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TGA Proposes Breast Implant Ban

Australia’s medical device regulator has proposed taking 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.

How it works:

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.

Why it matters:

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.

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

The details:

For more information on the proposed regulatory action, including information on the specific textured implants, can be found at the TGA breast implant hub.

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