The TGA (Therapeutic Goods Administration) are Australia’s regulatory body for pharmaceuticals and medical devices.

On the TGA’s business plan 2018-19, they state that they receive a budget of $163 million annually.

This budget comes from the costs that ‘are recovered through fees and charges levied on sponsors and manufacturers of therapeutic goods. 

At the senate inquiry into transvaginal mesh Dr Bonython and University of Canberra associate professor Bruce Arnold told the inquiry that the TGA's "industry-funded model of regulation" raises serious questions about the regulator's independence.

“The current regulatory framework is a complete bypass of the interests of consumers. They don't have a stake at the table,"

Both believed that there needed to be a clear break between the regulator and the parties they were trying to regulate.

As Dr Bonython said there was a "lack of political will" to make hard decisions to protect consumers.

Women and men who are suffering from medical devices, including surgical mesh, breast implants contraceptive implants like Essure and Mirena, joint prostheses, cardiac stents and pacemakers know too well about the TGA’s close ties to industry and what it feels like to have their voices silenced and excluded from important regulatory decisions.

On the 10th of April the TGA called an emergency meeting around the regulation of textured breast implants as new data was linking a specific lymphoma cancer BIA-ALCL directly to these implants.

Currently Australia has 90 women who have been diagnosed with the breast implant related cancer and there have been three deaths.

One surgeon from the Australian Society of Plastic Surgeons called for these implants to be banned. However, the voices of women who have been diagnosed with BIA-ALCL lymphoma cancer and women who have been implanted with these textured implants were excluded from this meeting.

Following this meeting The TGA announced that instead of banning the textured implants like France and Canada, it would instead write to manufactures, asking them to provide data on the number of implants that have been supplied in Australia along with physical implant samples of within 10 days.

It has now been 10 weeks since this emergency meeting and the TGA continue to maintain radio silence on the status of textured implants. Women who have and continue to be implanted with these implants, just like men women suffering from surgical mesh implants, Essure implants, hip implants, stents will be unable to seek compensation from the TGA for its failure to act.

As Dr Bonython and told the Senate inquiry ‘The TGA can't be sued for negligence. It doesn't matter how negligent the regulator, it can get away with it, which is problematic because it removes any incentive towards carefulness’.

Furthermore, this lack of accountability also extends to the TGA’s responsibility to inform the Australian public once a device has been recalled or banned.

According to the Head of the TGA John Skerritt when asked about the TGA’s responsibility to men and women or the Australian public that a device has been recalled, his consistent reply has been that the TGA "didn't have enough budget”

Furthermore when pressed on why women with Essure were not informed their device was recalled, he replied that ‘It is now regarded as a communication problem between patients and their Doctors’.

Finally, the TGA, despite it being a criminal offence for manufactures to not report complications with penalties of a jail terms and substantial fines as still not prosecuted one mesh manufacturer for failing to report complications.

If you would like more information on Breast Implants and Essure can access their closed facebook groups in the link below

Breast Implants Australia and New Zealand
https://www.facebook.com/groups/BreastImplantIllnessAustraliaNZ/

And

Essure Problems Australia and New Zealand
https://m.facebook.com/groups/995375637192617/

Finally we wish to thank everyone who has signed and supported this petition.