Publications

Published: 20 December 2016
Revised:  13 September 2017
Revised:  28 May 2018

Breast implants and anaplastic large cell lymphoma

Update - additional confirmed cases of anaplastic large cell lymphoma

9 May 2018

Consumers and health professionals are advised that since the statement below was published, the Therapeutic Goods Administration (TGA) has confirmed more cases of anaplastic large cell lymphoma (ALCL) in Australian patients, with a total of 72 cases reported to date.

The previous advice outlined in the 'Information for consumers' and 'Information for health professionals' sections below remains current, and will be updated as new information becomes available.


Update - additional confirmed cases of anaplastic large cell lymphoma

13 September 2017

Consumers and health professionals are advised that since the statement below was published, the TGA has confirmed more cases of anaplastic large cell lymphoma (ALCL) in Australian patients, with a total of 56 cases reported to date.

The Medical Journal of Australia last month published an article(link is external) discussing anaplastic large cell lymphoma (ALCL) in the context of the Australian Breast Device Registry and advocating strategies to strengthen the registry.

The Plastic and Reconstructive Surgery Journal in May published an epidemiological study(link is external) of patients in Australia and New Zealand.

The US Food and Drug Administration also published an update regarding this issue(link is external) on 23 March 2017.

Accordingly in the 'How can the risk be reduced?' section of 'Information for health professionals' contained within our original statement below, our advice regarding pocket irrigation has been updated slightly.


Information for Women with Breast Implants

20 December 2016

The Ministry of Health is advising anyone with breast implants concerned following an Australian report showing a slight increase in an already known rare risk of cancer that no immediate action need be taken if they are well.

The Ministry has yet to study the detail behind the recently released statement, but says that women with implants should regularly check for swelling or pain in their breasts, and to contact their GP or surgeon if concerned.

The latest report is believed to clarify the risk.  It shows that for every 1000 to 10,000 women with implants, one woman may get a case of anaplastic large cell lymphoma, which can be successfully treated by removing the implant.

There have been three cases of the rare cancer, linked with implants reported to Medsafe in New Zealand, and 46 in Australia.  The New Zealand cases were treated by removing the implant. One New Zealand case was reported in 2014 and the other two in 2015.  The three New Zealand patients had implants in place for 4 to 12 years. No further information about the New Zealand cases is currently available. 

The US FDA has warned about the link between implants and the rare instances of this type of cancer since 2011. This information would usually be part of the information provided to anyone receiving implants.

The US FDA reported a small, but increased risk of the rare type of lymphoma in 2011 (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm240000.htm)

Other countries, such as Australia, have provided similar alerts and advice then and since.

The NZ Association of Plastic Surgeons has published information about this issue at http://plasticsurgery.org.nz/consumer-information/issues/bia-alcl-faqs/.

Australia’s equivalent of Medsafe, the Therapeutic Goods Administration will now be undertaking a formal risk benefit review next year and New Zealand has been invited to participate.
Latest TGA release and FAQs

Medsafe will be obtaining more information about the outcomes of the three cases in New Zealand and that information will be provided to the Therapeutic Goods Administration to consider as part of next year's review.

Anyone concerned about their implants should get in touch with their GP or surgeon.