BIA-ALCL and Breast Implants – Update, Risks and Useful Links

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Guide to BIA-ALCL – FAQs and Breast Implant Risks

In Australia, there have been some rare cases of BIA-ALCL in the news. The condition of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is still under investigation through scientific research and medical device monitoring.

The latest BIA-ALCL research was presented in May 2021 at the Aesthetic Society Plastic Surgeons Conference in Miami. (Virtually Attended)

  •  90 million women across the world have breast implants that are well-tolerated.
  • As of May 2021 – there have been 994 total cases of BIA-ALCL worldwide (357 in USA)
  • As of May 2021 – There have been 37 recorded deaths from BIA-ALCL worldwide
  • There are NO Confirmed cases associated with Smooth Breast Implants (only textured implants and mostly Allergan textured implants)
  • There are a number of specific surgeons (clusters) that have a larger number of BIA-ALCL cases – Why? – investigations continue
  • FDA and Authorities are still NOT recommending the removal of textured implants from asymptomatic patients

Although BIA-ALCL can be fatal, data suggests that EARLY diagnosis and certain medical treatments can be very effective in treating this condition.

 

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Overview of BIA-ALCL and Breast Implants

A brief synopsis of what is currently recognised about BIA-ALCL. Also known as Breast Implant-Associated Anaplastic Large Cell Lymphoma;

How does the TYPE of breast implant affect the risk of BIA-ALCL?

  • BIA-ALCL does NOT appear linked with ALL types of breast implants – textured implants are more linked to BIA-ALCL (See below)
  • There may be a link between risk factors and Implant texture. Regardless of the content fill being saline or silicone.
  • IMPLANT HANDLING or contamination (bacteria) and traumatic impact to the chest is also under investigation.
  • Exploration into Genes, regional variances and other factors is also underway
  • Collection and analysis of DATA shows the risk rate is currently RARE (See Micromorts)

BIA-ALCL FAQs – Breast Implant-Associated Lymphoma Update

What is BIA-ALCL?

  • Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of cancer that can grow in the breast in association with certain types of breast implants.
  • Although it arises in the breast,  BIA-ALCL is not technically a ‘breast cancer’.
  • This is because it develops from immune cells and not breast tissue.
  • However, it has recently been classified as a type of cancer. It’s a type of non-Hodgkin lymphoma (cancer that arises from immune cells).
  • BIA-ALCL is usually localized to the breast where it surrounds the implant. However, on rare occasions, it can spread to other parts of the body if left untreated.
  • The cancerous lymphoma cells are commonly found in either;
    • fluid (effusion) that collects around the implant
    • Or, they can come together to form a lump.
  • Breast implant-associated lymphoma CAN happen with both saline and silicone implants.
  • However, it seems to be related only to implants with a textured surface (shell).
  • Surgical removal of the implants and the cancerous tissue is usually curative. Some patients may need chemotherapy or radiotherapy.

Read here the Update on Breast Implant-Associated ALCL (BIA-ALCL): Everything We Know In 2021.

Below are some FAQS about BIA-ALCL.

How common is BIA-ALCL worldwide?

Breast implant-associated lymphoma is a rare condition, and only around 10 patients receive BIA-ALCL diagnoses annually worldwide. The condition is still just now becoming more known to doctors and the numbers are still changing. According to the American Society of Plastic Surgeons, so far, 885 have been diagnosed with BIA-ALCL, with 39 deaths worldwide. The vast majority of cases and mortalities were identified in women who had textured implants from the manufacturer “Allergan”.

On the other hand, only 4.5% of the reported BIA-ALCL cases are of women with smooth implants. More importantly, all these women previously had textured implants or implants of an unknown type. So, there are currently no cases of breast implant lymphoma associated purely with smooth implants.

The number of breast implant-associated cancer cases is likely to increase now that plastic surgeons and patients are more aware of the condition. Current worldwide estimates show that 1 in 86,000 women to 1 in 2,200 women with textured implants end up developing breast implant-associated cancer. The risk is higher with textured Allergan implants compared to other brands.

How common is BIA-ALCL in Australia?

According to a recent review by the Therapeutic Goods Administration (TGA), a total of 104 cases of BIA-ALCL have been reported in Australia up until July 2020. Over half of these cases have an association with Allergan implants. All the reported cases were observed with textured implants, and up until now, no cases have been reported with smooth implants. A total of 4 Australian women have died from breast implant-associated cancer in the past 10 years – mostly related to early treatment with chemotherapy.

The estimate from the TGA is that between 1 in 2,500 and 1 in 25,000 people with breast implants end up developing breast implant-associated lymphoma.

What are the symptoms of BIA-ALCL?

If you’re considering getting breast implants or already have implants, you’re probably asking yourself how you would know if you have breast implant-associated lymphoma. The overall risk of BIA-ALCL is generally very low and breast symptoms are more likely to be non-cancer related. However, you should know the symptoms just to be safe.

On average, symptoms of BIA-ALCL take around 8 years to appear, but this can happen much sooner. Self-examination may be helpful in noticing any changes in your breast. Keep in mind that whenever you have any breast implant-related symptoms, you should immediately be assessed by a certified plastic surgeon to identify the cause. Symptoms of breast implant-associated cancer include;

  • Change in breast size
  • Change in breast shape
  • Fluid accumulation
  • Asymmetry between breasts
  • New lumps
  • Pain in your breast
  • Redness and swelling

If you experience any of these symptoms, let your plastic surgeon know as soon as possible. You should also note that swelling or lumps in the armpits also warrant medical evaluation.

BIA ALCL best known implant brands - Mentor breast implant sizes Allergan breast implants

What are textured implants?

Breast implants, whether with silicone or saline filling, can have either a textured or a smooth surface. Fortunately, only a minority of breast implants currently used by surgeons are textured according to the current estimates. Textured implants have a rough thick outer shell that helps them adhere to the surrounding tissue and stick in their place. All tear-drop implants have a textured surface since it’s critical that they maintain their correct alignment. Moreover, textured implants carry a lower risk of capsular contractures (formation of scar tissue around the implants). Over 90% of BIA-ALCL cases have been reported in textured implants, especially those by Allergan. Despite the reports of BIA-ALCL, many surgeons still use textured implants in some cases when necessary since the overall risk of developing lymphoma is too low with other implant brands.

Is BIA-ALCL dangerous?

Thankfully, research has shown that with proper treatment, up to 93% of patients are cancer-free after three years of follow-up. So, we can safely say that the prognosis and outcomes are usually good. Worldwide BIA-ALCL cases total 885, with 36 deaths.

Proper treatment of breast implant-associated lymphoma includes surgery to completely remove the old implants, surrounding tissue, and fibrous capsule. Early diagnosis is key to improving outcomes. In some cases, patients might need further chemotherapy and radiotherapy.

Should I reconsider getting a boob job or remove my implants?

First, you should keep in mind that BIA-ALCL is very rare. The vast majority of cases were reported in textured implants, specifically Allergan implants. Despite that, many women might still worry when hearing about the risk of lymphoma with some breast implants, and we understand. Your surgeon’s job is to make you aware of the risk you are taking when getting an implant, no matter how unlikely it is. He/she will weigh the risks and benefits of each implant type and choose one that gives you the best outcome and minimizes any risks.

Whether you currently have implants or are considering getting implants, you should always be aware of the symptoms of BIA-ALCL, and make sure to visit your plastic surgeon if any symptoms appear.

If you already have breast implants, regardless of their type, and no symptoms of BIA-ALCL, the TGA and most international health authorities do not recommend that you have them removed since the risk of lymphoma is extremely low. You just need to look out for any new symptoms and changes in your breasts and contact your surgeon promptly if you have any concerns. Any change in size, symmetry, swelling, or pain in your breasts should not be left without a medical assessment.

If you receive a BIA-ALCL diagnosis, do not delay getting implant removal surgery with excision of the surrounding tissue. Hopefully, as experience has shown, surgical removal will be enough to cure the condition.

What does BIA-ALCL stand for and what is the risk ratio of BIA-ALCL?

  • BIA-ALCL stands for Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL).
  • The estimated risks of developing BIA-ALCL from breast implants is between 1 in 1000 to 1:30,000 to 1 in 100,000.

Most Health Professionals And Surgeons Agree The Risk Of BIA-ALCL Is Rare, Far Rarer Than Breast Cancer, For Example, When Evaluated In Terms Of The Number Of Implant Patients Without Bia-Alcl And The Number Diagnosed With Alcl.

  • Research suggests that there is a link between BIA-ALCL and specific types of breast implants.
  • Certain grades of textured breast implants have led some experts to believe that highly textured implants (grades 3-4) may allow for bacterial growth to occur around the implants, versus fluid accumulation/bacterial growth ratios found for smooth implants.

CURRENTLY, NO ‘SMOOTH’ BREAST IMPLANT PATIENTS HAVE BEEN DIAGNOSED WITH THIS DISEASE, AS OF THE TIME OF PUBLICATION AND AFTER SEVERAL YEARS OF BIA-ALCL DATA COLLECTION AND RESEARCH

Do implants lead to breast cancer?

  • BIA-ALCL is NOT breast cancer, but rather a cancer of the immune system.
  • BIA-ALCL is believed linked to bacteria and/or fluids that develop around certain types of breast implants, primarily textured ones.
  • The illness is thought to presents around 3 to 7 years after breast prosthesis implantation, with a 7 year incubation period being most frequently quoted.

What are the signs and symptoms of BIA-ALCL?

  • Symptoms can vary from person to person.
  • Swelling, pain and/or lumps in the breast should be medically assessed/investigated.
  • As should any other unusual or concerning symptoms or changes to the breast(s).
  • If you have any of the Breast symptoms above you should investigate them with or without breast implants.
  • Any changes, pain, swelling or lumps or bumps in breasts can indicate an underlying health condition including cancer or early-stage BIA-ALCL.

How many people in Australia or New Zealand have been diagnosed with BIA-ALCL?

  • Estimates vary and therefore adjustments to figures are necessary.
  • It is thought that so far 107 Australian women have gotten a BIA-ALCL diagnosis.

Is BIA-ALCL common or rare? What are the real risks?

  • The disease is extremely rare, given 107 diagnoses so far out of an estimated 250,000 women with breast implants in Australia.
  • This figure is not a final figure, however; and experts disagree on risks (the risk range for BIA-ALCL is 1:1000 to 1:100,000 per estimates from various statisticians).
  • A new breast implant database and breast implant patient tracking database will help refine and solidify this estimate as well as incidents of BIA-ALCL.

Is it true that there is only a link to BIA-ALCL and texture implants?

  • Data collection is ongoing, however, no cases of BIA-ALCL currently involve smooth implants.
  • At this time, it appears there is an association with the surface texture of the breast implants and the formation of fluid and/or bacterial accumulation, and/or inflammation, in the breast implant area, which can eventually result in ALCL in some patients.
  • While fluid/bacteria build-up can happen on some textured implants for a minority of patients and may have a connection to ALCL; it is still quite rare according to the statistics currently available.

The TGA is giving some manufacturers of textured implants a chance to provide additional safety data on textured breast implants for the next 6 months. The TGA has recommended a ban and recall, but currently, that is in the effect of a TGA action to SUSPEND the use of certain types of breast implants (textured ones) for 6 months before deciding based on further evidence of the association and risk factors including risks vs benefits of breast reconstruction for mastectomy patients.

Based on current data, it appears there is only a link to textured breast implants thus far with BIA-ALCL, not smooth breast implants.

  • Currently, there is no evidence to suggest other factors, like patient variables, impact BIA-ALCL.
  • The condition risk ratio is also not known with a degree of certainty. Albeit appears rare in terms of 1:1000 to 1:80,000 according to available data and statisticians.

Is BIA-ALCL curable?

  • Early diagnosis of BIA-ALCL appears to allow for effective treatments of BIA-ALCL (cancer-related to breast implants, again, not breast cancer but a cancer of the immune system)
  • Treatment for BIA-ALCL is usually surgical removal of the implants; often, if discovery happens early, this is the only treatment necessary other than potential breast modifications or enhancements using other means. There may be a limit on this for patients with little natural breast tissue.

Treatment for BIA-ALCL – early detection

Early diagnosis is helpful in treating BIA-ALCL

  • Treatments for BIA-ALCL can vary from patient to patient.
  • Most treatments require the removal of textured breast implants.

The success rates for treating BIA-ALCL in the early stages are encouraging, and why it’s important to see your Surgeon and/or medical team if you have any symptoms of concern after having breast implants; and to stay observant.

  • Treatment for BIA-ALCL often does involve removal of the existing textured implants (early-stage detection)
  • Treatment may also involve other therapies, such as chemotherapy if required (such as for late diagnosis)

Breast Implant Monitoring Recommendations by Medical Boards, ASAPS and ASPS

Current medical recommendations for women with breast implants in relation to BIA-ALCL:

  • STAY observant of any signs, changes or symptoms that might indicate an issue with your breast implant results
  • Get ANNUAL checkups with your SURGEON
    • arrange earlier or more frequent check-ups and surgery reviews if you have any concerns
    • Address any of your questions and/or concerns directly to your Surgeon
  • NOTIFY your Surgeon immediately if you:
    • Notice ANY changes to your breast surgery results
    • Have any swelling or pain in the breast area
    • Observe lumps or bumps in the chest area or lymphatic regions (armpits)

BIA-ALCL and Textured Breast Implants

What should you do if you have concerns about BIA-ALCL?

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) usually involves a swelling of the breast, typically 3-14 years after surgery to insert breast implants. This swelling is due to an accumulation of fluid. BIA-ALCL can less commonly take the form of a lump in the breast or a lump in the armpit.

It is a very rare condition. The risk estimate of BIA-ALCL is between 1-in-1,000 and 1-in-10,000. Although fatalities have been recorded, the vast majority of cases are cured by the removal of the implant and capsule surrounding the implant.

If you notice any of these problems (swelling or a lump), or you have any concerns surrounding your implants, please seek medical advice and attention. Although it is very unlikely that there is a link between any problems and ALCL. Other complications are more likely the cause and often have simple solutions if you consult with your GP or Surgeon.

Because BIA-ALCL is rare, health experts do NOT recommend the removal of breast implants where there are no problems with the implant.

Therapeutic Goods Authority updates & information on BIA-ALCL

Information for consumers about BIA-ALCL, its symptoms and treatments are available on the TGA’s breast implant hub. The full article on the TGA’s initial views following recent laboratory testing and statistical analysis can be read here.

So what next?

As the condition is rare, experts do NOT recommend removal of breast implants where there are no problems with the implant. BIA-ALCL is more likely to occur in rougher surfaced or textured implants, and the TGA is proposing to either cancel or suspend particular implant products. There are alternative smooth breast implants available and these currently have no association with known cases in Australia.

Because the risk to women who already have these implants is very low, experts do not recommend that women who have implants already need to have them removed, unless BIA-ALCL has been diagnosed. Although the option of removal and/or replacement of breast implants is always an option.

The proposed action by the TGA does not change this advice. If you have concerns please speak to your GP or surgeon. No decision has been made to suspend or cancel the relevant products at this time (9 July 2019).

What breast implants have the TGA suspended?

textured breast implants banned in Australia

TGA Suspended Textured Breast Implants in Australia related to BIA-ALCL

Breast implants were recently in the news when the TGA suspended specific types of implants in Australia.

DOES TGA ACTION MEAN BREAST IMPLANTS ARE NOW BANNED IN AUSTRALIA? – NO!

No. This regulatory action is a suspension and request for further information from suppliers and manufacturers. It is essentially a precursor to a potential TGA recall and breast implant ban (a 6-month suspension of manufacturing permissions for certain textured implants and tissue expanders), not an actual ban.

However, a TGA suspension essentially has the same effect as a ban, for the interim time (e.g., the TGA is suspending manufacturing and implementing a recall of non-implanted breast prosthesis until further safety data and SAEs such as BIA-ALCL are collected and assessed by health experts, medical device safety investigators and health statisticians over the next 6 months).

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Breast Implant Brand Suspensions

Suppliers have 6 months to supply additional safety data about their breast implant products, along with the following,

  1. Numerous brands of textured implants were suspended and/or recalled as they appear linked with a rare form of cancer, BIA-ALCL.
  2. Details of the breast implant brands suspended and/or being considered for bans by the TGA are listed below and/or can be found on the TGA’s website.
  3. The TGA is recommending potential bans and/or recalls of breast implants, so in September 2019, the TGA temporarily suspended manufacturing permits for suppliers of particular types of implants.
  4. Suppliers of these implants have 6 months to provide further safety study data to the TGA’s expert panel.
  5. Further breast implant assessments and/or ban or recall recommendations will be decided next February, in 2020.

 

TGA Ban on Implants: Facts, Figures and Faq’s

Update on breast implant bans in Australia from September 2019 and what patients need to know.  If you have symptoms of BIA-ALCL or related concerns, see your original Breast Surgeon and/or health care team immediately for assessment. This information is based on data as of September 2019, when the TGA announced its ban on specific types of breast implants.

Which Types of Breast Implants Did the TGA Ban in Australia?

  • There is a temporary suspension with a view towards a potential recall/ban on various types of breast implants (per the TGA)
  • Types suspended include textured implants and tissue expanders as shown in the table below.

Excerpt and below table from the TGA’s published alert about breast implants and BIA-ALCL

‘The TGA has decided to take regulatory action in relation to all un-implanted breast implants and tissue expanders sold in Australia. However, even if your breast implants are being cancelled, suspended or recalled, medical experts do not recommend removing them if you do not have symptoms of BIA-ALCL. This is because BIA-ALCL is very rare, and the risk of undergoing surgery could be higher than the risk of developing BIA-ALCL.’

Suspension-of-un-implanted-Breast-implants-table
Source: TGA

What are the details of the TGA breast implant ban?

  • The TGA put a temporary suspension (and are proposing a ban) on certain types of textured implants
  • They are proposing cancelling, suspending, and/or insisting on a recall of several types and brands of breast implants used in Australia. Including specific texture types, this is in relation to evidence that some forms of texture implants have a link to a higher risk of developing Anaplastic Large Cell Lymphoma (ALCL or BIA-ALCL).

Breast Implant Brands impacted by the TGA suspension (ban, stock recall) include:

  • ‘Natrelle’ implant models marketed by Allergen
  • Johnson & Johnson
  • Emagin / Sebbin
  • Euro Implants
  • JT Medical

More information on impacted breast implant brands.

 Is it necessary to remove all textured breast implants to prevent BIA-ALCL?

  • The TGA does not recommend the removal of existing breast implants where there are no symptoms.
  • The current recommendation is to leave your breast implants if no signs or symptoms are present; and remember, all surgery carries risks.
  • The reason is that there may be more factors in the development of BIA-ALCL than JUST the texture of the implant alone. However, confirmation on this is yet to happen.
  • This is a contributing factor are to why the TGA is giving manufacturers another 6 months to provide more safety data.

In other words, the TGA’s recommendation to suspend (Or Ban and Recall) certain types of textured Implants is at the current time, a temporary measure while further analysis into Breast Implant Safety And BIA- ALCL Risk Data.

The current belief is that BIA-ALCL has a 4 to 10-year incubation period, but this can vary.  See your Surgeon or Medical Team if you have any signs or symptoms of BIA-ALCL or other breast implant-related concerns. 

Should I remove my textured implants?

FAQ: ‘I have textured implants; should I remove my textured breast implants as a precaution surgery to prevent BIA-ALCL?’

  • Per the TGA there is no need to remove Implants that are in place, and not causing any concerns or symptoms.
  • Many other health and safety experts agree that removal of implants without signs, concerns or symptoms is unnecessary. Many women with implants remain healthy and fine.
  • It’s important to remember that this is a rare disease – while statistics vary between, 1:1000 to 1:80,000 it is still rare.
  • Breast cancer risks, for example, are about 1:8 (around 12%) in comparison to 1 in 1000 for BIA-ALCL as the current worst-case risk ratio. This is subject to data collection.
  • The TGA and other Surgeons have expressed concern that some unscrupulous surgeons will prey on women who have anxiety about BIA-ALCL even without symptoms or even with smooth implants vs textured ones.

Is BIA-ALCL curable?

  • BIA-ALCL does appear to be effectively treatable when diagnosed early
  • There may be variants of ALCL and patient risks and outcomes can vary
  • The average onset time frame is about 7 to 8 years after augmentation
  • Certain blood markers for testing AND targeted BIA-ALCL treatments are undergoing further efficacy review and clinical assessments
  • Read more about the treatment of BIA-ALCL

Current Research continues to investigate:

  • potential BIA-ALCL occurrence rates and mortality risks
  • possible BIA-ALCL risk factors including:
    • certain textured breast implants – e.g., surface texture types rather than FILL content
    • bacteria contamination to implants AND/OR
    • trauma to the chest region
    • regional variances and genetic predispositions

Further reading on BIA-ALCL and Breast Implants

You can Search browsers for the latest scientifically validated data and check the education, study design and source of information. For more information on diagnosis, treatment and monitoring of the condition please visit

Breast Implant Monitoring: Recommendations from the Australian Plastic Surgery Association (ASPS)

FDA USA Media Release

Article Sources and Further Reading

BIA-ALCL RECOMMENDATION

We advise patients to remain diligent in monitoring their implant results. Moreover, it is VITAL you attend all checkups with your original plastic surgeon.

You might want to:

  • stay informed about new research and ALCL risk rate data
  • evaluate the source and statistics of any related news articles
  • monitor your surgery results and health and attend all check-ups
  • contact us with any questions, concerns or requests for implant exchanges or removal

Want your implants removed or changed out with more modern implants such as MENTOR or MOTIVA?

NEED A BREAST IMPLANT CHECK OR REVIEW?

Did you have breast augmentation at our clinic? Is it time for your annual implant review?

We encourage patients of our Surgeons to PHONE US at any time IF you have questions or concerns about your existing implants. You can also contact us if you:

  • Want to schedule your re-examination or annual surgery review
  • Need your address, phone contact details and email records updated
  • Would you like to discuss your implant options?
  • Would you like to have your old implants taken out?
  • Do you want new implants?

What if you had your breast implants inserted somewhere else?

For a new patient surgery consultation for breast implant removal, implant surgery revision or breast implant remove-and-replace procedures, implant size changes or other breast surgery, phone the Patient Care Team today

Last updated: 19/07/2021
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Michelle Staughton
Michelle Staughton - Patient Liaison Manager at Coco Ruby Plastic Surgery in Melbourne, Victoria, Australia

Our Specialist Plastic Surgeons

With a wealth of experience and training, our Specialist Plastic Surgeons are dedicated to best practice patient care and education, customising Breast Enlargement Surgery for each and every patient to best meet their needs and desired surgical outcomes.

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What to do next?

Our Patient Liaison Team can assist with any questions you may have when considering a procedure. You can send in an enquiry form below or call our Melbourne Clinic between 9 am – 5 pm Monday to Friday.

Phone 1300 264 811, Email us: enquiries@cocoruby.com.au or Book a FREE 15-minute Phone Chat with our Patient Liaison Manager or a Virtual Consultation with a Surgeon.


Disclaimer: Results depend on individual patient circumstances and can vary significantly. Results may also be impacted by a variety of factors including your lifestyle, weight, nutritional intake and overall health. Consult your Specialist Plastic Surgeon for details. This information is general in nature and is not intended to be medical advice nor does it constitute a doctor-patient relationship. Surgery risks and complications will be covered in detail during a consultation with your Surgeon.