TGA update on rare cancer associated with breast implants

20 December 2016
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The Therapeutic Goods Administration has released an updated web statement on the number of cases and the estimated risk of the rare cancer, anaplastic large cell lymphoma (ALCL) in a small number of women with breast implants.

In liaison with its overseas regulatory partners, the TGA has been closely monitoring issues related to ALCL and breast implants.

In mid-December this year the TGA updated its advice on this issue on the website to provide the number of identified cases, estimated risk of ALCL, and to encourage consumers and health professionals to monitor implants for changes and to report cases to the TGA.

The TGA has received 46 reports of breast implant-associated ALCL in Australia since 2007, three of which resulted in death.

TGA is currently working with international agencies and working groups to better understand the relationship between ALCL and breast implants.

The TGA convened an expert advisory panel including representations from plastic surgeons, cosmetic surgeons, breast-cancer surgeons, cancer epidemiologists, data analysts and public-health practitioners, which met on 16 November 2016, to provide on-going advice.

TGA medical advice remains that women with breast implants should discuss any concerns they do have with their doctor.

As the risk is very low, at this time, the TGA does not recommend preventative breast implant removal in patients without symptoms or other abnormality.

If patients are concerned they should see their doctor.

The situation will continue to be closely monitored by the TGA and patients and health care providers will be kept fully up to date.

More information, including advice to women with a breast implant, is available at www.tga.gov.au.

Background

On 26 January 2011, the US Food and Drug Administration (FDA) announced a safety communication to warn about an association between breast implants and anaplastic large cell lymphoma. The risk of a patient developing this type of lymphoma is very low.

The TGA has been monitoring the situation and has been in communication with the FDA and specialist groups over the issue. The Australian Society of Plastic Surgeons posted guidance for patients on this issue in January 2011. The statement reiterates the information in the FDA publication.

Anaplastic large cell lymphoma (ALCL) is a rare cancer of the immune system that can occur anywhere in the body. According to the Surveillance, Epidemiology, and End Results Program of the U.S. National Cancer Institute, an estimated 1 in 500,000 women per year in the United States is diagnosed with ALCL.

Media contact: Kay McNiece, 0412 132 585