Gino Kenny Questions Status of CMO Mesh Recommendations

Thanks Kirk and good morning to all our guests. Just I want to just focus most of my questions in relation to the CMO's report in 2018. Can you hear me? Yep, you can hear. So my questions are on the CMO report four years ago in relation to its 19 recommendations. So you said 11 have been completed. Could you name a number of them recommendations that have been completed in that category? Yeah, I might ask Cleanna to come in. So there are a number of recommendations. I might start in terms of the completed, working in conjunction with other stakeholders, develop comprehensive evidence-based information resources about mesh devices and the services in place. So that's one of the ones. I don't know whether you want me to read out, but I can provide a report to the committee on each one, because they're quite lengthy in terms of the detail of the recs. Can you accept that we'll get that full report? Yeah. Yeah. And the five outgoing, could you kind of elaborate on, say, a number of them in relation to the ongoing recommendations? Yeah. So there, and I might just for ease of reference, there are four in particular, which are ongoing, and they relate to professional training requirements and mesh surgical unit facilities. So for ease of reference, and I won't go through them all again, because they're quite lengthy. The recommendations eight to 11, and mainly they've been comprehended by recommendation 12, which is around national clinical guidance. But they do refer to, I suppose, when the pause is lifted. So they only come into being when the pause is lifted. So they require that pause to be lifted. So that's four of the recommendations. The other one that's ongoing is recommendation one, which is around, it relates to, it's under the heading of patient information and consent. And I suppose that's in draft. But again, it needs to be updated in line with new research and best practice when the system is on notice that the pause is to be lifted. So again, it relates to that, the lifting of the pause. And the three that are no longer deemed clinically appropriate. Could you elaborate on that? Yeah, I might get clean it to come in on that if that's okay. So that relates to mesh for prolapse surgery, and it's now not going to be a recommendation that mesh, you know, would be used in prolapse surgery and the clinicians, you know, would advise that going forward. So in that case, it, you know, makes them mute in that case. So we do have guidance going forward to deal with that. Okay. And just my final question is in relation to the overall programme itself. And obviously, four years ago, it was pause. Do you envisage that the programme could recommence under, you know, the recommendations fulfilled, the recommendations carried out, and with the consent of obviously, medical professionals and obviously, the women that have kind of suffered terribly in relation to this, but is it envisaged that the programme could recommence in the future? Yeah, I might come in first and I'll bring clean in. Secondly, one of the issues for us, and we've heard through the testimony from the women affected by a number of the members here, is the significant learning, there's no doubt, from the response to the recommendations that we've put in place across a number of headings. And that's recognised and we need to hear that. And I've heard that from a number of the members, as I say, and the women affected. And so that's something we need to take on board. I suppose it has been always our intention after set up of the service and that operational response, that we'd have a national oversight group in place to have a look at the service in terms of what we've put in place, and what learnings we can take from that, and some of the learnings from today, obviously, as well, and our engagement with the groups. But on the specific question again, around lifting the pause, that oversight group, the intention around that was to look at whether that would be appropriate. But I might get cleaner to come in on the mechanics of that. Yeah, I guess it wouldn't be our role to lift the pause in that the CMO caused the pause in the first place for good reasons. But should the pause be lifted, then obviously it would be a different landscape that you'd be talking about. So you'd be talking about tighter guidelines, designated people who would be approved to insert mesh under strict controls. You'd be talking about a database of those mesh. But we are, as a clinician group, aware there are a large number of people suffering from stress urinary incontinence symptoms for whom conservative measures have failed. And that mesh for stress urinary incontinence is recommended by a number of professional groups as an appropriate management for stress urinary incontinence. So there is that other competing interest of large numbers of women also in clinics suffering from incontinence. But the landscape would be different, the controls would be different, and the oversight and data collection would be different. So, yeah, okay, so obviously where I'm taking from that, that, yeah, the program could be recommenced in the future. And just for my final question, in relation to this procedure done elsewhere outside this jurisdiction, how prevalent is, you know, this procedure done in, say, in Britain or mainland Europe? So there's been different approaches in different countries. So, for example, in Germany, I don't believe there was a pause, there is a pause. And, you know, mesh itself was not taken off the market, you know, in any place. In the Netherlands, the response was along the lines of clinical governance, again, tightening regulations and guidelines and that. And in New Zealand and Australia, there were slightly tighter controls as well in that area. So different approaches taken in different countries. But it is fair to say, you know, mesh is being used in many other countries, yes. Okay. Dr. Morphy, has it, has, in your experience, has the procedure ever been, has it been banned in any country around the world? Whether, you know, where a government or a health authority said it would be. It has been paused as opposed to being banned, you know. So, so, yeah, that, you know, and, and from the HPRA would say there was no report of a particular device, for example, being, you know, taken off the market or unsuitable to use in that way. Yeah. Yeah. And does it cause you concern that, you know, different countries have paused the program itself? Because obviously there is, there's obviously concerns not only in this country, but also elsewhere that, you know, a medical procedure could be actually detrimental to somebody else. I think it's, it's, you know, in retrospect, what possibly the problem is, not so much the medical device in itself, but how widespread it's used and what indications and the counselling and the other options that were given to people, as opposed to a particular device being unsafe in itself. I think that would be fair to say, and the responses in the different countries would seem to indicate that the safety measures put in place were along the tightening the controls and the indications for that, as opposed to being more indiscriminate. And do you, do you see the program recommencing in the future in Ireland? I know it's difficult to say, but. As I say, it's not, it's not for the HSE to lift a pause. So we, we will await. Who would that, who would make that decision? Well, the CMO, essentially it was the CMO. So, I mean, the CMO recommendations, you know, we've been working to complete the CMO recommendations. So that will be the first step. Thanks. Thanks. That was that.