Written evidence submitted by Dr Nicholas Farr, Research Fellow at University of Sheffield [BIP0080]

Date: 30.06.2025

Author:

  1. My name is Dr Nicholas T.H. Farr, EPSRC Research Prize Fellow at the University of Sheffield. In addition to my university employment, I provide expert testimony in international litigation concerning the degradation of medical devices within the human body, most notably in relation to surgical mesh.
  2. Regarding breast implants, I am currently collaborating with the NHS Implant Analysis Service on a first-of-its-kind study investigating the degradation of breast implants and potential links to associated with Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This research is uniquely enabled by rare access to explanted breast implants from NHS patients. As part of this ongoing work, I was invited to participate in a Parliamentary Round Table on breast implant safety, held on April 23, 2025.
  3. My research has contributed to a new understanding of polymeric implant degradation [1-5] and its long-term clinical implications [6]. This work involves close collaboration with world-leading clinicians to develop advanced materials characterisation techniques and in vitro testing methods [7]. These methods are designed to better replicate the physiological pressures within the human body, with a focus on developing more ethical and representative testing models, including alternatives to traditional animal testing. In particular, my research highlights that clinical interventions must be developed and validated differently for men and women.
  4. This research has led to numerous peer-reviewed academic publications, aimed at both clinical and patient audiences [7-12]. Given this background, I feel well-placed to address two of the questions posed by this inquiry.

Research:

Question posed “What are the gaps in research around the safety of cosmetic procedures, including breast implants?”

  1. Firstly, it is important to recognise that the UK is home to world-class research institutions and leading experts in women’s health and patient safety. However, despite this capability, significant research gaps remain when it comes to the safety of cosmetic procedures, particularly breast implants, and more broadly, the impact of medical devices on women’s health.
  2. My primary concern is not only the lack of funding but a more fundamental issue: a systemic failure to understand and prioritise research into sex-specific health risks and the unique physiological and societal factors affecting women’s health. Research on many women-specific conditions, including the long-term safety of cosmetic implants and medical devices, has been neglected for decades. This neglect contributes to a shallow evidence base that leaves patients and clinicians unable to make truly informed decisions.
  3. The recent work of the National Academies of Sciences, Engineering, and Medicine in the United States, A New Vision for Women’s Health Research (2025) [13], provides a powerful model for how nations can begin to address these deficits. It demonstrates the importance of first identifying and documenting the structural barriers and knowledge gaps in women’s health before meaningful change can occur. I would like to see a similar initiative established in the UK, possibly through a sub-committee within the Women and Equalities Committee, tasked with developing a national research agenda for women’s health. This would give UK-based researchers applying for UK Research and Innovation (UKRI) and other funding streams a clear mandate and rationale for tackling neglected areas of women’s health and device safety.
  4. The work of the US National Institutes of Health (NIH) Committee on the Assessment of Research on Women’s Health, formally authorised in late 2023, provides a useful blueprint in the interim. It acknowledges that while women tend to live longer than men, they often do so in poorer health and with more chronic pain. Yet women’s physiology remains under-researched and poorly understood. Women-specific hormonal changes and their impacts on organ systems across a woman’s lifespan are rarely accounted for in research protocols, device testing models, or regulatory assessments.
  5. This gap in fundamental understanding has real consequences for safety. The failure to incorporate sex-specific differences into the testing and development of medical devices, particularly those used in cosmetic or permanent procedures such as breast implants, results in devices that are not optimally designed for women’s bodies. For example:
  1. Moreover, cosmetic procedures occupy a regulatory and research grey area, in some cases being categorised as elective and thus escaping the scrutiny applied to other forms of healthcare. This contributes to the absence of long-term safety data, especially when procedures involve permanent or semi-permanent medical implants.
  2. Addressing these research gaps will not be quick or easy. Even with adequate funding, closing decades of oversight will take time. But it is imperative that the UK commits to this work now. Cosmetic safety and women’s health should not continue to be marginal areas of science when the tools, expertise, and international models for progress are available.

Remedy and Recourse:

Question posed “What recourse should individuals have when procedures go wrong or products are faulty, and is further legislation or regulation required to support that recourse?”

  1. In most cases, legal redress for faulty medical devices relies heavily on the ability of patients to bring a claim against manufacturers under the Consumer Protection Act 1987 (CPA). However, the current framework, particularly the 10-year long-stop rule, poses significant barriers for patients. Unlike other consumer products, implantable medical devices can fail in complex and delayed ways, often due to long-term degradation, fatigue, or biological interaction with the body. This means the effects may only become evident over a decade after implantation.
  2. Under the CPA, patients have three years from the date of injury or knowledge to bring a claim, but in no event later than ten years from when the product was first “put into circulation”. This typically means the date the device left the manufacturer or was supplied to the hospital, rather than the date it was implanted. Given also that many devices have a shelf life of up to five years before use, this ten-year rule can, in some cases, expire before symptoms of failure ever arise. As recent media reports suggest, legal representatives have had to turn away thousands of potential claimants simply because their claims fall outside this statutory window [14].
  3. To address this, I support the extension of the long-stop period, in line with the new EU Product Liability Directive 2024/2853, which proposes increasing the long-stop from 10 to 25 years in cases involving latent damage. This is a more proportionate approach to reflect the unique nature of medical device failure timelines and would provide fairer access to redress.
  4. However, even with a longer limitation period, patients face significant hurdles in establishing causation. Particularly in cases where failure emerges slowly or presents ambiguously. The 2018 case of Gee v DePuy International Ltd [15] illustrates this issue. Here, the court accepted DePuy’s argument that statistical evidence about revision rates was unreliable due to confounding factors. This highlights the courts’ reluctance to rely solely on population-level statistics to prove individual causation.
  5. In my view, epidemiological data can highlight trends, but cannot on its own, prove causation in a specific patient. To overcome this evidentiary gap, access to explanted materials and the forensic testing of removed implants, can play a transformative role. Such analysis enables the identification of unique, patient-specific mechanisms of failure and is more likely to satisfy courts evaluating claims of product defect under the CPA. Unfortunately, there is currently no accessible or structured mechanism for patients to commission such testing, despite the fact that patients retain ownership of explanted devices under Health Notice HN(83)6, Section 3.
  6. My last point of concern relates to the persistent lack of transparency surrounding financial relationships between industry and healthcare professionals. A factor that significantly undermines informed consent, public trust, and patient safety, particularly in the context of breast implant procedures.
  7. Although concerns about industry influence have been long highlighted, including in the First Do No Harm report [16], the UK still lacks a comprehensive, mandatory disclosure system. Currently, information about payments or incentives from implant manufacturers to clinicians or hospitals is patchy, inconsistent, and largely reliant on voluntary reporting. This fragmented approach has left patients in the dark about potential conflicts of interest that could influence clinical recommendations or decisions around device use.
  8. By contrast, other countries have implemented robust, centralised registers that require industry to disclose all payments to healthcare providers. These systems, such as the US Sunshine Act, have strengthened accountability, improved prescribing behaviour, and allowed patients to make more informed decisions.
  9. In the UK, however, such transparency remains absent in the medical device sector. As a result, there is no reliable mechanism for patients, regulators, or even NHS organisations to track the influence of commercial relationships in this space. This vacuum risks repeating past mistakes, where opaque industry ties have contributed to inadequate oversight, delayed safety action, and avoidable harm.
  10. Clearer and legally mandated transparency would support ethical innovation while safeguarding patients. It would also reduce inefficiencies and costs arising from biased clinical choices or unnecessary interventions. With the UK aiming to lead in life sciences and med-tech, the absence of a credible transparency regime puts both patients and the integrity of the system at risk.
  11. To conclude, I strongly recommend legislative or regulatory amendments that would:
  1. Extend the long-stop period for medical devices to 25 years, particularly where latent defects are concerned;
  2. Mandate a national mechanism for explant retention, or provide clear pathways for patients to access such testing independently;
  3. Introduce a central, statutory transparency register for industry payments to healthcare professionals, modelled on the US Sunshine Act;
  1. Without these changes, patients harmed by defective implants risk being left without remedy, not because their claims lack merit, but because the current system is structurally incapable of accommodating the realities of long-term implant performance

June 2025

References

[1] Farr NTH, Gregory DA, Workman VL, Rauert C, Roman S, Knight AJ, Bullock AJ, Tartakovskii AI, Thomas KV, Chapple CR , Deprest J et al (2024) Evidence of time dependent degradation of polypropylene surgical mesh explanted from the abdomen and vagina of sheep.. Journal of the Mechanical Behavior of Biomedical Materials, 160.

[2] Farr NTH, Workman VL, Saad S, Roman S, Hearnden V, Chapple CR, Murdoch C, Rodenburg C & MacNeil S (2024) Uncovering the relationship between macrophages and polypropylene surgical mesh. Biomaterials Advances, 159.

[3] Farr NTH, Rauert C, Knight AJ, Tartakovskii AI & Thomas KV (2023) Characterization and quantification of oxidative stress induced particle debris from polypropylene surgical mesh. Nano Select.

[4] Farr NTH, Klosterhalfen B & Noé GK (2023) Characterization in respect to degradation of titanium‐coated polypropylene surgical mesh explanted from humans. Journal of Biomedical Materials Research Part B: Applied Biomaterials.

[5] Farr NTH, Roman S, Schäfer J, Quade A, Lester D, Hearnden V, MacNeil S & Rodenburg C (2021) A novel characterisation approach to reveal the mechano–chemical effects of oxidation and dynamic distension on polypropylene surgical mesh. RSC Advances, 11(55), 34710-34723.

[6] Farr NTH, Achenbach P & Sievert K-D (2025) Effects of degradation-associated polypropylene particles in the surrounding tissue after surgical mesh implantation. Nature Reviews Urology.

[7] Farr NTH, Workman VL, Chapple CR, MacNeil S & Rodenburg C (2024) Strengthening preclinical testing to increase safety in surgical mesh. Nature Reviews Urology, 21, 515-516.

[8] Farr NTH – Patient Engagement Q&A “ The impact of implanting plastic surgical mesh: Q&A with researcher Nicholas TH Farr | Sling The Mesh” Accessed 26/06/2025.

[9] Farr NTH – Patient  Safety Learning Charity “Medical device safety: effective testing is key - Medical devices (new) - Patient Safety Learning - the hub” Accessed 26/06/2025.

[10] Daily Mail Online “Material commonly used in vaginal mesh implants starts to degrade within 60 days of being implanted in the pelvis, study reveals | Daily Mail Online” Accessed 26/06/2025.

[11] Farr NTH – Medscape “Safety Under Scrutiny: A Call to Enhance Preclinical Testing” Accessed 26/06/2025.

[12] The Independent “Vaginal mesh particles ‘could trigger autoimmune response even after removal’ | The Independent” Accessed 26/06/2025.

[13] National Academies of Sciences, Engineering, and Medicine. 2025. A New Vision for Women's Health Research: Transformative Change at the National Institutes of Health. Washington, DC: The National Academies Press. https://doi.org/10.17226/28586.

[14] Daily Mail Online. (2025, March 20). “Scandal of the women harmed by medical implants who are BANNED from seeking compensation | Daily Mail Online” Accessed 26/06/2025.

[15] Gee & Others v DePuy International Limited [2018] EWHC 1208 (QB).

[16] Cumberlege, J. (2020). First do no harm: The Independent Medicines and Medical Devices Safety Review.