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The Medicines and Healthcare Products Regulatory Agency (MHRA) – Written Evidence to the Women and Equalities Select Committee
Breast Implants are regulated as class III implantable medical devices. Medical devices are classified into four classes of increasing levels of risk (Class I, Class IIa, Class IIb and Class III). Class III medical devices are regarded as higher risk devices. In order to place their device on the UK market, a manufacturer must demonstrate that their medical device meets the relevant requirements of a conformity assessment and is in compliance with the Medical Devices Regulations 2002 (as amended). Higher risk medical devices require the conformity assessment to be conducted by an Approved Body or Notified Body (an organisation which is designated to conduct a conformity assessment of the device).
Since 1 January 2021, there have been several changes to how medical devices are placed on the market in Great Britain. A new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the GB market. The MHRA will also accept CE marked devices (the marking valid for the EU market) on the Great Britain market until, at the latest, 30 June 2030 depending on device type and classification.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. While the MHRA does not authorise medical devices it operates the UK medical device vigilance system, working in collaboration with healthcare and regulatory stakeholders both in the UK and worldwide. This includes carrying out market surveillance and enforcing the medical device legislation. One of the roles of the 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.
Adverse incident reports regarding a medical device, including safety concerns involving defective (not of an acceptable quality), falsified or fake healthcare products, can be reported by healthcare professionals and members of the public to the Yellow Card scheme. The scheme is a spontaneous reporting system run by the MHRA and acts as an early warning system for potential safety issues. The scheme is not compulsory, but it is strongly encouraged through professional standards, for healthcare professionals to report incidents directly to us. Reporting by members of the public is voluntary. Manufacturers also have a legal obligation to report serious adverse incidents to the MHRA.
Poly Implant Prothèse (PIP)
1.1. Poly Implant Prothèse (PIP) was a French manufacturer which produced silicone gel breast implants from 1991 to 2010. PIP fraudulently changed the filler material used in their implants after obtaining CE certification, without notification to their Notified Body. As part of our market surveillance for medical devices, we worked with the NHS and other health partners to ensure the PIP issue was properly investigated.
1.2. The rupture rate for PIP implants is around 2 times higher than that for other implants. Ruptured PIP implants have been found to cause local reactions around the implant area in a small proportion of women, which can result in symptoms such as tenderness or swollen lymph glands.
1.3. The PIP UK Expert Group concluded in their final report that PIP implants are clearly substandard although there is no evidence of a significantly increased risk of clinical problems in the absence of rupture or that local reactions cause serious long-term health issues(June 2012). The toxicological assessment of the non-approved silicone contained in PIP breast implants at the time of the investigation indicated that the silicone was not carcinogenic.
1.4. The MHRA closely monitors Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) a very rare form of non-Hodgkin lymphoma (cancer of the immune system) as well as other lymphomas and cancers. As of 31 December 2023, we had received 81 reports of confirmed BIA-ALCL where the surgery occurred in the UK and 6 reports where the surgery occurred outside of the UK. The current estimated incidence of BIA-ALCL, based on confirmed cases where surgery occurred in the UK, is 1 per 16,500 implants sold. We have not seen any evidence that PIP implants carry a greater risk of BIA-ALCL than other breast implants, or that they lead to an increased risk of other cancers. We have not received any confirmed reports of BIA-ALCL occurring in patients who have only ever had PIP breast implants. We have 6 confirmed reports of BIA-ALCL in patients who had previously had a PIP implant but at the time of diagnosis had an implant from a different manufacturer. This makes it difficult to ascertain which implant was associated with the BIA-ALCL because it can take years to develop following implantation. This data has limitations as outlined on the BIA-ALCL webpage, in particular these numbers have been collected through spontaneous reports via our Yellow Card Scheme.
1.5. The MHRA have received reports from people with a variety of symptoms associated with different brands of breast implants and not just PIP implants. These symptoms are sometimes referred to as Breast Implant Illness (BII). BII is not a recognised disease, but it is a term sometimes used by people to describe the health problems they associate with their breast implants. The reports we have received are not limited to a particular manufacturer or type of implant and include silicone and saline (salt water) filled implants, smooth or textured (rough) surface implants. A link between breast implants and the reported health problems has not been established as there is no single disease which could explain the symptoms that some people or their clinicians are reporting to us. Worldwide, research into the safety of breast implants has continued over the last 30 years. Whilst there remains no definitive evidence or known scientific process demonstrating that breast implants cause the symptoms reported to us, we continue to assess any emerging research that would increase our understanding of this issue.
2.1. The MHRA issued guidance in 2012 that advises that if a woman has PIP breast implants and is concerned or the implants are causing unwanted symptoms, they should discuss with their doctor whether they should be removed. Patients with PIP breast implants can have their implants removed (not replaced) on the NHS, if their doctor agrees. Guidance for patients produced by the NHS and MHRA lists the options for removal available. The MHRA’s guidance on the removal of PIP breast implants has not changed since it was first issued.
2.2. We are aware that some women may have experienced difficulties requesting for their PIP implants to be removed. It is important that the individual benefits and risks of taking the implants out or leaving them in for each patient should be discussed. These include the risks associated with major surgery. The NHS and private clinics are best placed to comment on this.
2.3. The MHRA has discussed the access to the removal procedure with the Plastic, Reconstructive and Aesthetic Expert Advisory Group (PRASEAG), most recently in 2023. Members were aware of stalled progress with the evidence-based interventions programme outlined above. It was noted that surgeons have a duty to see and investigate patients with symptoms or concerns and that they should not be turning down implant patients based solely on the original implant not being implanted by the NHS.
3.1 We are unable to comment on regulatory decisions from other countries, however the different healthcare systems between countries needs to be considered.
3.2 The MHRA guidance regarding PIP breast implants is based on the latest evidence available to us, including that related to structural integrity (rupture) and chemical and toxicological testing which is consistent with what has been agreed upon internationally. PIP implants are significantly more likely to rupture or leak silicone than other implants, by a factor of around 2-6 and this difference is detectable within five years of implantation. Chemical and toxicological testing available worldwide demonstrated that the non-approved silicone contained in PIP breast implants at the time of the investigation was not carcinogenic.
3.3 The MHRA conducted a thorough benefit risk assessment including evidence from the PIP UK Expert Group & worldwide regulators as well as considering the wider risks of surgery associated with preventative action in the absence of rupture.
3.4 The MHRA keeps the safety of all breast implants under continual review via our post-market surveillance activities. We do not hold any evidence that suggests the original guidance needs updating based on safety risks, which is reflected in the MHRA having received no reports of BIA-ALCL occurring in patients who have only ever had PIP breast implants.
4.1. One of the concerns for women with breast implants at the time of PIP was that women didn’t know if they had PIP breast implants. Therefore, as part of the future UK medical device regulations we intend to improve the traceability of medical devices through introduction of Unique Device Identifiers (UDI), which will help identify individual medical devices and who manufactured the device or placed it on the market.
4.2. The MHRA acknowledges that there were difficulties in contacting all patients implanted with a PIP breast implant. Since 2016 the Breast and Cosmetic Implant Registry (BCIR) collects data on all types of breast implant and removal surgery in England, Scotland and Northern Ireland by the NHS and private providers. The aim is to help detect emerging safety issues and trace patients if necessary.
5.1. The MHRA considers all benefits and the risks of a product when making a recommendation. Cost implications are not within the remit of the MHRA and are not considered in recommendations. The health impacts are addressed in earlier questions.
Wider Breast Implant Issues
6.1. The MHRA has formed an independent expert advisory group; the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) to provide advice regarding breast implant related safety issues. PRASEAG members have worldwide-recognised expertise and provide a greater understanding of the potential risks to patients including risk of anaplastic large cell lymphoma. The group also advise on how to communicate and engage with patients and healthcare professionals on implant related safety.
6.2. The MHRA has published extensive guidance on breast implants including Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) - GOV.UK (www.gov.uk), Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the capsule around breast implants - GOV.UK and Symptoms sometimes referred to as Breast Implant Illness - GOV.UK.
7.1. The MHRA does not regulate procedures. Anyone who is experiencing an issue with a medicine or device is encouraged to report through the Yellow Card Scheme.
7.2. The MHRA currently does not regulate cosmetic products without a medicinal purpose and therefore does not hold data or assessment on the wider cosmetic products on the UK market. As such, our data sources on the wider concerns around cosmetic devices are limited.
7.3. The UK is in the process of developing the future Medical Device Regulations. The response to the consultation on these published in June 2022 indicate that 87% of respondents were in favour of including devices without a medicinal purpose, with the majority supporting inclusion of all product types listed in the consultation which include those with a cosmetic purpose. The MHRA intend to conduct further consultation and engagement with trusted stakeholders on certain aspects of our proposed policy approach to the future enhancement of our regulations, including products without an intended medical purpose.
8.1. The MHRA have conducted extensive research into how patients perceive the risks of breast implants. The output from this research identified opportunities to improve risk communication prior to breast implant surgery. The report of this research made recommendations around how communication could be improved. The MHRA worked with the PRASEAG to implement these recommendations.
8.2. As a result, the MHRA has worked with manufacturers to ensure that risks of breast implants including BIA-ALCL are included in Information for Users/ Patient Information Leaflets and on websites.
8.3. The three major surgical associations with members who perform breast implantation, British Association of Aesthetic Practitioners (BAAPS), British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) and Association of Breast Surgery (ABS) have worked to produce information on risk available to practitioners and patients through joint statements and information leaflets. The MHRA recommends that prospective patients are provided with information about breast implant surgery and possible complications either in written format or via an online link to the information sheets jointly written by the three Associations.
8.4. In addition, the MHRA is developing a cosmetic breast implant risk awareness tool in collaboration with patients who have undergone or are considering cosmetic breast implants and clinicians within PRASEAG. The checklist aims to empower the patient to understand the current known risks associated with breast implants and cosmetic augmentation surgery by encouraging further discussion with their surgeon. The checklist is not designed to replace the informed consent process between the patient and the surgeon but to aid discussion to ensure understanding of the short and long-term risks of surgery and breast implants. This tool is being finalised before roll out. A similar tool is to be developed for patients making decisions about reconstruction surgery.
9.1. The role of the 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 PIP breast implants were withdrawn from the UK in 2010 and two independent reviews have identified lessons learned. The health system has since enacted important changes.
9.2. The Howe Review of 2012 focused on the actions of the MHRA and DHSC following the discovery of the fraudulent activities of PIP, the French manufacturer of breast implants. The evidence detailed in the Howe Report shows that the MHRA fulfilled its obligations in terms of reviewing and responding to the incidents reported to them involving PIP breast implants. The Howe Report confirmed the MHRA was active in pursuing PIP about incidents involving its implants. Its focus was on determining if there were underlying problems with the implants, or if the incidents reported were the expected result of the widespread use of a type of device that has a tendency to fail over time.
9.3. The Report made 15 recommendations aimed at prevention of such an incident arising in the future and, if it did, identifying the matter sooner so remedial action could be taken. The recommendations were acted upon by the MHRA, DHSC and through the Keogh Review.
9.4. The Keogh Review of the Regulation of Cosmetic Interventions reported in 2013 outlining the findings of a review of regulation in the cosmetic interventions sector, following the PIP implant scandal which exposed lapses in product quality, after care and record keeping.
9.5. The Keogh Review found the cosmetic interventions sector is growing rapidly and that the existing regulatory framework has not kept pace with changes, providing insufficient protection against many of the potential risks from cosmetic procedures. The Keogh Review found there were three key areas in which changes were needed: high quality care with safe products, skilled practitioners and responsible providers; an informed and empowered public to ensure people get accurate advice and that the vulnerable are protected and accessible redress and resolution in case things go wrong.
9.6. DHSC led a programme of work to implement the majority of the Keogh review recommendations including:
2016 - the establishment of the Breast and Cosmetic Implant Registry (BCIR)
2016 – the GMC published ethical guidance for doctors performing cosmetic interventions
2017 - the Government introduced a duty on the CQC to rate and assess the performance of providers of surgical cosmetic procedures
9.7. Recommendations relating to the regulation of cosmetic intervention products were primarily addressed via the introduction of new requirements in the EU legislation on the regulation of medical devices. Though the EU legislation did not take effect in Great Britain due to EU Exit, the MHRA is developing a future regulatory framework for medical devices that will ensure patients have access to the safe and effective medical devices they need. The first step is the introduction of new Post-Market Surveillance regulations, which will come into force in June 2025, and strengthened legal requirements for how manufacturers monitor and report on their devices once used in clinical practice. We intend to follow this with updates to the UK Medical Device Regulations later this year, which aim to improve device traceability and patient safety by introducing additional measures that must be taken before a product reaches the market. This will include requirements for unique device identifiers (UDI), implant cards, new rules to ensure that claims are consistent with intended purpose, and changes to the classification of some medical devices, such as implantables, to better reflect potential risks to patients and ensure risk proportionate requirements for manufacturers.
9.8. Regarding mesh, following recommendation from Baroness Cumberlege, who chaired the Independent Medicines and Medical Devices Safety Review (IMMDS), in July 2018 the UK government implemented a national period of high vigilance restriction (‘a pause’), in the use of surgical mesh/tape for treating stress urinary incontinence (SUI), and for uro-gynaecological prolapse where the mesh is inserted through the vaginal wall. This pause was extended in 2019 and remains in place.
9.9. NHS England established 9 specialist mesh centres across England to support women who have experienced adverse impacts from mesh surgery and is monitoring progress on meeting the conditions of the national pause on vaginal mesh insertion procedures. NHS England will only make changes to the national pause linked to clinical advice and following consultation with a wide range of stakeholders including patients, professional bodies and NHS organisations.
9.10. We are keeping this issue under close review and will continue to work with colleagues across the health sector, to monitor and examine evidence as it becomes available.
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