surrounding the breast implant and is usually contained by the fibrous capsule around implants.
• It does not develop in the breast tissue.

What are the related symptoms?

• The most common symptom is continued swelling of the breast
• Other symptoms include a lump in the breast or armpit area
• The swelling is caused by fluid collection accumulating around the implant, as the lymphoma develops around the implant and within the fibrous capsule developed by the body

What are the risks of BIA-ALCL?

• Due to the rarity of the disease, it can be difficult to provide an accurate estimate of risk. Based on current data, experts estimate the risk of ALCL is between 1:1,000 to 1:10,000, however some medical literature estimates that the risk is in the range of 1:3,000 and 1:30,000.
• Approximately 95% of cases occur between 3 and 14 years after the initial implant procedure.

Are some women at more risk than others?

• Unfortunately, it is impossible to predict whether some women are more at risk of the disease than others. To date though, no Australian cases have been reported amongst women who have had smooth implants inserted.
• The disease can occur with both saline and silicone gel-filled type of implants, and it is currently uncertain whether textured polyurethane implants carry different risks based on available data.

How is it diagnosed?

• It is usually diagnosed by ultrasound scan following persistent swelling in the breast.
• If the fluid is detected, then it is removed and tested for BIA-ALCL.
• The presence of fluid does not necessarily mean you have BIA-ALCL, however, the fluid must be tested as tests such as mammograms are insufficient to diagnose the disease.
• PET/CT scans can be performed to monitor the disease once properly diagnosed.

How is it treated?

• In the vast majority of cases, the implant and capsule surrounding the implant are removed. It is likely your surgeon will remove both implants, even if the disease is present in only one implant. This is to minimise the risk of the disease developing in the opposite breast as well.
• If there is a solid lump as well as fluid, you may be required to undergo chemotherapy or radiotherapy also.
• The management of the breast implant-associated-ALCL requires a multidisciplinary approach, with all patients needing a referral to a surgeon with significant experience with breast implants, as well as the involvement of a haematologist who specialises in lymphoma. If diagnosed, you will likely require ongoing monitoring and management of your breasts.

Can I replace my implants after treatment?

• Current protocols indicate that both implants should be removed during treatment.
• While implants are not replaced at the same time as the treatment operation, smooth implants have been re-inserted after 12 months in certain cases.
• Re-insertion suitability depends on if there has been adequate treatment and little to no progression of symptoms or the presence of the disease.
• However, it should be noted the safety of reinsertion following a positive diagnosis and treatment is still being investigated.

Should breast implants be removed regardless?

• As it is a particularly rare form of cancer, experts do not recommend removal if no symptoms are present. If you are concerned about your risk, it’s recommended you consult with your doctor to discuss your options.
• Regardless of BIA-ALCL, breast implants are not designed to last a lifetime and are usually replaced after 10-15 years. The longer the breast implant is present, the more likely it is to become defective – for example through capsular contracture or rupturing – and will need to be replaced.

Are there ways to make implant surgery safer?

• Increasingly, evidence suggests that bacteria can be a leading cause of other implant complications. To ensure the best outcomes, infection control standards should be a top priority.
• Specialist Plastic Surgeons are highly trained to maximise health and safety standards to keep the risk of infection low.
• Surgeons often follow a comprehensive 14-point plan to minimise the presence of bacteria around the implant.

Where can I get more information?

• The TGA has been monitoring BIA-ALCL since 2011 and is the government body responsible for the approval of the use of all medical devices including breast implant.
• In 2016 the TGA established a working group to investigate and seek advice on BIA-ALCL and included Specialist Plastic Reconstructive & Cosmetic Surgeons, cosmetic surgeons, breast-cancer surgeons, cancer epidemiologists, and public health officials.
• Further updates and information regarding the disease and any changes to consumer protections can be found at the TGA website here.

We value the safety and health of all our patients above all else. If you have any concerns regarding your breast implants, do not hesitate to contact us to book a consultation or make an inquiry.