Senate Inquiry

/Senate Inquiry
Senate Inquiry2019-04-09T23:14:28+10:00

“Unfinished Business” National Mesh Implant Forum

was held in Melbourne, Australia on 5th April 2019.  The Forum was instigated by the Health Issues Centre, with assistance from other health consumer organisations from around Australia.

Addresses were received by:

Senator Rachel Siewert, The Australian Greens, Chair of the Senate Committee who convened the Senate Inquiry into Transvaginal Mesh, whose recommendations were handed down in March 2018, and for which the Government offered an official response in October 2018.

Adjunct Professor John Skerritt of the Therapeutic Goods Administration who provided a presentation based primarily around the “National Action Plan” which was released the day prior to the forum.

Hon Tony …. addressed the audience with a pre-recorded video.

Pip Brennan and Melissa Fox (from two of the major Health Consumer organisations) provided their history of involvement with mesh injured advocacy.

        

TGA Presents its “National Action Plan” announced the previous day.

Presented by Adjunct Professor John Skerritt

“Unfinished Business” National Mesh Implant Forum

Melbourne Australia 5th April 2019

2019 April 4 – TGA Releases Action Plan

Thirteen months following the release of the Senate Inquiry Recommendations, the TGA has today tabled the following action plan. This comes just one day before Australia’s inaugural mesh conference “Unfinished Business” National Mesh Implant Forum in Melbourne (5th April 2019) organised by Health Issues Centre in conjunction with the other health consumer bodies from around Australia.

<<< Click on the picture to view the report on the TGA website.

Australian Federal Health Minister, Hon. Greg Hunt MP announces to the National Mesh Forum audience via videolink, $2.3 million funding for a National Pelvic Floor Surgical Registry

5th April 2019 “Unfinished Business” National Mesh Implant Forum, Melbourne, Australia

“… on mesh implants. The title of the forum, Unfinished Business, I think is apt and appropriate, and respectful of all of those women who have suffered from agonising conditions, as a result of mesh implants which have led to potentially catastrophic results. Not just physical, but mental health, emotional health, chronic, agonising pain leading to dependency in some cases, on opioids or other pain killers, or simply the grounding pain and impact of that on mental health.

We know the link between chronic pain and mental health is absolutely, absolutely fundamental..

So we established, as a parliament, with my strong encouragement, the Senate Inquiry into the historical abuse and failure into mesh implants.. And the findings, as everyone here knows, were devastating and powerful.. And it wasn’t …… the parliament doing it’s best …so in response to that, the first thing that I did, was to issue a national apology. I re-affirm that apology today. So many women have suffered so badly and catastrophically.

So I want to acknowledge that pain and that suffering and say again, I am sorry for what has happened in the past. Our practical response has been to insure the TGA has taken an absolutely thorough approach to reviewing all of the mesh implants and the vast majority have been reviewed and removed from the market.

There is, of course, a place, given that so many women who suffer from prolapse of the pelvic floor, urinary incontinence or other issues, do require surgery. Approximately a quarter of them still require some form of mesh or equivalent procedure.

So as a consequence of that, we’ve also issued new interim MBS items for medicare items for both for removal and for implantation, but with much higher standards and guidelines. And in particular, establishing a national action plan on mesh implants, and that’s involved much greater scrutiny of the devices, much higher standards for the procedures, and also ensuring that, as a government, we are taking steps forward to help with education and in particular, information. So that women and doctors have all the information that they need.

Going forwards however, there is a very important thing, I am delighted to announce that after very careful review, and this is a deep personal commitment, the Australian Government will provide $2.3 million to establish a National Pelvic Floor Surgical Registry. This will help track all of those women who have pelvic floor surgery. It will keep a record of devices and it will mean that we are able to have the real record going forwards, that we should always have had.

I can’t speak for the past. I can only speak for the present and the future and it is our time, and our responsibility to deliver this outcome. This registry could have taken a long time, if we had worked with the states, and we still want wish to do the work with the states, but if we had of waited for COAG it wouldn’t have happened for a long time. So, in taking that decision, on your behalf, announcing that decision, and funding that decision, so the pelvic floor surgical registry will be funded by the Australian Government. The advice we have is $2.3 million is what is required, if more is however required, we will fund that.

So this is your moment, it’s overdue recognition, but it’s real action, and it will protect women, it will protect their (…) health, but it will also protect their mental health, that it’s the acknowledgement that which has occurred in the past, on our watch, thanks to your work, we are taking that action.

I want to thank you, I want to acknowledge the suffering of those women who have had suffered historic wrongs, but above all else to give will give you a real note of hope, that going forwards, this registry will help you, and help us, make a profound difference.”

 

Senate Inquiry Report (March 2018) Parliament of Australia
Recommendations from Senate Inquiry Report – March 2018

Senate Inquiry Report released – 28th March 2018

“For the women who have been affected, it has had life-changing and lifelong consequences,”

Chair of the Community Affairs References Committee, Senator Rachel Siewert.

Media Release

Rachel Siewert 28 Mar 2018

The Senate Community Affairs References committee has tabled its report on the risks and impacts of transvaginal mesh implants, which have been carried out since the late 1990’s to treat stress urinary incontinence and pelvic organ prolapse in women.

“Many women who have had transvaginal mesh implants have had devastating complications resulting in ongoing emotional trauma, embarrassment, shame, depression, debilitating pain, recurring infection and a poor quality of life.

“The inquiry heard from many women who are living with the consequences of having had these implants. It is heartbreaking that for so long the experiences of these women have been ignored. These women have been let down, the system has failed them.

“The committee has made 13 recommendations that aim to address the needs of women living with mesh related complications, and also to improve the regulation process so that this sort of failure of the system doesn’t occur again.

“The committee recommends that 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.

“We need to review the system for reporting adverse events including mandatory reporting of such events, we also need to see proper information provided to women about the risks of implantable devices, and a more comprehensive post marketing monitoring scheme with a progress report to the Senate by the end of November.

“Further we need a register of all high-risk implantable devises, and also need improved standards of care and better credentialing so that women get the best possible treatment.

“I urge the Government to take up these recommendations as a matter of urgency, women have suffered for too long.

“I thank the women who gave evidence to the inquiry. The committee has tried its upmost to highlight the pain and suffering experienced and to offer a way forward, I urge the Government to act on the recommendations”.

How did we get here?

In 2012 New Zealanders “Mesh Down Under” started a support facebook group for mesh injured.

NZ Mesh Down Under Facebook Support (Closed Group)


In late 2014, Carolyn Chisholm founded the Australian Pelvic Mesh Support Group (APMSG) following her implantation of a TVT earlier that year and subsequent removal in St Louis USA in late 2014. There were 6 original members who joined the new group in 2014, providing support and continued lobbying within Australia and also bringing information from other overseas groups to the women of Australia.

Australian Pelvic Mesh Support Group (Closed Group) APMSG


One of the original six, and one of our founders, Kim Blieshcke, went to meet Senator Hinch back on 4th October 2016. She said:

“At this time we had approached a number of agencies and Members of Parliament and no one would listen. On 3rd October 2016, Senator Hinch offered an appointment for 10.00 the next morning as he was leaving to go overseas Carolyn Chisholm and myself flew to Melbourne to attend this meeting.

Senator Hinch was shocked and saddened to hear the plight of so many women in Australia and promised to help us by giving a speech about Transvaginal Mesh in the Senate. He lobbied and was granted a Senate inquiry into the use of Transvaginal Mesh and the surgeons that use this product. The Senate Committee invited submissions over the coming months, which hundreds of mesh injured women provided. Once the submission period ended, the Committee held hearings in Melbourne, Perth, Sydney and Canberra, where many brave women stood and told their harrowing stories. Many tears were shed during these hearings by both the women and the politicians present.”

Senator Derryn Hinch

Senator Derryn Hinch has always been a force to be reckoned with throughout his career, his quest for truth and Justice is commendable, we at Mesh Injured Australia Incorporate thank him deeply for his tenacity and continued support for Mesh injured Australians.

https://www.youtube.com/watch?v=itoGIBAX0FY

https://www.youtube.com/watch?v=47-NBrKmqTE

Senate Community Affairs Committee – Transvaginal Mesh Inquiry

Senate Community Affairs Committee – Transvaginal Mesh REPORT


Actions

The HCNSW Transvaginal Mesh Steering Committee, which includes two MIA founding members, was established in January 2018.  Anthony Brown, the Executive Director of Health Consumers NSW supported the start up of this important committee, and has introduced the group to various important health contacts in NSW Health, Local Health Districts, Womens Health NSW and other important groups to discuss mesh injury.

Following tabling of the Senate Inquiry’s report in March 2018, Health Consumer groups, with input from the HCNSW Transvaginal Mesh Steering Committee, and other key interested parties, wrote an open letter to the ACSQHC.

Click here to view the collaborative open letter to ACSQHC

Click here to view the response from ACSQHC – August 2018

The HCNSW Transvaginal Mesh Steering Committee also took it upon themselves to write directly to the Federal Health Minister Hon. Greg Hunt MP regarding the report tabled by the Senate Inquiry in March 2018.


2018 October 10 – Minister Hunt apologies before tabling Government’s response to the Senate Inquiry.

The Senate inquiry and report identified failures across the health system leading to “catastrophic” results for an unknown number of women implanted with devices for more than three decades.

The Senate report recommended a review of doctors’ relationships with device manufacturers “to prevent the payment of inducements” to doctors and teaching hospitals, mandatory reporting of adverse events by doctors, a registry for all high risk implantable devices, a more comprehensive monitoring scheme for devices approved for use in Australia, and government agency oversight of a more effective informed consent process by doctors.

Mr Hunt said the government supported, or supported in principle, 12 of the 13 recommendations, but stopped short of a retrospective audit of transvaginal mesh procedures since the devices were introduced in Australia. Transvaginal mesh devices are polypropylene supports implanted into a woman via the vagina after complications following childbirth, including incontinence and prolapse.

The audit was strongly supported by pelvic mesh victims and public health groups after evidence health authorities did not know how many women had received implants, and how many were experiencing significant problems following mesh surgery.

The Newcastle Herald has reported since 2014 on women across Australia being ignored for decades when they have reported complications following mesh surgery.

On Wednesday Mr Hunt said the inquiry raised awareness about serious and longstanding impacts reported by some women following mesh-related procedures.

“I acknowledge the strength of the women who spoke at the public hearings, recounting deeply private and often traumatic experiences. The inquiry identified how we can recognise and support the women affected, and make improvements to Australia’s health care system,” he said.

“Our main aim and collective efforts are focused on restoring affected women’s confidence in our healthcare system, now and into the future.”

He said the government had already strengthened pre-market assessment of surgical mesh products by identifying them as high risk, had enhanced post market surveillance, introduced new Medicare items for the removal of mesh and launched a new Therapeutic Goods Administration web hub for consumers and professionals to find information about mesh.