What is urogynaecological mesh?

Urogynaecological surgical mesh (also known as transvaginal or pelvic mesh) is a netlike device that may be placed in, and attached to, the pelvis. It is also known by other names such as 'sling', 'tape', 'ribbon' and 'hammock'.

Urogynaecological mesh is most commonly used to treat two conditions: pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse occurs when a woman's pelvic muscles weaken and the pelvic organs, including the bladder, rectum and uterus, drop into the vagina. Stress urinary incontinence is the leaking of urine during activities that push down on the bladder, such as coughing, sneezing or exercising.

Why some urogynaecological mesh can no longer be supplied in Australia

The TGA has determined the risks to patients from certain types of urogynaecological mesh device, as described above, outweigh the potential benefits. This determination followed reviews of international studies published in 2016 and 2017, and an examination of the clinical evidence for each mesh device in the Australian Register of Therapeutic Goods (ARTG). With the exception of special pathways for accessing unapproved products, such as a clinical trial, these devices cannot be supplied in Australia.

A complete understanding of the risks and benefits of a medicine or medical device can take many years to emerge. As a regulatory agency, the TGA strives to balance timely access to promising medical interventions with the safety of patients.

The TGA approved the first urogynaecological mesh devices for supply in Australia in 1998, and first received a report of an adverse event in 2006. There were very few reports of adverse events until 2013, when the number began to increase. Since then, a significant number of patients have reported adverse effects from urogynaecological mesh implants, such as chronic pain and erosion of mesh into the vagina. Complications from transvaginal mesh have had a profoundly negative impact on the lives of some women.

Some other types of urogynaecological mesh remain approved for supply in Australia because their use continues to be supported by evidence. These include mid-urethral slings for the treatment of stress urinary incontinence, and urogynaecological mesh devices that are inserted through the abdomen.

2019: US FDA stops the sale of three mesh devices

In April 2019 the United States (US) Food and Drug Administration (FDA) ordered the manufacturers of three urogynaecological mesh products to stop selling them in the US. The FDA explained its reasoning and detailed its assessment of these devices when it announced the decision.

These products included the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System, both made by Boston Scientific, and the Restorelle DirectFix Anterior, made by Coloplast.

The Australian approval of these devices had already been cancelled by the TGA in 2017. In January 2018, the TGA cancelled the approval of all mesh devices for transvaginal placement in the treatment of pelvic organ prolapse; and banned the use of single incision mini-slings to treat stress urinary incontinence. At the same time, the TGA imposed new conditions on all other urogynaecological mesh devices used to treat pelvic organ prolapse, to stop their use in the transvaginal procedure as well.

Since December 2018, all mesh devices seeking continued market supply in Australia have been required to undergo a comprehensive review by the TGA; including a requirement for detailed clinical evidence as part of the TGA’s up-classification of this range of products to Class III (high risk) devices.

1998 – The TGA approved the first urogynaecological mesh devices for supply in Australia.

2006 – The first report of an adverse event related to a urogynaecological mesh device was reported to the TGA.

2008 – The TGA commenced monitoring of reported concerns about urogynaecological mesh.

2013 – Reports of adverse events began to increase significantly.

August 2016 – The TGA urged consumers and healthcare professionals to report adverse events related to urogynaecological mesh, after recognising they were likely being under-reported.

November 2017 – The TGA cancelled the approval of two types of urogynaecological mesh after determining the risks to patients outweighed the potential benefits.

July 2018 – The Australian Government introduced changes to the Medicare Benefits Schedule (MBS) to address patient safety concerns regarding the use of urogynaecological mesh in pelvic organ prolapse surgery.

December 2018 – The TGA:

• cancelled the approval of all mesh devices placed transvaginally for pelvic organ prolapse and slings for stress urinary incontinence
• placed conditions on all remaining urogynaecological mesh devices used to treat pelvic organ prolapse, to stop their use in transvaginal-placement procedures
• required all mesh devices to be subject to a comprehensive review by the TGA before they can be supplied in Australia, including a requirement for detailed clinical evidence as part of the TGA’s up-classification to Class III (high risk) devices
• required manufacturers of new permanently implantable devices, including urogynaecological mesh, to provide patient information leaflets with the device.

December 2020 – The TGA:

• approved the supply of four urogynaecological mesh products (see below), which were previously approved as Class IIb medical devices, under the higher standards for Class III (high risk) devices
• extended the approval of the same four urogynaecological mesh products as Class IIb devices from 1 to 11 December as a transitional measure, until they were formally added to the ARTG as Class II devices
• cancelled the approval of all other Class IIb surgical mesh devices and removed them from the ARTG.

Approved urogynaecological mesh devices

The following four products are approved as Class III devices as of 11 December 2020, when new ARTG entries were published. Their approval as Class IIb devices remained valid during a transitional period (1–11 December 2020).

For more detailed information on approved and cancelled urogynaecological mesh devices, see 'TGA actions after review into urogynaecological surgical mesh implants'.

Up-classification of urogynaecological mesh

Medical devices are categorised into classes based on their level of risk. Classifications range from low risk (Class I) to high risk (Class III). Most urogynaecological mesh devices were previously classified as Class IIb (medium–high risk) devices.

All urogynaecological mesh device applications have been classified as Class III devices since 1 December 2018. Under transitional arrangements, sponsors of urogynaecological mesh devices that were approved under the old classification had to re-lodge their applications with the TGA under the new classification by December 2020 for continued inclusion in the ARTG. Where applications were not received, the TGA removed those devices from the ARTG.

The TGA has a risk-based approach to the regulation of medical devices, which means the regulatory requirements for medical devices correspond to the risk they pose to patients. Reclassifying all surgical mesh devices as Class III medical devices means they will receive the most rigorous evaluation when the TGA receives applications to supply these devices in Australia.

Strengthening the assessment of medical devices is part of the broader regulatory reform agenda set by the Review of Medicines and Medical Devices Regulations.

Improving information for consumers

The Australian Government now requires manufacturers to provide certain specific details about their medical devices to consumers via patient information leaflets and patient implant cards.

Patient information leaflets

• Since 1 December 2018, manufacturers of new permanently implantable devices (other than those exempt devices such as sutures, tooth crowns and wires) are required to provide patient information leaflets with the device, including new urogynaecological mesh devices.
• Under transitional arrangements for urogynaecological mesh devices already on the market, patient information leaflets have been required since 1 December 2019.
• Under transitional arrangements for other permanently implantable devices (other than exempt devices) already on the market, patient information leaflets will be required from 1 December 2021. This includes surgical mesh that is not used for urogynaecological applications.

Patient implant cards

• Since 1 December 2018 manufacturers of new urogynaecological mesh devices are required to provide patient implant cards detailing the make, model and type of device.

• Under transitional arrangements for urogynaecological mesh devices already on the market, patient implant cards have been required since 1 December 2019.

• Patient implant cards have been required since 1 December 2020 for other new permanently implantable devices (other than exempt devices), including surgical mesh not used for urogynaecological applications.
• Under transitional arrangements for other permanently implantable devices (other than exempt devices) already on the market, patient implant cards will be required from 1 December 2021. This includes surgical mesh not used for urogynaecological applications.

The TGA is working with sponsors to meet the requirements.

Together, patient information leaflets and patient implant cards assist doctors to ensure patients are aware and provide informed consent, and enhances the traceability of medical devices in the health system.

Patient information leaflets help consumers understand their device, including its approved use, intended patient population, potential adverse effects and relevant precautions for users.

Patient implant cards provide patients with the details of the medical device they have had implanted, and must include:

• the name and model of the device
• either its batch code, lot number or serial number
• its unique device identifier (if any)
• the manufacturer's name, address and website.

Improving information for consumers is part of the broader regulatory reform agenda set by the Review of Medicines and Medical Devices Regulations.

Since 17 January 2018, TGA has required sponsors to update the instructions for use (IFUs) for mid-urethral slings used to treat stress urinary incontinence, including to add information about adverse events such as severe chronic pain, groin pain and bladder perforation. The IFUs support consultations between surgeons and patients about the purpose of the surgery and its potential benefits, risks and complications.

A list of updated IFUs is on the page, 'TGA actions after review into urogynaecological surgical mesh implants'.

Urogynaecological mesh and Medicare

On 1 July 2018, the Australian Government introduced changes to the Medicare Benefits Schedule (MBS) to address patient safety concerns regarding the use of urogynaecological mesh in pelvic organ prolapse surgery. As a result, MBS rebates are only payable for procedures that do not employ the use of urogynaecological mesh.

There are also three new interim items on the MBS for the surgical removal of urogynaecological mesh in symptomatic patients. More information on the changes is available on the Department of Health website.

National Clinical Quality Registries

In February 2021 the Department of Health published the National Clinical Quality Registry and Virtual Registry Strategy 2020-2030. The strategy was developed by the Australian Government in partnership with the Australian Commission on Safety and Quality in Health Care (the Commission), state and territory governments and key stakeholders.

This work complements and builds upon the Commission's Framework for Australian Clinical Quality Registries. It considers ways to provide a nationally consistent approach to the selection, funding, implementation, management and performance of CQRs to improve the safety and quality of clinical practice and patient outcomes.

A CQR is a way of monitoring the safety and quality of medical devices. Examples of existing CQRs that monitor medical devices include:

• Australian Breast Device Registry
• Australian Orthopaedic Association National Joint Replacement Registry
• Australasian Pelvic Floor Procedures Registry

Consumers and healthcare professionals are strongly encouraged to report adverse events related to medical devices directly to the TGA via the online medical device reporting form.

All reports made through the online medical device reporting form are assessed and entered into the TGA’s Incident Reporting and Investigation Scheme (IRIS).

There are a number of state based and non-government support services available to women who are experiencing complications or seeking information related to transvaginal mesh.

The Australian Pelvic Mesh Support Group and Mesh Injured Australia offer support to women who have been injured by transvaginal (pelvic) mesh implants in Australia.

Women in any state or territory can make an appointment with their doctor to discuss concerns or questions. Some states and territories also have specialised contact lines and support services for transvaginal mesh (see below).

We have received a number of queries regarding Centrelink support services. Links to relevant Centrelink websites and information support lines are provided below to assist.

The NSW Agency for Clinical Innovation has developed a Decision Aid for Women Experiencing Stress Urinary Incontinence, and an overview of options for managing the condition.

The Australian Commission on Safety and Quality in Health Care has developed resources for consumers, clinicians and health service organisations on transvaginal mesh. These include:

• fact sheets on treatment options for pelvic organic prolapse and stress urinary incontinence
• information on the risks and benefits of different treatment options
• questions to consider asking your doctor.

The Consumers Health Forum of Australia (CHF) has published information on the requirements for patient information leaflets and patient implant cards for implantable medical devices in:

• the CHF consumer guide to reforms
• a CHF webinar on medical devices patient implant card and patient information leaflet.

The Health Consumers' Council has published a pelvic mesh consumer update.

Resources from medical professional colleges

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) has published a suite of pelvic mesh resources. This includes information for patients on the different uses for urogynaecological mesh products and links to the College's comment on the Senate inquiry.

RANZCOG has made a statement on the use of mesh for the surgical treatment of vaginal prolapse and urinary incontinence. It discusses the different mesh procedures that have been used to treat different conditions.

The UroGynaecological Society of Australasia (UGSA) published a patient information page dedicated to urogynaecological mesh, including patient testimonials, information sheets, videos and guidance for where patients can get help within Australia.

The TGA published information about its regulatory changes to up-classify surgical mesh devices and options for practitioners or hospitals seeking to use cancelled devices.

The Royal Australian College of General Practitioners (RACGP) published an article on what GPs need to know about the Senate inquiry into urogynaecological mesh implants. It includes information on how the outcome of the inquiry will impact future treatment options and how GPs can approach treatment of affected women.

The RACGP produced the webinar, Stress Urinary Incontinence & Aiding Patient Decision Making, in September 2018.

The Australian Commission on Safety and Quality in Health Care developed resources for consumers, clinicians and health service organisations on urogynaecological mesh , including information on care pathways for the management of pelvic organ prolapse and stress urinary incontinence. They also include guidance for hospitals on the credentialing of senior medical practitioners to implant and remove urogynaecological mesh for treatment of pelvic organ prolapse and stress urinary incontinence.

NSW Health has published information for general practitioners regarding mesh implant for pelvic organ prolapse. This fact sheet covers tips for GPs treating women with symptomatic pelvic organ prolapse, and women who have a urogynaecological mesh implant, with or without possible complications.

On 20 December 2017, NSW Health issued a safety notice (SN:015/17) on urogynaecological mesh implants for pelvic organ (vaginal) prolapse. It discusses background information on the use of mesh products, surgeon experience and patient selection, and informed consent. It also links to the 2017 TGA alert, 'TGA actions after review into urogynaecological surgical mesh implants'.

The NSW Agency for Clinical Innovation developed a Decision Aid for Women Experiencing Stress Urinary Incontinence, and an overview of options for managing the condition.

Health Victoria published a fact sheet on urogynaecological mesh complications, including the signs, symptoms and treatment options for affected women.

On 28 March 2018, the Senate Community Affairs References Committee reported on its inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters.

The Australian Government response to the committee’s inquiry was tabled in Parliament on 10 October 2018.

A progress report on implementing the Government’s response to the inquiry’s recommendations was tabled in Parliament on 2 December 2019.

A final report on the Government’s response to the inquiry was tabled in Parliament on 29 July 2021.

The inquiry raised awareness of the serious and longstanding impacts reported by some women following mesh-related procedures.

It also identified improvements that can be made within Australia’s healthcare system to recognise and support affected women and the healthcare system more broadly.

The Government acknowledges the women who spoke at the public hearings and their significant effort in recounting their deeply private and frequently traumatic experiences, and the seriousness of the adverse events that affected them.

The Australian Consensus Framework for Ethical Collaboration in the Healthcare Sector (ACF) was launched in Tokyo on 20 July 2018.

The Australian Consensus Framework describes the values and ethical principles which should form the basis of collaboration and interaction among organisations in the healthcare sector, and aims to:

• promote collaboration and interaction among healthcare sector organisations and those who work within them to benefit patients, consumers, students, educators, communities, populations, healthcare systems and the healthcare sector
• encourage better dialogue, trust and respect between and amongst organisations in and working with the healthcare sector
• enhance the integrity and trustworthiness of organisations in the healthcare sector
• promote public confidence and trust in healthcare sector organisations by demonstrating a shared commitment to integrity and ethics.

The Medical Technology Association of Australia (MTAA) and its members have adopted all the ACF principles through the MTAA Code of Practice, which was ratified in November 2019. All MTAA employees and healthcare professional–facing employees of MTAA members must complete the Code training and align with the Code.