Business Context

New Zealand Breast Device Registry

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.