Textured breast implants review and recall

In July, the Therapeutic Goods Administration (TGA) called for a review into all textured breast implants, with the possibility of a ban. The review was called as the result of an apparent association between some textured implants and a rare form of lymphoma (blood cancer) called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIAALCL). Following this review, implant manufacturer Allergan issued a worldwide recall of its
textured breast implants and tissue expanders from the market.

This means that these expanders and implants are no longer able to be used in breast reconstruction or breast augmentation surgery anywhere in the world.

The risk of breast implant associated lymphoma is rare – approximately 1 in 2,000 women will develop the condition. As a result, surgeons and health experts are not recommending removal of breast implants where there are no problems with the implant.

However, we understand this news has made many women anxious. BCNA advises women who have had implant-based reconstructions to talk to their breast surgeon, plastic surgeon or the hospital where their surgery was performed to find out whether textured or smooth implants were used. The recall does not affect smooth breast implants.

Women who notice any sudden changes around their implant, such as new swelling or a lump, should notify their doctor.

BCNA has been closely monitoring this issue and worked with Cancer Council Australia to provide a submission to the TGA on behalf of our members. This submission highlights 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. In the meantime, BCNA will keep our members up to date via our website, social media and our monthly Network News email newsletter.

  • Find out more about the TGA’s review of textured breast implants at the TGA website
  • Listen to breast surgeon Melanie Walker explain BIA-ALCL and the risks around textured implants on the BCNA website.
Issue 85
Spring 2019