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

O'Neill, J. (2021) Lessons from the vaginal mesh scandal: enhancing the patient-centric approach to informed consent for medical device implantation. International Journal of Technology Assessment in Health Care, 37(1), e53. (doi: 10.1017/S0266462321000258) (PMID:33843515)

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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: O'Neill, Dr Jennifer
• Authors: O'Neill, J.
• College/School: College of Medical Veterinary and Life Sciences > School of Life Sciences
• Journal Name: International Journal of Technology Assessment in Health Care
• Publisher: Cambridge University Press
• ISSN: 0266-4623
• ISSN (Online): 1471-6348
• Published Online: 12 April 2021
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in International Journal of Technology Assessment in Health Care 37(1):e53
• Publisher Policy: Reproduced in accordance with the copyright policy of the publisher