Breast implant registry to be piloted in early 2025

An Irish breast implant registry (IBIR) will be piloted in early 2025 in advance of a wider roll-out, the Medical Independent has been informed.

The National Office of Clinical Audit (NOCA) is engaging with potential pilot sites and finalising the specifications for the web-based application with the IT provider.

Ms Breda Horan, IBIR Project Manager, said the collection of high-quality data on breast implant activities is a vital patient safety initiative to improve long-term monitoring of devices.

While participation is not mandatory, the IBIR team will “continuously work to increase awareness and understanding of the registry among both healthcare providers and the public”.

Asked about the participation of private hospitals/clinics, Ms Horan said there is “commitment from private healthcare providers to be involved in the registry and this is evident through membership of the steering committee and participation in IBIR stakeholder events”.

All patients will be asked to sign a consent form prior to their surgery for the IBIR development project. The retrospective capture of implant and device details is currently outside the scope of the registry.

Mr Jason Kelly, interim Clinical Lead of the IBIR development project, stated: “Given the emergence of the association of anaplastic large cell lymphoma and some breast implants, off the market since December 2018, this registry is of huge importance in demonstrating and monitoring the safety of breast implants. It also provides a mechanism of identifying early important trends that may result in key changes to what types of implants we use and in what clinical scenarios they are best used or avoided.”

Ms Clodagh Flynn, patient and public interest representative on the IBIR development project steering committee, commented: “As a breast implant recipient who developed sepsis post-surgery and subsequently had implants changed due to an implant recall, I am committed to contributing my personal experience to improve the outcome for breast implant recipients in the future.”

Ms Flynn said the registry would be a valuable tool in protecting patients and providing a rapid avenue to implant recipients in the case of a product recall.

In 2019, a HSE serious incident management team (SIMT) was established to provide guidance in the context of international cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer associated with some breast implants. One of the SIMT’s recommendations was the establishment of a national breast implant registry.

To date, less than five reports of BIA-ALCL have been received by the Health Products Regulatory Authority.