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About the Registry

What is the New Zealand Breast Device Registry (NZBDR)?

The New Zealand Breast Device Registry: Te Rehita Taputapu Uma o Aotearoa is a registered Charitable Trust. The Trust’s vision is that Aotearoa New Zealand creates and maintains a comprehensive registry for implanted breast devices to monitor and reduce the risk of adverse outcomes and complications for women with these products.

The NZBDR is governed by a Board of Trustees and appointed stakeholder representatives including a consumer representative. The purpose of the NZBDR is to provide medical information, reporting, device tracking and auditing for complications for the women of New Zealand and their health professionals. This registry will make it possible to trace patients in the event of a product recall or safety concern related to a specific type of implant.

The New Zealand Breast Device Registry will hold a clinical record for all surgically implanted devices including breast prostheses, tissue expanders and alloplastic and biological meshes. It also records all associated surgical procedures including both primary and secondary (revision procedures), the indications for those procedures and all complications.
Implantable breast devices include:

Breast prostheses: these are used to permanently restore volume following mastectomy as a form of breast reconstruction, restore volume for breast hypoplasia and breast asymmetry, and for aesthetic breast augmentation;
Tissue expanders: these are temporary devices used to restore volume following mastectomy as a form of breast reconstruction;
Alloplastic and biological meshes: these are used to provide tissue support at the time of breast reconstruction.

Why does New Zealand need a Breast Device Registry?

The Breast Device Registry holds information regarding the use of all implantable breast devices including prostheses and meshes, related procedures and complications. Breast Device Registries are considered an international standard of care. However, up until 2024 New Zealand has never had a Breast Device Registry; NZAPS considered this to be a significant public health issue. The previous standard of care in New Zealand was for individual practitioners and institutions which treat patients using breast devices to hold their own records. This makes accessing the information extremely difficult and inconsistent, as there is no centralised repository for the data and there is no ability to cross reference the data held. Moreover, there is no minimum data set that is collected. For those data sets collated by individual practitioners there is no system for passing on guardianship of any data when a practitioner retires. Over the last 20 years there have been four major product recalls related to implantable breast devices associated with patient risk, but no simple way to identify the women affected. In 2022 NZAPS entered into negotiation with MedicAlert, a New Zealand charitable organisation which specialise in health data systems. MedicAlert® Foundation has designed a bespoke model for a comprehensive domestic breast device registry, which is fit for New Zealands health care environment and keeps all New Zealand data on shore.

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Ethics Approval

The New Zealand Breast Device Registry: Te Rehita Tapatapu Uma o Aotearoa operates in ompliance with our ethics approval provided by the Health and Disability Ethics Committee (HDEC), as well as the Privacy Act 2020, the Health Information Privacy Code and the principles of Te Tiriti o Waitangi / Māori data sovereignty.

HDEC is a Ministerial committee whose function is to secure the benefits of health and disability research by checking that it meets or exceeds established ethical standards. For more information, you can visit the Health and Disability Ethics Committee website.

All data requests for research purposes are reviewed for ethics approval before release. Only de-identified data is released.

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Governance of the Registry

The New Zealand Breast Device Registry Charitable Trust’s purpose/ kaupapa is to provide and administer a clinical registry of implanted breast devices for women in Aotearoa New Zealand. The NZBDR is coordinated through the NZAPS offices in Wellington. MedicAlert® Foundation is the custodian of the NZBDR data. The governance of the registry is by an appointed board. The Board comprises representatives of all the relevant stakeholders, including clinicians, consumer representatives and relevant administrative organisations.

The board currently consists of the Trustees of the NZBDR Charitable Trust; the President of BreastSurgANZ (New Zealand) or nominee; and consumer/ community representative (nomination by the Breast Cancer Foundation of New Zealand to and approval by the Trustees). It may also include nominees from the following organisations: Te Whatu Ora (Health NZ) or Te Manatu Hauora (on nomination to and approval by the Trustees); Accident Compensation Corporation (ACC) (on nomination to and approval by the Trustees); and the Medical Technology Association of New Zealand (MTANZ) (on nomination to and approval by the Trustees). Nominated board members are appointed for a two year term. The Board representatives dedicate their time and expertise to the NZBDR voluntarily.

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Collaborators

New Zealand Assocation of Plastic Surgeons: Te Kāhui Whakamōhou Kiri (NZAPS/TKWK) is a non profit, professional association devoted to the maintenance of excellent ethical and professional standards within the field of cosmetic and reconstructive plastic surgery.
https://plasticsurgery.org.nz/

MedicAlert® Foundation is a New Zealand non-profit charitable organisation providing lifesaving medical emergency services for people with life-long health conditions.
https://www.medicalert.co.nz/

Breast Surgeons of Australia and New Zealand (BreastSurgANZ) is a membership based Society representing specialist breast surgeons treating patients with benign and malignant breast disease in Australia and New Zealand.
https://www.breastsurganz.org/

Breast Cancer Foundation NZ is the country's foremost breast cancer education and awareness organisation. Breast Cancer Foundation NZ are working towards a vision of zero deaths from breast cancer. We provide support, life-saving education and help fund vital research into more effective treatments.
https://www.breastcancerfoundation.org.nz/

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Overseas Breast Device Registries:

The Australian Breast Device Registry (ABDR) is a Commonwealth-funded Monash University-led health initiative that records health data relating to breast device surgery.
https://www.abdr.org.au/

United Kingdom > The Breast and Cosmetic Implant Registry (BCIR) was opened on 10 October 2016. It captures the details of all breast implant procedures completed in England, Scotland and Northern Ireland by both the NHS and private providers.
https://digital.nhs.uk/data-and-information/clinical-audits-and-registries/breast-and-cosmetic-implant-registry