MORE than 1750 Australian women have responded to a call for submissions to a Senate inquiry into how pelvic mesh devices came to be cleared for use in Australia, and the experiences of women who were implanted with them.
A Lake Macquarie woman, Judy, was one of them.
Her experiences demonstrate why a Senate inquiry – and possibly more – is needed.
Judy, then aged 36, was implanted with a device for incontinence in 2003. Her doctor told her the mesh was new and had a high success rate. It was only on Sunday, and after 14 years of severe complications, that Judy learnt doctors were warned about serious complications linked to the mesh she received at almost exactly the time she was being implanted.
We now know the device, the Intravaginal Sling or IVS, was invented by Australian Dr Peter Petros, and developed and marketed in America by Tyco where it was incorrectly cleared for use in prolapse as well as incontinence cases, despite the 2003 Australian warning that it could not be recommended even for incontinence.
The IVS device became the “predicate” case which other pelvic mesh manufacturers in America cited to have their own pelvic mesh devices cleared for use. It is only recently, after what has become known as the “Mesh decade”, and after tens of thousands of women around the world have taken legal action, that regulators are being held to account for what is a global catastrophe.
The Senate inquiry is expected to reveal the failure of science. Manufacturers withdrew devices, and some were cancelled, after evidence relied on to market the devices was found to be deficient, and in some cases seriously so.
It is expected to reveal the failure of regulators, medical colleges, the medical fraternity in general and individual doctors in what should be the most basic and fundamental of responsibilities – the care of patients.
Too many have been keen to point out that tens of thousands of women have been implanted with pelvic mesh devices as a way of minimising the problem. But as Australia’s medical device regulator conceded in a working paper in 2013, it is probably only aware of 10-20 per cent of the adverse cases and so has no real way of establishing the size of the problem.
And that is just not good enough.