Intended for healthcare professionals

  1. Carl Heneghan, director,1,
  2. Fiona Godlee, editor in chief2
  1. 1Centre for Evidence Based Medicine, Oxford, UK
  2. 2The BMJ, London, UK
  1. Correspondence to: C Heneghan carl.heneghan{at}

A mandatory device registry is long overdue

The use of surgical mesh for vaginal prolapse and stress urinary incontinence increased rapidly for 20 years and then fell from grace, mainly because of a failure to take patient safety seriously. The BMJ investigation by Jonathan Gornall123 itemises the many failings that made this rise and fall inevitable: the lack of postmarketing studies; the failure to establish device registries; the influence of financial conflicts of interest; and, in the UK, the ineffectual role of the National Institute for Health and Care Excellence. Between them, these factors distorted the research evidence and adversely affected the care that women received, causing many of them unnecessary and irreparable harm. “Nobody involved with the mesh revolution emerges covered in glory,” says Gornall.1

The first duty of healthcare systems should be to avoid unintended or unexpected harm during the provision of healthcare. The mesh story shows how healthcare systems around the world have failed in this duty. Systemic problems exist with how medical devices are approved, and, once they are on the market, how they are assessed as …

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