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Registry Governance

Registry Coordinator

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:

1. 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;
2. Tissue expanders: these are temporary devices used to restore volume following mastectomy as a form of breast reconstruction;
3. Alloplastic and biological meshes: these are used to provide tissue support at the time of breast reconstruction.

Governance Board

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

Meet the Team

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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,

Role of the Governance board

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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Clinical Advisory Group

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.

Meet the CAG Team

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.

Role f the CAG

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

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