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The Mesh Story

The above timeline sets out the major landmarks for transvaginal surgical mesh since its first approval in 1996

In 2014 an Oxford scientist, 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

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.

 

Red target with concentric circles against a grey backgroundNov 26th 2018: 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…

 

 

Graphic image of a red folder on its side, with a keyhole in the middle.Nov 6th  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 …

 

 

Oct 2018: 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”.

Oct 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

Feb 2018 at the UK Houses of Parliament Carl Heneghan, spoke at a meeting of the All Party Parliamentary Group into mesh.You can’t make an omelette without breaking a few eggs. Surgeon is …

Dec 2017.

BMJ press releases CEBM  research: Inadequate regulation for vaginal mesh products has exposed women …

BMJ Open publishes Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. BMJ Open 2017;7:e017125. 

BMJ publishes Heneghan CarlAronson Jeffrey KGoldacre BenMahtani Kamal RPlüddemann AnnetteOnakpoyaIgho et al. Transvaginal mesh failure: lessons for regulation of implantable devices. BMJ 2017; 359 :j5515

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Close-up of hands with a mesh overlay in teal and greyDec 6th The Guardian reports on  Oxford’s Centre for Evidence-Based Medicine, BMJ research and analysis:  Women harmed because vaginal mesh regulation ‘not fit for purpose’ along with the Daily Mail Regulation over vaginal mesh implants is inadequate;  Sky News ‘Inadequate’ vaginal mesh regulations put women at risk, warn experts and The Independent  Vaginal mesh study reveals how lax medical regulation puts women at risk

 

Older couple standing outside with an historic building in the backgroundNov 26th 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”

July 2018 The Guardian reports on a Houses of Parliament meeting where  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