Hostname: page-component-78c5997874-s2hrs Total loading time: 0 Render date: 2024-11-09T23:51:57.928Z Has data issue: false hasContentIssue false

Lessons from the vaginal mesh scandal: enhancing the patient-centric approach to informed consent for medical device implantation

Published online by Cambridge University Press:  12 April 2021

Jennifer O'Neill*
Affiliation:
College of Medical, Veterinary and Life Sciences, University of Glasgow, GlasgowG12 8QQ, UK
*
Author for correspondence: Jennifer O'Neill, E-mail: [email protected]; [email protected]

Abstract

The vaginal mesh scandal, in which thousands of women were irreversibly maimed by polypropylene mesh, revealed multilevel failures in medical device regulation and implantation, demonstrating that patient-centric care has not yet fully transcended from policy into practice. In law, informed consent is considered by a two-stage test: reasonable treatment and patient information disclosure. The standard of reasonable treatment is determined according to what is deemed acceptable in accordance with a body of medical opinion. However, such bodies of medical opinion were vulnerable to external influence from device manufactures. Vaginal mesh manufacturers were found to have had financial links to research, royal colleges, and influential clinicians, which then influenced the basis of the evidence-based practice that often guides such bodies of medical opinion. According to the Independent Medicines and Medical Device Safety Report, patients’ mesh complications were also frequently under-reported and patient-based evidence of harm disregarded. Patients were also not sufficiently informed of the material risks or reasonable alternatives to mesh, which is required of the second stage of informed consent pertaining to information disclosure. This paper makes the following recommendations: that conflict of interest disclosure be mandated, that greater value be afforded to patient-based evidence to improve evaluation of treatments, and that information disclosure for informed consent should relate to the risks, benefits, and alternatives to the surgical procedure and medical device. This will ensure that patients can evaluate whether surgeons are offering unbiased treatment options and are also informed of the potential long-term risks associated with device implantation.

Type
Policy
Copyright
Copyright © The Author(s), 2021. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Department of Health. Liberating the NHS: No Decision about me without me – Government response to the consultation. UK; 2012. Gateway Reference 18444 [cited 2021 Feb 8]. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/216980/Liberating-the-NHS-No-decision-about-me-without-me-Government-response.pdf.Google Scholar
General Medical Council. Good Medical Practice. [Updated November 2020]. UK; 2013. Code: GMC/GMP/1120. ISBN: 978-0-901458-73-5 [cited 2021 Feb 8]. Available from: https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice.Google Scholar
Heneghan, C, Thompson, M. Rethinking medical device regulation. J R Soc Med. 2012;105:186–8.CrossRefGoogle ScholarPubMed
Independent Medicines and Medical Devices Safety Review [Internet] Cumberledge J, CBE. 2018. [Updated 2020 Jul 31]. Evidence [cited 2021 Feb 8]. Available from: https://www.immdsreview.org.uk/Evidence.html Particularly from “Patient Groups-Pelvic Mesh” s.2.1.2, 3.1.8, 5.1.1, 5.1.2,6.1; Evidence of Properties of Mesh; Evidence from Clinicians, Academics and Other Individuals p15-31, Manufacturer Evidence: Ethicon.Google Scholar
Cumberlege J CBE. First do no harm – The report of the independent medicines and medical devices safety review. UK; 2020. ISBN 978-1-5272-6567-7 [cited 2021 Feb 8]. Available from: https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf.Google Scholar
The Supreme Court. Montgomery v Lanarkshire [2015] UKSC 11 [cited 2021 Feb 8]. Available from: https://www.supremecourt.uk/cases/uksc-2013-0136.html.Google Scholar
EUR-Lex. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC [cited 2021 Feb 8]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007L0047&from=en.Google Scholar
Heneghan, C. Updated EU medical device regulations: Do they make a difference? In: BMJ EBM Spotlight [Internet]. UK; 2018 [cited 2021 Feb 8]. Available from: https://blogs.bmj.com/bmjebmspotlight/2018/11/25/carl-heneghan-why-eu-medical-device-regulations-are-a-smokescreen/.Google Scholar
The European Parliament and the Council of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.Google Scholar
Bowers, S. [Internet] How lobbying blocked European safety checks for dangerous medical implants: Confidential injury and malfunction reports have tripled in less than 10 years in many countries. ICJI; 2018 [cited 2021 Feb 8]. Available from: https://www.icij.org/investigations/implant-files/how-lobbying-blocked-european-safety-checks-for-dangerous-medical-implants/.Google Scholar
Busico, V. Guilio Natta and the development of stereoselective propene polymerization. Adv Polym Sci. 2013;257:37–8.Google Scholar
Gornall, J. The trial that launched millions of mesh implant procedures: Did money compromise the outcome? BMJ. 2018;363:k4155.CrossRefGoogle Scholar
Emmett et al. v Ethicon Women's Health & Urology [Internet] Case ID 130701495 in Koutouzos GD. Pennsylvania woman awarded $41M pelvic mesh verdict. Wolters Kluwer; 2019 [cited 2021 Feb 8]. Available from: https://lrus.wolterskluwer.com/news/products-liability-law-daily/pennsylvania-woman-awarded-41m-pelvic-mesh-verdict-3/72205/.Google Scholar
Swift, SE. “First do no harm” and the emerging story of the vaginal reconstructive mesh implant. IUJ. 2007;18:983–4.Google Scholar
Gornall, J. Vaginal mesh implants: Putting the relations between UK doctors and industry in plain sight. BMJ. 2018;363:k4164.Google Scholar
Hurwtiz, B. How does evidence based guidance influence determination of medical negligence? BMJ. 2004;329:1024.CrossRefGoogle Scholar
Sackett, DL, Rosenberg, WMC, Gray, JAM, Haynes, RB, Richardson, WS. Evidence based medicine: What it is and what it isn't. BMJ. 1996;312:71.Google ScholarPubMed
Bailii. Duce v Worcester Acute Hospitals NHS Trust [2018] EWCA Civ 1307. Available from: https://www.bailii.org/ew/cases/EWCA/Civ/2018/1307.html.Google Scholar
Samanta, S, Mello, MM, Foster, C, Tingle, J, Samanta, J. The role of clinical guidelines in medical negligence litigation: A shift from the Bolam standard? Med L Rev. 2006;14:321–66.CrossRefGoogle ScholarPubMed
Mulheron, R. Trumping Bolam: A critical analysis of Bolitho's “gloss”. Camb Law J. 2010;69:609–38.Google Scholar
Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo, B, Field, MJ, editors. Conflict of interest in medical research, education, and practice. Washington (DC): National Academies Press; 2009 [cited 2021 Feb 8]. 2, Principles for identifying and assessing conflicts of interest. Available from: https://www.ncbi.nlm.nih.gov/books/NBK22937.Google Scholar
Hampton, JR. Guidelines for the obedience of fools and the guidance of wise men? Clin Med. 2003;3:279–84.Google ScholarPubMed
Outer House, Court of Session. AH v Greater Glasgow Health Board; and (second) Johnson & Johnson Medical Limited and others [2018] CSOH 57. Available from: https://www.scotcourts.gov.uk/docs/default-source/cos-general-docs/pdf-docs-for-opinions/2018csoh57.pdf?sfvrsn=0.Google Scholar
Sharma, T, Choudhury, M, Kaur, B, Naidoo, B, Garner, S, Littlejohns, P, et al. Evidence informed decision making: The use of “colloquial evidence” at NICE. Int J Technol Assess Health Care. 2015;31:138–46.CrossRefGoogle ScholarPubMed
Bradshaw, A. Listening to the patient's self-reported testimony: The authentic hermeneutical witness to the compassionate nurse? J Adv Nurs. 2013;70:60–7.CrossRefGoogle ScholarPubMed
Bailii. Kennedy v Frankel [2019] EWHC 106 (QB) [cited 2021 Feb 8]. Available from: https://www.bailii.org/ew/cases/EWHC/QB/2019/106.html.Google Scholar
Ford, AA, Rogerson, L, Cody, JD, Ogah, J. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2015;CD006375.Google ScholarPubMed
United States Food and Drug Administration (FDA). Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. 2011 [cited 2021 Feb 8]. Available from: https://www.fda.gov/files/medical%20devices/published/Urogynecologic-Surgical-Mesh–Update-on-the-Safety-and-Effectiveness-of-Transvaginal-Placement-for-Pelvic-Organ-Prolapse-%28July-2011%29.pdf.Google Scholar
Doyle, C, Lennox, L, Bell, D. A systematic review of the evidence on the links between patient experience and clinical safety and effectiveness. BMJ Open. 2013;3:e001570.CrossRefGoogle ScholarPubMed
Brown, K, Roseman, D, Shaller, D, Edgman-Levitan, S. Measuring patient experience as a strategy for improving primary care. Health Aff: Millwood. 2010;29:921–5.CrossRefGoogle Scholar
Campbell, P, Jha, S, Cutner, A. Vaginal mesh in prolapse surgery. Obstet Gynecol. 2018;20:4956.Google Scholar
Cockburn, T, Fay, M. Consent to innovative treatment. Law Innov Technol. 2019;11:3454.Google Scholar