The harms of transvaginal mesh
©
Shutterstock
In 2014 Professor Carl Heneghan joined an undercover investigation to expose how the regulation of medical devices is so lax that mesh packaging for fruit could be approved as a medical device to be implanted in people’s bodies.
Here is what has been happening since the "scandal of fruit netting ‘approved as surgical implant’" was reported in The Times:
26 November 2017
BBC reports Vaginal mesh operations should be banned, says NICE:
The University of Oxford’s Prof Carl Heneghan, an expert in the subject, said the draft guidelines were an admission that health services had “got this wrong” – calling the use of mesh a “catastrophe.”
6 December 2017
Underpinning research published:
Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process
Carl J Heneghan, Ben Goldacre, Igho Onakpoya, Jeffrey K Aronson, Annette Pluddemann, Kamal R Mahtani
BMJ Open 2017;7:e017125. doi: 10.1136/bmjopen-2017-017125
Analysis published:
Transvaginal mesh failure: Lessons for regulation of implantable devices
Carl J Heneghan, Ben Goldacre, Igho Onakpoya, Jeffrey K Aronson, Annette Pluddemann, Kamal R Mahtani
BMJ 2017;359:j5515
BMJ press releases research: Inadequate regulation for vaginal mesh products has exposed women …
Reports on the CEBM's BMJ analysis:
The Guardian: Women harmed because vaginal mesh regulation ‘not fit for purpose’
Daily Mail: Regulation over vaginal mesh implants is inadequate
Sky News: ‘Inadequate’ vaginal mesh regulations put women at risk, warn experts
The Independent: Vaginal mesh study reveals how lax medical regulation puts women at risk
February 2018
At the UK Houses of Parliament, Professor Carl Heneghan spoke at a meeting of the All Party Parliamentary Group into mesh. The meeting is reported in CAMBS Times.
July 2018
The Guardian reports on a Houses of Parliament meeting:
Senior doctors call for public inquiry into use of vaginal mesh surgery…
“With thalidomide you could see the visual representation. [With mesh] you can’t see it,” Heneghan told the meeting. “We should have a public enquiry."
October 2018
In a BMJ editorial, Surgical mesh and patient safety Carl Heneghan and Fiona Godlee refer to NICE guidance on mesh and call for a patient register of implants.
The Guardian reports: Vaginal mesh should be offered as last resort, health officials:
"Carl Heneghan, who previously called for a public inquiry into the use of mesh, said: “We’ve been far too quick to resort to surgery as a first choice when it should have been a last chance and as a consequence many women have suffered harm.” Heneghan described the guidelines as “step in the right direction”.
November 2018
The BMJ (blog): Unreported clinical trial of the week: prospective outcomes study of …
"Nick DeVito, Ben Goldacre, Carl Heneghan … Symbotex™, one brand of mesh, incorporates a bioabsorbable film into a nonabsorbable..."
The Guardian: Revealed: faulty medical implants harm patients around world:
"Replacement hips and vaginal mesh products sold to hospitals without any …. of investigations overseen by the MHRA at a time when complaints are soaring. … Carl Heneghan, a professor of evidence-based medicine at the…"
March 2019
Leading manufacturer exits vaginal mesh market:
International Consortium of Investigative Journalists quote Carl Heneghan, who said: “Failing products and an unwillingness to develop evidence of safety underpins the vast majority of medical device withdrawals.” He predicted other manufacturers are likely to follow Bard’s lead and withdraw from mesh products.
2021
The Long-Term Impact of Vaginal Surgical Mesh Devices in UK Primary Care: A Cohort Study in the Clinical Practice Research Datalink, published in Clinical Epidemiology