Update from TGA breast implant expert working group

What is BIA-ALCL?

Breast implant associated Anaplastic Large Cell Lymphoma is a type of cancer that is associated with textured breast implants. It is important to note that it is not breast cancer but a cancer of the immune system, which grows in the fluid and scar tissue around the implants. The Therapeutic Goods Administration (TGA) has concluded that it is an extremely rare type of cancer, with only 78 known cases (including four deaths) in Australia as at 3 May 2019. It is estimated that in Australia, there are between 13,000 and 17,000 procedures involving breast implants undertaken each year.

The main symptom of BIA-ALCL is fluid swelling in the space between the implant and the implant capsule. Some women have also reported experiencing pain and lumps in the breast or armpit. The Australian Society of Plastic Surgeons (ASPS) have stated the cancer can be treated effectively if it is diagnosed early. Treatment usually consists of surgery to completely remove the implant itself and the surrounding capsule.

Updates from TGA

On 9 April 2019, the TGA reported that the breast implant expert working group had convened in response to the decision of equivalent regulators in France and Canada to ban certain textured implants from their markets. You can read the entire update here:  https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma

In summary, TGA’s update included the following:

  • A formal request has been issued under the Therapeutic Goods Act 1989 to Australian suppliers of textured implants for information including data and product samples.
  • Globally, a number of other regulators including the American Food and Drug Administration (FDA) and other European regulators have deferred making a decision with respect to the removal of implants from the market.
  • It was concluded that BIA-ALCL is rare and there are benefits to the use of textured implants in particular surgeries.
  • Globally, it is generally agreed that it is not necessary to remove breast implants unless BIA-ALCL has been properly diagnosed.
  • Obtaining further data, specific to the Australian Market will enable the TGA to make an informed decision with respect to the safety of certain implants and whether or not certain types should be banned.

On 3 May 2019 the TGA provided a further update with respect the progress of the monitoring and evaluation of breast implant products. It is estimated that a decision with respect to regulatory action will be made by mid-June. You can read the further update in full here: https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma

The TGA has also provided a list of considerations and questions that you should ask your surgeon prior to undergoing surgery involving breast implant devices. The TGA recommends that you:

  • Ask your surgeon about the benefits and risks of different types of implants;
  • Ask your surgeon if they contribute to the Australian Breast Device Registry (ABDR);
  • Talk to a health professional before you consider overseas surgery; and
  • Know the symptoms of breast implant associated cancer.

Cases of women with BIA – ALCL

Despite the position of the TGA to delay making a decision on the regulation of textured implants until further data is obtained, we have seen cases of women with textured implants who have contracted BIA-ALCL. The ASPS recommends that a discussion of the risk of contracting BIA-ALCL from certain implants be included in the process of obtaining informed consent.

Turn to Turner Freeman

Sally Gleeson, medical negligence partner and her team of lawyers are experienced in cases involving complications of breast augmentation surgery. If you have suffered complications as a result of a breast augmentation surgery or have been diagnosed with BIA-ALCL, please contact us so that we can assess your case. Alternatively, if your surgery was performed by The Cosmetic Institute, you can register your interest in our Class Action below.

Register in our Class Action

We invite you to register your interest in the class action against TCI with Turner Freeman Lawyers. It is important that you put your hand up to be counted. If you have suffered complications as a result of surgery by TCI, please register on our website and our medical negligence Partner, Sally Gleeson or one of her team members will be in touch to explain the process.