Risks of BIA-ALCL and use of Highly Textured Implants

The TGA announced a review of textured breast implants and we would like to provide our patients with some more information regarding this announcement. The TGA announcement refers to a rare form of lymphoma (ALCL) and the data shows the risk of this rare lymphoma varies widely (see below), depending on the type of surface texture of the breast implant.

ALCL is generally observed in women 7-10 years after their surgery and often presents as a swelling or a lump.

BIA-ALCL Cases and some deaths have been reported in Australia and the TGA has advised that the majority of these cases were cured by removal of the implant and the surrounding breast capsule.

Lately, more awareness has been raised regarding the risks and symptoms of implant breast lymphoma and several precautions have been taken to avoid it.

Specialist Plastic Surgeon Dr Jeremy Hunt has completed hundreds of breast augmentation procedures in Australia. Dr Hunt is a Sydney plastic surgeon who practices in Sydney and Wollongong NSW. Please ask Dr Hunt about the risks of BIA-ALCL during your consultation.

What Is BIA-ALCL?

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a very rare type of cancer associated with textured breast implants.

This type of breast lymphoma occurs in the immune cells close to the breast implants and usually takes years to develop. Very few women are diagnosed with BIA-ALCL each year, but those who are can be successfully treated with the surgical removal of the implant with the surrounding scar tissue.

About Breast Implant-Associated Anaplastic Large Cell Lymphoma

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an extremely uncommon type of cancer that can arise in breast implant patients. BIA-ALCL is not breast cancer but a cancer of the immune system. It develops in “T-lymphocytes” immune cells that are close to the breast implants.

Breast lymphoma develops slowly over the years and most cases are diagnosed 8-10 years on average after breast implant surgery.

BIA-ALCL is a relatively newly observed condition – the first case was described in 1997. In 2008, a case study in the Netherlands found one of the first associations between ALCLA and breast implants.

It wasn’t until 2011 that the US Food and Drug Administration (FDA) established an association between ALCLA and breast implants. And in 2016, the World Health Organization (WHO) classified BIA-ALCL as a condition separate from other anaplastic large cell lymphomas with unique characteristics that include:

Exclusively T-lymphocyte cancer cells
Cancer cells that are CD30+ (positive for the presence of the CD30 receptor protein and tumour marker)
Cancer cells that are anatomically close to a breast implant

Recently, both plastic surgeons and patients have become more familiar with this rare condition and more informed about it.

How Common Is BIA-ALCL?

Breast lymphoma after breast implants is a very rare type of cancer.

The risk of getting BIA-ALCL can range widely – between 1 in 3,817 and 1 in 300,000 in breast implant patients worldwide . In Australia, the chance of having lymphoma in the breast after a breast implant is between 1 in 2,500 and 1 in 25,000.

So far, more than 800 BIA-ALCLA cases have been reported worldwide with at least 33 consequent deaths.

1 in 7 cases reported globally occur in Australia which is higher than expected. However, this may be because until 3-4 years ago 85% of implants used in Australia were textured instead of smooth implants.

Risk Factors for BIA-ALCL

Investigations have revealed that the risk of developing BIA-ALCL is closely related to the type of breast implant and its manufacturer. Most of the cases of breast lymphoma are reported in patients with BIOCELL textured surface implants manufactured by Allergan aesthetics.

The risk of BIA-ALCLA with BIOCELL is 6 times higher when compared with other textured implants. This may be because BIOCELL implants are more textured than other implants.

To date, in Australia, all reported lymphoma cases associated with breast implants occurred in patients with textured or polyurethane implants and none in patients with smooth implants.

Breast lymphoma has not yet been associated with smooth implants directly. Instead, lymphoma has been reported in patients with smooth implants who have already had textured implants before. Nonetheless, the United States FDA believes that we cannot rule out the association between smooth implants and BIA-ALCL because full details of the history of implants are unknown.

Although the cause of implant-associated breast lymphoma is still not very clear, scientists suspect the following risk factors:

The large surface area of textured implants and their rough sandpaper-like surface can cause chronic inflammation which eventually leads to cancer
The rough and large surface of the implant can also trap more bacteria creating a biofilm (a colony of microbes) that causes inflammation and can lead to lymphoma
Bacterial contamination at the time of the surgery can cause prolonged breast inflammation
Genetic predisposition in the patients can make them more susceptible to developing lymphoma; mutations in JAK1 and STAT3 genes increase the risk of developing BIA-ALCL
Enough time has passed after breast implant surgery for the condition to develop

What are the Symptoms of BIA-ALCLA?

Symptoms of BIA-ALCLA may not necessarily indicate lymphoma – they can be symptoms of other benign breast conditions after a breast implant such as implant rupture or capsular contracture.

Symptoms that may indicate lymphoma in patients with breast implants include:

An effusion or persistent seroma (fluid collection) around the implant – the most common clinical symptom of BIA-ALCLA
Swelling of the breast
Asymmetry (one breast becoming larger than the other)
Pain or discomfort in the breast area
A mass or a lump (lymphadenopathy) in the breast or under the armpits is a less common symptom of breast lymphoma

A defining symptom of breast lymphoma after implant placement is that the size of the breast may get bigger. This doesn’t usually happen with implant rupture or capsular contracture.

Make sure to quickly inform your surgeon if you notice any changes in the size, shape, or feeling of your breast after getting an implant.

How is BIA-ALCLA Treated?

When a patient is diagnosed with BIA-ALCLA, the following steps will be taken:

The patient will be referred to an oncologist for evaluation
A PET/CT scan will be performed to look for any cancer that may have spread throughout the body. This will help determine the stage of the lymphoma which is crucial for treatment.
For patients with BIA-ALCLA localised only around the implant (in situ), Dr Hunt will remove the implant with the entire surrounding scar tissue capsule (en bloc capsulectomy and explantation) and reconstruct the breasts with or without new implants
Even if one implant is affected, both implants need to be removed
If lumps are found in the armpits, this may indicate that cancer has spread to the lymph nodes. In this case, a needle biopsy will be done to test lymph nodes. The lymph nodes may also be surgically removed for testing
Additional tests including blood tests and a bone marrow biopsy may be required
If cancer has spread to adjacent tissue (infiltrative lymphoma), it might be more serious. Infiltrative lymphoma may require additional therapy after implant removal, such as chemotherapy, or more rarely radiation therapy or stem cell transplant therapy

Following implant removal, patients are commonly observed for 2 years with imaging tests like PET-CT scans with 3 to 6-month check-ups. Nevertheless, lymphoma recurrence is very rare after surgical removal of the implants.

For patients who receive timely and adequate treatment, the prognosis is very good. Around 93% of patients are cancer-free at 3 years following treatment.

How to Reduce the Risk of BIA-ALCLA?

Breast implant associated cancer doesn’t develop often. Current data suggest that the less textured the breast implant is, the lower the risk of developing cancer.

Furthermore, a leading hypothesis suggests that a bacterial infection after implant placement can cause inflammation which leads to BIA-ALCLA.

That’s why Dr Hunt follows evidence-based precautions to decrease the risk of breast implant lymphoma, such as:

The use of prophylactic antibiotics to protect against bacterial infections
Proper skin preparation before breast surgery
Careful atraumatic dissection of the breast during surgery
The use of nipple shields to prevent bacterial spillage into the wound during breast implant placement
Maintaining good sterility to avoid bacterial infections
The use of a Keller funnel to deliver the implant without contaminating it

Patients should also be aware that implants are not for life. Breast implants are typically removed after 10-15 years.

The longer the implant has been placed, the more likely it would need removal because of contracture, rippling, movement, or rupture.

What Australia’s TGA is Doing

The Australian Therapeutic Goods Administration (ATGA) has been taking measurements to ensure the safe use of textured implants.

As a result, 3 models of breast implants and tissue expanders have been suspended and 5 others were cancelled in Australia.

Additionally, breast implants and tissue expander devices that have not been suspended will require strict conditions, such as:

All cases of BIA-ALCL must be reported to the TGA within 10 working days of the sponsor being aware of the case
The TGA should be provided with six-monthly reports of Australian and worldwide data supply, adverse events, and complaints regarding the used textured implants
Clear written information about the risk of BIA-ALCL must be provided with all devices to both the clinician and patients

These regulations and actions are done to make the use of textured implants less dangerous.

Updates on Breast Implants

In October 2021, the United States FDA issued new guidelines and regulations regarding the manufacturing, sales, distribution, and labelling of breast implant products. New labelling for breast implants includes:

A boxed warning
Patient decision checklist that should be signed by both the patient and physician. The checklist ensures that the patient understands the risks, benefits, and other information regarding the breast implant.
Updated screening recommendations for ruptured implants
Description of the implant device with a list of the specific materials used
Patient device card

The FDA also expects implant manufacturers to have these updates posted on their websites.

These FDA guidelines aim to raise awareness of the risk of breast implants and help patients make an informed decision before their breast surgery.

Should I Still Get Textured Implants?

Although breast implant-associated lymphoma occurs mainly with textured implants, the risk of that happening is less than 0.1%.

In addition, certain brands of textured implants have a lower risk for BIA-ALCL than other brands. For example, macro textured and polyurethane implants have a higher risk and are banned in certain countries like France.

On the other hand, it’s still okay to use other types of textured implants because they still haven’t been associated with breast lymphoma.

The Australian Therapeutic Goods Administration (ATGA)’s efforts have also limited the availability of problematic textured implants. Any breast implants with safety concerns or reported cases of BIA-ALCL is withdrawn until thorough investigations are done.

Benefits of using Textured Breast Implants

Using textured breast implants is sometimes preferred over smooth implants because they offer the following benefits:

A rough surface that adheres to the tissue around the implant. This prevents breast implants from moving around in the pocket
They reduce the chance of getting a misshapen chest caused by teardrop-shaped implants that could move around
Scar tissue sticks to the textured implant during the healing process. This reduces the risk of capsular contracture (a tight capsule of scar tissue that becomes hard and contacts around the implant)

It is very important to consider the risks and benefits of textured implants with your plastic surgeon before your surgery. This will help you make an informed decision on whether you should get a textured implant or not.

Should I Have My Breast Implants Removed?

If you have breast implants, even if they are textured, you don’t need to do anything except get regular check-ups and watch out for symptoms of lymphoma, contracture, or rupture.

Even if your breast implant brand has been recalled or suspended, you don’t have to remove it unless you have symptoms of BIA-ALCL or other complications. Especially since the risk of removal surgery is more significant than the risk of implant breast lymphoma; a very rare type of cancer.

Patients are advised to become familiar with the regular features of their breasts to spot any irregular changes. Regular self-examination similar to routine breast cancer awareness is also highly recommended for early detection of lymphoma.

Surgery after the early diagnosis of breast lymphoma can treat the condition. If the diagnosis is delayed, cancer may spread through the breast capsule or to local lymph nodes making the condition more dangerous and harder to treat.

What does this mean for our patients?

As over 90% of breast implants used by Dr Hunt have been micro-textured implants, it is important to highlight the difference between macro and micro-textured implants. The risk of ALCL with micro-textured implants is 1: 56,000 to 1:86,000, compared to macro textured implants which currently stand at 1: 1,000 to 1: 10,000. Therefore, the grouping of all textured implants into one category does NOT accurately reflect the risk of ALCL.

It is important to note that the TGA announcement does not suggest that those patients who have textured breast implants require any immediate medical attention. The TGA states that “because BIA-ALCL is rare, experts do not recommend removal of breast implants where there are no problems with the implant.”

We recommend that patients should monitor their implants with regular ultrasounds – something we have always encouraged patients to do. There is no suggestion that these implants need to be removed at present. If you are concerned about your breast implants, particularly swelling or hardening, then you should seek medical advice from your GP, or if you had your surgery with Dr Hunt you can contact us.

Medical References about Breast Implants and BIA-ALCL

Need more information about BIA-ALCL?

For more information on this announcement, please visit the TGA website.
Read more about the TGA’s information for consumers regarding ALCL.
The Australia Society of Aesthetic Plastic Surgeons has released a statement providing more information on the TGA and textured implants.

About Dr Jeremy Hunt – Specialist Plastic Surgeon

Dr Jeremy Hunt is a specialist plastic surgeon performing breast, body, face and nose surgery in Australia. He is a member of FRACS & ASPS and has over 20 years of experience providing plastic surgery in Sydney.

Careful, considerate and honest, Dr Jeremy Hunt works with you to find a solution that is optimal for your body and your lifestyle. Every patient is unique and, through his guidance, can achieve good results.

Dr Hunt’s personal, one-on-one service and attention to detail has given thousands of women and men from the Sydney & Wollongong NSW area and across Australia the aesthetic results they desire.

Dr Hunt’s qualifications and education

Dr Jeremy A Hunt MBBS FRACS graduated with a Bachelor of Medicine degree from Sydney University in 1990 and is a Fellow of the Royal Australasian College of Surgeons and member of the Australian Society of Plastic Surgery. He completed a Fellowship at the prestigious University of Texas in the United States, where he learnt from some of the world’s very best plastic surgeons.

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Tag: breast implants surgery

Risks of BIA-ALCL – Breast Implant-Associated Anaplastic Large Cell Lymphoma