Revised: 12 November 2019
Safety Information
Monitoring Communication
Breast Implants and anaplastic large cell lymphoma
Update: 7 November 2019
Update: 31 July 2019
Original Communiation: 11 April 2019
Update: 7 November 2019
The Australian regulator, the TGA, has decided to take regulatory action in relation to all un-implanted breast implants and tissue expanders sold in Australia. This action includes removal of some implants from the register and a six-month suspension on supply of other implants pending review of further safety and performance information to be provided by the sponsor.
New Zealand Market Actions
The regulatory situation in New Zealand is slightly different. However, sponsors of breast implants that are not able to be supplied in Australia have advised Medsafe that these will no longer be supplied in New Zealand.
Two suppliers of textured breast implants to the New Zealand market, Johnson & Johnson Medical NZ, and Allergan NZ whose products are still able to be supplied in Australia, have agreed that the same conditions imposed by the Australian TGA will be applied to devices supplied in New Zealand. This includes provision of a patient information leaflet and updated instructions for use to include the risk of BIA-ALCL, and the requirement for prompt reporting of adverse events to Medsafe.
Medsafe recommends that all adverse events associated with any breast implant, or any other medical device, are advised to Medsafe using the forms available on the Medsafe website at the following link: https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
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.asp
Recent actions taken by other regulators
The FDA has requested that certain textured breast implants and tissue expanders are recalled in the USA:
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.
