Guide to BIA-ALCL 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 being investigated through scientific research and medical device monitoring.
Although some women have died from BIA-ALCL, data suggests that EARLY diagnosis and targeted medical treatments can be very effective in treating this condition. (see Below)
Overview of BIA-ALCL and Breast Implants
A brief synopsis of what is currently recognised about BIA-ALCL ( Breast Implant-Associated Anaplastic Large Cell Lymphoma):
- BIA-ALCL is NOT the same thing as breast cancer – reference BIA ALCL is not the same as breast cancer.
- Effective treatments are available and show success for early-diagnosed cases
- Symptoms that might indicate BIA-ALCL are swelling, pain and/or lumps in the breast area or nearby lymph nodes
- Implant sensitivity or inflammation may occur for some women, which may lead some women to choose to remove their implants
- Research into BIA-ALCL risks and occurrence rates CONTINUES
- DATA is incomplete, and thousands of women have breast implants that are well-tolerated
- Studies are ongoing – REGISTRY data collection is encouraged
- Risks of having BIA-ALCL have been reported to range from 1:1000 to 1:30,000 but research continues to seek clearer data on potential disease dynamics, risk rates and risk factors
How does the TYPE of breast implant affect 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)
- Risk factors MAY be linked with IMPLANT TEXTURE (regardless of content fill being saline or silicone)
- IMPLANT HANDLING or contamination (bacteria) and traumatic impact to chest are also being investigated
- Genes, regional variances and other factors are also being explored
- Most DATA is being collected and the risk rate is currently considered to be RARE (See Micromorts)
Hence MORE RESEARCH is recommended to better assess which risk factors may be involved in the formation of BIA-ALCL as well as disease dynamics and treatment protocols.
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 to any signs, changes or symptoms that might indicate an issue with your breast implant results
- Get ANNUAL check ups with your SURGEON
- arrange earlier or more frequent check-ups and surgery reviews if you have any concerns
- be sure you let your Surgeon know of any concerns or questions
- NOTIFY your Surgeon immediately if:
- you notice ANY changes to your breast surgery results
- you have any swelling or pain in the breast area
- you observe lumps or bumps in the chest area or lymphatic regions (armpits)
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, with the estimated published risk of BIA-ALCL between 1-in-1,000 and 1-in-10,000. Although fatalities have been recorded, the vast majority of cases are cured by 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 any problems are linked to ALCL, other complications are more likely and are easily fixed if you consult with your GP or Surgeon.
Because BIA-ALCL is rare, health experts do NOT recommend 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. This update was originally posted on the TGA website. The full article on the TGA’s initial views following recent laboratory testing and statistical analysis can be read here.
So what next? (at July 2019)
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 have NOT been associated 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).
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 THIS 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).
Breast Implant Brand Suspensions
Suppliers have 6 months to supply additional safety data about their breast implant products, along with the following,
- Numerous brands of textured implants were suspended and/or recalled as they appear linked with a rare form of cancer, BIA-ALCL.
- 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.
- 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.
- Suppliers of these implants have 6 months to provide further safety study data to the TGA’s expert panel.
- 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 were Banned in Australia by the TGA?
- 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.’
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 textured breast implants used in Australia, in relation to evidence that some forms of textured implants are associated with a higher risk of developing Anaplastic Large Cell Lymphoma (ALCL or BIA-ALCL).
Breast Implant Brands impacted by the TGA suspension (ban, recall) include:
- ‘Natrelle’ implant models marketed by Allergen
- Johnson & Johnson
- Euro Implants
- JT Medical
More information on impacted breast implant brands.
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).
- 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.
- BIA-ALCL also appears linked with specific types of breast implants (not all breast implants are linked with BIA-ALCL).
- 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.
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).
- The Breast symptoms listed above should be investigated in women with or without breast implants, as 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 figures are being adjusted.
- It is believed 107 Australian women have been diagnosed so far with BIA-ALCL.
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 BIA-ALCL is only linked with textured implants vs smooth implants?
- Data is still being collected but so far, no cases of BIA-ALCL involve smooth implants.
- At this time, then, it appears the surface texture of the breast implants may be associated with 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, this may be associated with ALCL; yet 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 only textured breast implants are linked thus far with BIA-ALCL, not smooth breast implants.
- It is not yet known whether other factors, e.g. patient variables, may have an impact as well as the texture of the implant.
- 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 discovered early, that is the only treatment needed other than potential breast modifications or enhancements using other means (this may be limited in certain patients with little natural breast tissue)
WHAT IS THE RECOMMENDED TREATMENT FOR BIA-ALCL DETECTED EARLY?
Early diagnosis is helpful in treating BIA-ALCL
- Treatments for BIA-ALCL can vary from patient to patient.
- Most treatments require removal of the textured breast implants.
The success rates for treating BIA-ALCL in 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)
SHOULD I REMOVE TEXTURED IMPLANTS?
FAQ: ‘I have textured implants; should I remove my textured breast implants as a precaution surgery to prevent BIA-ALCL?’
- Implants that are in place, and not causing any concerns or symptoms, are not being recommended for removal surgery per the TGA (and much other health and safety experts agree that removal of implants without signs, concerns or symptoms is not thought necessary as many women with implants remain healthy and fine).
- It’s important to remember that this is a rare disease – while statistics vary, 1:1000 to 1:80,000 is considered rare.
- Breast cancer risks, for example, are about 1:8 (around 12%) compared to 1 in 1000 for BIA-ALCL as the currently anticipated worst-case risk ratio (subject to data being collected) and compared to a 1 in 80,000 risks also proposed by statisticians
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 it necessary to remove all textured breast implants to prevent BIA-ALCL?
- However, it is not recommended to remove implants if no signs or symptoms are present; and remember, all surgery carries risks.
- The reason is that there may be more factors involved in BIA-ALCL developing than JUST the texture of the implant alone; this has not yet been determined and is part of 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 Breast Implant Safety And BIA- ALCL Risk Data Is Being Assessed.
Further actions by the TGA to ban or recall either breast implants and/or tissue expanders is expected after they meet again with experts, to review available safety data, early 2020. BIA-ALCL is thought to have a 7-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. The TGA does not recommend removal of existing breast implants where no symptoms are reported.
ASAPS and the Minister of Health are anticipated to be encouraging a meeting between ASAPS, health experts and the TGA to discuss the TGA’s recommendations for breast implant bans and recalls.
The ASAPS believes that a broad ban on textured implants and tissue expanders will seriously limit mastectomy patients and other breast cancer survivors from reconstructive breast surgery shown to have a significant impact on self-esteem and positive psychological adjustments after radical mastectomy surgery in relation to breast cancers and genetic breast deformities.
The TGA will have an update on its recommended bans or recall issues for breast implants and tissue expanders when they converge again after evaluating further safety data from experts, patients, manufacturers and other stakeholders.
Last updated: 22/10/2019
LATEST BIA-ALCL STATISTICS
QUICK OVERVIEW 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
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
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
- TGA Breast Implant Hub
- Information for consumers from TGA
- Safety alert from TGA
- TGA Therapeutic Goods Administration update and review on safety of breast implants
- TGA media release for ALCL monitoring (2018 TGA information)
Breast Implant Monitoring: Recommendations from the Australian Plastic Surgery Association (ASPS)
- ASPS recommendation for women with Breast Implants who are worried about BIA-ALCL (accessed in 2019)
FDA USA Media Release
Article Sources and Further Reading
- Modern Primary Breast Augmentation: Best Recommendations for Best Results.
- Breast implant-associated Anaplastic Large Cell Lymphoma in Australia and New Zealand – high surface area textured implants are associated with increased risk.
- Dr Moncrieff – Newcastle
NEED A BREAST IMPLANT CHECK OR REVIEW?
Did you have breast augmentation at our clinic? Is it time for your annual review?
Patients of our Surgeons are encouraged to PHONE US at any time IF you have any questions or concerns about your existing implants OR to 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 like to discuss having their breast implants removed or replaced with newer 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
Patients are recommended to remain diligent in monitoring their implant results AND attend all yearly or scheduled checkups with their 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?
- Read more about replacing or removing your existing implants.
- Contact us for REVISION surgery or replacement and removal – send an enquiry form today or phone us at the numbers above.