Children’s storybook tells the history of the vaginal mesh implant scandal thanks to Cambridgeshire artist
PUBLISHED: 16:00 11 December 2017
A Cambridgeshire artist has created a children’s storybook-style mini film to help explain the corruption behind the vaginal mesh implant scandal.
Michelle Deyna-Hayward, created the original art work to provide a simple background to how the women’s health disaster happened.
The video comes amid growing calls from around the world for better regulation of medical devices.
This includes a damning assessment of the tragedy by Oxford University professor, Carl Heneghan, who said that inadequate regulation for vaginal mesh products has exposed women to unnecessary harm.
Michelle’s six minute storybook tells how mesh was approved in a piggy back approval system, where manufacturers do not have to carry out clinical trials.
Instead, they get approval under something called Substantial Equivalence, or the 510K route in America.
Michelle said: “When I first realised there were few patient safety checks I was shocked.”
She got involved as she lives in the same Fenland market town where Sling The Mesh founder, Kath Sansom, lives.
Working together the pair created the words and Michelle added the images.
“I didn’t even know what a TVT was,”Michelle said. “I heard Kath’s story while waiting for a hernia operation using mesh. I cancelled.
“I made enquiries and realised it was the same plastic material implant. I had to do something to help men and women who hadn’t had the heads-up I had.
“My painting of a guinea pig wearing frilly pants, seen in the video, shows women were, and still are, the human guinea pigs.”
Professor Carl Heneghan at Oxford University’s Centre for Evidence Based Medicine and colleagues argue that regulatory failings have enabled new mesh devices to be brought to market with inadequate evidence.
He says more than 100,000 women around the world are suing manufacturers after developing serious complications.
Professor Heneghan and his team traced marketing clearance for 61 mesh devices which show no new clinical trials at the time of approval.
His team argue that evidence consistently points to a lack of long term data.
And when longer term evidence did emerge, he said, it identified serious concerns.
Evidence from large trials did not emerge until 20 years after the first products were introduced and 12 years after the call for longer term studies, professor Heneghan said.
“In our view, to be considered safe and approved for widespread use, long term implantable devices should have been evaluated in studies with follow-up of at least five years,” he added.