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BCNA News 15 Aug 2019

Textured breast implant ban update

Breast Cancer Network Australia (BCNA) would like to update members on the latest developments on the potential ban of textured breast implants and tissue expanders.

TGA review

The Therapeutic Goods Administration (TGA) called for a review into textured implants in July. The review was called as the result of an apparent association between some textured implants and a rare form of lymphoma called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

BCNA worked with Cancer Council Australia to present a submission on behalf of members, highlighting several issues, including:

  • Restating BCNA's call for breast reconstruction surgery not to be categorised as cosmetic surgery
  • Highlighting that a ban on all textured implants would seriously impact women’s options for immediate breast reconstruction
  • Highlighting that the risk of BIA-ALCL is lower with micro textured expanders and implants than with macro textured devices
  • Calling on the TGA to consider allowing micro textured devices to be available so that women with breast cancer have an appropriate implant reconstruction option available to them
  • Calling on the TGA to consider the impact on women who already have textured expanders/implants in place
  • Recommending the TGA carefully consider its messaging to the public if a ban is implemented.

The TGA has prioritised the review. It is expected to take several months to consider all submissions and decide if any regulatory action is taken.

BIA-ALCL facts

BIA-ALCL is more likely to occur in rougher surfaced implants, and the TGA is proposing to either cancel or suspend particular products. There are alternative smooth implants available, and these have not been associated with known cases of BIA-ALCL.

Breast implant associated cancer is rare. The TGA advises that between one in 1000 and one in 10,000 people with breast implants are diagnosed with the condition. 

Allergan recall

On July 24, implant manufacturer Allergan issued a worldwide recall for its textured tissue expanders and breast implants. These expanders and implants are no longer able to be used in breast reconstruction or breast augmentation surgery anywhere in the world.

The Allergan ban does not affect smooth breast implants.

What should women do?

At this time, experts have advised that, due to the low risk of developing BIA-ALCL, it is not recommended that women with textured breast implants who have no symptoms of BIA-ALCL have them removed. 

BCNA advises women who have textured breast implants to talk to their breast surgeon or plastic surgeon about the implications for them. If you are unsure if you have textured or smooth implants, you can contact your surgeon or the hospital where your surgery was performed. More information is available from the TGA's website.

If you notice any sudden changes around your implant, such as new swelling or a lump, you should notify your doctor.

The TGA has advised that any scans required to investigate for suspected BIA-ALCL will be eligible for a Medicare rebate. 

It is also important to note that implants are not designed to last forever and will need to be replaced after about 10 – 15 years.

More information

BCNA CEO Kirsten Pilatti has recorded a video with Associate Professor Sanjay Warrier, President of BreastSurgANZ, to provide answers to some of the questions that have been raised about this issue. The video can be watched here.

Professional, confidential assistance is also available from the BCNA Helpline on 1800 500 258.