Fiona Nash (NSW, National Party, Deputy Leader of the Nationals) Share 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.