Breast implants and BIA-ALCL FAQs

Introduction

The aim of this document is to provide you with answers to the frequently asked questions or comments concerning breast implants and BIA-ALCL.

For each question, a simple and concise answer is provided, which should be suitable for use when conversing with your patient.

The document provides informative answers to strengthen understanding and improve clarity regarding breast implants and BIA-ALCL-associated risk. This document also provides compelling arguments that reinforce GC Aesthetics’ heritage and commitment to safety in breast implants.

Whilst this document is not extensive, we hope the key messages and supporting data are useful when handling questions relating to BIA-ALCL aetiology, signs and symptoms, diagnosis and risk factors. Should you encounter any questions or comments that are not included in the following resource, please consult with your GC Aesthetics medical team.

These responses are designed to be used reactively to address patient comments and questions. We sincerely hope this document is beneficial for your future conversations.

1.What is BIA-ALCL and what signs and symptoms of BIA-ALCL should you be looking for?

BIA-ALCL is a very rare type of blood cancer and there is a small but increased risk of it developing in women who have received breast implants.1,2 You should regularly check for redness, itching or any swelling or painful lumps around the implant.3 While it remains unlikely that you have developed BIA-ALCL, these symptoms should always be discussed with your surgeon if you have any worries or concerns. It is important that you look after your breast health regardless of having breast implants.

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

BIA-ALCL is extremely rare.4 In the UK, 1 woman out of 24,000 may develop BIA-ALCL after having breast implants.4 It is estimated that you are five times more likely to be fatally injured driving a car for an hour a day than be diagnosed with BIA-ALCL.5

3. What is the risk of developing BIA-ALCL with any GC Aesthetics products?

The risk of developing BIA-ALCL is extremely low. The risk of developing BIA-ALCL with GC Aesthetics’ textured implants is less than 0.0007%. There are no reported figures for BIA-ALCL with GC Aesthetics’ smooth implants (0%).†,6

4. Is the BIA-ALCL rate different across manufacturers?

A recent FDA report has highlighted that over 80% of the globally reported BIA-ALCL cases were associated with Allergan breast implants.7 The risk for GC Aesthetics’ textured implants is less than 0.0007% (less than 1 in 150,000)†, and it is currently 0% for smooth implants.†,6

It is important to have an annual breast check-up with your doctor.8 In addition to this, you should regularly check for any redness or itching on the breast, or any swelling or painful lumps around your implant.3 Should you have any worries or concerns, consult your surgeon immediately.

6. How is BIA-ALCL diagnosed and what are the options and prognosis for treating BIA-ALCL?

If you experience pain or swelling around your breasts it is likely that you have fluid around your implant. This is called a seroma but does not automatically mean you have BIA-ALCL. Diagnosing BIA-ALCL, requires a sample of the breast fluid around the implant to be taken and tested.3 In the unlikely event that BIA-ALCL is detected, surgery is needed to treat the condition and your breast implants will be removed. BIA-ALCL is curable with surgery alone in over 85% of the cases with a 98% survival rate at five years post-surgery.1

7. Do I need to have a textured implant removed, even if I am not experiencing any symptoms?

There is no reason for you to have a breast implant removed to prevent BIA-ALCL.4 The risk of BIA-ALCL is very low and no medical authority is currently recommending that implants should be removed.9

8. What is the likelihood of developing BIA-ALCL in patients undergoing breast reconstruction surgery after recovering from breast cancer?

Despite both cancers being located in the breast, it is important to note that BIA-ALCL is not the same as breast cancer.10 There are no data to suggest that you are more likely to develop ALCL than someone who hasn’t had breast cancer,1 and it is important to note that the risk for developing BIA-ALCL is overall extremely rare.1

REFERENCES

  1. Quesada AE, et al. Modern Pathol 2019;32(2):166–88;
  2. Miranda RN, et al. J Clin Oncol 2014;32(2):114–20;
  3. Kaartinen I, et al. Eur J Surg Oncol 2017;43(8):1385–92;
  4. Mercer NSG. Aesthet Surg J Open Forum 2019;1(1):ojz003;
  5. Sieber DA, et al. Aesthet Surg J 2017;37(8):887–91;
  6. BIA-ALCL GC Aesthetics Communication update. www.gcaesthetics.com/news (Accessed October 2019);
  7. The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication www.fda.gov/medical- devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue (Accessed October 2019);
  8. ANSM website. www.ansm.sante.fr/var/ansm_site/storage/original/application/c459764e5e140856e4e88495f1f84875.pdf (Accessed October 2019);
  9. Dixon JM, et al. BMJ 2018;363:k5054;
  10. FDA Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). www.fda.gov/ medical-devices/breast-implants/questions-and-answers-about- breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl (Accessed October 2019).
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