Rachel Siewert (WA, Australian Greens) Share this | Link to this | Hansard source

I present the report of the Senate Community Affairs References Committee on transvaginal mesh implants, together with the Hansard record of proceedings and documents presented to the committee. I move:

That the Senate take note of the report.

This report, entitled Number of women in Australia who have had transvaginal mesh implants and related matters, is about the women who have been affected by transvaginal mesh implants. Let me say at the outset that not every woman who has had a transvaginal mesh implant has had the severe consequences that a large number of women we heard about have had—I acknowledge that—but, for the women who have been affected, it has had life-changing and lifelong consequences. I want to say right from the start: it's those women who are at the heart of this report. Those women have suffered for too long. They have been ignored and they have been treated badly. It is essential that we acknowledge that they have been treated appallingly. They have suffered for so long without being heard. They have not been believed. In some cases, they've been belittled. They have been ignored. Well, for no longer shall they be ignored.

I would particularly like to thank all the women who have shared their experiences. Sometimes they felt embarrassment and shame. They articulated this to us. I thank them from the bottom of my heart for sharing their experiences with us. I'd like to share a quote from a woman who did not want to be named, but you'll find this quote in the report:

For those reading this they are words on paper or on an electronic device, but for those of us living with mesh, and especially those that have suffered complications, they aren't words, but physical pain, emotional trauma, fear, embarrassment, ridicule, shame, disbelief, depression, anxiety, derision, and aloneness.

For me, having heard the evidence we received, that sums it up. I hope that we never have to have another inquiry where we see such suffering from the witnesses—women who literally could not sit down for very long. They wanted to be at the hearings for the whole day to bear witness to what others have experienced and to give us their evidence. Many of them could not sit down for very long, so we saw them having to get up and sometimes leaning against a wall. Some had to bring in special cushions to sit on during the hearing. I never want to see women going through that experience again.

I'd like to acknowledge Senator Hinch, who worked so hard on this, and the other senators who also worked so hard on achieving a consensus report and the 13 recommendations that we made. We want to see them implemented so that other women don't have to go through what so many have had to go through. Women who have had adverse outcomes from these procedures, with devices that were put in for stress urinary incontinence or for pelvic organ prolapse, commonly known as POP, have been failed in a monumental way by the system and, I've got to say, by certain people in the medical profession whom they trusted and thought would give them the best advice possible and would carry out the procedure in a way that was world's best practice. It is my belief that the medical profession needs to acknowledge that some mistakes were made and that there were problems. That was acknowledged during the inquiry.

But I must say, as an aside, that an email I got recently because of a comment I had made about some people in the medical profession in relation to mesh indicates to me that we still have some way to go for some people in the medical profession to acknowledge that mistakes do happen and were made here. The committee recommends that:

… treatment guidelines developed by the Australian Commission on Safety and Quality in Health Care should clearly indicate that—

and this is the really important bit—

transvaginal mesh implantation should only be undertaken with fully informed consent and as a last resort when other treatment options have been properly considered and determined unsuitable.

In some instances where we were told that these sorts of implants should be used as a last resort, we had clear evidence that that in fact did not happen.

During the inquiry, the TGA made some very important announcements and decisions relating to these transvaginal mesh implants. They determined that devices should not be used for POP, pelvic organ prolapse, that the use of these procedures should be limited and that it should be ensured that patients had patient cards for devices. One of the issues that we were supposed to deal with through this inquiry was to find out exactly how many women in Australia have had transvaginal mesh implants and how many had had adverse consequences. But we can't answer that question, because the data hasn't been collected. We can't tell you exactly how many women have had these implants and how many women have had adverse consequences.

As I said, the committee made 13 recommendations, including recommendations that relate to adverse event reporting. The reason that we can't tell you how many women have had adverse consequences is that they don't collect the data and the definition of 'adverse consequences' is open to interpretation. There's no mandatory reporting. These are the sorts of issues that we say need to be addressed. We also say that there needs to be a registry of high-risk devices. While there's a specific registry of implantable devices, there's not a registry for transvaginal mesh, which is now a high-risk device. We also had issues around the training of doctors and surgeons that were doing the implant surgery and the credentialing in hospitals of the doctors and surgeons implanting such devices. We need to address that particular issue. There also needs to be an audit done of how many devices are out there.

Before I finish, I would like to again acknowledge the women who told us of their personal experiences, women who have been living with the pain and the consequences of the implantation of these devices. A number of women expressed very strongly the impact that this device and having this surgery have had on them and their families—for example, the splitting up of families and the loss of partners who just couldn't cope with the stress and the impact it has had. This should never have happened. We need to fix it. We need to provide support for these women who have been affected. It's going to affect some women for the rest of their lives, and that support needs to be given.

I'd also like to thank the secretariat who, as usual in our committee, have gone above and beyond. They have produced an excellent report and they've done excellent work in circumstances that were, in some instances, highly emotional, in making sure that we honoured the women who gave us their evidence and very personal accounts in very trying circumstances. I thank them for sharing their experiences.

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

Fifteen months ago, in November 2016, in one of my first adjournment speeches in this place, I talked about a procedure that many people in here, and millions of people out there, had never heard of. Even the few in the media who had were embarrassed to talk about it or report it, because it included the word 'vagina', as in transvaginal mesh. It was so non-U and so non-PC to talk about it that, when I submitted a notice of motion to the Senate for this public inquiry, another senator suggested I censor the term 'transvaginal' and call it 'pelvic' mesh—more palatable, apparently.

With public hearings all around the country last year, and with valuable contributions from the UK and New Zealand, we now know a heck of a lot more about this scandal. I think today, as we table our committee's long-anticipated report, it is worthwhile going back to November 2016 and some of the things that I said back then. I said:

Back in the 1950s and 1960s there was a morning sickness pill that women around the world were innocently taking. And they started giving birth to babies with no arms or legs. After an Australian doctor, William McBride, started making the connection between Thalidomide and deformed babies, drugs like Distaval were taken off the market and a shocked world asked: how could it have gone on so long? How could the drug companies in Australia have known for so many months and put so many pregnancies at risk? How could they put money before morality? Profit before pain? How could our medical authorities and health protection agencies have been so ignorant and so complacent? Thalidomide became a dirty word.

We now have a new four-letter word that's in the same category, a word for something that is not crippling babies but has crippled thousands of mothers both here and overseas—in fact, hundreds of thousands of mothers, we have discovered, around the world, in Australia, in New Zealand, in the United States, in Scotland, in Europe. The word, as you know now, is 'mesh'.

Once again, the drug companies and the so-called watchdogs like the TGA, the Therapeutic Goods Administration, have let victims down and are letting victims down. For about 20 years, this plastic or polypropylene mesh has been permanently embedded as postnatal hammocks, slings, netting, for prolapsed organs and stress incontinence—a so-called miracle treatment for male incontinence too. The mesh is meant to be chemically inert. Before any implanted device gets clearance from the FDA in the US, there must be guarantees that it is inert, is safe, won't change after contact with tissue fluids in the body, won't produce allergic reactions, won't incite inflammation, won't trigger your immune system, won't harbour and breed bacteria, and, crucially, will stay anchored wherever in the body it is installed.

Tragically, painfully, dangerously, transvaginal mesh does not pass those tests. We discovered that at our public hearings in Perth, Canberra, Sydney and Melbourne. To make the nightmare worse, these mesh hammocks are anchored deep in the thigh, the buttocks, the pelvic region, in muscles where nerves grow through the mesh, making it almost impossible to remove when things go wrong—like a wire netting fence getting overgrown with creeper in the backyard. It gets worse, as you will discover if you read our lengthy and comprehensive report. Over time this 'harmless' plastic netting can become brittle and start to break away in shards and splinters that start to float around the body, causing inflammation and excruciating pain. No wonder these slings have been called torture devices. There have been cases where a splinter has pierced a woman's vaginal wall and injured her partner during intercourse, and a large percentage of the relationships of these women have broken down. This was explicitly and starkly illustrated in some of the brave personal stories—mentioned by Senator Siewert—that many victims emotionally outlined to us.

No wonder some of these mesh products have been banned in Scotland and now here in Australia, for some operations, and across the ditch in NZ. No wonder there are nearly 100,000 lawsuits pending in the United States and some lawsuits here. Some crippled Australian women have taken out loans, or increased their mortgage, to cover the $35,000 or $40,000 cost of the removal operation overseas, because no Australian surgeons are really qualified to attempt total removals. I have now met and talked to heaps of women from all over this country who have suffered interminable pain, and physical and mental breakdowns, because of these implants. Some—many—have thought that suicide was the only solution. I hope that our report convinces them that they have been listened to and, more importantly, they have been believed.

It's important to remember: having first been told there was only a one per cent chance of an adverse reaction, they have since been treated like mushrooms: kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies and, sadly, even the TGA. At times, they've almost been convinced to believe that their pain and debilitating conditions were psychosomatic or, some were told, just a way to get more painkillers—and many GPs actually suggested that.

I want to go back to two victims' stories, although there are dozens of excruciating personal horror stories in our report. One is from Caz Chisholm. She started an online support group for transvaginal-mesh-injured women. What triggered my interest back in 2016, when she and Kim Blieschke flew from Perth and Port Pirie to Melbourne to meet me, was this description. She had written to me overnight:

These devices are in a woman's pelvis until she dies! We have been fighting tooth and nail for a suspension on mesh until an investigation is carried out but the doors have been closed on us and we believe that a Senate inquiry is the only way we are going to get to the truth of this situation. Transvaginal mesh damage is a worldwide problem and Australia is lagging in providing the help that women need to get their mesh devices out. There are only a few renowned surgeons in the world who can fully remove them. We need one of the surgeons to come to Australia to remove the devices for the women who are desperate to get them out. The pain is so excruciating for some that suicide has become a normal thought to ease the burden of living with the suffering for the rest of their life.

I can say to Caz: you got your inquiry, and I know this is just the start, not the denouement.

There was this bit, early on, from another victim, Toni Shannon:

I seriously cannot believe that from one innocent minor day surgery and under the trust of surgeon and the experts of the Australian medical system, that I am left with a permanent disability. I am unable to return to work as I cannot sit, stand, walk or drive for more than five minutes without excruciating pain

From the prime of my life I became crippled in less than three months. Thankfully, a world-renowned mesh removal surgeon from the USA removed my faulty and recalled product.

I now have severe incontinence, nevertheless, this is the least of my worries. Worse is that I am made to feel like a criminal by my insurance company because their doctor and our government do not believe that mesh causes these types of injuries. It has left me suicidal and abandoned. In this day and age, and in our country, I can't believe that this is happening.

She asked a question that we have tried to get answers to. That question, from a crippled victim: why would the TGA allow it, why would surgeons implant it and why is a permanent and life-threatening device put into a woman's body for a non-life-threatening problem such as incontinence? The foreign body mesh placed through the vagina cannot be safely removed and it is guaranteed to pick up bacteria, which will fester and create a biofilm, erosion, nerve and organ damage et cetera. She says it's not like a pacemaker, which can be implanted and then easily removed if there's a reaction or a fault. She says:

None of us were warned that removal of mesh is pretty much impossible. Few of us were warned that it was polypropylene. None of us were warned that there were over 100,000 legal cases against mesh and warnings throughout the world. None of us were tested for allergy or reaction to polypropylene before surgery. Most of us were only offered mesh as a treatment.

They were offered no alternatives.

The committee heard case histories and about some of the side effects: things like infection, bleeding, painful sexual intercourse, vaginal scarring, prolapse return, sepsis, immune system rejection, urinary problems, chronic pain—it went on and on and on. And there is the pain of daily living: stabbing pains when sitting on the toilet; stabbing pains when crawling into bed, when you're walking, when you're sitting at a desk. It truly is a national disgrace.

I was not exaggerating back in 2016 when I compared transvaginal mesh to thalidomide. This is one of the greatest medical scandals and abuses of mothers in our country's history. I said back then: 'I fervently believe a Senate inquiry is a must. We have to do it.' I thank Senator Siewert and the Community Affairs References Committee for letting me hijack them for this inquiry, and I thank the secretariat for such a comprehensive, if at times frightening, report. Personally, I believe that mesh using polypropylene should be banned for most, if not all, operations like POP and most stress incontinence treatments. At best, it should be used only as a last resort. I know now, after this year-long inquiry, that when I spoke about transvaginal mesh and thalidomide in the same breath in this chamber, I was wrong. Mesh is far, far worse. I seek leave to continue my remarks later.

Leave granted; debate adjourned.