Mesh, money and the damage done Bypass: University of Canberra academic Dr Wendy Bonython criticises health watchdog funding model for “complete bypass of the interests of consumers”.
Regulator: The Federal Department of Health’s Therapeutic Goods Administration complex in Canberra.
Frosty: Professor Chris Maher said he had a “frosty relationship” with the Federal health regulator because of pelvic mesh devices.
Alarm: Victorian Health Issues Centre executive Danny Vadasz said legislative reform was needed to protect health consumers.
Suffer: Australian women have suffered in silence for years because of systemic failures in the health system that allowed pelvic mesh devices to be marketed.
Devices: A sample of pelvic mesh devices marketed in Australia and the United States since 2002.
Campaigned: Women members of the Australian Pelvic Mesh Support Group campaigned for a Senate inquiry into how devices were approved for use in Australia.
TweetFacebookThe current regulatory framework is a complete bypass of the interests of consumers. They don’t have a stake at the table.
University of Canberra academic Dr Wendy BonythonWith hindsight, I think, everyone in the Therapeutic Goods Administration would say they wished that they didn’t allow these products through when there wasn’t much evidence supporting those products.
Professor Chris MaherUntil we have legislative reform public health will remain hostage to the sales and marketing targets of medical device manufacturers.
Victorian Health Issues Centre executive Danny Vadasz
“The recent quiet announcement of the up-classification of mesh devices still does not reassure as there is no guarantee consumers will be provided with relevant consent documentation and there is still no commitment to create a register to track the devices being implanted,” Ms Brennan said.
“There must be a separation between income for our regulatory body, and the approval of devices. No-one has a higher stake in a medical device than the patient who is having something permanently implanted and yet consumers are not at the decision making table of the TGA. This needs to change.”
Federal Health Minister Greg Hunt’s office referred questions to the TGA, which “totally rejected” claims it had a too-close relationship with industry because of its funding model.
“Industry has no say whatsoever in how TGA spends the revenue it receives from other industry charges. This system has been in place for more than 20 years and there has been no evidence of any sort of ‘regulatory capture’,” a spokesperson said.
“Other medicines and device regulators internationally also are fully or significantly funded by industry fees and charges and operate in the same way.This takes the burden off the taxpayer for such time-consuming scrutiny.
“It is accepted as best regulatory practice for regulators to have a good understanding of and working relationship with the regulated entities. So, while the TGA meets frequently with industry and other stakeholders, including consumer and healthcare groups, it maintains a professional but arm’s length relationship and does not include them in any final decision-making once consultations are completed.”
The TGA said it accepted evidence from an expert committee in 2008 that recommended it continue to monitor meshes, but the reported rate of complications was low. By 2013 an internal TGA report acknowledged its adverse event reporting systemonly received 10-20 per cent of all adverse eventsbecause it relied on manufacturers to report complications.
The TGA has not prosecuted one mesh manufacturer for failing to report complications, despite it being a criminal offence carrying a jail term and substantial fine.
In 2014 the regulator cancelled the first of more than 40 pelvic mesh devices and increased monitoring and reporting requirements for remaining devices.
In its statement the TGA said “it must be emphasised that the TGA does not regulate clinical practice and decisions by doctors to use these devices”.