Tag: Mesh

Senate Inquiry into Pelvic Mesh – A Scandal of International Proportions

On Wednesday 28th March, one day late, the Senate Inquiry into the “Number of women in Australia who have had transvaginal mesh implants and related matters” handed down is final report. The Senate Inquiry was championed by Derryn Hinch, who called pelvic mesh “the biggest medical scandal for Australian women since thalidomide in the 1950s and 1960s, when kids were born without arms and legs”.

Derryn Hinch had listened to the voices of the Australian Pelvic Mesh Support Group women who campaigned tirelessly to be heard. He was able to get the Senate Inquiry convened, and the hope  was that the Senate Inquiry would raise awareness of the permanent, life-altering consequences for some women and call for a ban on its use. However, instead of a ban on the use of mesh, the Inquiry has recommended that mesh only be used “as a last resort”. This Media Release from the Australian Pelvic Mesh Support Group outlines the view of the women across Australia who have suffered permanent, life-altering consequences of pelvic mesh to the Inquiry Report:

There are a few glimmers of hope for mesh-injured women in the report – but the wording used in the recommendations are so weak that it could, if not followed up by robust policy change, give Australian health authorities, specialists and primary carers permission to carry on as usual.

This article summarises the Inquiry Report and highlights the critical importance of always asking the questions you need to provide informed consent. It is simplistic to say that your doctor only has your best interests at heart. There are many other factors at play, as this pelvic mesh scandal has shown.

Complications

Chapter Two of the Inquiry’s Report is a must-read. It documents women’s experiences of complications from mesh implants, compounded by an inability or unwillingness of the medical profession to hear and respond to these reports. At great personal cost, women attended the Senate Inquiry hearings to tell their story:

I presented with mild stress incontinence with exercising and 2 years on I have total and uncontrollable urinary incontinence. I have had multiple hospital admissions, surgeries, invasive investigations and a total loss of my pride as a woman. Name withheld, Submission 458, p. [6].

I dragged myself to work each day and on weekends I was bedridden. I was unable to do normal things like shopping, cooking and housework without debilitating pain and fatigue. My relationship with my family, friends suffered as I could not handle social activities. Not being able to care for my new grandson broke my heart. Surfing was impossible and walking the dogs or doing other light physical exercise was just too painful. Name withheld, Submission 67, p. 1.

To this day, women will still be told “it’s not the mesh” by their GPs and specialists. Even by clinicians working in Mesh Clinics.

Consent

Does it seem peculiar that a Senate Inquiry would spell out the process for ensuring that patients provide informed consent to having a procedure? And yet that is exactly what Recommendation 6 addresses:

The committee recommends that the Australian Commission on Safety and Quality in Health Care prepare guidance material on effective informed consent processes, with a view to ensuring that a dialogue between a medical practitioner and patient should:

  • clarify the rationale for the proposed treatment;
  • discuss the range of alternate treatment options available and their attendant risks and benefits;
  • discuss the likely success and potential complications of the recommended treatment as they relate to the individual patient;
  • provide an opportunity for the patient to ask questions; and
  • confirm that the individual patient has understood the information discussed.

Here is one consent conversation, which was echoed in many of the submissions and evidence given to the Senate Inquiry:

I was told by my implanting surgeon that I would be back at the gym within 10 days post implant procedure and that I would be like a 16-year-old virgin after the implants. Committee Hansard, 18 September 2017, p. 1.

And many other women simply do not know they have been implanted with mesh. Here is another, common reflection from a woman in a submission to the Inquiry:

How can I have not known a foreign medical device had been implanted in my body without my consent? Name withheld, Submission 528, p. [1]

Reporting complications

There are key barriers to the reporting of complications:

1) it is not mandatory for clinicians to report complications:

…based on my experience and that of many other women in this town, I would not trust surgeons to report complications or gather accurate research data. We all have similar stories of complications, including crippling pain and terrible bowel and bladder symptoms, which were trivialised or denied, and we were told we were the only one with an adverse outcome, that it was our fault that our body had reacted to the mesh. We were abandoned by our surgeon and left to cope as best we could. Kathryn, Committee Hansard, 19 September 2017, p. 4.

2) women are simply not believed when they report complications:

The problem is acknowledging the symptoms in the first place, though. There are a lot of GPs who won’t acknowledge it and there are a lot of gynaecologists who won’t acknowledge it… How can they report it if they’re not acknowledging that your pain and complications are from your mesh? Carolyn Chisholm, Committee Hansard, 25 August 2017, p. 9.

3) it is a complex non-consumer friendly process, requiring the serial number of the mesh implant, which most women won’t have without getting their medical records, which may no longer be available:

Although I am interested in reporting the adverse events I have experienced to the TGA, the TGA Users Medical Device Incident Report is daunting and I simply do not have the detailed information they request for device identification… I have encountered obstacles in trying to obtain my medical records. Name withheld, Submission 477, p. 3.

Medical Device Companies – driving uptake

Prior to my involvement in this issue, I had no idea that medical device companies are the bodies that train clinicians in how to use them. Effectively, they can drive demand for their own product:

The sponsoring companies actively promote medical specialists who utilise their products to referring GPs and company-sponsored educational activities, where one of the aims of that activity is to increase utilisation of those products. Sponsoring companies are also actively involved in the education and provision of training to
medical specialists. Associate Professor Christopher Maher, Committee Hansard, 19 September 2017, p. 30.

What about women who have been injured by mesh?

Every aspect of women’s lives are impacted when there are severe complications. Inability to work means significant economic disadvantage. Sexual dysfunction can mean the end of a relationship. Pain robs life of its quality. Accessing medical assistance is hugely problematic when there is a lack of acceptance that the symptoms are related to mesh, and the lack of actual services. Mesh removal services are very patchy, and some women were advised that mesh removal would mean a colostomy for life. Women have voted with their feet and travelled to the US to access specialist mesh removal care which has not resulted in this awful choice between removal and a functioning bowel. The surgery is significant and the outcomes are uncertain. There is no guarantee the debilitating pain will cease once the mesh is removed.

The final Recommendation tries to address the range of impacts on women:

Recommendation 13: The committee recommends that State and Territory governments continue to work with the Australian Commission on Safety and Quality in Health Care to review the provision of services for the use and removal of transvaginal mesh devices. In particular, the committee recommends that consideration be given to the establishment of:

  • information and helplines that women who have received transvaginal mesh implants can contact for advice on the availability of treatment and support services, including financial support programs, in their state;
  • specialist counselling programs, to assist women who have sustained injuries following transvaginal mesh procedures;
  • specialist multidisciplinary units for the assessment and management of complications associated with transvaginal mesh procedures, comprising:
    • comprehensive diagnostic procedures, including relevant diagnostic imaging facilities and expertise;
    • specialist pain management expertise; and
    • high level expertise in the partial or full removal of transvaginal mesh;
  • advice and practical assistance for women who are seeking to access their medical records

The Health Consumers’ Council of WA is aware that many women impacted by mesh implants are seeking full removals, not partial removals. The reality is at present that there are few surgeons, if any, who can perform full removals in Australia. Women have completely lost trust in the clinicians who implanted them in the first place now assuring them that the mesh will be fully removed. Since the Inquiry has finished, we are aware of women who have sought imaging after enduring full removal procedures only to discover there is still mesh inside them.

Western Australia

Women in Western Australia are referred to this page on the Health Consumers Council website for up to date information. This is an area which is rapidly changing. Please contact HCC on 9221 3422 during office hours if further support is required.

Written by Pip Brennan, Executive Director of the Health Consumers’ Council (WA) Inc.

 

International Mesh Awareness Day – 1st May

Monday 1st May is International Mesh Awareness Day, the start of Mesh Awareness month.  It highlights the complications suffered by women who have had mesh implants to treat stress urinary incontinence and pelvic organ prolapse.

You may have seen a recent episode on The Project which highlighted the little known reality that when a urogynecological mesh implant goes wrong, it can go badly wrong, with life-changing effects for the women affected.  It has taken the recent media activity on the topic for some women to recognise the symptoms in themselves. And despite what Waleed Ally stated in the final moments of the Project episode on the topic, complications can occur quite some time after implanting, and only partial removal options exist for women.

 

The use of mesh is now the subject of a federal Senate Inquiry, which is taking submissions until the 31st May 2017. The Inquiry’s title “Number of women in Australia who have had transvaginal mesh implants and related matters” highlights that we simply don’t know how many women have had these implants, and how many of them have suffered complications.

 

Health Issues Centre Victoria is hosting a Facebook Page “Understanding pelvic mesh implants and impacts on women in Australia”. This page is part of a united response by health consumers councils across Australia to ensure women’s voices are at the heart of the Senate Inquiry Submission. It links to an anonymous survey where women and their families are able to provide feedback to inform the joint Submission. The page will be active until the Inquiry Submission deadline of 31st May 2017.

 

Pictured: Caz Chisholm holding both her awards

 

Here in WA, on Thursday 27th April, the Health Consumers’ Council announced our Health Consumer Excellence Awards. The winner of the Health Consumer Award, and the Rosemary Caithness Award to acknowledge outstanding service to health consumers was the same person – Caz Chisholm. Caz is one of the founders of the Australian Pelvic Mesh Support Group, a Facebook page which has grown from 39 members two years ago to just under 600 members in the last week, after the airing of the Project episode. She has spent significant time and energy raising awareness for women about the issue and providing essential peer support. She was also directly responsible for ensuring that the Senate Inquiry was successfully advocated for by Senator Hinch in the first place.

 

For women and families affected by pelvic mesh, we urge you to have your say to ensure the consumer voice is central to the Submission. Check the Having A Say section lower down on this page for the links to the different ways to provide your feedback.

 

Please also note that the health consumers councils across Australia have developed a Consumer Information Sheet which appears below and is also available as a PDF. Please contact us on info@hconc.org.au or 9221 3422 if you have any comments or concerns.

 

Consumer information

For women who have had, or are considering having surgery to treat stress urinary incontinence and pelvic organ prolapse

If you have been diagnosed with pelvic organ prolapse or stress urinary incontinence, the likelihood is that you will be offered surgery once non-surgical options such as physiotherapy have been exhausted.

 

Surgery for these two conditions are usually involves a mesh insertion or implant. It might be called tape or a sling. It is all the same from a consumer perspective and these products are collectively known as mesh. The Therapeutic Goods Advisory Website has an updated list of complications associated with surgery using mesh. https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications

 

Mesh implants have been offered to women since the late 1990s. The procedure is considered to be only partially reversible, and some women have travelled to America at their own expense to have mesh removed.

 

Before you consent to any surgical procedure, it is important to ask all the questions you need so you understand what you are consenting to. The Choosing Wisely campaign has created these questions to help you get started. http://www.choosingwisely.org.au/resources/consumers/5-questions-to-ask-your-doctor

 

1.      Do I really need this test or procedure?

Tests may help you and your doctor or other healthcare provider determine the problem and the procedures that may help to treat it.

2.      What are the risks?

Will there be side effects? What are the chances of getting results that aren’t accurate? Could that lead to more testing or another procedure?

3.      Are there simpler, safer options?

Sometimes all you need to do is make lifestyle changes, such as eating healthier foods or exercising more. Another option to ask your doctor about is native tissue repair.

4.      What happens if I don’t do anything?

Ask if your condition might get worse — or better — if you don’t have the test or procedure right away.

Stress urinary incontinence is not a life-threatening condition so consider carefully before undergoing any surgery. Do not consider surgery until all non-surgical options have been exhausted.

5.      What are the costs?

Costs can be financial, emotional or a cost of your time. Where there is a cost to the community, is the cost reasonable or is there a cheaper alternative?

 

What help can I access?

 

Having A Say

 

Complications associated with use of Pelvic Mesh

These are listed on Australia’s Therapeutic Goods Administration (TGA) website as follows: https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications

  • punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel (these may require surgical repair)
  • transitory local irritation at the wound site
  • a ‘foreign body response’ (wound breakdown, extrusion, erosion, exposure, fistula formation and/or inflammation)
  • mesh extrusion, exposure, or erosion into the vagina or other structures or organs
  • as with all foreign bodies, mesh may potentiate an existing infection
  • over-correction (too much tension applied to the tape) may cause temporary or permanent lower urinary tract obstruction
  • acute and/or chronic pain
  • voiding dysfunction
  • pain during intercourse
  • neuromuscular problems including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area
  • recurrence of incontinence
  • bleeding including haemorrhage, or haematoma
  • seroma
  • urge incontinence
  • urinary frequency
  • urinary retention
  • adhesion formation
  • atypical vaginal discharge
  • exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
  • mesh migration
  • allergic reaction
  • abscess
  • swelling around the wound site
  • recurrent prolapse
  • contracture
  • scarring
  • excessive contraction or shrinkage of the tissue surrounding the mesh
  • vaginal scarring, tightening and/or shortening
  • constipation/defecation dysfunction
  • granulation tissue formation.

 

Author: Pip Brennan, Executive Director of the Health Consumers’ Council. Consumer Member on the Australian Commission on Safety and Quality in Health Services Reference Committee.