Analysis

Transvaginal mesh failure: lessons for regulation of implantable devices

BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j5515 (Published 07 December 2017) Cite this as: BMJ 2017;359:j5515
  1. Carl Heneghan, professor1,
  2. Jeffrey K Aronson, clinical pharmacologist1,
  3. Ben Goldacre, senior clinical research fellow1,
  4. Kamal R Mahtani, clinical scientist in evidence based medicine1,
  5. Annette Plüddemann, MSc course director1,
  6. Igho Onakpoya, clinical research fellow1
  1. 1Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK
  1. Correspondence to: C Heneghan carl.heneghan{at}phc.ox.ac.uk

Carl Heneghan and colleagues describe how failings in the process for the marketing approval of implantable transvaginal mesh devices may have exposed women to avoidable harms and how to avoid their repetition

Concern is increasing that use of transvaginal mesh devices to treat stress urinary incontinence and pelvic organ prolapse has exposed women to avoidable harms. Part of the problem may lie with the governance of medical devices, which has enabled new devices to be brought to market with inadequate evidence, and over 100 000 litigation cases are now under way.1 We consider how improvements to both regulatory approvals and the structures supporting evidence based practice among clinicians could help prevent similar problems in the future.

Clinical background

Mesh has been used to treat stress urinary incontinence and prolapse for the past 20 years because it overcomes the need to harvest native tissue, is less invasive, takes less surgical time, and has been thought to reduce the risk of recurrent prolapse. Transvaginal mesh made from polypropylene is used to treat stress urinary incontinence. This operation involves creating a bladder sling using a strip of mesh (referred to as tape) that is inserted through vaginal and abdominal incisions. Similar techniques are used to treat pelvic organ prolapse, with vaginal mesh made from the same material used to support the tissues which hold the vaginal walls and uterus in place. Although the evidence for use of bladder slings is to some extent reassuring,2 that for vaginal prolapse mesh has been controversial.3

The many different brands of mesh devices currently available are predominantly polypropylene based. However, they differ in pore size (macroporous or microporous) and fibre configuration (braided, woven, or monofilament); fibres can include a non-absorbable coat with a thin layer of porous collagen, and surface area can vary.4 Polypropylene mesh …

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