BIA-ALCL: Facts for Patients

What is it?

  • BIA-ALCL (Breast Implant Associated – Anaplastic Large Cell Lymphoma) is a rare type of T Cell Lymphoma that has been reported in varying association with some types of breast implants.
  • Currently, the risk of developing BIA-ALCL remains very low, with estimates ranging from 1 in 10,000 women to a worst-case estimate of 1 in 1,000 women. Even the worst-case estimate of 1 in 1,000 means that 99.9 per cent of women with these implants will not get BIA-ALCL.

Which implant types were suspended?

  • In October 2019, Australia’s regulatory authority, TGA (Therapeutic Goods Administration) suspended a long list of various brands of Breast Implants based on their type of textured surfaces and potential to cause BIA-ALCL
  • Included in the list of suspended implants were Polytech’s ‘Tear-Drop’ Shape Silicone Implants from Germany.
  •  However, these implants are still accessible on an individual patient basis under TGA’s Special Access Scheme whereby your Surgeon can apply on your behalf to TGA and seek its approval for him/her to use these implants.

How does BIA-ALCL present?

  • BIA-ALCL usually presents as a swelling of the breast, typically 3 to 14 years later with 50% of cases presenting by 7-8 years after implantation. This swelling is due to an accumulation of fluid in the implant pocket and is known as a Seroma.  Not all Seromas are due to BIA-ALCL.
  • Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.

How is BIA-ALCL diagnosed?

  • If a Seroma develops, the fluid around the implant is aspirated under ultrasound guidance to avoid injury to the implant and sent for analysis. If tests exclude BIA-ALCL, there is no need for further treatment other than regular follow-up and repeat aspiration if the implant pocket fluid re-accumulates.
  • If testing of the fluid does confirm the presence of BIA-ALCL, the treatment is removal of both implants and their surrounding fibrous capsules. This usually suffices to cure the problem.
  • If the BIA-ALCL presents as a breast lump or enlarged lymph gland in the armpit, excision biopsy of the lump would be required.

How is BIA-ALCL Treated?

  • Fluid-only patients are cured by removal of the implants and the capsule around  them and it is essential that all women who are diagnosed with fluid-only BIA-ALCL have the curative surgical treatment.
  • This leaves one or two women in 10,000 who do have a cancer beyond the fluid. In most of these, the cancer cells are localised in the fibrous capsule that surrounds the implant. These patients are also cured by the removal surgery and do not need any other treatment.
  • The risk of developing an invasive cancer that needs chemotherapy and/or radiotherapy in addition to the removal is less than 1 in 10,000 and, when this is needed, it is usually curative. The risk of dying from BIA-ALCL does exist but is so small it cannot be reliably calculated. It is considered to be less than 1 in 1 million.
  • To put this into further perspective, the risk of any Australian woman, with or without breast implants, of developing breast cancer (not BIA-ALCL) is 1 in 8. The lifetime risk of developing any kind of Lymphoma is 1 in 50, and the risk of developing BIA-ALCL is between 1 in 10,000 women to a worst-case estimate of 1 in 1,000 women.
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