The US FDA decision to order manufacturers of transvaginal surgical mesh to stop selling devices

On April 2019 the US FDA announced it had ordered Boston Scientific and Coloplast to stop selling their devices used for transvaginal repair of pelvic organ prolapse. The devices affected are the Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System manufactured by Boston Scientific and the Restorelle DirectFix Anterior device manufactured by Coloplast.

The TGA cancelled these devices from the Australian market in November 2017. All mesh devices used transvaginally for pelvic organ prolapse and mini incision slings for stress urinary incontinence were cancelled in January 2018 and all remaining urogynaecological mesh devices used to treat pelvic organ prolapse have had conditions imposed to exclude the transvaginal procedure.

In December 2018, all mesh devices seeking continued market supply in Australia are now required to undergo a comprehensive review by the TGA, including of detailed clinical evidence as part of our implementation of up-classifying this range of products to Class III (high risk) devices.

Transvaginal mesh may be used to treat pelvic organ prolapse and stress urinary incontinence

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

Transvaginal 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.

Some transvaginal meshes can no longer be supplied in Australia

The TGA approved the first transvaginal meshes for supply in Australia in 1998. The first adverse event reported to the TGA was in 2006. Very few reports were submitted until 2013. In more recent years, there has been an increase in the number of patients reporting adverse effects from transvaginal mesh implants. Examples of these adverse effects include chronic pain and erosion of mesh into the vagina. For some women, complications from transvaginal mesh have had a profoundly negative impact on their lives.

Following reviews of recent international studies published in 2016 and 2017, and an examination of the clinical evidence for each mesh supplied and included in the Australian Register of Therapeutic Goods, the TGA determined that the risks to patients from some of these meshes outweigh the potential benefits.

In 2017, the TGA cancelled the approval of two types of transvaginal mesh. The first was transvaginal mesh that was inserted through the vagina to treat pelvic organ prolapse. The second was the single incision mini-sling that was used to treat stress urinary incontinence. With the exception of special pathways for accessing unapproved products, such as a clinical trial, these devices can no longer be supplied in Australia.

The TGA's approval for some other types of transvaginal mesh remains in place because the use of these devices continues to be well supported by evidence. Mid-urethral slings for the treatment of stress urinary incontinence can still be supplied in Australia. Transvaginal meshes that are inserted through the abdomen (rather than the vagina) can also be supplied in Australia.

Our understanding of the risks and benefits for medicines and medical devices evolves over time

A complete understanding of the risks and benefits for a medicine or medical device can take many years to emerge. Similar to other regulatory agencies, the TGA strives to balance  timely access to promising medical interventions and protecting the safety of patients. The TGA will continue to monitor the safety of transvaginal mesh implants, as we do for all medicines and medical devices. The TGA urges consumers and health professionals to report any adverse side effects that they experience with transvaginal mesh and other medicines and medical devices.

Cancelling transvaginal mesh products that are not supported by the latest scientific evidence

On 28 November 2017, the TGA cancelled the approval of two types of transvaginal mesh. The first was transvaginal mesh that was inserted through the vagina to treat pelvic organ prolapse. The second was the single incision mini-sling that was used to treat stress urinary incontinence. With the exception of special pathways for accessing unapproved products, such as a clinical trial, these devices can no longer be supplied in Australia. Our decision to cancel the approval of these devices was informed by the results of our review into transvaginal mesh implants.

The TGA's approval for some other types of transvaginal mesh remains in place because the use of these devices continues to be supported by the latest scientific evidence. Mid-urethral slings for the treatment of stress urinary incontinence can still be supplied in Australia. Transvaginal meshes that are inserted through the abdomen (rather than the vagina) can also be supplied in Australia.

Lists of approved and cancelled transvaginal meshes are available on the page, 'TGA actions after review into urogynaecological surgical mesh implants'.

Ongoing safety monitoring

The TGA has been monitoring concerns about transvaginal mesh since 2008. Recognising that adverse events associated with transvaginal mesh were likely being under-reported, we have urged both consumers and health professionals to report these events to us.

The TGA will continue to monitor the safety of transvaginal mesh implants, as we do for all medicines and medical devices. The TGA urges consumers and health professionals to report any adverse side effects that they experience with transvaginal mesh and other medicines and medical devices.

Strengthening the pre-market assessment of transvaginal mesh

The Australian Government has strengthened the assessment of surgical mesh devices. From 1 December 2018, all new surgical mesh devices, including transvaginal mesh devices, seeking approval from the TGA will need to meet the higher regulatory requirements of a Class III medical device.

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 transvaginal meshes were previously classified as Class IIb (medium to high risk) devices. All transvaginal meshes will be re-classified as Class III (high risk devices) from 1 December 2018. Sponsors of transvaginal mesh devices that were approved under the old classification will need to re-lodge their application with the TGA under the new classification by December 2020.

The TGA has a risk-based approach to the regulation of medical devices. The regulatory requirements are greater for high risk medical devices than low risk medical devices. Reclassifying all surgical meshes as Class III (high risk) medical devices means that these devices will receive the most rigorous evaluation when the TGA receives an application to supply the device 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 has facilitated providing important information to consumers. From 1 December 2018, manufacturers of all new permanently implantable devices (other than those exempted; for example, sutures, tooth crowns, wires etc) will need to make available patient information leaflets with the device. Patient implant cards detailing the make, model and type of device will also need to be supplied for all new transvaginal mesh devices. Existing implantable devices will have until December 2021 to develop these materials. Together, patient information leaflets and patient implant cards will assist consumers and doctors in the informed consent process and enhance the traceability of medical devices in the health system.

Patient information leaflets provide important information and understanding to consumers about each device. The leaflets will outline information relating to the device's approved use, intended patient population, potential adverse effects and relevant precautions for users.

Patient implant cards will facilitate patients' awareness of the details of the medical device that they have had implanted. These cards 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 (if any) and 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.

As a further action, the TGA has required sponsors to update the Instructions for Use (IFUs) for mid-urethral slings that are used to treat stress urinary incontinence. The updates were effective from 17 January 2018 and involved adding information about adverse events such as severe chronic pain, groin pain and bladder perforation. The IFUs can be used during consultations between surgeons and patients to discuss the purpose of the surgery as well as the benefits, risks and complications. A list of updated IFUs is included on the page, 'TGA actions after review into urogynaecological surgical mesh implants'.

Updating the Medicare Benefits Schedule

On 1 July 2018, the Australian Government introduced changes to the Medicare Benefits Schedule (MBS) to address patient safety concerns regarding the use of transvaginal mesh in pelvic organ prolapse surgery. MBS rebates will now only be payable for procedures that do not employ the use of transvaginal mesh. There are also three new interim items on the MBS for the surgical removal of transvaginal mesh in symptomatic patients. More information on the changes is available on the Department of Health website.

National Clinical Quality Registries

The Australian Government is working with the Australian Commission on Safety and Quality in Health Care (the Commission), state and territory governments and key stakeholders to develop a National Clinical Quality Registry (CQR) Strategy.

This work complements and builds upon the Commission's Framework for Australian Clinical Quality Registries and will consider 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

Consumers and health care professionals are strongly encouraged to report medical device related adverse events 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).

The Database of Adverse Event Notifications (DAEN) for medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices used in Australia since 1 July 2012. You can access more information on the DAEN on our website. Up to 17 September 2018, the TGA received 351 adverse event reports on transvaginal mesh.

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.

Resources from the Australian Commission on Safety and Quality in Health Care

The Australian Commission on Safety and Quality in Health Care (the Commission) has developed resources for consumers, clinicians and health service organisations on transvaginal mesh. The Commission's resources include fact sheets on treatment options for pelvic organic prolapse and stress urinary incontinence. These fact sheets outline the risks and benefits of different treatment options as well as questions to consider asking your doctor.

Resources from consumer groups

• The Consumers Health Forum of Australia (CHF) recently published information on the requirements for patient information leaflets and patient implant cards for implantable medical devices:
  • The CHF consumer guide to reforms
  • CHF webinar on medical devices patient implant card and patient information leaflet
• The Health Consumers Alliance of SA has compiled a number of articles about the impact of pelvic mesh, tape or sling implants
• The Health Consumers' Council has published a pelvic mesh consumer update
• Health Consumers Queensland has a page dedicated to transvaginal mesh.

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 page hosts information for patients, outlines the different uses for transvaginal mesh products and links to the College's comment on the Senate Enquiry.

RANZCOG's web statement on the use of mesh for the surgical treatment of vaginal prolapse and urinary incontinence discusses the different mesh procedures that have been used to treat different conditions.

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

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

The Australian Commission on Safety and Quality in Health Care has developed resources for consumers, clinicians and health service organisations on transvaginal mesh.  These resources include information on care pathways for the management of pelvic organ prolapse and stress urinary incontinence. They also include guidance for hospital credentialing of senior medical practitioners to implant and remove transvaginal 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 when treating women with symptomatic pelvic organ prolapse, women with transvaginal mesh implant and no complications, and women with transvaginal mesh implant and possible complications.

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

Health Victoria has published a fact sheet on transvaginal mesh complications which also discusses the signs, symptoms and treatment options for affected women.

On 15 February 2017, the Senate referred to the Community Affairs References Committee for an inquiry on the 'Number of women in Australia who have had transvaginal mesh implants and related matters'. The inquiry was chaired by Senator the Hon Rachel Siewert and reported on 28 March 2018.

The inquiry held five public hearings and comprehensively looked at:

1. the number of women in Australia:
   1. who have had transvaginal mesh implants;
   2. who have had transvaginal mesh implants who have experienced adverse side effects; and
   3. who have made attempts to have the mesh removed in Australia or elsewhere.
2. information provided to women prior to surgery about possible complications and side effects.
3. information provided to doctors regarding transvaginal mesh implants and possible complications and side effects.
4. any financial or other incentives provided to medical practitioners to use or promote transvaginal mesh implants.
5. the types and incidence of health problems experienced by women with transvaginal mesh implants and the impact these health problems have had on women's lives.
6. the Therapeutic Goods Administration's:
   1. role in investigating the suitability of the implants for use in Australia;
   2. role in ongoing monitoring of the suitability of the implants; and
   3. knowledge of women suffering with health problems after having transvaginal mesh implants.
7. options available to women to have transvaginal mesh removed.

The Senate report, the terms of reference and submissions to the inquiry are available on the Parliamentary website.

The Australian Government response to the Senate inquiry into the ‘ Number of women in Australia who have had transvaginal mesh implants and related matters’ was tabled in Parliament on 9 October 2018.

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

It also identified where improvements can be made within Australia’s health care system to recognise and support women affected 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.

You can read the Australian Government’s response to each of the inquiry’s recommendations in the published response.

A Progress Report on implementing the Australian Government Response to the recommendations made in the Senate Community Affairs References Committee inquiry into the ‘Number of women in Australian who have had transvaginal mesh implants and related matters’ was tabled in the Parliament on 2 December 2019.

Australian Consensus Framework for Ethical Collaboration in the Healthcare Sector

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

The Australian Consensus Statement describes the values and ethical principles that 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 that benefits 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.