Responding to the evidence
[W]e believe this is a catastrophic failure of the health
system to protect women and ensure they have access to safe health care. We
feel that women have been let down by their doctors, by the manufacturers of
mesh and by the TGA as the regulator.
The committee concurs with the Public Health Association of Australia's
(PHAA) description of the complications resulting from transvaginal mesh
implants as constituting a serious public health issue requiring a response at
both an individual and at a population level, including counselling, public
education, clinical interventions and long-lasting protective mechanisms. The committee
also considers that this inquiry has highlighted significant shortcomings in
Australia's reporting systems for medical devices, with flow-on consequences
for the health system's ability to respond to in a timely and effective way to
concerns arising from the use of medical devices.
The committee is acutely aware that at the heart of this serious public
health issue is a group of women who have borne a great cost: the cost of
living with, and trying to seek treatment for, debilitating complications that
have undermined their quality of life and that of their families. As the
committee has heard, this in turn has exacted an enormous toll on their emotional
These women have also shouldered the burden of drawing attention to
their plight and mobilising action to address it. In the process, they have
borne the opprobrium of those who fear transvaginal mesh devices will be
banned. It has taken a great deal of courage for women to come forward and
discuss these most intimate and traumatic details in public. The committee
makes no apology for placing these women and their lived experience at the
forefront of this inquiry.
The committee is aware that, concurrent with this inquiry, a number of
initiatives have been being progressed to respond to the concerns raised. In
some cases, this work spans the period from the introduction of urogynaecological
mesh for use in Australia. In other cases, the initiatives under consideration
are a direct response to more recent accounts of pain and suffering from women
living with complications from transvaginal mesh implants.
At the same time, the committee is acutely aware that for many of the
women suffering as a result of transvaginal mesh implants, the responses to
date have been slow in addressing the concerns they have raised and, for some,
will make little difference to their circumstances.
This final chapter considers the responses of regulators, the medical
profession and device manufacturers and presents the committee's conclusions
Regulation of the introduction and use of transvaginal mesh implants
As noted in Chapter 1, responsibility for investigating the suitability
of medical devices for use in Australia rests with the Therapeutic Goods
Throughout this inquiry, the committee has heard criticism of the TGA's management
of the introduction and regulation of transvaginal mesh products.
The key concerns raised in submissions to the committee have focused on:
the stringency of the TGA's premarket assessment of transvaginal
mesh devices for use in Australia;
the pace of the TGA's response to evidence regarding serious
complications associated with transvaginal mesh products; and
the effectiveness of the TGA's adverse event reporting system, as
discussed in Chapter 3.
However, Professor John Skerritt told the committee that, while no one
should be proud or happy about the sequence of events that have happened,
Australia's response has been ahead of that of the United States Food and Drug
Administration (US-FDA) and ahead of Europe in many cases.
In evidence to the inquiry, the TGA explained that assessment of the
safety and efficacy of medical devices is undertaken on the basis of a
combination of pre-market assessment and ongoing post market review. Professor
Skerritt explained that:
the evidence that you use to look at whether it is
appropriate for a product to be on the register [Australian Register of
Therapeutic Goods (ARTG)] is a combination of the evidence that was provided
and reviewed at the time of the application to be put on the market as well as
the continuously evolving nature of evidence from clinical studies and
day-to-day experience with these products worldwide.
In its submission to the inquiry, the Department of Health (Department) advised
that the TGA has continued to monitor evidence regarding the safety of
urogyneacological mesh devices as it has evolved. As new evidence has emerged,
the TGA has taken steps to apply greater stringency to pre-market assessment
processes. In some cases, this has resulted in devices being removed from the
register, either by the TGA or the device manufacturer or sponsor.
Submitters and witnesses to the inquiry have questioned the TGA's
pre-market assessment of transvaginal mesh devices, suggesting that the TGA has
approved mesh devices for use in the Australian market without a strong
evidence base and on the basis of substantive equivalence.
In responding to these criticisms, the TGA told the committee that there
is a tension for regulators between acceding to the desire to gain timely
access to new treatments and the need to assess the evidence regarding the
efficacy and safety of each device.
A commonly expressed concern throughout the inquiry has been that
transvaginal mesh devices were introduced without rigorous clinical trials.
Professor Skerritt explained that one of the challenges in the
assessment of medical devices is the time it takes to establish the safety and performance
of a new technology. He explained that it is not possible to conduct 'double
blind, randomised clinical controlled trails on a device, especially an
implanted device' in the same way as can be done with medicines.
...one of the challenges with medical devices, especially those
used in fairly specialised surgical techniques, is that you'll never be able to
go out and say, 'We'll do a trial of a thousand people,' and then come back
when you've done a trial of a thousand people and it's all one big trial. The
evidence base is always evolving. I know that sounds easy to say but that's
just the nature of it. It is the same with medicines for rare diseases—because
the disease is rare you're never going to get enough people to do a trial with
1,000 people before you put it on the market.
The committee notes evidence received from medical practitioners
proposing that new medical devices should, in the first instance, be approved
for use in carefully monitored clinical trials with ethics approval and by
surgeons who have adequate training.
Submitters have also raised concerns that some transvaginal mesh devices
appear to have been introduced to the Australian market without a thorough
pre-market assessment purely because they were considered similar to a device
already listed on the Australian Register of Therapeutic Goods (ARTG), known as
Ms Adriana Platona explained that, in order for the TGA to approve an
application on the basis of substantive equivalence, the sponsor of the device would
need to provide comparative analysis to demonstrate that any differences
between the products—in materials, design, clinical evidence—would not impact
on the safety and efficacy of the device. Ms Platona explained that the two
devices would need to have the same intended purpose, in the same anatomy and
have the same manufacturer.
Professor Skerritt explained that the TGA's approach is not the same as
the process applying in the United States:
All medical device products—and these were class IIb or class
III, depending on whether they contained a biological origin component—all
class IIb products, are required to have undergone conformity assessment either
within Australia or by a European organisation. The Americans have a process
that's a 'me too'. They call it their 52K process. We don't have such a
process. When our regulatory system was reviewed by government, or by a panel
of three experts who reported to government, over the last three years, it was
recommended that we did not adopt such a process. We've never had one. So any
product that has been put onto our register in the last decade or more has been
through a review, either in Europe or by ourselves.
The TGA advised that whether or not the assessment of a device is
conducted overseas, the decision to include it on the ARTG is always a decision
of the TGA.
Re-classification of surgical mesh
devices and introduction of patient implant cards
As part of the government's agreement that the TGA should align its
processes with the European Union regulatory framework,
the TGA recently announced that surgical mesh devices would be reclassified as
Class III (high risk) from 1 December 2018. As noted in Chapter 1, in
Australia, synthetic surgical meshes are currently classified as Class IIB. The
change in classification means that all new applications for marketing approval
for surgical mesh in Australia will require additional conformity assessment
certification. Manufacturers of existing urogynaecological devices will need to
lodge a reclassification application no later than December 2020. 
In announcing the measures, the TGA advised that:
In light of concerns expressed by many women who have
undergone surgery with an urogynaecological mesh device, a two years transition
period applies for this up-classification measure from the commencement of the
At the same time, measures were introduced to address concerns about the
level of information provided to consumers about surgical devices. These
patient cards for implantable medical devices (patient implant
cards): to be implemented from 1 December 2018 for all new urogynaecological
mesh devices and from December 2021 for all existing implantable devices;
a patient information leaflet for all implantable medical
devices: to be implemented from 1 December 2018 for all new permanently
implantable devices, from 1 December 2019 for all existing urogynaecological
mesh devices and from 1 December 2021 for all other existing surgical mesh
The TGA told the committee that, while, the regulatory framework
finalised by the European Union in May 2017 includes extensive revisions, these
two measures were progressed first due to their ability to positively impact on
patient safety around mesh devices.
Patient implant cards are intended to ensure that patients are aware of
the details of the device they have been implanted with. The committee notes
that this should assist the traceability of devices and patients in the event
of the need to alert patients and health practitioners to safety issues such as
precautions or recalls. Under the Therapeutic Goods (Medical Devices) Amendment
(Implantable Medical Devices) Regulations 2017 (regulations), the patient
implant card must include the name and model of the device, either the batch
code, lot number or serial number of the device, the device's unique device
identifier and the manufacturer's name, address and website.
The patient information card will be complemented by a patient
information leaflet which must also be provided with each device. The leaflet
will provide more detailed information and must identify the device, its
intended purpose and include information such as the kinds of patients for whom
the device is intended to be used and warnings about potential adverse effects
and relevant precautions. The regulations also provide that the leaflet must be
able to be readily understood by patients.
The committee welcomes the recently announced measures to increase the
level of pre-market scrutiny applied to all surgical mesh devices. While noting
the breadth of devices captured by the measures, the committee considers that
the re-classification of these devices as high risk is an appropriate
regulatory response to the evidence available regarding the risks associated
with transvaginal mesh devices.
The committee is concerned at the length of time afforded to
manufacturers of devices that are currently listed on the ARTG to provide a
reclassification application. The committee considers that compliance with the
new requirements ought to be achievable in a shorter timeframe. At the same
time, the committee notes that the significance of the up-classification of surgical
mesh devices, for the regulation of transvaginal mesh devices currently listed
on the ARTG must be seen in the context of other measures announced in December
2017 and January 2018.
The committee welcomes the requirements to increase the level of
information available to consumers regarding medical devices. The committee
considers that these requirements will go some way to addressing some of the
key concerns identified in this inquiry. In particular, a patient implant card
should ensure that all patients know exactly which device has been implanted and
this should in turn assist them, and their medical practitioners, should they
need to seek advice or treatment in relation to possible complications. The
card should also make it easier for patients to monitor any developments in
relation to the safety of the particular device they have received.
Postmarket review and monitoring
The TGA advised the committee that it continually monitors international
developments in the use and regulation of devices. Since the introduction of
mesh devices in Australia in 1998, the TGA has undertaken three post-market
reviews: in 2008; 2010 and a major review in 2013. The Department's submission
provides a chronology that places the actions of the TGA in the context of
regulatory responses internationally up to the release of the Scottish
Independent Review of Transvaginal Mesh Implants on 27 March 2017.
This chronology is included at Appendix 1 to this report.
In late 2017 the TGA took steps to remove certain urogynaecological mesh
devices used in the treatment of pelvic organ prolapse (POP) and single
incision mini-slings used in the treatment of stress urinary incontinence (SUI)
from the ARTG.
On 17 January 2018, the TGA announced that it had amended the
information that must be provided to consumers in relation to adverse events
associated with urogynaecological mesh implants.
Removal of transvaginal mesh products
On 30 November 2017, the TGA announced that it had decided to remove
transvaginal mesh devices solely used for the treatment of POP from the 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
The committee notes that the Australian Commission on Safety and Quality
in Health Care (ACSQHC) had reached a similar conclusion in September 2017. Professor
Debora Picone advised the committee that the ACSQHC had reached the view
that transvaginal mesh implants for the treatment of POP should be used only in
a research context due to the uncertainly surrounding long term effects and
risks of complications.
The decision includes single incision mini-slings which are used in the
treatment of SUI, as distinct from mid-urethral slings. The TGA noted that
there was a lack of adequate scientific evidence for it to be satisfied that
the benefits of these devices outweigh the risks to patients.
The committee notes that special arrangements will enable medical
practitioners to access unapproved devices either through the Special Access
Scheme, by becoming an Authorised Prescriber or for the purposes of clinical
trials. Professor Skerritt explained:
So it's not an outright ban. Access to cancelled devices is
still possible through a special access scheme—through authorised prescriber
clinical trials schemes. But all of these schemes require additional oversight
by an ethics committee and/or a medical expert, who will look at the individual
case for using that product. It won't be, 'Just grab something off the shelf
that happens to be available in the hospital.'
Professor Skerritt emphasised to the committee that this latest
regulatory action is the outcome of a process that has been evolving over
several years as evidence has emerged:
As the evidence evolved, we then assessed the clinical
evidence. We then went out to the companies. We gave them time to answer, 'Show
us your evidence as to why you believe the benefit risk is still appropriate.'
A number of companies said, 'We don't have it,' and they withdrew the products,
and we withdrew some of their other products.
The TGA noted that there have been suggestions that the TGA should
restrict access to mesh devices to certain individual medical practitioners
with particular high-level skills. The TGA explained that it has no legal
authority to apply such a restriction, but that consideration of credentialing
is being undertaken by the ASQHC.
Some people have suggested that we should, as TGA, only allow
particular individual expert surgeons to use those particular products. We have
no powers under our legislation to restrict particular devices to particular
individual medical practitioners with particular high-level skills.
Increased information requirements
for urogynaecological mesh implants.
On 17 January 2018, the TGA announced that as a result of further
post-market review of urogynaecological mesh implants, it had required sponsors
of mid-urethral sling implants used in the treatment of SUI, to include
information about certain adverse events, such as severe chronic pain, groin
pain and bladder perforation, in the device instructions for use of the
product. Ms Platona advised the committee that two sponsors had chosen to
update the information and a third sponsor— Johnson & Johnson—elected to
withdraw its devices from the market.
Ms Platona confirmed that there are now seven entries on the ARTG for
urogynaecological mesh and 14 devices remaining.
The committee welcomes the TGA's decision to remove transvaginal mesh
products solely used for transvaginal POP procedures from the ARTG. The
committee also welcomes the removal of single incision mini-slings. The
committee remains concerned about the continued listing of MUS. Notwithstanding
evidence provided to the committee regarding the apparent safety of MUS
devices, the committee is concerned by the personal accounts it received from
women who have experienced severe complications following transvaginal mesh
procedures employing MUS.
The committee notes the changed requirements regarding the type of
information to be provided in the Instructions for Use for each device.
However, the committee is concerned that such information may not be readily
accessible to consumers, in particular, to enable them to make an informed
decision about such devices. These concerns are considered under the
committee's findings on informed consent.
The committee accepts that the assessment and approval of medical
devices is a continuous process of review and that regulatory responses to
emerging issues need to be carefully considered and evidence based. However,
the committee considers that criticisms of the lag in the regulatory response
to emerging evidence of complications in relation to transvaginal mesh products
Capturing and recording data
A key concern to the committee is that there is no clear indication of
how many women have received transvaginal mesh implants in Australia or how
many women have experienced complications. Not only is there no single source
of data on the use of transvaginal mesh implants, but each of the potential
sources of data available is subject to significant limitations.
The ability to collect and analyse data is central to an effective and
efficient health care system. The committee considers that the ability of
regulators and the medical profession to arrive at evidence based responses to
concerns relating to medical procedures involving implantable devices is
greatly impeded without access to accurate and timely data about the use of
such devices in Australia. The committee considers that there is an urgent need
to improve existing reporting systems and examine options for greater
complementarity between data sets.
Reporting adverse events
The committee is particularly concerned about the lack of reliable data
available to inform the TGA's post-market monitoring activities. In Chapter 3,
the committee noted its concern at the level of underreporting of adverse
events involving transvaginal mesh implants and noted the significance of this
for post-market monitoring by the TGA and individual device sponsors. The
committee is particularly concerned that underreporting of adverse events
associated with transvaginal mesh products has 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 considers that accurate and timely reporting of adverse
events is fundamental to a robust post-market monitoring scheme. This in turn
has flow on benefits for effective and timely regulation of the use of medical
devices. The committee is concerned that failures in the current adverse
reporting system have contributed to delays in the identification of
complications associated with the use of transvaginal mesh products.
As previously discussed, while adverse event reporting is mandatory for
device sponsors, it is voluntary for medical practitioners. In Chapter 3, the
committee noted that, to a significant degree, device sponsors are reliant on
reporting from medical practitioners and patients to identify adverse events.
The committee also expressed concern that there was some potential for
inconsistency in the reporting of adverse events and concluded that clear
criteria should be available to guide the reporting of adverse events.
Evidence to the committee indicates that many women who have been
implanted with transvaginal mesh devices were not aware that they could report
the complications they were experiencing to the TGA or to the device
manufacturer. The committee notes that discussion in the media of complications
associated with mesh devices, together with the activities of the Australian
Pelvic Mesh Support Group, and to some extent this inquiry, may have
contributed to an increased awareness of adverse reporting among women who have
received mesh implants. However, many women who have attempted to report
adverse events have told the committee that they have found the process
Many women have experienced difficulty gaining access to their medical
records. The committee considers that the introduction of patient implant cards
will assist in this regard in the future. However, the committee is concerned
that there is a large cohort of women who have experienced complications
following transvaginal mesh implants who should be encouraged to report these
complications to the TGA. Many of these women will require assistance to access
their health records. The committee considers that these women should not be
required to pay to access their medical records.
In its 2011 inquiry into the regulatory standards for the approval of medical
devices in Australia, this committee recommended that the TGA put in place
mechanisms to educate and encourage doctors to report adverse incidents
associated with medical devices. The committee also recommended that
consideration be given to the introduction of mandatory reporting of adverse
events by medical practitioners.
The committee notes that the TGA has periodically published media
releases on its website encouraging both patients and medical practitioners to
report adverse events. The TGA has also met with patient groups and provides
alerts through RSS and Twitter to patient groups, individual doctors and medical
colleges. However, the TGA is not funded to undertake large-scale
consumer/community information programs. In this regard, it relies upon
partnerships with clinical and consumer groups.
The committee notes that the TGA is committed to examining the scope
within its budget and within its legal mandate to stimulate reporting by
patients and doctors.
The committee notes that the TGA does not have a legal basis to mandate doctors
to report adverse events.
Noting the vital role of adverse reporting in post-market surveillance,
the committee recommends that the Australian Government, in consultation with
the states and territories and the Medical Board of Australia, review the
current system of reporting adverse events to the Therapeutic Goods
implement mandatory reporting of adverse events by medical
provide guidance on what constitutes an adverse event for use by
consumers, medical practitioners and device sponsors;
improve awareness of the reporting system;and
examine options to simplify the reporting process;
The committee recommends that the Therapeutic Goods Administration and
the Australian Commission on Safety and Quality in Health Care develop an
information sheet to be provided to recipients of patient cards for implantable
devices providing guidance on appropriate action to take in the event of an
adverse event, including guidance on seeking appropriate treatment and support
and on reporting the event.
Establishment of a national
register of medical devices
As noted previously, the committee is concerned that it is not possible
to accurately identify the number of women who have received transvaginal mesh
implants. The committee considers that an understanding of the true scale of
the risk posed by transvaginal mesh devices, or any implantable medical device,
is fundamental to tailoring an effective regulatory response.
The committee notes that there is widespread support for the
establishment of a national register of medical devices. Medical practitioners
and professional colleges emphasised the importance of capturing and evaluating
longitudinal data to facilitate the evaluation of the safety and efficacy of
medical devices. As noted in Chapter 3, many of the women who wrote to the
committee could not understand why there was not already a register of medical
The committee notes that some medical specialists and colleges have been
maintaining their own registers or databases. While there is no doubt that
there is merit and value in this, the committee considers that the issues
identified in this inquiry demonstrate a clear need for a national database.
Professor Stephen Robson, President of the Royal Australian and New
Zealand College of Obstetricians and Gynaecologists summarised the arguments
for a national register by stating:
One of the key issues identified has been the need for a
register of women who have had mesh surgery. It's likely that other
implantables in the future will be subject to question and concern, and I call
on the government to establish a national implantables register. Many
Australians have or will have different implants—joints, mesh, other
implants—and, rather than having multiple different registries, there should be
a single, appropriately funded and independently run national register of
implantables. It could be funded by the manufacturers of implants and it should
be integral to the e-health records system in Australia. The next phase of
implants in Australia will be genetic implants, and it's imperative that a
national register is embedded in health care in this country before that phase
The significance of a national device register was identified by the Review
of Medicines and Medical Devices Regulation (MMDR Review). The MMDR Review noted
that the timely and effective post-market monitoring of medical devices is an
essential element of an effective regulatory system.
It stated that device registries play an important role in post-market
monitoring as they can provide detailed information about patients, procedures
and devices not routinely collected through other means.
Recommendation 22 of the MMDR Review recommended the establishment of a
registry for all high-risk implantable devices, noting that the Australian
regulatory body should continue to collaborate with overseas medical device
regulators to actively share registry data, with a view to facilitating timely
identification of emerging safety concerns.
The Government deferred consideration of this recommendation on the
ground that establishing and maintaining registries requires careful
consideration of the range of registries managed by a variety of organisations
and how they could be sustainably managed and funded in the future.
The Department and the Medical Technology Association of Australia (MTAA)
noted that any consideration of how an implantable devices registry would be
funded, should recognise that such a registry would have benefits across the
health system including to hospitals, patients and device manufacturers.
The committee recognises that there are important considerations in the
establishment of a database, not least of all the cost of establishing and
maintaining it. The committee notes that registers have been established under
interim arrangements for certain devices. The committee also notes advice
received during the inquiry that work is currently underway to consider the
appropriate approach to the establishment of a register or registers.
The committee recommends that the Australian Government prioritise
consideration of the implementation of Recommendation 22 of the report of the
Review of Medicines and Medical Devices Regulation recommending the
establishment of a registry for all high-risk implantable devices, together
with consideration of the feasibility of establishing such a registry on a cost
recovery basis, and provide to the Senate by 29 November 2018 a progress report
on work to date.
Improving the accuracy of other
In Chapter 3 the committee noted a range of potential sources of data
that could be used to gain an informed understanding of complications arising
from the use of transvaginal mesh devices and procedures. These include the
claim data held by private health insurance companies, Prostheses list data,
hospital records and databases maintained by medical professional colleges. In
each case the committee noted some important limitations on these data sets.
In particular, the committee noted evidence that suggested the Medicare
Benefits Schedule (MBS) codes relating to surgical procedures for POP and SUI
are a potential source of valuable data about the use of medical devices.
However, these codes are procedure based and do not distinguish between
procedures using a mesh device or native tissue and is of limited assistance in
identifying the number of women who have attempted to have mesh devices
removed, either partially or fully.
While the committee understands that the MBS is primarily a mechanism
for providing a subsidy for listed services, the committee considers that there
is benefit in revising the codes allocated to surgical procedures for the
treatment of POP and SUI to improve the accuracy of the data collected.
The committee notes that the Gynaecology Clinical Committee of the MBS
Review Taskforce has reviewed MBS items for the use of biological and permanent
mesh, together with other gynaecology related items, and has recommended:
revising MBS item numbers so that mesh and non-mesh surgery can
be distinguished to enable better data collection;
restricting the use of mesh to patients who are undergoing
revision surgery (i.e. primary operative repairs have failed to relieve
introducing specific MBS items for mesh removal.
The committee was advised that these recommendations would undergo
public consultation during 2017, before the MBS Taskforce makes its final
recommendations to government. The committee notes that it has been six months
since the MBS Taskforce endorsed the release of a report by the Gynaecology
Clinical Committee for public consultation on 20 September 2017.
The Gynaecology Clinical Committee's report has not been released to date.
The committee recommends that the Medicare Benefits Schedule Taskforce prioritise
release of the report of the Gynaecology Clinical Committee for consultation.
The committee considers that improved coding and reporting of procedures
for implantable devices has the potential to contribute valuable information to
the post-market monitoring of all medical devices. Further, the integration of
existing data sets has the ability to contribute to a more complete
understanding of the level and seriousness of complications with medicines and
medical devices as they arise.
The committee notes that the MMDR Review recommended the establishment
of a more comprehensive post-market monitoring scheme for medicines and medical
devices. It recommended better integration of available datasets to support the
analysis of data from the Pharmaceutical Benefits Scheme, the Medicare Benefits
Scheme, eHealth records, hospital records and device and other relevant
registries and datasets.
The government accepted this recommendation, noting the development of a
more comprehensive post-market monitoring scheme will enhance consumer
protection and complement existing post-market monitoring processes.
The committee received evidence during the inquiry that as part of its
work on the development of clinical guidance, the ACSQHC is also considering
appropriate recording of the details of products that are implanted, either
through administrative data collections, such as the MBS and clinical coding of
hospital separations, clinical registries or electronic records such as My
The committee recommends that the Australian Government prioritise the
establishment of a more comprehensive post-market monitoring scheme and provide
to the Senate by 29 November 2018 a progress report on work undertaken to date.
Improved clinical practice
The committee notes the evidence from medical practitioners throughout
the inquiry acknowledging the need to improve the standard of care provided to
women with POP and SUI. In particular, the committee notes the acknowledgement
that there have been circumstances where the doctor-patient relationship has
not supported women through their treatment for POP and SUI as it should and
cases where the medical profession has not dealt with women correctly.
The committee is deeply concerned by the evidence received regarding the
information provided to women to enable them to provide their informed consent
to a transvaginal mesh procedure. The committee is particularly concerned that,
despite the availability of detailed guidance and patient information leaflets
produced by specialist colleges and societies, many women appear to have
received little or no information to assist them to make a decision or provide
their informed consent. The committee is dismayed by reports that some women
were not advised that a transvaginal mesh implant was being used as part of
The committee notes the comprehensive and systematic consent processes
outlined by sub-specialist urology and gynaecology units and considers that
these provide a useful model for other practitioners.
The committee notes the evidence received that an effective consent
process must involve a dialogue between the medical practitioner and the
patient and must be tailored to the need of the individual patient. As a
minimum this dialogue should:
outline the full details of the proposed treatment;
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
The committee notes that the ACSQHC is currently finalising resources
that should assist women to inform themselves about procedures recommended to
them. The resources will provide explanations of the symptoms of POP and SUI
together with the range of treatment options available. The committee notes
that these resources have been developed following extensive consultation with
women affected by complications of transvaginal mesh.
The committee is interested to see how women will be directed to these
resources. The committee is mindful that many people experience difficulty
locating information on websites. The committee believes that helplines
established by state and territory governments (discussed further below) should
ensure that they direct women affected by transvaginal mesh to these resources.
The committee supports the development and publication of information
resources by the ACSQHC for women experiencing POP or SUI and notes that these
resources will support the process of informed consent between a patient and
their medical practitioner.
However, the committee notes evidence to the inquiry about the
inconsistent and at times cursory manner in which consent has been obtained
from patients undergoing transvaginal mesh procedures. The committee is deeply
concerned by reports that some medical professionals have not provided patients
with detailed guidance and patient information leaflets. The committee is
particularly concerned by the evidence of the APMSG that guidance prepared by
RANZCOG has not been used to guide the process of informed consent in many
Therefore, the committee considers that, in addition to patient
information resources, the ACSQHC should develop guidance material on effective
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
Care pathways for POP and SUI
In addition to patient information resources, the committee notes that
the ACSQHC is also developing care pathways for POP and SUI to describe the
clinical consideration to be made when assessing women with POP and SUI. The
ACSQHC told the committee:
The pathways provide clinicians with an evidence-based
approach to first line management, specialised surgical and non-surgical care
and the types of medical specialists who may be involved in providing care.
The ACSQHC told the committee that the surgical pathways being developed
will use a traffic light approach to help identify options for surgical
treatments based on the strength of evidence and patient outcomes for each type
The ACSQHC's guidance on care pathways is intended to improve the
provision of appropriate, safe care through the standardisation of care
processes, to enable patients to receive 'the sequence of evidence-based
assessment and treatment actions that will deliver the best outcomes.'
In its submission the ACSQHC states that in developing this guidance, it
has drawn on the most recent evidence and clinical advice, including statements
issued by RANZCOG, the Urogynaecological Society of Australasia and the United
Kingdom National Institute for Health and Care Excellence. The ACSQHC has also
considered an international consensus pathway on treatment of POP developed by
the International Consultation on Incontinence Surgical Management Prolapse
Consideration has also been given to the role played by General Practitioners
(GPs) in the assessment of women with POP and SUI, as well as their role in
caring for women following transvaginal mesh procedures. In its submission, the
ASQHC recognises the important role accessible information on care pathways for
POP and SUI can play in raising the awareness of GPs of the complications that
may be associated with transvaginal mesh procedures, available referral
pathways and management of symptoms. This work is being undertaken in
partnership with Primary Health Networks and the Royal Australian College of
The committee notes that interactive web versions of the pathways are
being developed and that this should allow easier access for clinicians
reviewing treatment options and also in explaining various care pathways to
women seeking treatment.
The committee notes that professional colleges and specialist societies
have an important to role to play in the continuing professional development of
specialist doctors and in providing guidance on effective practice in their
specialty. RANZCOG explained their role to the committee:
Once doctors have specialist qualifications, it is our role
to monitor their continuing professional development activities, but it's also
our role to guide practice and provide guidance to the profession: guidance as
the appropriate ways to manage clinical conditions in women's health and
standards for professional behaviour.
The committee considers that resources of the type described by the
ACSQHC have the potential to greatly improve the standard of information
available to both patients and medical practitioners and looks forward to
reviewing these resources once they have been released.
The committee notes that final approval processes for the care pathways
resource are underway and that the ACSQHC is also developing a care pathway for
the removal of transvaginal mesh following complications.
The committee recommends that treatment guidelines developed by the
Australian Commission on Safety and Quality in Health Care should clearly
indicate 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.
The committee recommends that the medical professional specialist
colleges and societies ensure that processes are in place to draw their
members' attention to the resources released by the Australian Commission on Safety
and Quality in Health Care and implement arrangements which require members to
consider the resources in their practice.
Appropriate governance for the introduction of new devices and procedures
The committee received a range of evidence regarding the governance that
should be applied to the use of new devices. Some witnesses to the inquiry have
suggested that new devices should be used in restricted circumstances
The committee understands that there are already well-accepted
governance procedures available through ethics approval committees that medical
practitioners could use to ensure the timely and safe introduction of new
devices and procedures. The committee was told that ethics approval committees
ensure that the use of the device or procedure is subject to an appropriate
model of oversight, supports informed consent and provides for appropriate
follow up with patients post- surgery.
Evidence has also been received proposing that transvaginal mesh
procedures should be restricted to medical practitioners who are highly skilled
in such procedures.
Training and credentialing of
senior medical practitioners
In Chapter 4, the committee noted concerns regarding the knowledge and
skill of surgeons practicing transvaginal mesh procedures. Based on the
evidence of personal accounts received from individual women, the committee
considers that there is a need to improve the awareness of medical
practitioners, especially General Practitioners, of symptoms associated with
surgical mesh devices. 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 committee understands that registered medical practitioners must
ensure they comply with Continuing Professional Development requirements set by
the Medical Board and medical practitioners with specialist registration must
continue to meet the requirements set out by their relevant college.
RANZCOG advised the committee that it had been providing guidance and
advising caution regarding transvaginal mesh surgery to its member for a decade.
The committee heard similar evidence from a number of professional colleges and
societies regarding their role in the provision of training and information to
The committee is therefore concerned by reports that transvaginal mesh
has been used as a first response treatment, without considering alternative
treatment options, indicating to the committee that transvaginal mesh has been overused
by some medical professionals.
Evidence to the committee indicates that there is a need to review the
current training models to ensure that the skill levels of medical
practitioners to diagnose and treat POP and SUI meet minimum quality standards.
In particular, the committee notes evidence that procedures involving
transvaginal mesh devices should only be performed by surgeons who can
demonstrate that they have the requisite skills, in settings where their
performance can be audited and complication rates can be recorded. For example,
RANZCOG stated that there is evidence which indicates more highly skilled
surgeons with big caseloads tend to have fewer complications. RANZCOG told the
committee that this is true for any surgical procedure, not just transvaginal
The committee received evidence that some surgeons have been keeping
their own personal data bases to enable them to review their own complications
The committee received evidence that, based on such analysis, some surgeons no
longer use transvaginal mesh devices in the treatment of their patients.
The committee notes that some specialist surgical units have a practice of
holding regular multidisciplinary meetings to discuss all planned surgery,
complimented by regular surgical audits and use this to inform their practice.
Specialist colleges and associations told the committee that there was
merit in reviewing how surgeons are trained and accredited.
RANZCOG told the committee that it considers that a formal mechanism is
required to ensure that training in new surgical techniques occurred. Professor
Robson told the committee:
it's become clear to us that there is the need for a formal
mechanism to ensure that training in new surgical techniques should be
undertaken by experienced surgeons with an ongoing audit of the cases that they
do—certainly during their training period. We have been recommending this,
again, but we don't have any actual power to enforce our own recommendations. I
believe there's an opportunity to include these sorts of mechanisms and
pathways as part of revalidation, and this could be an ongoing project we'd be
happy to work with the Medical Board of Australia in realising.
5.110 ACSQHC advised
the committee that it considers there is potential to apply credentialing to
other health professions and indicated that this would form a key part of the
resources being developed to support improved care to women requiring treatment
for mesh complications and mesh removal surgery.
5.111 The committee
notes that the ACSQHC has 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 credentialing guidance has been developed in consultation with the Royal
Australasian College of Surgeons, RANZCOG, the Urological Society of Australia
and New Zealand, the Transvaginal Mesh Reference Group and state and territory
5.112 The guidance
will set out the experience and qualifications that senior medical
practitioners need to be credentialed to implant and remove mesh for treatment
of POP and SUI. It includes recommendations on:
device specific training;
requirements for maintaining skills;
monitoring and reporting patient outcomes;
the type of specialty support services hospitals should have if
they offer implantation and removal of transvaginal mesh; and
the requirement for post-operative follow-up.
The ACSQHC advised that states and territories will use the guidance in
their local credentialing processes and that it would be working to promote the
use of the guidance for credentialing across private hospitals.
The committee recommends that the Commonwealth, state and territory
health Ministers require that guidance developed by the Australian Commission
on Safety and Quality in Health Care for the credentialing of medical
practitioners who perform transvaginal mesh procedures should underpin credentialing
processes in all public hospitals and work with private hospitals to encourage
the adoption of a similar requirement.
The committee acknowledges that the changes by the TGA to restrict the
use of transvaginal mesh for POP means that transvaginal mesh will in effect only
be available under a special access scheme and will limit the ability of
medical professionals to utilise transvaginal mesh for the treatment of POP
except in certain circumstances.
At the same time, the committee is deeply concerned by the personal
accounts of women expressing their lack of faith in medical professionals
following their experience with transvaginal mesh. The committee heard that
women trusted their doctor to fully inform them of the risks and benefits of
transvaginal mesh, alternative treatment options, and to be adequately skilled
to perform the transvaginal mesh procedure and identify complications arising
from the procedure. For many women this trust has now been lost.
The committee believes that professional medical colleges and specialist
societies should demonstrate leadership in this area by implementing governance
arrangements which limit the use of all transvaginal mesh to skilled
specialists. The committee believes this would go some way to restoring the faith
in medical professionals of women who have suffered from transvaginal mesh
The committee recommends that medical professional colleges and
specialist societies implement governance arrangements for transvaginal mesh
procedures which require that their members:
are trained in the use of the specific device;
are adequately skilled to perform the specific procedure,
including procedures for partial or full removal of transvaginal mesh devices;
work within a multidisciplinary team;
monitor and report patient outcomes; and
maintain a record of the outcomes of such procedures, including
Auditing transvaginal mesh
The committee has received a great deal of evidence emphasising the
important distinctions between treatment of POP and SUI and the important
differences between transvaginal mesh devices. Medical practitioners have
encouraged the committee to note the differences in complication rates between
different procedures and different devices.
The committee notes that the personal accounts it has received cover a
very wide range of procedures and devices. These personal accounts underscore
the importance of gaining a much closer understanding of the factors that may
contribute to either success or severe failure in individual cases. The
committee has heard variously that complications can be attributed to the
device, the procedure or the patient or a combination of these.
While noting the number of studies and trials drawn to its attention
throughout this inquiry, the committee considers that there is a pressing need
to undertake an audit of all available sources of data in Australia to gain a
more complete understanding of the use of transvaginal mesh procedures and the
incidence and nature of complications associated with different types of
devices and procedures. The committee considers it is important that such an
audit should endeavour to capture information on the impact of transvaginal
mesh procedures on the quality of life of the women who have received them.
The committee is all too aware that the currently available sources of
data make this a challenging task, however, the committee considers that
without an appropriately expert review of this nature, Australia risks
repeating mistakes made in the introduction of transvaginal mesh products in
the introduction of future devices.
The committee recommends that Commonwealth, states and territory
governments commission the Australian Commission on Safety and Quality in
Health Care to undertake an audit of transvaginal mesh procedures undertaken
and their outcomes since the introduction of transvaginal mesh devices for use
in the Australian market.
The role of device manufacturers in
promoting the use of transvaginal mesh implants
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.
5.125 The Health
Consumers Councils across Australia (HCC) expressed concern that such
incentives could lead to unsafe treatment practices. The HCC submission stated
that Health Consumers Councils have been informed that there are clinical
variations with a higher number of mesh procedures performed in certain states.
The HCC was not able to substantiate this claim, but submitted that such
concerns warrant further investigation.
5.126 The Australian
Pelvic Mesh Support Group (APMSG) drew the committee's attention to
urogynaecological conventions sponsored by device manufacturers where the
programs have included 'mesh' updates. The APMSG questioned the reason for this
involvement, noting that many surgeons seemed to be unaware of the severe
complications posed by urogynaecological mesh devices.
The committee has been assured that the majority of medical
practitioners have been motivated only by a desire to provide relief to women
suffering with POP and SUI. Medical practitioners explained the importance of
receiving training and guidance in the use of new devices and of the role
played by surgeons the provision of such training.
Specialist medical colleges assured the committee that there are
appropriate governance systems in place to guard against unprofessional
relationships between device manufacturers and medical practitioners. RANZCOG
advised the committee that the vast majority of surgeons do not have any
financial incentive to use particular transvaginal mesh products. The committee
notes that any doctors who do have a financial relationship with a company are
expected to declare any interest as recommended by the Code of Conduct for
Doctors in Australia.
Representatives of device manufacturers assured the committee they have
acted ethically and responsibly in the research, development and supply of
medical devices. Each emphasised the care and compassion they feel for patients
who have experienced adverse side effects as a result of devices they
manufacture and affirmed their commitment to support and help patients.
5.130 The MTAA advised
the committee that its members are bound by a Code of Practice (code) to
promote ethical interactions with healthcare providers. The aim of the code is
to ensure that healthcare providers are not influenced in their decision making
around the use of medical devices through financial or other inducements.
5.131 The code
any supplier expenditure on education events be reasonable and
set in an appropriate context;
supplier financial contribution to conferences should be
reasonable and proportionate to the educational content of the of the event;
gifts to be restricted to those that are of educational value and
very small value.
5.132 Compliance with
the code is monitored and Mr Ian Burgess told the committee that there is a
self-regulatory and disciplinary process for non-compliance that can result in
the imposition of fines.
The committee understands the symbiotic nature of the relationship
between device manufacturers and medical practitioners but, while it notes the
codes of conduct that each sector has in place to guard against
unprofessionalism, it is concerned by some of the evidence it has received. In
particular, evidence that medical practitioners have proposed transvaginal mesh
products as a 'quick fix' or preventative option for minor symptoms of POP and
SUI or been overenthusiastic in their embrace of this new technology is
In its inquiry into the regulatory standards for the approval of medical
devices in Australia, the committee recommended that then Department of Health and Ageing undertake work to address the issue
of inducements paid by pharmaceutical companies and medical device
manufacturers to doctors and teaching hospitals.
In its response to the report, the Government agreed with the
recommendation in principle, but noted 'that a legislative framework for
ethical conduct of industry in the promotion of therapeutic goods to healthcare
professions is not warranted in the Australian context at this time. The
Government committed to working with industry to support stronger
self-regulation, better communication and shared systems for complaints reporting.
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.
Addressing the needs of women living with mesh related complications
5.137 The committee is
very mindful of the need to ensure adequate and readily accessible support is
available for all women who have received transvaginal mesh implants and those
who may be considering such surgery in the future. In particular, the committee
understands the importance of ensuring treatment and support is available for all
women currently living with mesh related complications.
5.138 The committee
notes evidence that emphasises the need for standardised, multidisciplinary, holistic
care to support women in their rehabilitation.
In particular, the committee notes the importance of specialist pain management
in the treatment of complications following transvaginal mesh surgery. The
committee recognises concerns that the current resources and supports available
to women may be inadequate to address their needs.
5.139 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 and improved coordination and
designation of services to promote more coordinated access services.
5.140 The ASQHC
advised that the service model framework it is developing regarding the optimal
service for removal of mesh will also draw together information on the services
available in each jurisdiction.
5.141 In the meantime,
the committee notes that a number of states and territories are implementing
support services to respond to the needs of women living with mesh related
complications. The services differ between states and are in various stages of
implementation, but give an indication of the types of services under
5.142 In September
2017, the Western Australian Minister for Health announced the:
Establishment of a confidential free contact line to provide a
link to expertise and clinical services and help determine how many women in WA
have mesh-related symptoms; and
Establishment of a mesh register to prospectively record the use
of pelvic and abdominal mesh.
5.143 The Western
Australian Government's Healthy WA website provides information on pelvic mesh,
possible complications and symptoms; and treatment for these. The website
advises that the King Edward Memorial Hospital (KEMH) is planning to commence a
mesh complication service (Mesh Clinic) run by Urogynaecologists with a
dedicated multidisciplinary team. The website advises that KEMH will be seeking
consumer input, including from the APMSG, in establishing this clinic.
5.144 The Victorian
Minister for Health made an announcement on 19 December advising:
the establishment of the Victorian mesh information and help
the availability of specialist programs to assist women with
complications following mesh procedures.
5.145 The Victorian
Government has provided further information regarding the use of transvaginal
mesh, possible complications, alternative treatment options and the
availability of support services on its Better Health Channel website.
New South Wales
5.146 At the
committee's Sydney hearing, Dr Kerry Chant, Chief Health Officer, NSW Ministry
of Health (NSW Health), described work that it was undertaking in consultation
with specialist urogynaecologists and the State's five public sector specialist
clinics to address the needs of women who have sustained injuries following
transvaginal mesh procedures. This work comprised steps to ensure that
mesh-injured women are supported by a multidisciplinary team, led by a
urogynaecologist and incorporating effective pain management. This work is
being complemented by the development of information resources to support
informed consent and guidance for general practitioners to enable them to
provide appropriate care. NSW Health is liaising with the ACSQHC in developing
5.147 Dr Marianne Gale
told the committee that NSW Health is considering the need to ensure device
information is appropriately captured and the development of stronger guidance
about the need to record implanted devices on the discharge summary for each
NSW Health also advised that it supported strengthening adverse reporting
5.148 In December
2017, the NSW Government released a safety notice advising:
Patients seeking access to medical records should be assisted and
where health information sought relates to continued treatment and/or future
management, no charge should be raised.
Patients presenting with symptoms following transvaginal mesh
procedures should be provided with information sheets and supported to access
multidisciplinary specialist services for the assessment and management of
Mesh removal should only be considered at specialist centres with
the appropriate multidisciplinary model in place, including a qualified
urogynaecologist as the lead, and comprehensive diagnostic procedures in place,
including someone experienced in performing and interpreting pelvic floor
Supporting disciplines to include: pain services; pelvic floor
physiotherapists and psychology. Urology and colorectal units should be
available for consultation.
The location of specialist multidisciplinary services with an
Guidance on reporting adverse events to the TGA and incidents,
near-misses or complaints to the Incident Information Management System. 
Australian Capital Territory
5.149 On 9 January
2018, the ACT Health announced that it is directly contacting all women who
have been identified as having undergone transvaginal mesh procedures at
Canberra Hospital and Health Services within the past 10 years to notify them
of the issues and the options available to them if they are concerned. A
dedicated phone service and email address has also been established.
The committee considers that the support and referral services being
established by the states and territories go some way to providing an
appropriate level of care for women suffering from mesh related complications.
The committee encourages states and territories to continue to work with the
ACSQHC and women affected by transvaginal mesh in the implementation of
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
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
advice and practical assistance for women who are seeking to
access their medical records; and
the provision of further guidance for medical professionals on
recording the use of implantable devices on medical records and reporting
adverse events to the Therapeutic Goods Administration.
The committee wishes to say to the women who have given us evidence that
it has heard them. It understands the different perspectives that have been
brought to this inquiry. The committee hopes that the findings and
recommendations that it has made as a result of this inquiry serve women well
by improving regulatory processes and care pathways such that they are robust,
evidence based, clinically sound and focused on good patient outcomes.
The committee thanks all women for their courage in coming forward to
provide their very personal accounts to the inquiry.
Senator Rachel Siewert
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