1 October 2016 - January 31 2018
Patient records: 12,301
The Breast and Cosmetic Implant Registry was opened on 10 October 2016. This is expected to capture the details of all breast implant procedures completed in England by both the NHS and private providers.
Patient records: 12,301
The Department of Health directed NHS Digital to carry out this work in response to Recommendation 21 of the Keogh Review of the Regulation of Cosmetic Interventions.
The Directions from the Department of Health are available at Directions for Breast and Cosmetic Implant Registry
The registry is designed to record the details of any individual, who has breast implant surgery for any reason, so that they can be traced in the event of a product recall or other safety concern relating to a specific type of implant. The registry will also allow the identification of possible trends and complications relating to specific implants.
Explicit patient consent will be required to add their details to the registry in addition to the usual consent for the surgical procedure. Patient information leaflet and consent forms are available in the documents section below.
NHS Digital is working closely with the Department of Health, Medicines and Healthcare Products Regulatory Agency (MHRA), patient representatives, relevant professional bodies and other agencies to develop the BCIR. Representatives of these groups provide clinical input, advise on content, governance and outputs via the Breast and Cosmetic Implant Registry Steering Group.
Data will be submitted by providers using the NHS Digital secure online Clinical Audit Platform (CAP).
Surgeons and staff submitting data to CAP will be required to register to use the system by creating an account with NHS Digital and completing and submitting a User Registration form which has been "signed off" by the provider organisation's Caldicott Guardian. The registration process form can be found in the documents section of this page.
Local processes should be developed to submit any data. The following documents are available to provide information and support:
For further information or if you have any queries please contact NHS Digital's Contact Centre on 0300 303 5678, or alternatively email firstname.lastname@example.org and include Breast and Cosmetic Implant Registry in the subject line so your enquiry can be easily forwarded on to the BCIR project team.
The following manufacturers are providing funding to support the delivery of BCIR:
G&G Biotechnology Ltd