Proposed Regulatory Action for Textured Breast Implants

Australia’s medical device regulator, has today announced that it is proposing to take

strong and decisive action to suspend or cancel and recall certain textured breast implants

from the Australian Market, following a review of apparent links to rare forms of cancer.

The Therapeutic Goods Administration (TGA) proposed regulatory action follows an

extensive review of an apparent association of Breast Implant Associated Anaplastic Large

Cell Lymphoma (BIA-ALCL) and some textured breast implants.

The Morrison Government supports the actions of the TGA and recognises its authority

and integrity as a regulator of medicines and medical devices.

Expert opinions estimate that the risk of breast implant associated lymphoma is rare at

between 1-in-1,000 and 1-in-10,000.

Experts do not recommend removal of breast implants where there are no problems with

the implant.

Breast implant associated lymphoma is usually cured if detected early.

If you have concerns about your breast implants, see your general practitioner and seek

review by your surgeon.

To monitor outcomes for patients with breast implants, the Government established the

Australian Breast Device Registry and provides funding through Medicare for the

treatment of complications resulting from breast implants.

The Morrison Government is providing $48.2 million over 2017-18 to 2022-23 to the

McGrath Foundation for breast cancer nurses. This includes increasing the number of

Commonwealth-funded McGrath Breast Care Nurses from 57 to 98 by 2022-23.

In the 2019-20 Budget, the Government invested $32.6 million over four years to list

additional magnetic resonance imaging (MRI) and positron emission tomography (PET)

items on the Medicare Benefits Schedule for the detection and evaluation of breast cancer.

It is expected that this will support around 14,000 patients each year.

The Morrison Government supports access to quality, safe and effective health care and

actions from regulators that are in the interest of public health and safety.

The TGA has published information on the proposed regulatory action, including

information on the specific textured implants, on the TGA breast implant hub.

/Media Release. View in full here.