In this blog, Patient Safety Learning considers key patient safety issues relating to complications from surgical mesh implants, highlighting further sources of opinion and research on the hub.
Monday 1 May 2023 is International Mesh Awareness Day, marking the start of Mesh Awareness Month. Mesh Awareness Day aims to highlight and raise awareness of serious complications experienced by patients as a result of having mesh surgery.
Mesh implants in healthcare
Surgical meshes are medical devices designed to provide additional support when repairing weak or damaged tissue.[1] Mesh may be made of synthetic or biological materials and has been used since the 1950s to treat a variety of conditions in both men and women.
For some patients this leads to improvements in their condition and does not result in harm. However, there are a significant number of patients who have experienced serious avoidable harm because of complications following mesh implants. These concerns have most commonly been raised about mesh when used to treat:
- pelvic organ prolapse (POP)
- stress urinary incontinence (SUI)
- rectal prolapse
- hernias.
Independent Medicines and Medical Devices Safety Review
In recent years, there has been increasing recognition of significant safety concerns about complications stemming from mesh used to treat SUI and POP. This awareness has been largely driven by activism and campaigning by patients and patient groups. In many countries, such as the United States, Canada, Australia, New Zealand, France and the UK, this has led to mesh devices being removed from use for some procedures.[2]
In the UK, the issue has received heightened attention due to its inclusion in the Independent Medicines and Medical Devices Safety (IMMDS) Review, which looked at the harmful side effects of medicines and medical devices and how to respond to them more quickly and effectively in the future.[3] The review focused on the use of three medical interventions in England, one of which was pelvic mesh implants for the treatment of POP and SUI.
The IMMDS Review highlighted a shocking degree of harm associated with the three interventions it considered. It outlined a range of serious safety concerns relating to the use of surgical mesh. In the rest of this blog, we will look at some of the key patient safety issues highlighted by patients and patient campaign groups and action taken and still needed following the IMMDS Review. We will highlight further sources of opinion and research on the hub.
Failures of informed consent
One of the serious patient safety issues highlighted by the IMMDS Review was an absence of informed consent as part of the process of a patient deciding to have mesh surgery.
When considering treatment, a patient should be given all the information about what that treatment involves – this is known as informed consent. Informed consent includes considering the benefits and risks, whether there are reasonable alternative treatments and what will happen if the treatment does not go ahead.[4] In the UK, doctors have a legal duty to disclose information to patients about risks.[5]
In the IMMDS Review, there were some truly shocking examples of lack of informed consent for pelvic mesh patients:
“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”.[6]
These failures not only relate to initial mesh insertion, but also extend to procedures to remove implants:
“…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.”[7]
Dismissal of patient experiences
Following incidents of avoidable harm, listening to and understanding patients’ experiences is a vital source of patient safety insight that can be utilised to prevent future harm. However, in the case of patients harmed by mesh, there are far too many examples of patients being ignored, dismissed or belittled when raising concerns about complications as a result of these procedures.
Last year in a blog and community post on the hub we highlighted some of the shocking comments that had been made to mesh patients by healthcare professionals, shared by members of the Sling The Mesh support group. These varied from inappropriate sexual comments to complete dismissal of concerns. Recounting their experience, one patient who had a hernia mesh implant said:
“A hospital consultant said, ‘Hernia mesh can’t cause these problems (inflammation, autoimmune [issues], joint pain, muscle pain, allergies, Lichen Sclerosis, etc). You're getting confused with vaginal mesh… If hernia mesh were a problem, I would've heard about it and I've not seen one single case in my entire career... don't you think I would've heard if there were problems?’ After I persisted in telling him the scale of the problem he then raised his voice and said, ‘You'll never prove it.’ And that spoke volumes! I guess he is still saying he has never heard of a single case. He also told me to stop believing what I read on the internet.”[8]
It is hard to overstate the emotional and psychological impact that being belittled and ignored can have on a patient. Not taking patient concerns seriously acts both as a barrier to future learning and serves to undermine trust among harmed patients in the healthcare system and healthcare professionals. It represents a failure to act on a key source of patient safety insight, patient experience, and is a huge missed opportunity to avoid or address avoidable harm and make safety improvements in clinical practice.
Difficulties accessing information, treatment and support after complications
Following an early recommendation made by the IMMDS Review, the UK Government suspended the use of mesh to treat POP and SUI.[9] Implementing a further recommendation made by the Review in 2020, the Government also agreed to establish specialist mesh centres to offer comprehensive treatment, care and advice, including removal surgery, to women harmed by pelvic mesh implants. The NHS has established 10 specialist mesh centres across the UK, nine in England and one in Scotland.[10]
However, there have been significant concerns raised about these new specialist centres, as highlighted in a blog on the hub last year.[11] Some key concerns include:
- long waiting lists for patients
- inconsistencies in surgical training between different centres
- tokenistic approaches to engaging with patients in the development of these services[12]
- some centres being run by surgeons who initially implanted mesh, undermining trust in their services.
Sharing their personal experience on the hub, one patient specifically highlighted concerns about aftercare at one centre, stating:
“There doesn’t seem to be much information out there about recovery, or what to expect. It is a complex procedure that involves picking the mesh away from your flesh. Having been damaged once, I feel very nervous about what the outcome of the removal surgery might be, but I don’t feel that I have any choice other than to get it done and try to get some of my life back.”[13]
Specific concerns about aftercare have also been raised by patients with rectopexy mesh. Rectopexy mesh removal procedures require skilled colorectal and urogynaecology teams working together and can be complicated by a variety of factors, including the need for a stoma, the potential for mesh fixation devices being left behind following surgery and issues relating to nerve damage.[14]
Inadequate data, research and regulation
To prevent avoidable harm recurring, having and learning from adequate data and insight is key. But in the case of mesh-related harm, lack of adequate data is another area of concern.
The IMMDS Review recommended a retrospective audit of women who had pelvic mesh surgery to gather data to build a picture of the nature and extent of harm. The UK Government accepted this recommendation, and commissioned NHS Digital to undertake an audit of all pelvic floor surgery completed between 2006 and 2011.[15]
However, significant concerns have been highlighted about the limitations of the data used for this audit, highlighted in a House of Commons Health and Social Care Select Committee report, which states:[16]
“Although the retrospective audit of mesh implants is an encouraging first step, it will be unlikely to reflect and take into account all of the adverse effects women have experienced due to the nature of data used in the audit. We therefore recommend that the Government consider an alternative strategy for how to proactively contact those who have had the procedure about their postoperative experiences and possible side effects.”[17]
There are also concerns about major gaps in the regulation of mesh and other implantable medical devices. The IMMDS Review highlighted that in the UK, these gaps in the regulatory system contributed to the continuation of mesh surgery for many years despite widespread patient safety concerns.[18] Lack of research and adequate data on complications meant that devices were approved without the necessary rigour to ensure they were safe. While action that aims to address some of these issues is underway, it remains to be seen how effective this will be in reducing harm through better regulation.[19]
However, one encouraging development is a gradually increasing base of academic research about mesh-related harm. One recently published study examined the experiences of patients with complications attributed to vaginal mesh surgery so that this knowledge can contribute to improvements in care for those considering mesh, or mesh removal, surgery. The authors of this study highlighted the importance of drawing on this experience, stating that their findings “provide important insights into experiences that, if placed at the centre of healthcare systems, will ensure safer and more inclusive healthcare”.[20]
Lack of redress for harmed patients
In recognition of the shocking evidence of avoidable harm resulting from pelvic mesh implants, the IMMDS Review argued that the UK Government had a “strong ethical responsibility to provide redress”.[21] It recommended that a specific scheme should be set up for mesh injured patients. This remains an unresolved issue, with the Government rejecting this recommendation and instead pointing towards patients having the right to take healthcare providers and manufacturers to court.[22]
However, as highlighted in a blog published on the hub earlier this year, this is simply not an option for many mesh-injured patients. Commenting on one case highlighted in the blog, Patient Safety Learning’s Chief Executive Helen Hughes said:
“When responding to the IMMDS Review, the Government rejected a recommendation to introduce a separate redress scheme for mesh on the basis that patients could take healthcare providers to court for clinical negligence, or manufacturers for product liability. However, as this case sadly illustrates, the legal complexities involved in this means that for many mesh-injured patients this is simply not an option, leaving them with no alternative route to help meet the cost of any additional care and support they may need.”[23]
The Government have now commissioned the Patient Safety Commissioner for England to review again this issue of redress for patients harmed by pelvic mesh and sodium valproate, two of the three interventions covered by the IMMDS Review. In a recent response to a question on this from the Health and Social Select Committee, they stated that:
“It is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take. The work is expected to take around four months and the Patient Safety Commissioner will publish a report of the findings.”[24]
Patient Safety Learning believes that the Government’s response to the recommendations of the IMMDS Review concerning redress was wholly unsatisfactory.[25] If the Government is to make the initial apology it gave to patients harmed by the medical interventions covered by the Review genuine and meaningful, there must be redress as well as learning for action and improvement.
The need for more action on mesh-related harm
It’s clear that there are still serious outstanding patient safety issues concerning surgical mesh implants and care and treatment when complications arise as a result of these interventions. Mesh to treat POP and SUI remains in use in many countries and, in the UK, mesh is still in use for hernia operations and other procedures. The health system globally needs to maintain a focus on ensuring that all informed consents reflects current research and knowledge. It also needs to respond appropriately to patient concerns if complications arise and to collect the right data following incidents of harm.
Share your insights
For surgical mesh and a wide range of other forms of care and treat, patient testimonies have played a key role in raising awareness of concerns around issues such as informed consent, lack of aftercare and systemic failures to identify and act on serious patient safety concerns. Without these insights, we would be significantly less aware of the scale of avoidable harm in healthcare and miss out on a key source of insight and knowledge that can be applied to improve patient safety.
If you are a patient with experience of mesh-related harm, or a healthcare professional with insights to share on this topic, we’d welcome hearing from you on this issue.
- Comment below (register for free first)
- Contact the hub team
References
[1] House of Commons Library, Briefing Paper Number CBP 8108, Surgical mesh implants, 4 September 2019. https://researchbriefings.files.parliament.uk/documents/CBP-8108/CBP-8108.pdf
[2] Nathalie Ng-Stollmann, Christian Fünfgeld, Boris Gabriel and Achim Niesel, The international discussion and the new regulations concerning transvaginal mesh implants in pelvic organ prolapse surgery, International Urogynecology Journal, 2020. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497328/
[3] The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[4] NHS England, Consent to treatment, Last Accessed 27 February 2023. https://www.nhs.uk/conditions/consent-to-treatment/
[5] UK Supreme Court, Montgomery v Lanarkshire Health Board, 2015. https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf
[6] The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[7] Ibid.
[8] Patient Safety Learning’s the hub, Community post, Doctors shocking comments to women harmed by mesh, 22 June 2022. https://www.pslhub.org/forums/topic/258-doctors-shocking-comments-to-women-harmed-by-mesh/
[9] Medicines and Healthcare products Regulatory Agency, Pause on the use of vaginally inserted surgical mesh for stress urinary incontinence, 17 July 2018. https://www.gov.uk/government/news/pause-on-the-use-of-vaginally-inserted-surgical-mesh-for-stress-urinary-incontinence
[10] The British Association of Urological Surgeons, Vaginal Mesh Complications, Last Accessed 25 April 2023. https://www.baus.org.uk/patients/sui_mesh_complications.aspx
[11] Patient Safety Learning and Sling the Mesh, Specialist mesh centres are failing to offer adequate support to women harmed by mesh, 25 August 2022. https://www.pslhub.org/learn/patient-safety-in-health-and-care/womens-health/specialist-mesh-centres-are-failing-to-offer-adequate-support-to-women-harmed-by-mesh-patient-safety-learning-and-sling-the-mesh-r7418/
[12] Kath Sansom, Tokenism in patient engagement is unethical – but is also dangerous, 26 September 2022. https://www.pslhub.org/learn/patient-engagement/tokenism-in-patient-engagement-is-unethical%E2%80%94but-it-is-also-dangerous-a-blog-by-kath-sansom-r7657/
[13] Anonymous, “There is no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery, 1 May 2022. https://www.pslhub.org/learn/patient-safety-in-health-and-care/womens-health/%E2%80%9Cthere%E2%80%99s-no-problem-with-the-mesh%E2%80%9D-a-personal-account-of-the-struggle-to-get-vaginal-mesh-removal-surgery-r6677/
[14] Patient Safety Learning and Sling the Mesh, Consultation Response: Mesh Complications Management Training Pathway, 10 February 2022. https://s3-eu-west-1.amazonaws.com/ddme-psl/ConsultationResponse_PatientSafetyLearningandSlingTheMesh_100222.pdf
[15] House of Commons, Question for the Department of Health and Social Care: Surgical Mesh Implants, UIN 103061, 5 December 2022. https://questions-statements.parliament.uk/written-questions/detail/2022-12-05/103061
[16] Kath Sansom, A mesh ‘audit’ is meaningless unless we have reliable data and hear from those who have been harmed, 6 March 2023. https://www.pslhub.org/learn/patient-safety-in-health-and-care/womens-health/a-mesh-%E2%80%98audit%E2%80%99-is-meaningless-unless-we-have-reliable-data-and-hear-from-those-who-have-been-harmed-a-blog-by-kath-sansom-r8866/
[17] Health and Social Care Select Committee, Follow-up on the IMMDS report and the Government’s response, 20 January 2023. https://publications.parliament.uk/pa/cm5803/cmselect/cmhealth/689/report.html
[18] Kath Sansom, Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies, 15 April 2021. https://www.pslhub.org/learn/patient-safety-in-health-and-care/womens-health/regulatory-flaws-women-were-catastrophically-failed-in-the-mesh-primodos-and-sodium-valproate-tragedies-r4398/
[19] Health and Social Care Select Committee, Government response to the Committee’s report on follow-up on the IMMDS report and the Government’s response, 24 April 2023. https://committees.parliament.uk/publications/39130/documents/192387/default/
[20] Francine Toye, Matthew Izzet-Kay, Karen L. Barker and Abigail McNiven, The experience of women reporting damage from vaginal mesh: a flexible thematic analysis, 23 March 2023. https://www.thelancet.com/action/showPdf?pii=S2589-5370(23)00095-0
[21] The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[22] Department of Health and Social Care (DHSC), Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1004573/government-response-to-the-report-of-the-immds-review.pdf
[23] Kath Sansom, The difficulty of medical negligence cases and why financial redress from the Government is so important for mesh victims, 17 January 2023. https://www.pslhub.org/learn/patient-safety-in-health-and-care/womens-health/the-difficulty-of-medical-negligence-cases-and-why-financial-redress-from-the-government-is-so-important-for-mesh-victims-r8534/
[24] Health and Social Care Select Committee, Government response to the Committee’s report on follow-up on the IMMDS report and the Government’s response, 24 April 2023. https://committees.parliament.uk/publications/39130/documents/192387/default/
[25] Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021. https://www.pslhub.org/learn/investigations-risk-management-and-legal-issues/investigations-and-complaints/investigation-reports/other-reports-and-enquiries/a-year-on-from-the-cumberlege-review-initial-reflections-on-the-government%E2%80%99s-response-patient-safety-learning-23-july-2021-r4911/
