Senate Community Affairs Legislation Committee [Part 2], , 4:35:19 to 4:38:41
The committee examines the regulatory history of pelvic mesh and the TGA's move to reclassify surgical mesh products to a higher risk category.
Topics: Health, Public safety
Speakers: Speaker 35, Speaker 29, Senator Ellie Whiteaker, Tracey Duffy, Unknown Speaker
>> All right. Um I think I've got time for one last quick question. Um it's about pelvic mesh. So it's been associated with severe and life-changing complications caused real damage. As I understand it, it got into the Australian market through the substantial equivalence test or pathway I should say and um and it meant it avoided clinical trials, but the pathway still exists. Is that appropriate?
>> The pathway still exists and it's still appropriate, but we I might ask um Dr. cuss to to maybe um uh explain the fact that um our response to mesh has has meant that the mesh products themselves um are at a higher classification now and what that actually means.
>> Dr. Amanda Cus, medical advisor for the medical advice product quality division. Um it's a really relevant point because substantial equivalence is an appropriate um form of assessment um for products. In the case of pelvic mesh back in 201617 when the inquiry began, it was clear that some of the mesh products that had been uh approved and included in the artg were approved uh on the basis of of more generalized indications. So for example, support of uh soft tissues. Um as a result of that inquiry and the the review that the TGI undertook at that time, we proceeded to uh implement quite a number of uh regulatory activity. Um as a result, part of that activity was to actually remove some of those measures from um use uh from supply. But as Miss Duffy said, one of the other activities that we undertook was to ensure that we then reviewed mesh in general, surgical measures in general and we upclassified uh those products to a higher classification rate. What that means with respect to substantial equivalence is that those class 3 highest level medical devices undergo quite a substantial and significantly robust assessment um that looks at not just substantial equivalents and looks for other information in terms of evidence for a product can include uh comparisons to other devices as you suggest but also include um evidence for the device itself if there is evidence. So direct clinical trials, clinical investigations and it also includes other forms of evidence such as uh registry information as well um which is very valuable. So for example, if there's a registry in another country that's got quite a lot of um sort of evidence for that particular product, we can utilize that as well in our assessment.
>> Thank you for answering my questions.
Thank you chair. Um we have very brief. >> You happy to hold till tomorrow? Okay, let's do that given we're bang on 11. Um, no, no, it's not your fault. Um, thank you everyone for being here today and we look forward to seeing you again tomorrow morning when we will continue this outcome and the committee now