BIA-ALCL, BIA-SCC, and other various cancers

Updated 14 September 2022

Breast implant-associated – Anaplastic Large Cell Lymphoma (BIA-ALCL)

Breast implant-associated – Squamous Cell Carcinoma (BIA-SCC) and other various cancers

The Australian Society of Plastic Surgeons urges women with breast implants to be vigilant in monitoring for any changes, including lumps, pain, swelling, or skin changes in their breasts, and to contact their doctor if this occurs.

Breast implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare cancer that can be effectively treated if detected early.

There are also reports of cancers including squamous cell carcinoma and other various lymphomas developing in the scar tissue around breast implants. This is different from BIA-ALCL. 

The ASPS is concerned there may be confusion in the community surrounding BIA-ALCL and the other cancers associated with breast implants, and therefore seeks to clarify the key known facts.

  • It is a cancer of lymphatic cells and a form of Non-Hodgkin’s Lymphoma
  • It is not a breast cancer
  • It occurs in association with breast implants and to date exclusively with exposure to textured implants (i.e. no case has been reported with exposure to smooth implants alone)
  • It occurs in women who have had implants for both cosmetic and reconstructive indications
  • It takes an average of 7-10 years after implant insertion before it develops
  • The most common presentation is a fluid swelling around the breast implant and in the space between the implant and breast implant capsule – late seroma. The diagnosis of the tumour is made by examination of the seroma fluid
  • Early stage disease is curative with surgery alone
  • Disease which has spread through the capsule, forming a mass or which has spread to local lymph glands carries a worse prognosis
  • Squamous cell carcinoma is a cancer of squamous cells
  • Lymphoma is a cancer of lymphatic cells, but is different to BIA-ALCL
  • They are not breast cancers
  • It occurs in association with breast implants and has been found in the capsule of textured and smooth, silicone and saline implants
  • It can occur years after implants have been placed

The most accurate risk published to date  studying BIA-ALCL is from a detailed study of numerator and denominator in Australia and New Zealand. This showed that the risk for implants with high surface area texture, Allergan Biocell and Slimed polyurethane, were around 10 times higher (approximately 1 in 2800 to 1 in 7000) compared with implants with lower surface area texture (1 in 35,000 for Mentor Siltex). The risk was calculated only for companies that complied with a request for provision of sales data. We did see ALCL arising from other implant manufacturers but were not able to calculate risk due to their refusal to supply data for analysis.

The study also identified clusters of multiple cases arising from the same practice. These clusters are currently under investigation, with the consent of the centre and/or surgeon, and there is insufficient evidence presently to comment as to likely causative factors.

The risk associated with BIA-SCC and other cancers is currently unknown. However, to date, the FDA is aware of less than 20 cases of BIA-SCC and less than 30 cases of various cancers associated with breast implants. The TGA is not currently aware of any cases in Australia.

Recent news articles suggested that there is a link with cut-price providers. There is no such link that has been established to date by analysis of evidence.

A unifying theory was proposed by the ANZ epidemiology paper and has become widely accepted worldwide as the best explanation for factors that cause BIA-ALCL. (Knight et al, 2016)

  • Textured implants (with a higher risk for high surface area textures)
  • Bacterial contamination at the time of surgery to reach a threshold to cause inflammation
  • Patient genetic predisposition
  • Time for the process to develop

Bacteria have been identified in association with these tumors, similar to the association between gastric lymphoma and Helicobacter pylori.

The underlying causes of BIA-SCC and other various cancers associated with breast implants are still unknown, and is an area of emerging research and reporting.

When BIA-ALCL is suspected, imaging by ultrasound and CT scan or MRI of the breast is performed. A mammogram is not useful for detecting the disease.

Most cases of BIA-ALCL are cured by surgery with the removal of the implant and the surrounding capsule. If there are implants in both breasts then both implants are removed even if symptoms only appear on one side.

If there is a solid lump or the cancer has spread, chemotherapy, radiotherapy or additional surgery may be required.

If BIA-SCC is suspected, the current advice is to perform breast ultrasound and MRI with and without contrast. If disease is confirmed, a PET-CT should be considered prior to surgical intervention. Fine needle aspiration (FNA) and cytology testing should also be performed. Specimens should be sent for immunohistochemistry including CD30, ALK, CK 5/6, p63 and flow cytometry to look for T-cells, squamous cells and keratin.

At present, evidence suggests that the treatment that produces the best outcome is explantation with en bloc capsulectomy. During surgery, fresh seroma fluid should be collected, in addition to representative portions of the capsule and specific pathology requests to investigate for both BIA-ALCL, and BIA-SCC.

 

The exact number of breast implants in women is hard to determine however in 2020 about 1.6 million implants were inserted worldwide  and about 207,000 women had their implants removed. (International Society of Aesthetic Plastic Surgery, ISAPS)

Implants are not life devices and most will need revision in due course. The most common reasons for revision are capsular contracture, implant migration, poor aesthetic result, size change and rupture.

Different types of implants perform differently, give different outcomes and have different relative risks of these complications.

Conservatively there are 30 million women (60 million implants) in the world with textured implants. According to the Australian Breast Device Registry (ABDR), approximately 50% of breast implants inserted in Australia in 2020 were textured.

There are a total of 993 confirmed cases of BIA-ALCL worldwide as of January 4, 2021 (ABDR, 2021). Data from the Macquarie University team included 112 confirmed BIA-ALCL cases between the years of 2007 to 2019 in Australia.

There are around 32 reported deaths worldwide. 4 of these deaths were in Australia (Ionescu et al, 2021).

The incidence rate of BIA-SCC and various other cancers of the breast implant capsule are currently unknown. However, to date, the FDA is aware of less than 20 cases of BIA-SCC and less than 30 cases of various lymphomas. The TGA is not currently aware of any cases in Australia.

The risk for Australian women of breast cancer is about 1:8. These are separate diseases.

We support the maturing of the Australian Breast Device Registry as the best way to prospectively collect outcome data following breast implant surgery.

All patients undergoing breast implant surgery must provide informed consent that includes a discussion of risks of BIA-ALCL, SCC and various cancers of the breast capsule surrounding the implant.

Implant selection should take into account what the patient already has, what the goals are, the patient’s lifestyle and the risks relative to various implant options.

Implant specific risk should be discussed in the context of overall benefits of a particular implant type and/or texture.

Routine implant removal is not indicated for asymptomatic women with breast implants including textured implants.

All women with implants who note changes in their breasts should seek advice. The overwhelming majority will not have BIA-ALCL,SCC and various cancers of the breast capsule surrounding the implant.

The Therapeutic Goods Administration (TGA) has been updating information regarding breast implant associated-anaplastic large cell lymphoma for over a decade.

Recent FDA correspondence has detailed reports of squamous cell carcinoma and various lymphomas being identified in the scar tissue (capsule) that forms around breast implants. This is different from BIA-ALCL.

The TGA has been posting updated information about BIA-ALCL since 2011 and this updated alert was generated following a recent expert advisory panel in view of additional research performed by a joint BIA-ALCL task force with representatives from the Australian Society of Plastic Surgeons, Australasian Society of Aesthetic Plastic Surgeons, New Zealand Association of Plastic Surgeons, the Australian Breast Device Registry and the Peter MacCallum Cancer Centre.

The relationship between breast implants and BIA-SCC and other various cancers was identified by the FDA in 2022, and is an area of emerging research and reporting.

#1 What is breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)?

  • A rare type of lymphoma that develops adjacent to breast implants
  • It usually develops as a swelling of the breast 3 to 14 years after the insertion of breast implants which is due to fluid collecting around the implant or it can present as a lump in the breast or armpit

#2 What is the difference between BIA-ALCL, BIA-SCC and the other various cancer types? Are they the same thing?

BIA-SCC is a cancer of squamous cells, whereas BIA-ALCL and other lymphoma types are cancers of lymphatic cells.

BIA-ALCL, BIA-SCC and other cancers are not same as breast cancer

  • BIA-ALCL develops in the fluid around breast implant and is usually contained by the fibrous capsule around implants
  • BIA-SCC and other various cancers develop in the scar tissue that forms around the breast implant
  • They do not develop in the breast tissue

#3 What are the symptoms of BIA-ALCL?

  • The most common symptom is a persistent swelling of the breast but can include other symptoms such as a lump in the breast or armpit
  • These symptoms develop between three and 14 years following the insertion of breast implants and most commonly around eight years
  • The swelling of the breast is due to fluid accumulating around the implant
  • The lymphoma develops around the breast implant in the fluid and in most cases is contained within the fibrous capsule the body makes around the implant and is not in the breast tissue itself

#4 What are the symptoms of breast implant associated BIA-SCC and other cancers? 

  • Of the reports that are currently available, symptoms associated with these conditions include swelling, pain, lumps and skin changes.

#5 What is the risk of developing BIA-ALCL?

  • This is a rare disease and only about 50 patients have been identified in Australia and about 10 in New Zealand
  • Because this is a rare disease it is difficult to be certain about the absolute risk of developing this disease
  • The risk may be around one in 5000 for women with breast implants (for each woman who develops this disease there are 4999 women who don’t)
  • The risk of breast cancer is about one in eight women

#6 What are the risk factors and incidence of developing BIA-SCC or other types of lymphoma? 

  • At this stage the incidence rate and risk factors for developing these conditions is unknown.
  • However, to date, the FDA is aware of less than 20 cases of BIA-SCC and less than 30 cases of various cancers.
  • The TGA is not currently aware of any cases in Australia.

#7 Are some women more at risk than others?

  • For BIA-ALCL, the risk for implants with high surface area texture, Allergan Biocell and Slimed polyurethane, were around 10 times higher (approximately 1 in 2800 to 1 in 7000) compared with implants with lower surface area texture (1 in 35,000 for Mentor Siltex). The risk was calculated only for companies that complied with a request for provision of sales data. We did see ALCL arising from other implant manufacturers but were not able to calculate risk due to their refusal to supply data for analysis.
  • The study also identified clusters of multiple cases arising from the same practice. These clusters are currently under investigation, with the consent of the centre and/or surgeon, and there is insufficient evidence presently to comment as to likely causative factors.
  • It has occurred in women who have breast implants for cosmetic reasons and also for breast reconstruction
  • It has occurred in women with both saline implants and silicone implants
  • BIA-SCC and other cancer types have been identified in both smooth and textured, saline and silicone implants.

#8 How is BIA-ALCL diagnosed?

  • If a woman develops swelling of the breast which has an implant they are sent for an ultrasound scan and if fluid is detected this will be removed and tested for BIA-ALCL
  • Specific tests are asked for to exclude or diagnose BIA-ALCL
  • Most fluid collections around breast implants are not BIA-ALCL but proper testing will be able to tell them apart
  • Mammograms are not useful in diagnosing BIA-ALCL
  • In confirmed cases MRI and PET/CT scans may be performed to help stage the disease

#9 How is BIA-SCC diagnosed? 

  • If BIA-SCC is suspected, the current advice is to perform breast ultrasound and MRI with and without contrast.
  • If disease is confirmed, a PET-CT should be considered prior to surgical intervention.
  • Fine needle aspiration (FNA) and cytology testing should also be performed. Specimens should be sent for immunohistochemistry including CD30, ALK, CK 5/6, p63 and flow cytometry to look for T-cells, squamous cells and keratin.

#9 Should women with breast implants be screened for BIA-ALCL, BIA-SCC or other cancer types?

  • At this point expert opinion is that women without symptoms or changes in their breasts do not need regular ultrasound scans
  • Breast implants are not life long devices
  • If there are changes in your breasts associated with breast implants and especially if there is general swelling or a lump you should have a breast examination and this may need to be investigated further

#10 What is the treatment of BIA-ALCL?

  • The majority of cases are cured with the removal of implants and the fibrous capsule around them from both breasts.
  • The majority of patients require no additional treatment.
  • Less commonly additional treatment such as chemotherapy and radiotherapy may be required

#11 What is the treatment of BIA-SCC? 

At present, evidence suggests that the treatment that produces the best outcome is explantation with en bloc capsulectomy. During surgery, fresh seroma fluid should be collected, in addition to representative portions of the capsule and specific pathology requests to investigate for both BIA-ALCL, and BIA-SCC.

#12 Should breast implants be removed just in case?

  • Breast implants are not lifelong devices and in general all will need to be removed or replaced at some point. The commonest reasons for implant removal or replacement are capsular contracture, implant migration, implant rupture
  • Without symptoms or signs of BIA-ALCL, BIA-SCC or other lymphoma types, routine implant removal is not required unless there are other concerns

#13 Do we know what causes BIA-ALCL?

  • Australian and New Zealand Plastic Surgeons in partnership with local and international research organisations are at the forefront of investigating this disease and we are working proactively with the government to keep them informed (Therapeutic Goods Administration -TGA and Medsafe in New Zealand)
  • Bacteria have been identified within the lymphoma and around implants in affected breasts
  • There is accumulating evidence that a long-term inflammatory response to the presence of these bacteria is one of the factors that may cause of BIA-ALCL
  • There may also be genetic factors involved for individual women
  • We are continuing to investigate this disease to improve our understanding

#14 Are there ways to make breast implant surgery safer?

  • There is accumulating evidence that bacteria are associated with other complications of breast implant surgery as well such as the risk for capsular contracture which does not lead to cancer
  • Infection control standards are extremely important in breast surgery to ensure best outcomes and Specialist Plastic Surgeons are expertly trained to ensure the highest standards of patient safety and lowest risk of infection

#15 What should you do if you are concerned about your breast implants?

  • Firstly you should contact your surgeon and if you are unable to do this you should see your GP for a referral to a Specialist Plastic Surgeon
  • If you have swelling of the breast associated with a breast implant you may need a referral for an ultrasound to remove some fluid for testing and this will be able to determine if BIA-ALCL is present and Immunohistochemistry is performed to identify a T-cell lymphoma that is positive for the CD30 receptor protein (CD30+) and negative for the anaplastic lymphoma kinase gene translocation (ALK-)
  • Most breast swelling that occurs after breast implants is not due to BIA-ALCL however it does needs to be excluded

#16 Can new breast implants be inserted when BIA-ALCL is treated?

  • Current treatment protocols indicate that the removal of both breast implants with the capsule around them is required because a small number of cases that have been diagnosed on both sides at the same time
  • Implants are not replaced at the same operation
  • Smooth implants have been re-inserted 12 months following the adequate treatment of BIA-ALCL without disease progression however the safety of this strategy is still being investigated

#17 Where can I get more information?

  • The Therapeutic Goods Administration (TGA) is the government body responsible for the approval of the use of all medical devices including breast implants
  • The TGA has recently updated its public information about BIA-ALCL.
  • Visit their website here.

#18 What should I do if I am considering breast implants?

  • Women who are considering breast implant surgery should discuss the risks and benefits of the procedure with their Specialist Plastic Surgeon including the risks of BIA-ALCL, BIA-SCC and other types of lymphoma.
  • There are different implant types available and implant selection needs to take into account the risks and benefits of specific choices.
  • Implant selection will be different from one person to the next.
  • Breast implants are not lifetime devices and women with breast implants should all consider that they will require revision or replacement of the breast implants at some time

 

A list of recalled, cancelled and suspended implants can be found on the TGA breast implants hub at https://www.tga.gov.au/hubs/breast-implants

To read the full TGA update: www.tga.gov.au

Breast implant information updates can be viewed here.

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