Revised: 31 July 2019

Safety Information

Monitoring Communication

Breast Implants and anaplastic large cell lymphoma

 

Update 31 July 2019

New Zealand Recall

One New Zealand supplier of textured breast implants and tissue expanders, Device Technologies New Zealand, in consultation with Medsafe, has published a medical device recall of textured breast implants. The recall only applies to unused implants, i.e. those in the distribution chain.

Device Technologies Ltd, 0800 659 912

Advice to Patients

Textured breast implants and tissue expanders and being reviewed by regulators around the world following an increasing number of cases of anaplastic large cell lymphoma (ALCL) being reported. Because ALCL is rare, regulators, including Medsafe, have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.

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.

To date Medsafe has received six adverse event reports where breast implant associated anaplastic large cell lymphoma has been diagnosed. Information about reporting an adverse event can be found at our website:

https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.as

Recent actions taken by other regulators

The FDA has requested that certain textured breast implants and tissue expanders are recalled in the USA:

https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

The Australian regulator, the TGA, has completed a review and laboratory assessment of textured breast implants on the Australian market. At the date this website was updated, the TGA stance was not confirmed:

https://www.tga.gov.au/hubs/breast-implants

 

Published:  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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