Breast and Cosmetic Implant Registry

Back

Privacy notice

The Breast and Cosmetic Implant Registry was set up following clear recommendations in the Keogh Review of the Regulation of Cosmetic Interventions, which was an independent report in the protection of people who have cosmetic surgery following issues caused by faulty Poly Implant Protheses (PIP) breast implants in 2010. NHS Scotland began participating in the registry in 2019, through direction from the Scottish Government.

The main aim of the registry is to be able to trace and inform affected patients in the event of any future recall of a failed implant. The registry will also allow the identification of possible trends and complications relating to specific implants.

In order to monitor and improve patient safety, a Breast and Cosmetic Implant Registry (BCIR) has been developed. It records the:

  • implants that have been used for patients
  • organisations and surgeons that have carried out the procedures

The registry provides the benefits of:

  • improving patient safety
  • the ability to recall patients in a timely and more effective manner in the event of a product recall
  • enabling the earlier identification of potential issues with a specific surgical device or implant which could result in a product recall
  • ability to compare patient outcomes and longer-term effect of surgical devices and implants against comparable (‘equivalent’) alternative procedures and implants
  • improving post-market monitoring of Class III and Class IIb implantable medical devices and treatment with them
Who we are

The Breast and Cosmetic Implant Registry is delivered by NHS England (formerly NHS Digital) on behalf of the NHS Scotland health boards. The registry is overseen by a steering group which includes representation from

  • patient groups
  • the Department of Health and Social Care
  • the Medicines and Healthcare Products Regulatory Agency (MHRA)
  • the Scottish Government
  • relevant professional bodies
  • relevant professional cosmetic and surgical professional groups including the British Association of Aesthetic Plastic Surgeons (BAAPS), the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), and the Association of Breast Surgery (ABS)
  • other appropriate agencies

The steering group provides expert advice on:

  • clinical matters (keeping patients safe and providing good care)
  • content (what the registry says and contains)
  • governance (how the registry is kept accurate and safe)
  • outputs (what the registry provides to the people who access it)
  • reports

NHS England is supported by the relevant cosmetic and surgical professional groups:

  • British Association of Aesthetic Plastic Surgeons (BAAPS)
  • British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS)
  • Association of Breast Surgery (ABS)

Scottish Patient Data began being added to the registry in 2019 following a request (made under section 255(1) of the Health and Social Care Act 2012) from Scottish Government to join SDIIS to NHS England, formerly NHS Digital. This is the system which supports the outcomes and recommendations by the Keogh Review from 2010.

What personal data is shared and processed?

The surgical team will provide the following information to the BCIR:

  • the patient’s Community Health Index (CHI) number
  • the patient’s family name
  • the patient’s first name
  • the patient’s current postcode
  • the patient’s date of birth
  • the patient’s gender
  • the surgeon’s name
  • details of the surgical procedure
  • details of the implant used

This is so that appropriate contact can be made in the event of a future recall.

Information in the register may be shared with the following parties for the purposes defined in this Privacy Notice:

  • NHS England
  • Public Health Scotland (PHS) as requested
  • NHS National Services Scotland (NSS) as requested
  • NHS Scotland territorial health boards (their own patient data only) as requested
  • secondary care providers – including NHS Providers, Independent Sector Healthcare Providers (ISHPs) and private healthcare providers involved in the reporting and recording process (their own patient data only) as requested
What is our lawful basis to use your information?

The following lawful bases are used to process personal data as part of the Breast and Cosmetic Implant Registry:

  • the processing is necessary for the performance of a task carried out in the public interest
  • the processing of your health, and any other sensitive information about you, is necessary for the management of health and social care systems
  • for reasons of public interest in relation to public health
  • for scientific and statistical research in the public interest
How long do we keep your data?

The data is held in the registry for the length of time which NHS Scotland remains part of the registry process and your implant care plan is in place.

The data used within the registry forms part of your health record, and will be kept by your health board in line with their Records Retention Policy. If you want to know what time period this is, you should contact your clinical team, or your local health board’s Data Protection Officer.

Where is my personal data stored?

Data in the BCIR is restricted to NHS England supplier data centres within the UK; subject to Data Protection (2018) legislation.

No data will be transferred or processed outside of the UK.

Read further information about how the registry works and the security measures used.

What are my rights?

Individuals have a number of rights set out in legislation to support them and ensure their information and privacy is protected securely. These rights, in relation to the registry are:

  1. The right to be informed – sets out how we are using your personal data. This is done through this privacy notice and should have been done by the patients clinical team by providing the Registry information leaflet at the time of treatment.
  2. The right of access – provides the individual access to the information held in the registry about them. This information should be a direct copy of the details which are held within the individuals health record. Read further information about accessing your health records.
  3. The right to rectification – if you believe the registry contains inaccurate information about your treatment you should contact your clinical team directly, or contact the registry administration team by email to enquiries@nhsdigital.nhs.uk or by phoning to 0300 303 5678.
  4. The right to erasure – as the registry is part of the ongoing care and treatment plan and data is processed using lawful basis 6(1)(e), the right to erasure most likely does not apply as it is unlikely that treatment can be undertaken without the processing of key information.
  5. The right to restriction of processing – as the registry is part of the ongoing care and treatment plan and data is processed using lawful basis 6(1)(e), the right to restriction of processing most likely does not apply as it is unlikely that treatment can be undertaken without the processing of key information.
  6. The right to object – as the registry is part of the ongoing care and treatment plan and data is processed using lawful basis 6(1)(e), the right to object most likely does not apply as it is unlikely that treatment can be undertaken without the processing of key information.
  7. The right to data portability – as we are processing data using lawful basis 6(1)(e), the right to data portability does not apply.
  8. Rights in relation to automated decision-making – these rights are not applicable because there is no solely automated decision making carried out by the Breast and Cosmetic Implant registry.

Not all rights apply all of the time. If you are concerned about the registry or how it is used you should discuss this with your clinical team, and/or the registry team. All requests are considered on a case-by-case basis.

Read further information about your rights

How to exercise your data protection rights

You can raise any privacy and data protection concerns with the registry team, the NHS National Services Scotland Data Protection Officer (“NHS NSS DPO”) or the NHS England Data Protection Officer (“NHSE DPO”):

The Breast and Cosmetic Implant Registry team

Email address: enquiries@nhsdigital.nhs.uk

Phone: 0300 303 5678

Contact details of the NHS NSS DPO

Email address: nss.dataprotection@nhs.scot

Data Protection Officer

Gyle Square

1 South Gyle Crescent

Edinburgh

EH12 9EB

Contact details of the NHSE DPO

E-mail address: england.dpo@nhs.net

Data Protection Officer

Delivery Directorate

NHS England

Quarry House

Quarry Hill

Leeds

LS2 7UE

Complaints and appeals

If you are unhappy with the way in which your information is used, you should first raise this with your clinical team or health board or the registry team (contact details are above). If this does not resolve the issue and you will be able to make a formal complaint following the processes which the relevant body will make you aware of.

If you have already made a formal complaint to the relevant body and are not happy with the outcome, you have the right to lodge a complaint with the Information Commissioner’s Office (ICO). The ICO is the supervisory authority responsible for data protection in the UK.

The Information Commissioner

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

ICO main helpline number: 0303 123 1113

ICO Scotland office contact number: 0303 123 1115

Website: www.ico.org.uk

How to contact us

If you have any queries or concerns about the Breast and Cosmetic Implant Registry please contact the registry team by emailing enquiries@nhsdigital.nhs.uk or phoning 0300 303 5678.

Last updated:
07 October 2021

Also on NHS inform

There are no NHS operators available to chat at this time