The Therapeutic Goods Administration proposes breast implant recall after cancer links

Health scare: The national medical device regulator is recommending suspending or cancelling some textured breast implants because of their apparent links to cancer.
Health scare: The national medical device regulator is recommending suspending or cancelling some textured breast implants because of their apparent links to cancer.

Australia's medical device regulator has announced it is proposing to take action to suspend or cancel and recall some textured breast implants from the market.

It follows 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.

BIA-ALCL usually involves a swelling of the breast, typically three to 14 years after the operation to insert the breast implant.

This swelling is due to an accumulation of fluid. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.

Although fatalities have been recorded, the vast majority of BIA- ALCL are cured by removal of the implant and the capsule surrounding the implant.

Expert opinions estimate that the risk of breast implant associated lymphoma is rare at between 1-in-1,000 and 1-in-10,000.

They 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.

But if patients are concerned they should see their GP and seek their surgeon's review.

The federal government states that it supports the actions of the TGA and recognises its authority and integrity as a regulator of medicines and medical devices.

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.

It is providing $48.2 million across 2017-18 to 2022-23 to the McGrath Foundation for breast cancer nurses. This includes increasing Commonwealth-funded McGrath Breast Care Nurses from 57 to 98 by 2022-23.

In the 2019-20 Budget, the government invested $32.6 million across 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 TGA's breast implant hub has information to support people with any concerns about their implants.

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