Written evidence from Mark Hughes, Business and Policy Manager, Patient Safety Learning [BIP0002]

Response to a Women and Equalities Select Committee call for evidence: Concerns surrounding breast implants, cosmetic surgery and patient safety, including Poly Implant Prothèse breast implants

Introduction

This submission sets out the response of Patient Safety Learning to the Women and Equalities Select Committee’s targeted call for evidence looking at broad concerns surrounding breast implants, cosmetic surgery and patient safety, including Poly Implant Prothèse breast implants.

Patient Safety Learning is a charity and independent voice for improving patient safety. We harness the knowledge, enthusiasm and commitment of healthcare organisations, professionals and patients for system-wide change and the reduction of harm. We believe patient safety is not just another priority; it is a core purpose of health and social care. Patient safety should not be negotiable.

Through our work we support safety improvement through policy, influencing and campaigning and the development of ‘how to’ resources such as the hub, our free award-winning platform to share learning for patient safety, and our unique Patient Safety Standards and support tools.

the hub is home to a growing number of networks for people involved in patient safety.

These communities of interest are informed by subject matter experts, providing forums to

share knowledge and good practice. We are increasingly being approached by NHS

England and other key patient safety stakeholders who are seeking the views of these

groups in their development of new policies and programmes. These networks include

patient safety specialists, patient safety partners and organisational leaders with patient

safety expertise. They provide a rich and valuable insight from what we term the ‘patient

safety frontline’.

We welcome the opportunity to submit this evidence to the review. We would be happy to

expand further or discuss any of the points covered in this document as appropriate.

Call for evidence submission

1. Poly Implant Prothèse breast implants

1.1              Patient safety concerns relating to Poly Implant Prothèse breast implants has to date not been a core focus of Patient Safety Learning’s work as charity, so we would not claim to have any expert knowledge on this issue. We are however aware of the tireless campaigning efforts of patients and patient groups such as the PIP Action Campaign.

1.2              We strongly suggest that the Select Committee, if it has not already done so, seek evidence directly from this group and other affected patients. In particular, they would be able to share direct experience of problems accessing/barriers to corrective surgery and other support for ongoing related health issues and necessary treatment. We would also suggest that the Committee consider the PIP Action Group’s views on how to ensure that the voices of women and families affected by this scandal are heard, either by a public inquiry or another vehicle.

2. Are there any cosmetic procedures that are currently popular that are a cause for concern?

2.1              On the hub, our platform for sharing learning for patient safety, we have had a specific patient safety concern raised by a medical tattoo artist proving 3D areola-nipple tattoos within the NHS and private healthcare. She highlighted safety concerns relating to poor standards of education in this area of healthcare, highlighting the harm this can cause patients both physically and emotionally.[1]

2.2              Areola tattooing is a form of medical tattooing. It is used to recreate a 3D realistic areola-nipple complex (or restore the natural areola-nipple complex), enhancing the results of breast surgeries. This highly specialised skill can be used to help patients in their healing journey after mastectomy surgery, gender-affirming surgery and cosmetic breast surgery, promoting body confidence and improving mental wellbeing.

2.3              In her blog, Tanya raises concerns that due to a lack of proper education, training and continued support, these tattoos are being performed within medical facilities using unsuitable equipment, techniques and practices. This results in patients receiving poor quality areola tattoos that are, at best, fading away within a few short months and, at worst, causing severe scarring and trauma to the skin.

2.4              She informed us that many medical professionals and health care providers have been trained to use micropigmentation pigments for areola tattooing. They are told that these pigments are ‘semi-permanent’, vegetable dyes that will eventually disappear. In her blog she advises that this is not correct and does not allow patients to provide true informed consent.

2.5              She notes that once pigment (of any kind) is implanted in the dermis layers of the skin (the layers in which a tattoo should sit in the skin) then ‘semi-permanent’ results cannot be guaranteed. What most patients find is that they are left with a faded, usually unnatural in colour, areola tattoo. She noted that in most cases this is more distressing to the patient to look at than having no areola at all.

2.6              Elaborating on this issue, in her blog she advised that using pigment in this way leads people to have regular ‘top ups’ to maintain the tattoo. Repeatedly disrupting the already delicate skin and scarred tissue (particularly after surgery) can result in further damage being done to the skin, which can lead to more scar tissue being created and will cause poor healed results of your tattoo. Pairing this with unsuitable equipment and techniques, increases the risk of damage and scarring even further.

2.7              Tanya concluded by suggested that strong practices and processes needed to be developed in this area.

3. Are patients given enough information on the risks associated with implants and/or cosmetic surgery in general as to be able to give informed consent to procedures?

3.1              As the Committee will be aware, the landmark UK Supreme Court judgment Montgomery v Lanarkshire Health Board case in 2015 reaffirmed informed consent as a principle in law, setting out the legal duty of doctors to disclose information to patients about risks.[2]

3.2              Despite this legal obligation, far too often we see cases of avoidable patient harm where there has been failure of informed consent. Although this is an issue that can impact any patient, this is often particularly notable in health conditions and areas of care that predominantly affect women.

3.3              Considering medical implants, this was particularly prominent in regard to pelvic mesh implants by the Independent Medicines and Medical Devices Safety (IMMDS) Review, which uncovered a truly shocking degree of avoidable harm over a period of decades.[3] It highlighted cases where women underwent pelvic mesh procedures without being aware that mesh would be used.

3.4              Specifically, it stated that “We have been appalled by the numbers of women who have come forward to say they never knew they had had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh or were misinformed as to the extent of longer term adverse side effects. They did not know because no-one told them, let alone sought their properly documented informed consent. And we subsequently heard from women who underwent mesh removal surgery on the understanding that it would be a full removal. They consented to the operation on the basis of that understanding only to discover in the weeks, months, and in some cases years that followed that that was not the case”.

3.5              More broadly, Patient Safety Learning believes that plans to improve informed consent need to be a core part of the Government’s delivery plan for its Women’s Health Strategy.

3.6              The Strategy refers to the increased use of patient decision aids and conversation aids to support informed consent, including a series of digital tools called iDecide to better support informed decision-making in labour. While such tools are important, they need to form part of a wider programme of work to create meaningful change. The IMMDS Review highlighted some important points around this, which we believe should inform the Government’s approach in this area:

• Greater thought needs to be given to help patients better understand risk.
• Information around consent should be shared in way that is clear and meaningful.
• Talking to, or hearing from, others who have experienced the same intervention with or without complications could be hugely beneficial and should be considered as part of the informed consent process.
• Patient decision aids should be validated, standardised for each procedure and be jointly developed with patients, reflecting their experiences and outcomes.

3.7              Work around informed consent in the Women’s Health Strategy, and this broader culture change, will need to be accompanied with clear leadership, delivery plans and effective resourcing if we are to move towards a safer healthcare system for women.

4. What responsibility does the state have to reverse medical errors, specifically in response to serious patient safety scandals linked to medical implants (for example PIP and mesh)? And what responsibility does the state have to reverse medical errors carried out by private providers?

4.1              When it comes to failures of the healthcare system that result in avoidable harm to patients, rarely does the fault for these issues sit in isolation with one body. This harm often arising from a number of failings across the system. The Government is the body that is ultimately responsible for the healthcare system, and when that system fails patients, it has a unique responsibility to address this harm.

4.2              The IMMDS Review recommended the creation of networks of specialist centres for pelvic mesh to provide comprehensive treatment, care and advice for those affected by implanted mesh. We supported this recommendation.[4]

4.3              In the case of Poly Implant Prothèse breast implants, where a private company fitted these, the initial moral obligation would be on them to facilitate corrective surgery if this is required.

4.4              However, if the private provider is unwilling to do so, or unable to for another reason (e.g. they no longer exist/operate) we believe the NHS should step in to ensure the patient is supported in their choice. Consideration should also be given in cases like this to the likely demand for this support, to ensure the availability of services. Long waiting lists for corrective surgery are likely to cause further distress and compound patient physical and psychological harm.

4.5              In addition to reversing medical errors, when it comes to major patient safety scandals, there is often a strong case for redress – whether this be financial or non-financial support – aimed at meeting the needs of harmed patients and providing the opportunity for restorative justice. While avoidable harm caused to patients and their families cannot be changed, redress provides an opportunity to clearly show concerns have been heard, listened to and responded to for the individuals concerned and to prevent future harm to others.

4.6              In may be the case that such harm has been carried out by private providers, rather than public services. However, there is often also an important role played in these issues the wider healthcare system, including the Department of Health and Social Care, NHS England and regulatory bodies.

4.7              Concerning financial redress, when harm is caused by private providers, patients can still face a significant uphill struggle to get compensation. There is considerable evidence of this from many patients and families harmed by sodium valproate, pelvic mesh and hormone pregnancy tests.[5] Too often the clinical negligence route is simply not viable and, in the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need.

4.8              The current approach of the Government is to provide redress on specific issues where it is “considered necessary”.[6] However for patients and the public there does not appear to be a clear rationale or set of criteria for making these decisions. It has taken 40 years of campaigning for the Government to just recently announce a process to consider compensation for victims of the contaminated blood scandal. It is hard to see how harmed patients can have confidence that the existing approach to considering decisions on redress is transparent, fair, consistent, or timely.

4.9              Patient Safety Learning supports the recommendation made by the IMMDS Review in 2020, rejected by the previous Government, that a new independent Redress Agency for those harmed by medicines and medical devices should be created to ensure consistency across different types of patient harm.

April 2025