Breast and Cosmetic Implant Registry - January to December 2024, Management Information

In April 2024, the BCIR transitioned to the NHS England Outcomes and Registries Programme. From this date, BCIR data shall be captured through the Outcome Registries Platform. All historical BCIR data was migrated to the ORP at this time.

The NHS England Outcomes and Registries Programme was established in 2022 to develop a single, unified registry solution – the Outcome Registries Platform. The platform consolidates existing implantable device-level registries and implements new outcome registry data collections to address data and vigilance gaps, enabling the prevention of patient safety issues and adverse outcomes.

The programme builds upon an improved model for patient engagement and involvement, and maximise governance, clinical leadership, and specialty-specific data roadmaps to deliver patient-centred change.

In collaboration with the devolved administrations, the programme is also developing an approach to enable secure data sharing, system interoperability and UK-wide coverage, where it is appropriate to do so.

The ORP addresses the need for a more consistent approach to assure safety and satisfactory outcomes, and fulfils the recommendations of the Independent Medicine and Medical Device Safety Review (IMMDS) (2020) and Paterson Inquiry (2020).

A key function of the BCIR is to support the identification of patients affected by breast implant product recalls. BCIR records details of patients who have undergone breast implant surgery, and the details of the implants they received.

In the event that the MHRA issues an alert, recall or Field Safety Notice relating to a breast implant, the BCIR Team will analyse the registry to identify any patients impacted, and issue a notification to the relevant implanting hospital. It is the responsibility of the original implanting hospital to contact the patient directly if this is deemed necessary for any further assessment or consultation.

As part of the transition of the BCIR onto the ORP, the registry’s legacy data has undergone additional validation and cleansing processes to ensure its accuracy for future publications. Authorised clinicians are also able to audit and correct their legacy data and submit new records to the registry for procedures that have occurred in the past. Because of these factors, figures presented for previous years in this report may not match previously published counts.