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New report: a damning indictment of health system’s failure to care for women

The Senators inquiring into the use of transvaginal mesh implants in Australia were very clear about their intentions.

They wanted their report to enable people to hear and learn from the experiences of women who’d been harmed – by the mesh implants, as well as by the subsequent responses of health professionals, systems and regulators.

The Senate Community Affairs References Committee report makes for harrowing reading, recording the emotional and physical traumas of hundreds of women who shared often deeply personal stories.

“The committee has sought to place these women at the forefront of this inquiry,” says the report – while acknowledging evidence “that the vast majority of women who have had transvaginal mesh procedures as part of treatment for stress urinary incontinence (SUI) or pelvic organ prolapse (POP) have not experienced complications as a result of their surgery and have experienced improved quality of life.”

The Senators state: “The committee considers that it is of no consolation to women who have lost so much to be told that they are part of a very small minority.”

The report also records the Senators’ damning assessment of health professionals and services involved in the cases they considered: “Even allowing for the positive accounts provided to the committee and the fact that some accounts are recalling events of over ten or fifteen years ago, they present the medical profession in a very poor light.”

Since beginning the inquiry in February 2017, the committee received 555 submissions and said they had been “struck by the extent to which women who have had adverse experiences following transvaginal mesh surgery have struggled to be heard as they have sought to raise concerns about their symptoms”.

The vast majority of more than 500 women who wrote to the committee had experienced adverse events following surgery to implant surgical mesh.

The committee said they received “many accounts describing the challenges and frustration that patients have faced in having their symptoms addressed, or indeed taken seriously”, and that these struggles to cope with their symptoms and to find support and treatment have had “far reaching and devastating impacts on their lives and the lives of their families”.

Some women had waited years for recognition and treatment to address their symptoms, “all the while suffering debilitating pain, physical limitations, social isolation and financial and emotional stress”.

“Sadly many women recounted being spoken to angrily or disrespectfully when they have asked questions about their symptoms and spoke of feeling humiliated, embarrassed and upset… Other women have been told that their symptoms are imagined.”

Dismissive and disrespectful

Committee members said they could “find no reasonable justification for the dismissive and disrespectful treatment many women have experienced from trusted medical professionals”.

They cited Stella Channing of the Australian Pelvic Mesh Support Group, who told the committee: “To add insult to injury, many women who have gone for consultations have been scoffed at, mocked, humiliated and disregarded by some of their doctors”.

These comments, invalidating women’s lived experience, showed “how the health system silences, shames and blames the victims,” Channing said.

The committee also expressed deep concern “about the inconsistent and at times cursory manner in which consent has been obtained”, and said that “many women appear to have received little or no information to assist them to make a decision or provide their informed consent”.

The Senators were “dismayed” by reports some women had not been told they had received a transvaginal mesh implant as part of treatment. As well, some were not informed that the implant is intended to be permanent and can be difficult to remove.

One woman who had transvaginal mesh surgery in 2004 to address minor incontinence told the committee of her horror when she learnt that the mesh was permanent.

The report cites a Consumers Health Forum submission that there had been “a catastrophic failure of the health system to protect women and ensure they have access to safe health care”, and that women had “been let down by their doctors, by the manufacturers of mesh and by the TGA [Therapeutic Goods Administration] as the regulator”.

The committee members said they encourage “women not to accept unprofessionalism by medical practitioners and to consider reporting any concerns they might have, either to the medical practice or hospital, or in the case of more serious complaints, to the health care ombudsman in the relevant state”.

They agreed with a Public Health Association of Australia description of the complications resulting from transvaginal mesh implants as a serious public health issue requiring a response at an individual and a population level – including counselling, public education, clinical interventions and long-lasting protective mechanisms.

Women’s stories

The report includes many distressing accounts from women of the wide-ranging impacts upon their health and lives, including their relationships.

Symptoms include chronic vaginal pain and recurrent urinary tract infections. Many woman told of experiencing mesh exposure or erosion ­– the protrusion of mesh fibres through the vaginal wall, which can lead to discomfort and pain, including bleeding and pain during intercourse, as well as infections, adhesions to the bowel and bladder and faecal incontinence.

Stella Channing told the committee:

The women have lost their health, and in many cases they have lost their jobs, their careers, their homes and, in some cases, their husbands. The pain and complications cause them to be isolated from their friends and families, and many suffer from depression, anxiety and PTSD. Many women are shocked and in despair when they realise that they will probably never regain their health or their life back.

The Women’s Health and Research Institute of Australia told the committee that “often words cannot convey the degree of human suffering we are seeing”.

Many women said they had withdrawn from social and family activities, too embarrassed to explain their symptoms to friends and family and unable to engage in work or normal social activity. Others told of their inability to care for their children or interact with their grandchildren.

The committee was struck by how many women reported the breakdown of their marriages; many found it extremely painful or impossible to sustain an intimate relationship after the surgery, and spoke of the emotional pain and grief involved.

Many women told of the financial toll of needing treatment for complications from mesh surgery, including for pain management, scans, and incontinence and mobility aids.

Women had used up their leave, drawn upon their superannuation, sold valuables and, in some cases sold or mortgaged houses and drawn on the generosity of friends and family to fund their treatment.

Some had travelled overseas to have the mesh devices removed.

Meanwhile, the committee heard that some hospitals have been charging patients to release medical records.

Background to the inquiry

A timeline at the end of this article describes the history of transvaginal mesh implants, a form of urogynaecological mesh that is implanted in a surgical procedure via an incision in the vagina or abdomen to address pelvic floor conditions.

The mesh is a synthetic net-like substance designed to provide extra support to repair weakened and damaged internal tissue. Its holes allow the body’s own tissues to grow into the mesh.

Mesh devices for the treatment of stress urinary incontinence (SUI) or pelvic organ prolapse (POP) are usually made from the same material, but the procedures to implant them are different and each has different risks and benefits.

The report says the prevalence and severity of problems associated with transvaginal mesh implants has risen since the first adverse event was reported in Australia in 2006. These can occur immediately after surgery or take years to manifest.

Class actions have been initiated against manufacturers and suppliers of urogynaecological mesh devices in a number of countries, including the US, UK, and Canada.

Internationally, women have been at the forefront of efforts to lobby for reviews of the use of transvaginal mesh, leading to inquiries in New Zealand, Scotland, England and other countries.

In 2016, the latest update of the Cochrane systematic review of clinical publications of evidence on the use of mesh for POP concluded that mesh “might be useful for particular individual women, who might be willing to accept the risks, but that there was limited information regarding the benefits and risks and more research was needed”.

The Senators’ report highlights the complexity of regulatory and oversight arrangements for the mesh devices, involving the TGA, the medical colleges and the Australian Commission on Safety and Quality in Health Care (ACSQHC).

The TGA undertook its first post market review of urogynaecological meshes in 2008, in response to a United States Food and Drug Administration safety alert.

Professional colleges influence the standard of care delivered by practitioners through education and training, the provision of guidance for the management of clinical conditions in women’s health and standards for professional behaviour and research.

However, while the colleges can guide and advise, they have no regulatory role in relation to standards of clinical practice, outside auditing doctors’ compliance with continuing professional development. Credentialing of individual doctors is the responsibility of credentialing committees within individual hospitals.

Report’s findings

Limitations with data sources meant the committee could not make a definitive finding on how many women have had transvaginal mesh implants in Australia, although one expert estimated that between 150,000 and 175,000 transvaginal mesh procedures had been performed for POP and SUI.

Nor could the committee establish how many women had experienced complications.

However, it is clear that adverse events have been significantly under-reported to the TGA, with the Health Issues Centre recording that 2,400 women had provided it with personal accounts of adverse events by August 2017.

Data provided by Medibank indicated that, in the years 2012-2013, four per cent of patients insured by Medibank who had transvaginal mesh inserted had a readmission within the next three years for a complication associated with that implant.

The committee said it was concerned that under-reporting of adverse events associated with transvaginal mesh products had “provided a false indication of the safety of such devices and contributed to delays in responding to the issues identified. The committee is deeply concerned that this has resulted in more women suffering complications.”

The committee heard a range of evidence regarding the interactions between device manufacturers or sponsors and medical practitioners. Such concerns ranged from questions over the presence of sponsor representatives in the surgical theatre to the possibility of financial inducements to medical practitioners to use specific products.

Recommendations

The committee notes widespread support for the establishment of a national register of medical devices and said such work currently underway through COAG should be prioritised.

The committee recommends the TGA take action to educate and encourage doctors to report adverse incidents associated with the use of medical devices, and recommends that the Department of Health and Ageing introduce mandatory reporting for health practitioners to the TGA on relevant issues, including problems with medical devices.

The TGA and the ACSQHC should develop an information sheet for recipients of patient cards for implantable devices providing guidance on appropriate action if an adverse event occurs.

The committee welcomed recently announced measures to increase the level of pre-market scrutiny of surgical mesh devices, and requirements to increase the level of information available to consumers regarding medical devices.

The committee said TGA moves to restrict the use of transvaginal mesh for POP meant the mesh would in effect only be available under a special access scheme and will limit the ability of medical professionals to use transvaginal mesh for the treatment of POP except in certain circumstances.

The committee recommends that the Department of Health work with the Medical Technology Association of Australia and the Medical Board of Australia to review the systems in place within the device manufacturing industry and the medical professions to support consistent, high ethical standards, with specific emphasis on systems in place to prevent the payment of inducements to medical professionals and teaching hospitals.

It also recommended that Commonwealth, states and territory governments commission the ACSQHC to do an audit of all transvaginal mesh procedures undertaken in Australia, and their outcomes.

Other measures in train

The committee notes that the ACSQHC is finalising resources on the symptoms of POP and SUI together with the range of treatment options available, and is also developing care pathways for these conditions, and for the removal of transvaginal mesh.

The ACSQHC has also developed guidance for the credentialing and training of senior medical practitioners who implant transvaginal mesh for the treatment of POP and SUI and also for the removal of transvaginal mesh.

The ASQHC advised the committee that each state and territory is reviewing the provision of services for the use and removal of transvaginal mesh, and some have developed specific information resources and support services, including dedicated telephone information and referral services.

The report said the ACSQHC should also develop guidance material on effective informed consent.

“There is also a clear need to improve the communication skills of some medical practitioners to ensure that they are communicating effectively with, and listening to patients,” the committtee said.

Mixed reaction

The Consumers Health Forum said the report highlighted the need for rigour and scrutiny in the introduction of medical devices such as mesh, the requirement for effective training including for the possible removal of mesh devices, and close surveillance of the performance of such products.

The Forum’s CEO, Leanne Wells, said: “We support the position that mesh should be the last resort and other measures should be fully explored first. This is not to deny women the choice of having a mesh implant but this must be linked to improved informed consent.”

She acknowledged that the TGA had already begun work on introducing patient device cards and consumer device information leaflets, which will begin to take effect with new urogynaecological devices from 1 December.

A statement by state and territory based health consumer organisations welcomed the report’s recognition of the extent and impact of harms to women, but said they had hoped the report would have gone further.

“We are disappointed that a more cautious approach wasn’t taken, to recommend the suspension in use of all mesh until the data is in to establish their safety and efficacy,” said Melissa Fox, CEO of Health Consumers Queensland.

“These devices will continue to be implanted in women in hospitals across Australia tomorrow, and not one more woman should be unwittingly subjected to this high-stakes surgical intervention until we can be assured of their safety.”

However, she welcomed the report’s recommendations for strengthened provisions for informed consent, only using mesh as a last resort, requiring mandatory reporting of complications, establishing a register and having the ACSQHC do an audit of transvaginal mesh procedures in Australia.

“The Commission must be resourced to do this in a timely manner and the audit should also include procedures done by private specialists,” she said.


Timeline

(Taken from report, with additions and edits by Croakey)

1996

First urogynaecological meshes approved for supply in the USA

1998

First urogynaecological meshes approved for supply in Australia

2006

TGA receives the first adverse event report relating to a urogynaecological mesh

2008

The US-FDA issues a Safety Communication recommending that surgeons should undertake specialised further training and should notify patients that mesh is permanent, complications can occur, and these cannot always be resolved with further surgery.

TGA investigates Australian adverse event reports for urogynaecological meshes and consults an expert panel. It is agreed that the TGA will continue to monitor mesh reports and emerging clinical evidence.

TGA and NZ Medsafe seek advice from the Medical Device Incident Review Committee. The committee emphasises the need for informed patient consent and surgeon training when using such devices.

2009

US-FDA releases statement: a literature review demonstrates conflicting information on the success rates for transvaginal mesh placement and further investigation is required.

2010

Health Canada releases a notice to hospitals informing healthcare professionals of the complications associated with urogynaecological mesh.

TGA undertakes a targeted postmarket review of specific urogynaecological meshes in response to a report that meshes are difficult to visualise once implanted.

2011

FDA releases an updated communication advising that adverse events a no longer considered rare, there is no compelling evidence of greater success with mesh in posterior compartment, and some evidence of greater efficacy in anterior compartment. All patients should be advised that long-term data on safety of mesh is limited and alternatives to mesh should be discussed.

2012

US-FDA issues orders for manufacturers to conduct postmarket surveillance

TGA publishes a web article, Concerns with urogynaecological surgical mesh implants

TGA commences a comprehensive postmarket review of published literature for urogynaecological meshes

2013

Australian Department of Health establishes a Urogynaecological Devices Working Group to consider the available clinical evidence and to contribute to the postmarket review activities being undertaken by the TGA

TGA commences a broad review of all urogynaecological meshes available for supply in Australia.

2014

Health Canada issues an updated notice to hospitals and patients advising that Health Canada continues to receive reports of complications, including some serious and life altering events.

Scottish Cabinet Secretary for Health and Wellbeing appeals to NHS Scotland to suspend transvaginal mesh procedures pending the outcome of an independent review.

The MHRA releases a statement that there is no regulatory justification for removing surgical mesh from use in UK hospitals.

TGA reports on the postmarket review into all urogynaecological meshes available for supply in Australia and there is a significant reduction in the number of urogynaecological meshes available on the Australian market.

2015

New Zealand report into the safety of surgical mesh is published

Scottish independent review into urogynaecological mesh – interim report is published

NHS England Releases the Mesh Working Group Interim Report.

European Commission (SCENIHR 2015) report into the safety of urogynaecological meshes suggests limiting mesh surgical procedures wherever possible, certification systems for surgeons, and appropriate patient selection and counselling.

2016

FDA reclassifies urogynaecological POP mesh as Class III – a high risk device. Manufacturers are given 30 months to provide updated evidence. The reclassification does not apply to all implantable meshes.

NZ House of Representatives Health Committee releases a report that includes a recommendation for the establishment of a centralised surgical registry. RANZCOG releases a response welcoming the report and the recommendation that meshes remain available as a surgical option.

The Australian Pelvic Mesh Support Group meets with Ministerial Advisors and senior Department of Health officers. This meeting includes discussion on how to encourage patient adverse event reporting in Australia.

TGA publishes a web article urging the reporting of adverse events relating to urogynaecological surgical mesh.

Health Canada considers powers to require mandatory reporting of adverse events by healthcare institutions – Vanessa’s Law.

RANZCOG publishes a statement advising that transvaginal mesh is not recommended as the first line of treatment for any vaginal prolapse. Surgeons should consider clinical trial recruitment for use of any new mesh types.

A Cochrane Review is released comparing mesh to native tissue repair for POP and reports that while permanent mesh has some advantages over native tissue, there are also disadvantages in its routine use.

The Lancet publishes a Scottish multi-centre trial into urogynaecological mesh (PROSPECT study). It finds no benefit in using mesh for surgical treatment of POP in comparison to traditional surgical methods. TGA is considering taking appropriate regulatory action.

2017

The EU confirms regulatory reclassification of all surgical mesh to Class III and Australia proposes to commence the regulatory process to reclassify all surgical meshes as Class III (the USA the reclassification of meshes which occurred in 2016 is limited to urogynaecological mesh used in POP).

Scottish independent review into urogynaecological mesh – final report published

4 July 2017 a class action against Johnson & Johnson Medical Pty Ltd and Ethicon commences in the Federal Court of Australia.

30 November 2017, the TGA announced that it had decided to remove transvaginal mesh devices solely used for the treatment of POP from the Australian Register of Therapeutic Goods (ARTG). In making this announcement, the TGA advised that, following a review of the latest international studies and the clinical evidence for each product, it was of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks the devices pose to patients. The ACSQHC reached a similar conclusion in September 2017.

2018

17 January 2018, the TGA announced that it had amended the information that must be provided to consumers about adverse events associated with urogynaecological mesh implants, such as severe chronic pain, groin pain and bladder perforation, in the device instructions for use of the product. Two sponsors chose to update the information and a third sponsor — Johnson & Johnson — elected to withdraw its devices from the market. This left seven entries on the ARTG for urogynaecological mesh and 14 devices remaining.

 

 

 

 

 

 

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