Melbourne Plastic Surgery Blog

Melbourne Plastic Surgery Blog

Information regarding breast implant associated Anaplastic Large Cell Lymphoma

Thursday, June 28, 2018

Following renewed media interest regarding the correlation between breast implants and an increased risk of developing Non-Hodgkin’s Lymphoma Mr Mutimer thought the timing pertinent to outline key information related to BIA-ALCL.  

The following information has been sourced from the Australasian Society of Aesthetic Plastic Surgeon’s website and summarises what we know to date:

FACTS ASSOCIATED WITH BIA-ALCL

  1. It is a cancer of lymphatic cells and a form of Non-Hodgkin’s Lymphoma.
  2. It is not a breast cancer.
  3. 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).
  4. It occurs in women who have had implants for both cosmetic and reconstructive indications.
  5. It takes an average of 7-10 years after implant insertion before it develops.
  6. The commonest 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 condition is made by examination of the seroma fluid.
  7. Early stage disease is curative with surgery alone.
  8. Disease which has spread through the capsule, forming a mass or which has spread to local lymph glands carries a worse prognosis.

RISK 

The most accurate assessment of risk published to date 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 (biocell, Alllergan and polyurethane, Silimed) were around 10 times higher (1 in 4,000 to 1 in 7,000) compared with implants with lower surface area texture (1 in 60000 for siltex Mentor). 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.


CAUSATION

Recent media stories suggested that there is a link with cut-price providers. No such link that has been established to date by analysis of the 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.

The unifying theory cites four inter-related factors:

  1. Textured implants (with a higher risk for high surface area textures)
  2. Bacterial contamination at the time of surgery to reach a threshold to cause inflammation
  3. Patient genetic predisposition
  4. Time - for the process to develop.
Bacteria have been identified in association with these tumours, similar to the association between gastric lymphoma and Helicobacter pylori.

I'VE HAD BREAST IMPLANTS OR AM CONSIDERING SURGERY - WHAT SHOULD I DO NEXT? 

If you currently have breast implants and are concerned you should consult with a Specialist Plastic Surgeon who will determine what type of implants you have and address your concerns.

Similarly if you are considering breast implant surgery it is important to schedule a consultation with a Specialist Plastic Surgeon to discuss the risks and benefits, including the risk of BIA-ALCL. There are different types of implants available and selection needs to take into account the risks and benefits of specific choices.

For more information or to book a Consultation with Mr Keith Mutimer – Specialist Plastic Surgeon phone 03 9592 0522 or submit a confidential enquiry via our website.

 

Breast Implant Study

Tuesday, November 11, 2014

On 11/11/14 The Herald Sun Newspaper reported on a recent breast implant study - linking breast implants to breast cancer.  

 The Australian Society of Plastic Surgeons have issued the following media release in response to this study:


 


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This information has been summarised from the Australasian Society of Aesthetic Plastic Surgeons recent statement on Breast Implant Associated ALCL.

Understandably, a number of patients with breast implants have been alarmed by the increase of coverage in the news regarding Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) following the announcement that the TGA were reviewing the safety and ongoing availability of textured breast implants in Australia.

Here's a summary of current information and what you need to know:

  • The TGA announced on 11 July 2019 that it had completed its review and laboratory assessment of textured breast implants on the Australian market.
  • The next steps are either a proposal to cancel or a proposal to suspend certain types of textured implants by specific manufacturers. 
  • You can find the full list of implants in question on the TGA’s website.
  • It is important to note that BIA-ALCL is not breast cancer. 
  • It is a rare type of lymphoma that develops adjacent to breast implants, usually as a swelling of the breast 3-14 years after insertion.  This swelling is due to fluid building up in the fibrous capsule that surrounds the implant and does not develop in the breast tissue itself.  It can also present as a swelling or lump in the breast or armpit.
  • BIA-ALCL is a rare condition, with 92 patients confirmed in Australia and New Zealand.  Due to its rarity, it's difficult to be sure about the exact level of risk of developing this disease.  The risk of developing ALCL with textured implants differs with different grades of texture from one in 2,800 to one in 80,000.  Comparatively, breast cancer occurs in one in every eight women.
  • In the case of BIA-ALCL, the key to effective treatment is early diagnosis and specialist treatment.
  • In the early stages, BIA-ALCL is slow-growing and curable by surgery alone.
  • The cause is currently unknown but Australian and New Zealand Plastic Surgeons, along with local and international research organisations are working tirelessly to find the cause.
  • BIA-ALCL can occur in both breast reconstruction cases and cosmetic cases, as well as affecting both saline and silicone implants. 
  • At this time, there is no evidence to suggest the benefit of routine removal of breast implants if you do not have symptoms of this condition.

What should you do if you are concerned?

  • If your surgery was performed at Brighton Plastic Surgery, please ring us and we can inform you about what implants you have, and we can guide you through the clinical review process. If your surgery was conducted elsewhere and you are unsure of the type of breast implant used in your surgery, details will be in your original surgeon's medical files, and they will be able to inform you if it is a textured implant.
  • If you are unable to contact your original surgeon, please see your GP who can get you in contact with a Specialist Plastic Surgeon for a full clinical evaluation.  It would be recommended that this occur in any patient with breast implants, who are exhibiting symptoms of this condition.

We recommend that you click here to read the full statement from the Australasian Society of Aesthetic Plastic Surgeons.