Note: Where available, the PDF/Word icon below is provided to view the complete and fully formatted document
Disclaimer: The Parliamentary Library does not warrant or accept liability for the accuracy or usefulness of the transcripts. These are copied directly from the broadcaster's website.
A controversy in the treatment of vaginal prolapse -

View in ParlViewView other Segments

Norman Swan: Up to one in two women have what's called a vaginal prolapse, usually associated with having had a baby. The name is misleading, it's actually a bit like a hernia but an internal one where the pelvic organs, like the bladder and bowel, bulge into the vaginal wall. In some women it can affect their ability to pass water, their bowel function and their experience of intercourse.

The treatment of vaginal prolapse has become hugely controversial. The original operation simply kept the tissues away from the vagina by stitching, but a few years ago device manufacturers produced mesh, claiming it would strengthen the area and make for a longer lasting, more effective repair.

Class actions against mesh manufacturers and litigation against a gynaecologists have claimed serious complications involving, among other things, erosion of the mesh through the vaginal wall. It's an example of a surgical treatment which became popular with little good evidence to suggest it worked better than what came before it. That's why a group of researchers in what's called the Cochrane Collaboration have reviewed the international literature comparing mesh repairs with the traditional native tissue approach. Associate Professor Chris Maher, a urogynaecologist at the University of Queensland and the Wesley Hospital, and a user of the mesh, was one of the authors.

Christopher Maher: So these were introduced really in about 2003 to 2004 in Australia, maybe a little bit earlier in America and in Europe. And in 2008 the FDA had some concerns and they issued an alert that they were seeing increasing reports of adverse outcomes, pain and bleeding where the mesh starts to erode into the vaginal tissue. The occurrence of this in our study was when the women were examined and carefully looked for that it occurred in about 12%. And about 8% of the women required a surgical intervention to correct that problem.

Norman Swan: What you did in this study was review all the evidence, because often these surgical procedures are introduced with no randomised trial, without knowing they are better, just the belief that it's better. And you've try to bring all the data together, comparing the different techniques.

Christopher Maher: There was 37 trials in our study that we reviewed, and there was 4,000 women.

Norman Swan: What did you find?

Christopher Maher: There was a definitive reduction in the amount of women who had a recurrence of the prolapse if a mesh was used. Also a significant reduction in the number of women who may have been aware of the prolapse if they had a mesh repair as compared to those who had the traditional repair. But there were some problems associated with the meshes as well around what I discussed, where the mesh can rub or protrude into the vaginal tissue and cause of the symptoms that we described, of bleeding, pain or problems with sexual relationships.

Norman Swan: And the need for re-operation. So how much daylight was there in between the tissue repairs that you described at the beginning, the sutures and so on, versus the mesh in terms of the benefits, and how much daylight was there in terms of the problems of the mesh versus the problems of the tissue repair, which clearly were less.

Christopher Maher: If after the native tissue repair…

Norman Swan: That's the suturing.

Christopher Maher: Yes, the suturing, so 19% of women may have recurrence of symptoms. And if you use the mesh repair, say 12%. So a 7% reduction in the number of women who would have experienced the awareness of prolapse. On the counter side, if 5% of women required a surgical intervention for any reason following the traditional repairs, just over twice as many, 11% required surgery for management of complications from the mesh exposures or urinary incontinence or prolapse after the mesh surgeries.

Norman Swan: Okay, so what's the takeaway here? What do you say to women who are sitting in your rooms with vaginal prolapse? How do you make the decision?

Christopher Maher: Norman, I need to just let you and your listeners be aware that many of the products that we evaluated now have been removed voluntarily by the manufacturers from the market. There are newer products on the market…

Norman Swan: Whose manufacturers are no doubt claiming that they are much better than the older mesh, without very much evidence to support it, I suspect.

Christopher Maher: You've nailed it, you've heard this story before Norman, and what I could say to listeners is that the newer meshes may have a better outcome, they may have the same outcomes or they may in fact have a worse outcome, but at this stage we definitely do not know.

Norman Swan: Okay. You've neatly sidestepped my question, which is; how do you make the blooming decision?

Christopher Maher: Look, it comes down to a very strong informed consent process now. So in my own practice there is alternatives to the trans-vaginal meshes or the vaginal approach to the management of these prolapses, and in the Cochrane review within the next two months we will have completed another review, and that will shed more light on the comparison between abdominal surgeries for the management of these problems as compared to vaginal interventions.

Norman Swan: So instead of operating through the vagina you make an incision in the lower abdomen, and then is it still a tissue repair where you do a sling operation from the top, it's just that you have got better access? Is that what the story is?

Christopher Maher: So just the access question, Norman, first, it is done through the abdomen. Frequently these surgeries are performed through keyhole surgery, or sometimes even now many clinicians might even perform them with a robot. And the materials that are used abdominally frequently are a mesh. And the FDA drew a very clear statement when they made their final reports in 2012 that the safety surrounding those abdominal interventions was not in question. And the traditional surgeries are still effective for the management of many of the problems, and there is also alternative abdominal procedures that appear to have a very effective profile and safe profile.

Norman Swan: So how do we get to this place so many years later, Chris?

Christopher Maher: Look, Norman, it's a really good question. And in the last two years or three years we've had reviews in America, we've had reviews in the UK, Scotland, New Zealand, into how do we get to this place. And unfortunately we have this paradigm in medicine where clinicians and doctors are really keen to provide the best treatments for their patients.

Norman Swan: But there's a real question of ethics here, isn't there. You're taking informed consent for a treatment that has not been proven.

Christopher Maher: It's a really good point, Norman, and there needs to be some guidance and it's likely that there is going to be increased guidance to doctors to try and tame that really strong belief that they need to jump in early and take up new technologies or new innovations until the safety and efficacy of those interventions has been truly quantified. And there maybe needs to be some regulation of that to temper doctors' enthusiasm for good, and sometimes we know that the early jumping into new innovations has been beneficial for patients but there is plenty of stories that you are well aware of, including the hips, the breast implants, and possibly in the trans-vaginal mesh story that we are talking about today, where the benefits haven't been as much as we would have liked.

Norman Swan: And of course I assume the mesh is defined as a device medically?

Christopher Maher: It is, so in Australia through the TGA, yes.

Norman Swan: And devices are not as well studied as pharmaceuticals before they are allowed on the market as drugs, but there has also been the same controversy as conflicted doctors who are supported by the device companies to do the operation, creating thought leadership and, if you like, creating the fad. Is there any evidence of that in this story? This is where you fall out with all your colleagues, Professor Maher, is it not?

Christopher Maher: That's an important question, and the drivers of new technology and new innovations has traditionally been doctors, but unfortunately more recently many of the companies have been driving these new technologies, and they are very effective at communicating their message and transporting that message to doctors around the world and to patients. But the companies' enthusiasm and perhaps the doctors' enthusiasm may need to be tempered by further regulation perhaps to ensure that we don't keep repeating the same mistakes of early uptake of interventions or innovation before we know the complete efficacy and side-effect profile of those innovations.

Norman Swan: Associate Professor Chris Maher is a urogynaecologist at the University of Queensland and the Wesley Hospital.