THE Therapeutic Goods Administration’s targeted banning of some pelvic mesh devices on Wednesday is an indictment dressed up as a considered move by the regulator.
The TGA’s statement was soundly bureaucratic. There was “a lack of adequate scientific evidence” for a group of mesh slings, it said. An “examination of clinical evidence” for prolapse devices implanted through the vagina found the risks outweighed the benefits.
But some of these devices have been on the market for years. An unknown number – but certainly in the thousands – have been implanted in Australian women.
The scientific evidence for this group of more than 40 mesh prolapse and sling devices hasn’t changed over the years. The cold, hard fact is that the evidence for their safe use in women’s bodies was never there. There wasn’t even sound evidence the devices would do what their makers said – relieve women of some of the complications of childbirth.
It’s not unreasonable to reach the conclusion that the past decade or more has been one long experiment by mesh inventors, manufacturers and doctors, using women’s bodies as the testing grounds.
No-one told the women, of course.
They trusted doctors who told them the devices were safe. The doctors didn’t tell the women of the many millions in mesh manufacturer dollars sloshing through their gynaecological “training” conferences. The doctors didn’t believe there was a conflict of interest, or any likelihood that funding might influence whether they used mesh or not, despite good evidence that even small amounts of corporate funding is associated with changed prescribing habits.
Manufacturers certainly didn’t disclose how they targeted and funded “key opinion leader” doctors, who recommended mesh devices to other surgeons and GPs.
The TGA didn’t tell the women about an approval process that allowed mesh devices on the market because other devices had already been approved in other countries, and there was little or no evidence backing those devices anyway.
The Royal Australian College of Gynaecologists and Obstetricians stayed largely silent for years while it accepted mesh manufacturer funding. This was despite many women returning with mesh complications, and some doctors writing papers more than a decade ago warning that mesh devices were not based on good science.
The Australian Medical Association marketed one mesh device as an “Australian medical design breakthrough” and then said nothing about mesh for years after many women reported serious complications. It was, as AMA president Dr Michael Gannon conceded in August, “a long way from our proudest hour”.
“To call this a tragedy is not overstating it at all,” he said. Around the world more than 150,000 women have launched legal action in a compensation tsunami that is estimated could reach more than $20 billion.
The women knew nothing about all of the above because they trusted Australia’s health system, and gave what they thought was informed consent to surgery that many were assured was simple, effective, and involved little more than an overnight hospital stay.
But you can’t give informed consent in a system with no transparency where it’s needed, too many conflicts of interest, and no accountability for years when things go terribly wrong.
And yet, that is our health system.