The Irish Breast Implant Registry (IBIR) project is engaging with the Department of Health on a potential opt-out consent model.
Breast implant registries help to identify potential trends relating to specific implants. They also facilitate a rapid avenue to recipients if there is a product recall or safety concern. The IBIR is being developed in the National Office of Clinical Audit. The IBIR Clinical Lead is Ms Éilís Fitzgerald, Consultant in Plastic, Reconstructive, and Aesthetic Surgery.
High inclusion rates are a key determinant of the success of an implant registry, IBIR Project Manager Ms Breda Horan informed the Medical Independent (MI).
“International experience indicates that this is most effectively achieved through a mandatory or opt-out consent model. In light of this, IBIR is engaging with the Department of Health regarding the potential introduction of an opt-out consent model, which would require legislative change.”
Under an opt-out model, patients would be automatically included on the registry unless they actively declined to participate. Consent for the IBIR will be part of the discussion with the patient prior to surgery and they will receive an IBIR patient information leaflet. The registry will initially be established with an opt-in consent model.
A Department spokesperson told MI it acknowledges the importance of high participation rates as a key factor in the effectiveness of registries.
“Preliminary scoping work is underway in the Department to identify and review the policy, legislative, regulatory, and other considerations which may arise in establishing an opt-out model in this context.”
IBIR data will be collected prospectively for patients undergoing breast implant procedures in participating Irish hospitals and clinics. However, the participation of healthcare providers is not mandatory. “IBIR continues to engage with all relevant public and private healthcare providers to support awareness and participation as development progresses,” said Ms Horan.
The IBIR can also collect data where a patient presents to a participating Irish hospital or clinic for revision or explant surgery, including where the original implant procedure occurred.
Key reporting metrics have been identified collaboratively with clinicians and patient representatives. Preparations are ongoing to develop and implement the registry.
In 2019, a HSE serious incident management team (SIMT) was established following international cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The establishment of a national breast implant registry was among the SIMT’s recommendations.
BIA-ALCL is a rare, but important risk associated with breast implants, primarily macro-textured implants. BIA-ALCL has been particularly associated with the Allergan Biocell implant, which was withdrawn from the European market in December 2018.
Since the emergence of BIA-ALCL, the Health Products Regulatory Authority (HPRA) has received a total of eight reports. Seven cases were associated with the Allergan textured breast implant and one involved a different textured breast implant.
Currently, implant rupture is the most common complication relating to implants reported to the HPRA. A total of 20 such reports were received in 2024 and 2025.
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