Derryn Hinch (Victoria, Derryn Hinch's Justice Party) Share this | Link to this | Hansard source

My question is to the Minister representing the Minister for Health and Aged Care in the Senate, Senator Nash. Last week in the Senate I revealed the horror affecting thousands of women that is called transvaginal mesh. It is the modern scourge for women that thalidomide was back in the fifties and the sixties. It is commonly inserted into mothers who, after giving birth, develop incontinence and prolapse problems. Has the minister taken any steps to investigate this abomination since I raised the issue?

Fiona Nash (NSW, National Party, Deputy Leader of the Nationals) Share this | Link to this | Hansard source

I thank the senator for his question. Clearly these are matters that the government takes very, very seriously. We are sympathetic to any woman who is undergoing any circumstances that are causing distress when it comes to these types of situations. It is a very highly emotive issue for some—I do recognise that—but we also have to make sure that we are responding in relation to data and evidence. The TGA, as senators would know, is responsible for the safety and efficacy of medicines and medical devices. I can advise the senator, with the information provided to me, that steps have been taken.

The TGA has taken a number of steps: it has reviewed the safety of all pelvic meshes on the Australian Register of Therapeutic Goods, it has imposed additional reporting and approval requirements, and it has included additional warnings and risks in the instructions for use. The TGA actually reassessed the clinical evidence of approximately 100 devices and, as a result, removed almost three-quarters from the register. That product delisting began in August 2014 and continued in February 2015 and November 2015. As a result, the pelvic meshes that remain on the register meet the applicable safety and quality standards.

I do note that while, of course, we are very sympathetic to women in these circumstances, for the majority of women it has actually provided effective relief from conditions such as prolapse. I can also advise the senator that that the Australian Commission on Safety and Quality in Health Care has established a reference group on pelvic mesh that will ensure that clinical practice relating to the insertion of these products is appropriate, and that the mesh is only used by women in appropriate cases.

Stephen Parry (President) Share this | Link to this | Hansard source

Senator Hinch, a supplementary question?

Derryn Hinch (Victoria, Derryn Hinch's Justice Party) Share this | Link to this | Hansard source

More than 50 victims have written to the minister about this and, with the TGA taking new steps in reporting, can the minister make it mandatory for doctors to report the complications that women are suffering due to this product?

Fiona Nash (NSW, National Party, Deputy Leader of the Nationals) Share this | Link to this | Hansard source

In general underreporting is very much a focus and we want to ensure that, with any case of adverse event, reporting is appropriate. My understanding is that the issue has been very closely looked at to ensure that underreporting is addressed. The government will certainly continue to monitor this issue—monitor the safety and efficacy. I note that the minister is aware of this issue and, as with any other issue, she will continue to ensure that the TGA is continually monitoring these types of circumstances. If any new evidence or data is presented, it will be considered in the decision making with regard to these types of issues.

Stephen Parry (President) Share this | Link to this | Hansard source

Senator Hinch, do you have a final supplementary question?

Derryn Hinch (Victoria, Derryn Hinch's Justice Party) Share this | Link to this | Hansard source

Transvaginal mesh has roughly a one-in-three failure rate and leaves women in permanent and debilitating pain. In most cases it cannot be removed until the women die. Why won't the government suspend the use of this instrument of torture, pending an inquiry into its safety?

Fiona Nash (NSW, National Party, Deputy Leader of the Nationals) Share this | Link to this | Hansard source

Firstly, with the greatest of respect, I would certainly want to take those claims on notice; I do not want to accept those claims at face value. They do not necessarily align with information that I have been given on the adverse events that we have seen. What I would say is that, given the importance of this issue and given the senator's very real concern on this matter, it would be appropriate for me to facilitate a meeting with the minister directly so that the senator can raise his concerns directly with her and provide any additional data or evidence or information that might be of use to the minister in her consideration of this issue.