The Department commissions research through the National Institute for Health and Care Research (NIHR). The NIHR is not currently funding any specific research into long-term health effects of Poly Implant Prothèse breast (PIP) implants but welcomes funding applications for research into any aspect of women’s health. Applications are subject to peer review and judged in open competition, with awards being made based on the importance of the topic to patients and health and care services, value for money and scientific quality.

The Department does not hold information related to breast implant safety research funded by other sources.

The Government recognises the important work of the Women and Equalities Committee (WEC) and remains committed to addressing longstanding concerns around safety in the cosmetic sector.

We will issue the Government’s response to the WEC report on cosmetic procedures once the Department’s consultation on our proposed approach to introducing legal safeguards for high-risk cosmetic procedures is published. We intend to publish the consultation in the coming weeks.

The Outcomes and Registries Directions 2024 require that all healthcare providers of National Health Service funded care contribute data to the Breast and Cosmetic Implant Register. Therefore, compliance from both NHS and private clinicians, in relation to NHS funded care, is mandatory. Furthermore, work is ongoing within NHS England to ensure that all NHS and independent sector providers contribute data to the Medical Devices Outcomes Registry, following the recommendations of the Cumberlege Inquiry, with further information available at the following link:

https://www.england.nhs.uk/outcomes-and-registries-programme/

Guidance for clinicians and patients called Symptoms sometimes referred to as Breast Implant Illness, including autoimmune conditions, was published by the Medicines and Healthcare products Regulatory Agency in 2020 and updated in 2023. Healthcare professionals and anyone experiencing any symptoms that they believe to be associated with their breast implants are strongly encouraged to report these through the Yellow Card scheme.

Continuing professional development (CPD) opportunities for primary care workers are provided by royal colleges and professional bodies for each profession.

Primary care workers should ensure their own clinical knowledge remains up to date and are responsible for identifying learning needs as part of their CPD. This activity should include taking account of new research and developments in guidance, such as that produced by the National Institute for Health and Care Excellence, to ensure that they can continue to provide high-quality care to all patients.

General practices and primary care networks also have access to a regional Primary Care Training Hub, which will bring together education and training resources from National Health Service organisations, community providers, and local authorities. Training hubs are usually run by a clinical leader and a manager supported by a network of primary care staff with education and training professionals based in the community. They work closely with primary care networks and integrated care systems to support workforce priorities and tackle health inequalities to help meet patient and population demand.

Under existing medical device regulations, UK Medical Devices Regulations 2002, all medical devices must meet the Essential Requirements, which includes the use of designated standards that specify mandatory safety and performance criteria for those devices. As breast implants are the highest class medical device, class III, they must undergo rigorous pre-market testing by the manufacturer, which is then assessed by a third party such as a United Kingdom approved body or European Union notified body, before being registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and prior to being placed on the market in the UK. Once on the market, the manufacturer must continuously review the safety of their devices. The manufacturer is subject to annual surveillance and monitoring, alongside unannounced audits to ensure claimed standards of quality and safety management are being applied in practise. The MHRA also monitors emerging signals to determine if previously unrecognised risks exist or if the nature of known risks is changing.

Following the Cumberlege recommendations in the Independent Medicines and Medical Devices Safety Review, the MHRA has introduced post-market surveillance regulations to require that safety issues with medical devices are identified early. Further information on the review is available at the following link:

https://immdsreview.org.uk/

The MHRA is also developing a future regulatory framework to strengthen pre-market requirements for medical devices. This intends to introduce requirements for unique device identifiers, implant cards, and new rules to ensure that claims are consistent with intended purpose to better reflect potential risks to patients, increase containment of safety issues, and reduce patient harm.

The Department delivers research via the National Institute for Health and Care Research (NIHR). The NIHR welcomes funding applications for research into any aspect of human health and care, including the health impacts of breast implants. Through the NIHR, the Department funded a study to explore the long-term outcomes and cost-effectiveness of different methods of breast reconstruction, including implants, for women following a mastectomy. This research showed which methods of breast reconstruction were more likely to require later revision, supporting patients to make informed decisions about their treatment.

The Breast and Cosmetic Implant Registry (BCIR), set up in 2016, collects all implant data, and explant data where possible.

Practically, it is always difficult and often impossible to identify a model and product code on an explant. If explanted devices, or patients undergoing explant, cannot be linked to data collected at time of implant, then this often reduces explant data to 'patient, surgeon, location, date'. This in turn makes it impossible to monitor trends in explant/failure.

NHS England is in the process of clarifying and mandating the detail required in the BCIR and other device-related collections. This will place a greater responsibility on trusts to either identify a device at the point of explant, or to identify the device from internal trust records created during the same patient's implant procedure.

This will only be possible if the implant and explant are performed at the same trust. It is then the intention of NHS England to provide the same matching service for implant/explant where the trusts differ.

This solution will, when implemented, give a full, proactive picture of device longevity/risk, for the purposes of research and surveillance, alongside the existing ability to identify patients affected by a device recall notice.

Alongside this work, as part of the its reforms to the Medical Devices Regulations 2002, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced updated requirements for the post-market surveillance of medical devices, including implants, enabling both the manufacturer and the MHRA to identify issues with medical devices more easily and where necessary, for the MHRA to take fast action to safeguard public health.

Later this year, the MHRA intends to introduce a requirement for clinicians to provide patients with an implant card and information regarding any warnings, precautions, or measures to be taken by the patient or healthcare professional. This will strengthen transparency and support patients in understanding their implants.

The Breast and Cosmetic Implant Registry (BCIR), set up in 2016, collects all implant data, and explant data where possible.

Practically, it is always difficult and often impossible to identify a model and product code on an explant. If explanted devices, or patients undergoing explant, cannot be linked to data collected at time of implant, then this often reduces explant data to 'patient, surgeon, location, date'. This in turn makes it impossible to monitor trends in explant/failure.

NHS England is in the process of clarifying and mandating the detail required in the BCIR and other device-related collections.

This will place a greater responsibility on trusts to either identify a device at the point of explant, or to identify the device from internal trust records created during the same patient's implant procedure. This will only be possible if the implant and explant are performed at the same trust. It is then the intention of NHS England to provide the same matching service for implant/explant where the trusts differ.

This solution will, when implemented, give a full, proactive picture of device longevity/risk, for the purposes of research and surveillance, alongside the existing ability to identify patients affected by a device recall notice.

The Breast and Cosmetic Implant Registry (BCIR), set up in 2016, collects all implant data, and explant data where possible.

Practically, it is always difficult and often impossible to identify a model and product code on an explant. If explanted devices, or patients undergoing explant, cannot be linked to data collected at time of implant, then this often reduces explant data to 'patient, surgeon, location, date'. This in turn makes it impossible to monitor trends in explant/failure.

NHS England is in the process of clarifying and mandating the detail required in the BCIR and other device-related collections.

This will place a greater responsibility on trusts to either identify a device at the point of explant, or to identify the device from internal trust records created during the same patient's implant procedure. This will only be possible if the implant and explant are performed at the same trust. It is then the intention of NHS England to provide the same matching service for implant/explant where the trusts differ.

This solution will, when implemented, give a full, proactive picture of device longevity/risk, for the purposes of research and surveillance, alongside the existing ability to identify patients affected by a device recall notice.

The Breast and Cosmetic Implant Registry (BCIR), set up in 2016, collects all implant data, and explant data where possible.

Practically, it is always difficult and often impossible to identify a model and product code on an explant. If explanted devices, or patients undergoing explant, cannot be linked to data collected at time of implant, then this often reduces explant data to 'patient, surgeon, location, date'. This in turn makes it impossible to monitor trends in explant/failure.

NHS England is in the process of clarifying and mandating the detail required in the BCIR and other device-related collections.

This will place a greater responsibility on trusts to either identify a device at the point of explant, or to identify the device from internal trust records created during the same patient's implant procedure. This will only be possible if the implant and explant are performed at the same trust. It is then the intention of NHS England to provide the same matching service for implant/explant where the trusts differ.

This solution will, when implemented, give a full, proactive picture of device longevity/risk, for the purposes of research and surveillance, alongside the existing ability to identify patients affected by a device recall notice.

The role of the Medicines and Healthcare products Regulatory Agency (MHRA) is to monitor all incidents that are reported to us, making sure that these incidents are investigated fully and that any necessary action is taken. The poly implant prothèse (PIP) issue was a result of the use of a non-approved silicone in the production of the breast implants and fragile shells. Not all PIP implants manufactured during the affected period used industrial-grade silicone or had more fragile shells. As a result, rupture rates vary depending on the batch received and early rupture typically occurs within the first five to 10 years. Due to the overall fraudulent activity, we do not know how many fall into this category.

We worked with the National Health Service and other health partners to ensure the issue was properly investigated. It is important to note that while PIP implants are associated with a higher risk of rupture, leading to symptoms such as tenderness or swollen lymph glands, there is no evidence linking ruptured PIP implants to serious long-term health issues. The PIP breast implants were withdrawn from the United Kingdom in 2010, and two independent reviews have identified lessons learned, the Howe Review (2012) and the Keogh Review (2013), with further information available on both, respectively, at the following two links:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/216537/dh_134043.pdf

https://www.gov.uk/government/publications/review-of-the-regulation-of-cosmetic-interventions

One of the concerning issues for women with breast implants at the time of PIP was that women didn’t know they had PIP breast implants. It is estimated that approximately 47,000 British women had PIP implants fitted. We are unable to provide the granularity for individual constituencies, although further information is available at the following link:

https://www.nhs.uk/conditions/pip-implants/

However, please note that any PIP implants still in place have now exceeded 15 years in situ, which is the upper end of the 10 to 15 year typical life expectancy of a breast implant. As with any medical device reaching the end of its expected lifespan, clinical decisions regarding removal or replacement should be made on an individual basis in discussion between the doctor and the individual involved.

The health system has enacted important changes since the publication of reviews focused on PIP implants. As a result of the Keogh Review, since 2016 the Breast and Cosmetic Implant Registry collects data on all types of breast implant and removal surgery in England and Scotland, which aims to help detect emerging safety issues and trace patients if necessary.

As part of MHRA’s regulatory reform program, we are intending to also improve the traceability of medical devices through the introduction of Unique Device Identifiers (UDI) which will help identify individual medical devices and who manufactured the device or placed it on the market.

The Department commissions research through the National Institute for Health and Care Research (NIHR). The NIHR is not currently funding any specific research into the safety of breast implants but welcomes funding applications for research into any aspect of human health. Applications are subject to peer review and judged in open competition, with awards being made based on the importance of the topic to patients and health and care services, value for money, and scientific quality.

The Department does not hold information related to breast implant safety research funded by other sources.

As has been previously shared in evidence submitted to the Women and Equalities Select Committee in July 2025, with further information in the document attached, the Medicines and Healthcare product Regulatory Agency (MHRA) closely monitors Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system, not a breast cancer, and publishes the output from this monitoring on the GOV.UK webpage, at the following link:

https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl

The MHRA has developed, with advice from independent expert advisory group, a follow up strategy to collect further data on adverse incidents reporting BIA-ALCL. This has informed the information that is published on the MHRA webpage relating to BIA-ALCL which includes the most up to date number of confirmed reports of BIA-ALCL made to the MHRA, and the breakdown of the number of confirmed reports of primary BIA-ALCL cases by manufacturer of breast implant.

Please note that the data on the GOV.UK webpage should be interpreted in the context of the ‘Notes and limitations to the data’ section also provided on the webpage.

Decisions about the funding and provision of health services, including post-surgery bras and breast protheses, are the responsibility of local integrated care boards.

NHS England funded audits into primary and metastatic breast cancer to help identify and reduce inequalities and variations in care. Using routine data collected on patients diagnosed with breast cancer in a National Health Service setting, the audits bring together information to look at what is being done well, where it is being done well, and what needs to be done better. Findings were published in September 2025, and the NHS is acting on the findings.

Patient experience and outcomes remain a key priority for the Department, and we will continue to look for opportunities to improve all aspects of cancer care. The National Cancer Plan, due to be published early in the new year, will have patients at its heart and will cover the entirety of the cancer pathway, including people living with and beyond cancer.