In the late 1990s, a supposedly innovative treatment for stress urinary
incontinence (SUI) was introduced – transvaginal mesh surgery using the
mid-urethral sling (MUS) or tension-free vaginal tape. As the use of surgical
mesh in this way appeared to be equivalent to or better than existing
procedures and involved shorter surgery and recovery time, it soon became the
most frequently performed surgical procedure for the treatment of incontinence
Sling and tape devices first became available for clinical use in
Australia in 1998 and the release of the results of randomised controlled
trials (RCT) in 2002 and 2004 confirmed the benefits of this procedure over
traditional surgical procedures.
Procedures using these devices quickly became the standard in the treatment of
Apparent early success in the use of transvaginal mesh devices in the
treatment of SUI lead to their adoption in the treatment of pelvic organ
Early published data was relatively supportive of the safety and
efficacy of the use of mesh in the treatment of POP. However, there was a
considerable lag before data from RCTs became available. The first RCTs on the
use of mesh devices for the treatment of prolapse were not published until five
to seven years after the devices came into use.
While many women who have had a procedure using transvaginal mesh have
experienced no difficulties, some women do and for some of those women the
complications following their surgery have had a devastating impact on their
lives. The prevalence and severity of problems associated with transvaginal
mesh implants has risen since the first Australian adverse event was reported
Complications associated with mesh procedures can range from mild
discomfort to debilitating pain and may be evident immediately or may not
manifest for some years after surgery. The most severe symptoms of complication
can range from: immediate symptoms during or after surgery, such as bleeding,
perforation of organs and difficulty voiding; to medium or long-term symptoms
such as persistent difficulty voiding, chronic pain, persistent or recurrent
leakage; persistent infections and mesh exposure requiring surgery. A list of
adverse events associated with urogynaecological meshes is provided on the
Therapeutic Goods Administration's (TGA) website.
Over the last two decades there has been a rise in the prevalence and
severity of problems attributable to transvaginal mesh implants. Class actions
have been initiated against manufacturers and suppliers of urogynaecological
mesh devices in a number of countries, including the United States of America
(United States), United Kingdom and Canada. Previous cases in the United States
and Canada have awarded significant amounts to women who have suffered injuries
as a result of mesh implants while other cases have been settled prior to a
judgement being reached, without admission of liability.
In recent years, new evidence has emerged that has highlighted questions
around the regulation, marketing and use of transvaginal mesh devices,
particularly for POP, and the adequacy of the response to women who have
experienced adverse events.
Frustrated by the lack of recognition and support, women in a number of
countries have successfully lobbied for reviews of the use of transvaginal
mesh. In 2014, in response to petitions from women adversely affected by
mesh devices, New Zealand and Scotland established independent inquiries into
the safety of surgical mesh. The National Health Service (NHS) England established
a Mesh Working Group to address concerns raised by patients and clinicians. New
Zealand's Accident Compensation Corporation released its findings in March 2015
and released a retrospective update in October 2017.
The Scottish Independent Review of Transvaginal Mesh Implants released its
interim report in October 2015 and its final report in March 2017.
The NHS Mesh Working Group released an interim report in December 2015 and its
final report in July 2017.
In 2016, the latest update of the Cochrane systematic review of clinical
publications of evidence on the use of mesh for POP was published and 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.
In January 2017, the results of the 'PROSPECT' trial demonstrated no
treatment benefit in using a mesh device over native tissue repair in women
undergoing initial surgical treatment for POP. The trial concluded that the use
of mesh introduced the potential for mesh-related complications that are not
present in native tissue repair surgery.
The purpose of this inquiry
The purpose of this inquiry is to:
identify how many women in Australia have been adversely affected
following transvaginal mesh surgery;
consider the information and support provided to women undergoing
transvaginal mesh procedures;
consider the information provided to doctors and surgeons who recommend
and undertake transvaginal mesh procedures; and
examine the role of the TGA in approving and monitoring
urogynaecological mesh devices for use in Australia.
Conduct of the inquiry
Since this matter was referred to the committee for inquiry and report, the committee
has 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. More than 500 women wrote to the
committee during the inquiry. The vast majority of these have experienced
adverse events following surgery to implant surgical mesh and the majority of
these have struggled to find assistance and support. Many of these women
consider that the medical professionals they approached simply did not have
sufficient awareness or knowledge of symptoms of adverse events after a
surgical mesh implant. Some women were told that their symptoms were imagined.
Others were led to believe that they were the only person who had reported any
negative consequences following a transvaginal mesh procedure. Many women have
waited extensive periods, sometimes years, to receive recognition and treatment
to address their symptoms, all the while suffering debilitating pain, physical
limitations, social isolation and financial and emotional stress.
The committee has sought to place these women at the forefront of this
inquiry. At hearings in Melbourne, Perth, Sydney and Canberra the committee has
provided opportunities for individual women to speak directly to the committee
about their experiences.
The committee has also accepted written personal accounts from over 500 women
throughout the inquiry. The committee is indebted to each of these women for
bravely coming forward to discuss these deeply private and frequently traumatic
The committee commenced its inquiry in February 2017 and invited written
submissions by 31 May 2017. The committee continued to accept submissions after
this date. The committee received 555 submissions. The committee is grateful
to all those who provided evidence to the committee.
Types of devices and procedures
Throughout the inquiry, the committee heard a range of evidence
advocating for, or critical of, specific mesh devices and surgical procedures
using mesh. The committee does not pretend to have the expertise to evaluate
the relative merits of specific devices or procedures. The committee has
approached its task by focussing on the processes that those tasked with
regulating and prescribing such devices and procedures have followed.
The committee has also been mindful of current class actions and matters
before the Administrative Appeals Tribunal and has avoided commentary on
matters under active consideration.
Class actions and the committee's inquiry
On 4 July 2017 a class action against Johnson & Johnson Medical Pty
Ltd and Ethicon was commenced in the Federal Court of Australia. The committee
notes that class action against another manufacturer and supplier of
urogynaecological mesh products is being investigated.
In a submission to the inquiry, Maurice Blackburn Lawyers advised the
committee that it had been instructed to commence legal action on behalf of
three women in relation to a specific mesh product.
This Senate committee inquiry is a separate process from any class
action. Throughout the inquiry, the committee has sought to exercise care in
canvasing matters that witnesses may subsequently be questioned on in court.
The protection of parliamentary privilege means that witnesses at committee
hearings cannot be questioned in court on information they have provided to the
This report is presented in five chapters:
This first chapter provides background to the committee's inquiry
and an overview of the use and regulation of urogynaecological mesh in
Chapter 2 examines the experiences of women who have had
transvaginal mesh implants, including the types and incidence of health
problems they have experienced, and the impact these experiences have had on
Chapter 3 considers the sources of data available to assist in
determining the number of women in Australia who have had transvaginal mesh
implants and the number of women who have experienced adverse side effects.
Chapter 4 considers the information and support provided to women
prior to and following their surgery, regarding possible complications and side
effects and the options available to women who are experiencing side effects.
Chapter 5 considers the responses of regulators, the medical
profession and device manufacturers and presents the committee's conclusions
What is transvaginal mesh?
Transvaginal mesh is a form of urogynaecological mesh that is implanted
in a surgical procedure via an incision in the vagina to address pelvic floor
It is a synthetic (polypropolene) net-like substance that is designed to
provide extra support to repair weakened and damaged internal tissue. The mesh
has holes in it to allow the body's own tissues to grow into the mesh.
Urogynaecological mesh devices are used to treat SUI and POP. These are
common but different medical conditions that affect a significant number of
women and can result in a reduced quality of life for many women. One in three
women experience urinary incontinence after childbirth. Up to 50 per cent of
women who have given birth will have some prolapse present. These conditions may
present independently or together.
The use of transvaginal mesh in the treatment of pelvic floor
Throughout the inquiry, witnesses have emphasised that SUI and POP are
different conditions and that, while both conditions are often present in the
same woman and can be treated concurrently, each condition requires separate
assessment and treatment. 
Similarly, while mesh devices for the treatment of SUI and POP are usually made
from the same material, the procedures to implant them are different and each
has unique risks and benefits.
Stress urinary incontinence
SUI refers to the involuntary loss of urine which occurs with physical activity
such as coughing, sneezing, running or heavy lifting. It is caused by a lack of
support of the urethra and reduced function of the urethral sphincter. It can
result from the weakening of the tissues and pelvic floor muscles that support
the urethra as a result of pregnancy and childbirth, obesity, chronic cough,
constipation and age.
While SUI is a very common condition, affecting up to a third of women,
the committee heard that it can impact significantly on quality of life and the
psychological and psychosocial wellbeing of people who experience it.
Management of the condition can become progressively burdensome and costly.
For some women, the need to plan their daily activities so as to minimise
embarrassment impacts on their work, their ability to participate in social and
physical activities, and their family and intimate relationships.
SUI can be treated by non-surgical and surgical treatments.
Non-operative treatment options for SUI include general lifestyle changes, pelvic
floor muscle rehabilitation with a pelvic floor physiotherapist and continence
devices. Non- surgical treatment may be effective for women with minor degrees
Those women who continue to have symptoms may require surgery.
There are a number of different types of surgical procedures used in the
treatment of SUI. The committee heard that the most commonly used surgery uses MUS
to support the urethra or bladder neck. MUS are narrow tapes made from
polypropylene. Once inserted, scar tissue forms around the tape, holding it in
place and acting like a sling to support the urethra during increased abdominal
There are three different insertion methods used to insert MUS:
Retropubic (RPR) involving incisions in the vagina and just above
the public bone;
Transobturator (TOR) involving incisions in the vagina and in the
groin area; and
Single incision (SIS) involving an incision in the vagina only.
Throughout the inquiry the committee heard from medical practitioners
that the use of MUS for the treatment of SUI 'is established as a safe and
effective treatment, and regarded as the "gold standard" for SUI
It is described as minimally invasive surgery, performed under general
anaesthesia, and often as day surgery, with a relatively short recovery time.
The committee heard that prior to the introduction of the MUS, standard
incontinence procedures required major abdominal surgery with several days
hospitalisation, a prolonged recovery period and the risk of major
The Urological Society of Australia and New Zealand (USANZ) told the committee
that, compared to traditional incontinence procedures, such as a fascial sling
or a Burch Colposuspension, the MUS 'reduces the need for an abdominal incision
and as such is associated with a faster rate of recovery and can be placed in
patients who are older and have more complex health issues.'
Pelvic organ prolapse
POP is a common condition of weakness of the supporting ligaments and
muscles of the vagina and uterus. The symptoms of POP are varied and can range
in severity from symptoms that can be managed conservatively through pelvic
floor exercises, diet and lifestyle changes to symptoms requiring surgical
intervention. Symptoms can result in functional changes affecting the bladder
and bowel, as well as sexual function.
If left untreated, POP can have significant health, social and
psychological outcomes. There are a number of surgical procedures available for
the treatment of POP. POP can be treated by implanting surgical mesh to
reinforce the weakened vaginal wall supports. This surgery can be done through
the abdomen (trans-abdominal) or through the vagina (trans-vaginal).
The Royal Australian and New Zealand College of Obstetricians and
Gynaecologists (RANZCOG) advised the committee that transvaginal mesh was
introduced for the treatment of POP with the aim of better success rates than
are achieved with traditional native tissue repairs, which have a recognised
failure rate and commonly require repeat surgery.
Regulation of the introduction and use of transvaginal mesh in
Regulatory responsibility for the introduction and use of transvaginal
mesh devices in Australia sits across a number of entities, principally: the
TGA, the medical colleges and the ACSQHC, under the oversight of the Council of
Australian Governments Health Council.
Regulation of medical devices
Regulation of medical devices, including urogynaecological meshes, is
the responsibility of the TGA. The regulatory framework for medical devices
comprises pre-market and post market requirements. Pre-market, manufacturers of
all medical devices supplied in Australia must demonstrate compliance with
safety and performance requirements (known as Essential Principles). High risk
classified devices (Class III) undergo further mandatory pre-market assessment
prior to inclusion of the device into the Australian Register of Therapeutic
Goods (ARTG). Devices included on the ARTG are subject to ongoing post market
The TGA employs a risk-based approach to the regulation and the level of
regulatory oversight increases with the risk of the device. Evidence provided
at the time of application for registration of a device is reviewed in light of
evolving evidence from clinical studies and practical experience.
Urogyneacological mesh devices are currently classified as Class IIB (medium to
high risk). In July 2017, The TGA released a consultation paper seeking comment
on measures to align regulation of these products with European regulatory
Because the majority of medical devices supplied in Australia are
imported, the Australian regulatory framework is closely aligned with that in
Europe. This means that the Australian market authorisation process relies
significantly on regulatory assessment work undertaken in the European Union.
Sponsors seeking to supply a device in Australia, including devices
manufactured in Australia, can provide conformity assessment certification
issued to the manufacturer by a European Notified Body in support of their
In 2008 the TGA undertook its first post market review of
urogynaecological meshes in response to a United States Food and Drug
Administration safety alert. Since then the TGA has undertaken a series of
The TGA's post market monitoring is summarised in the chronology at Appendix 4.
The response of the TGA to evidence regarding the risk associated with
transvaginal mesh devices will be discussed further in Chapter 4.
Regulation of clinical practice
The TGA has no regulatory role with respect to clinical practice.
Responsibility for the quality of clinical practice rests with the individual
medical practitioner, assisted by codes of conduct, guidelines and policies
issued by the relevant professional college.
The framework for regulation of medical practitioners and the services
they provide is complex and responsibilities are shared by the Commonwealth,
state and territory governments, professional organisations, independent
statutory bodies and public and private hospitals.
However, under the Therapeutic Goods Act 1989 (Cth), the TGA does
have a role in regulatory oversight of the information that the sponsors of
devices must provide for all medical devices, known as Instructions for Use.
Professional colleges, such as RANZCOG and the Urogynaecological Society
of Australasia (UGSA), 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
Safety and quality in health care
Responsibility for leadership and coordination of improvements in safety
and quality in health care at a national level rests with the ACSQHC. The ACSQHC
is jointly funded by all governments and its work program is developed in
consultation with the Australian, state and territory Health Ministers. The ACSQHC
works in partnership with patients, consumers, clinicians, managers, policy
makers and healthcare organisations.
In June 2016, the Queensland Department of Health raised issues with the
ACSQHC concerning complications experienced by women who had undergone
transvaginal mesh procedures. Following a subsequent request from state and
territory health department representatives, the ACSQHC commenced an
examination of the safety and clinical aspects of the use of transvaginal mesh
products for the treatment of pelvic organ prolapse.
This work was informed by a literature review, and close consultation
with clinicians and with affected women through consumer forums between January
and March 2017.
Adjunct Professor Picone told the committee:
The great majority of
women who participated in the forums were physically and/or psychologically impacted
following the procedure and, in our view ... they have been very significantly
affected. It was not minor complications but very significant complications.
The ACSQHC is currently developing a number of guidance documents to
improve health care for women and to guide practitioners in the use of
transvaginal mesh for POP and SUI and for the removal of transvaginal mesh. The work of
the ACSQHC will be discussed further in Chapter 5.
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