Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)

3042_aps_lucinda_breast_128.jpgBIA-ALCL Quick facts

BIA-ALCL is a rare form of non-Hodgkin’s lymphoma that is associated with breast implants.

When diagnosed early and managed properly it is curable.

Australian and New Zealand Plastic Surgeons are at the forefront of research into this condition through international collaboration and are working with regulators to maintain public safety. This is a rapidly evolving area of research.

Without symptoms or signs of BIA-ALCL routine implant removal is not required unless there are other concerns.

In Australia there have been 55 cases of BIA-ALCL reported, with 4 associated deaths.

There is a differential risk of developing BIA-ALCL associated with breast implant type.

This risk is

Allergan,                                 1 in 3817

Silimed polyurethane,                        1 in 7788

Mentor (J & J) Siltex,             1 in 60631

Recently the Journal of Plastic and Reconstructive Surgery published the Australian and New Zealand epidemiological study on the incidence of BIA-ALCL in our community online ahead of print. This work is the fruit of more than two years of investigation by the 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.

FAQs on BIA-ALCL

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

A rare form of non-Hodgkin’s lymphoma that develops adjacent to breast implants.

  1. BIA-ALCL is not breast cancer

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

  1. What are the symptoms of BIA-ALCL?

The most common presentation is as a persistent swelling of the breast due to fluid collecting around the implant.

It can also present as a lump in the breast or armpit.

It usually develops 3 to 14 years after the insertion of breast implants and most commonly around 7 to 8 years after insertion of the implants.

  1. What is the risk of developing BIA-ALCL?

No woman who has only had smooth breast implants has developed BIA-ALCL.

The risk of developing BIA-ALCL with textured or polyurethane implants depends upon the type of implant.

High surface area textured implants have demonstrated a risk of around one in 4000 compared with one in 60,000 for low surface area textured implants.

For perspective, the risk of breast cancer is close to one in eight and the lifetime risk of a woman who lives to 84 years of age developing lymphoma is one in 50.

  1. Are some women more at risk than others?

BIA-ALCL has developed in patients having breast implants for cosmetic and reconstructive purposes.

BIA-ALCL has developed in patients with both silicone and saline implants.

There appear to be genetic factors that aren’t fully appreciated that effect the incidence of this disease and ongoing research is examining this connection.

All women who have developed BIA-ALCL have had exposure to textured or polyurethane breast implants.

  1. How is BIA-ALCL diagnosed?

If a patient develops a persistent fluid collection around an implant she should be investigated with an ultrasound and if fluid is identified this will be removed and tested for BIA-ALCL.

Specific tests are asked for using immunohistochemistry for CD30+ and ALK- atypical T cells.

Most fluid collections will be benign seromas and not BIA-ALCL however it does need to be excluded.

Mammogram is not useful.

MRI and PET CT scans are performed to help stage the disease and plan surgery once a diagnosis is established.

Patients should be managed by a multidisciplinary team.

It is important to recognise that there is no Medicare rebate for MRI in Australia for this indication but there is a rebate for PET CT when a diagnosis of lymphoma has been established.

  1. 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 (there is a rare incidence of bilateral disease).

All women treated without a delay to diagnosis and with appropriate management principles have achieved a complete remission.

  1. Should women with breast implants be screened routinely for BIA-ALCL?

Expert opinion at this time is that women without symptoms or changes to their breasts do not need regular ultrasound scans.

Breast implants are not lifetime devices: if there are changes in your breasts associated with breast implants and especially if there is generalised swelling or a lump women should have a breast examination and this may need to be investigated further.

  1. Should breast implant be removed just in case?

Breast implants are not guaranteed as lifetime devices and in general may need to be removed or replaced at some point.

The most common reasons for implant removal or replacement remain capsular contracture, implant migration, and implant rupture.

Without symptoms or signs of BIA-ALCL routine implant removal is not required unless there are other concerns.

  1. Do we know the causes of BIA-ALCL?

The “unifying theory” appears to be the strongest theory to date, it suggests that:

Bacteria in biofilm have been identified within the lymphoma and around implants in affected breasts, and that,

A long-term inflammatory response to the presence of these bacteria can lead to a polyclonal T cell response, and in genetically susceptible individuals this may lead to a monoclonal expansion and BIA-ALCL.

There is a global collaboration of researchers investigating the aetiology of this disease and it is a rapidly developing area.

  1. Are there ways to make breast implant surgery safer?

There is accumulating evidence that bacteria are associated with other complications of breast implant surgery such as the risk for capsular contracture and acute infection, neither of which 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 care and lowest risk of infection.

A 14 point plan has been developed using evidence based steps that can be undertaken during surgery to minimise the bacterial load around the implant.

These steps have been demonstrated to significantly reduce the incidence of capsular contracture.

The 14 point plan is a guideline and not every step will be applicable in every circumstance.

  1. What should you do if you are concerned about your breast implants?

Contact your surgeon or 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.

Specific investigations need to be requested during the analysis of the fluid: specifically a concern regarding ALCL needs to be indicated and specific immunohistochemistry for CD 30 receptor protein (CD30+) and negative for anaplastic lymphoma kinase gene translocation (ALK-).

Most women who develop a swelling of their breast associated with breast implants will have a benign fluid collection known as a seroma and not BIA-ALCL, but it still needs to be excluded.

  1. Can breast implants be re-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 have been diagnosed on both sides at the same time.

Implants are not replaced at the same time.

Smooth implants have been reinserted in a small number of patients following a period of delay for early stage disease, however the safety of this management plan is still being investigated.

  1. 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 risk of BIA-ALCL which should form part of the consent process.

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 based on multiple factors.

Breast implants may not be lifetime devices. Women with breast implants should consider that they may require revision or replacement of their breast implants at some stage in their lifetime.  The most likely reasons for this will be capsular contracture, implant migration, implant rupture or size change.

Based on BIA-ALCL, 12 May 2017, ASPS and ASAPS.

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