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Revised: 18 April 2019

Safety Information

Monitoring Communication

Breast Implants and anaplastic large cell lymphoma


11 April 2019

Regulatory Agencies around the world are investigating the safety of breast implants on the market following an increasing number of cases of anaplastic large cell lymphoma (ALCL) being reported. The French and Canadian regulators have taken action to remove selected textured implants from their market. Other regulators, including the US FDA and Australia have deferred making a decision until more information is available.

A breast implant expert working group has been convened by the Therapeutic Goods Administration in Australia. Medsafe will be involved in future meetings of this group.

Additional Information

To date Medsafe has received six adverse event reports where breast implant associated anaplastic large cell lymphoma has been diagnosed.

At this stage the advice for recipients of implants remains unchanged. Those who do not experience any changes or symptoms need take no action. Those who experience sudden, unexplained changes such as pain, lumps or swelling should see their general practitioner or the surgeon who carried out the breast implant surgery.

The New Zealand Association of Plastic Surgeons has published information on its website
http://plasticsurgery.org.nz/consumer-information/issues/breast-implant-associated-anaplastic-large-cell-lymphoma-alcl-faqs/

Medsafe cannot give advice about an individual’s medical condition. 

If you have any concerns Medsafe encourages you to talk to your healthcare professional

You are reminded that all adverse events relating to medical devices should be reported to Medsafe.
www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp

Information on breast implant associated anaplastic large cell lymphoma has been published by:

The Therapeutic Goods Administration (TGA) in Australia
www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma

The U.S. Food & Drug Administration (FDA)
www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA)
www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl

Previous information published by Medsafe
www.medsafe.govt.nz/publications/media/2016/InfoForBreastImplants.asp

Regulator Actions

Medsafe is continuing to monitor international reports and is working with suppliers in New Zealand to obtain information on the implants supplied and safety data.

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