National breast implant registry to be established

A national breast implant registry will be developed over the next two years, the HSE has confirmed.

The establishment of a registry has been a key aim of an expert advisory group (EAG) on breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a rare type of non-Hodgkin’s lymphoma associated with some breast implants.

A HSE spokesperson told the Medical Independent: “There was a submission for a national breast implant register made in 2022 as part of the 2023 HSE estimates process. Funding has been granted as part of the HSE National Service Plan process for 2023. The registry will be developed by the National Office of Clinical Audit, working with key stakeholders in the HSE as part of an existing service level agreement.”

It will take two years to develop the registry, the spokesperson outlined. “The scope of the registry includes all public, private healthcare providers and cosmetic clinics that carry out cosmetic and reconstructive breast surgery. This includes public hospitals, private hospitals, cosmetic clinics, and cosmetic tourism, eg, Irish citizens seeking this healthcare abroad.”

The ICOBRA dataset will be used to facilitate international benchmarking. This includes demographic details (ie, patient, surgeon, site); patient history; implant details; surgical approach and techniques; revision breast surgery.

A decision on inclusion of historic implants will be reached when the registry governance committee is established, added the spokesperson.

Breast implant registries have been established in several countries. They aim to facilitate tracing of patients in the event of a product recall or safety concern relating to a type of implant. Registries also allow for the identification of possible trends and complications relating to specific implants.

The HSE’s EAG was formed in 2021 in response to the international emergence of cases of BIA-ALCL. Most cases have been linked with Allergan textured implants, which have been recalled from the market. In Ireland “less than five” reports related to BIA-ALCL have been received by the Health Products Regulatory Authority to date.