15 October 2016: New registry will improve safety if implants fail
A new registry to safeguard the health of patients with breast and other cosmetic implants has been launched.
The registry will record the details of any individual who has breast implant surgery, so that they can be traced in the event of a product recall or other safety concern.
The Department of Health asked NHS Digital to develop and manage the Breast and Cosmetic Implant Registry (BCIR) in response to the Keogh Review of the Regulation of Cosmetic Interventions.
The faulty Poly Implant Prothèse (PIP) silicone breast implants in 2010 affected thousands of women when fraudulently manufactured silicone gel implants were recalled. Poor record keeping by some providers meant that many women were unable to find out if they had the faulty implants, and in some cases women could not be contacted where providers had gone out of business.
Explicit consent from patients will be required to add their details to the registry in addition to the usual consent for the surgical procedure.
Health Secretary Jeremy Hunt said:
"We want the NHS to be the safest healthcare system in the world and anyone who chooses to have a cosmetic procedure has the right to safe care. The PIP breast implant scandal in 2010 affected thousands of people which is why we asked NHS Digital to develop a new register which will allow people to be traced swiftly if that is ever needed."
Noel Gordon, Chair of NHS Digital, said:
"NHS Digital delivers technology and information services to make health and social care better and safer for patients. The Breast and Cosmetic Implant Registry supports this work, by marking a major step forward in improving patient safety for the thousands of people who undergo breast augmentation each year.
"We look forward to working with patients and providers to ensure that the benefits of this important registry are delivered."
Initially the registry will hold information about breast implant surgery, but in the longer term it will be expanded to cover other cosmetic implants over time, such as buttock or calf implants. It will also allow the identification of possible trends and complications relating to specific implants.
Its establishment is in response to recommendation 21 in Sir Bruce Keogh's Review of the Regulation of Cosmetic interventions, which called for a cosmetic implant registry "to provide better monitoring of patient outcomes and device safety".
The registry is expected to record more than 20,000 cases of implant surgery annually. Reporting of data will be done by the provider, via an online portal.
The BCIR is one element of a wider programme of work to improve the provision of cosmetic procedures in England. To date:
- In December 2015, the Royal College of Surgeons (RCS) published a minimum dataset to support the collection and collation of data relating to cosmetic surgical activity. More recently (Oct 2016), it launched new patient information to support patients to make informed decisions
- In January 2016, Health Education England (HEE) published new qualification requirements for providers of non-surgical cosmetic interventions, and those required to be responsible prescribers, that could apply to all practitioners regardless of previous training and professional background. This work is being taken forward by the Joint Council of Cosmetic Practitioners (JCCP)
- In April 2016, the General Medical Council (GMC) published new guidance to all doctors who perform cosmetic procedures (surgical and non-surgical)
- Care Quality Commission (CQC) has developed a new inspection framework for cosmetic surgery which came into effect in April 2015. The Department has also proposed extending the CQC's powers to rate more providers which is an important step forward in improving standards and will help to end the lottery of poor practice in parts of the cosmetic industry
- In June 2016, NHS Choices published new patient information to support patients to make informed decisions
- To address concerns around advertising, the Committee of Advertising Practice (CAP) and Broadcast Committee of Advertising Practice (BCAP) published new, expanded guidance on the marketing of cosmetic interventions in October 2013
- Work to ensure that products are safe is being taken forward by the MHRA and BEIS colleagues as part of some wider projects looking to revise the EU Medical Devices Directive and General Product Safety Directive. NHS England is working with MHRA to improve reporting of adverse incidents and device failure