WHY HAVE I BEEN INCLUDED?


Your surgeon has identified you as having undergone or about to undergo surgery relating to stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP).
If you are unsure about your diagnosis, please speak with your treating clinician.

PARTICIPATION

Your specialist (or their staff) at this hospital will enter your information into the registry.  Only relevant personal and health information will be entered.

This includes:

  • your name and contact details so we can link your health and wellbeing feedback with your procedures for analysis;
  • details of your pelvic floor disorder including any related conditions;
  • the type of procedure including any device details if used or removed during surgery;
  • whether you experience any complications; and
  • names of the hospital/s and doctors treating you.

Information will be collected from your current health service as well as any other health service or contributing surgeon should you have further pelvic floor surgery in the future. To make sure all the essential information has been entered, your medical records may be reviewed. This information will be recorded in a secure database.

To understand the outcomes associated with pelvic floor procedures, you may be invited to participate in questionnaires asking you about your outcomes of surgery such as urinary leakage, pain and discomfort during intercourse. Questionnaires are administered before surgery, and again six, 12 and 24 months post-surgery. These questionnaires may be completed online, by mail, or by telephone with trained APFPR personnel. Questions are asked before and after surgery to determine surgery outcomes and distinguish between existing and new concerns. Data will only be accessed and provided to the registry once the 14-day opt-out period has ended.

DO I HAVE TO TAKE PART?

This is an opt-out registry. This means that you need to tell us if you do not want to participate. If we do not hear from you, we may start collecting information about you. This may happen any time after two weeks from the date on your invitation letter.

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the registry at any stage and you can ask for your information to be deleted from the registry at any time. Please note however, if you choose to remove all your data from the registry, we will no longer have a record of you. This means that should you undergo additional SUI or POP related procedures in the future you may receive another invitation from the registry. For this reason, we prefer to keep a minimal amount of information to avoid recontact occurring. If you do NOT want your data to be entered onto the registry or would like to withdraw from the questionnaires component, you can opt out at any time by calling 1800 571 093 (toll free) or emailing apfpr@monash.edu and quote the office ID number on the letter.

Your decision whether to take part or not, will not affect your relationship with your treating hospital or specialist.

WHAT ARE THE BENEFITS OF PARTICIPATING?


 

Your information will make an invaluable contribution to the future of Australia’s health system by helping to improve medical device awareness and facilitate patient-centred care and safety. This project is designed to safeguard the health of people undergoing procedures involving stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Information is collected in a simple and secure way, and provides peace of mind for participants that their procedure details are recorded. Details of your surgery including any device used, will be kept indefinitely on the registry, and can be accessed by yourself and your clinician should this information be needed in the future. As more information is collected, the data produced will be analysed to inform new patients who are considering pelvic surgery with mesh to better understand the benefits and potential risks of these procedures. Aggregated outcomes from procedures involving devices over time will also be made available via public annual reports and to the Therapeutic Goods Administration.

WHAT ARE THE RISKS?


 

This registry will not have any immediate impact on the medical care you receive, however over time doctors will use the information from the registry to better understand devices and procedures that provide the best outcomes for future consumers. Should you feel distressed or uncomfortable when answering the questionnaires, you do not need to continue answering the questions. At any time, you can choose to withdraw from the registry or you can withdraw from the questionnaires only.

WHERE CAN I ACCESS SUPPORT?


 

Women who live with mesh-related complications should seek a referral from their GP for specialist services to assist the management of their clinical situation. There are also a number of patient-led support groups for people adversely affected by mesh-related procedures in Australia – please visit the Therapeutic Goods Administration’s Transvaginal (urogynaecological) surgical mesh hub for details of consumer support services in your area.

If you require immediate support please contact Beyond Blue 1300 224 636 or Lifeline 13 11 14.

If you are a person with lived experience and you wish to report historical mesh-related complications please visit the Therapeutic Goods Administration’s adverse events reporting web page.

FREQUENTLY ASKED QUESTIONS (FAQs)


What is a clinical quality registry?

Clinical quality registries are organisations that monitor quality of care by collecting health-related information from people who undergo treatment with a particular surgical procedure or device. Over time these registries mature to create powerful datasets that allow health professionals to monitor patient outcomes and report on the quality and safety of products and procedures that inform future treatment and wellbeing for all Australians.

What is the Australasian Pelvic Floor Procedure Registry (APFPR)?

The Australasian Pelvic Floor Procedure Registry (APFPR) is a Commonwealth Government health initiative established to record information about surgeries for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) procedures. It is a clinician-led national clinical quality register managed by Monash University.

The project is being managed by the Clinical Outcomes data Reporting and Research Program, part of Public Health and Preventive Medicine, Monash University. The APFPR is supported by funding from the Australian Government Department of Health.

Why is my information important?

The APFPR will play an important part in future health outcomes of Australians because it aims to record information that will ultimately be used to improve quality of care and increase the safety of patients undergoing procedures that involve medical devices such as pelvic surgical mesh. From the data collected from you and other participants APFPR researchers will track the long-term safety and performance of these procedures and establish the best surgical practice for optimal patient health outcomes.

When was the APFPR established?

The APFPR was established in 2019 with funding from the Commonwealth Department of Health following the Senate Community Affairs Reference Committee Inquiry into the Number of women in Australia who have had transvaginal mesh implants and related matters .

Why was the APFPR established?

This registry was established following a Senate Inquiry where brave Australians who suffered deeply private and frequently traumatic experiences as a result of mesh-related procedures shared stories that prompted important changes to our nation’s health system. The APFPR is a part of a broader response by the Commonwealth and State governments to support mesh-affected women. This register is the outcome of many personal efforts to raise awareness of the serious, long-standing impacts some women suffered following mesh-related procedures, and to ensure the adverse events that affected them should never happen again.

Why have I been asked to participate?

Your surgeon has identified you as about to undergo surgery relating to stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). If you are unsure about your diagnosis, please speak with your treating clinician.

What kind of information does the APFPR collect?

Your specialist (or their staff) at this hospital will enter your information into the registry. Only relevant personal and health information will be entered.

This includes:

  • your name and contact details so we can link your health and wellbeing feedback with your procedures for analysis;
  • details of your pelvic floor disorder including any related conditions;
  • the type of procedure including any device details if used or removed during surgery;
  • whether you experience any complications; and
  • names of the hospital/s and doctors treating you.

 

Information will be collected from your current health service as well as any other health service or contributing surgeon should you have further pelvic floor surgery in the future. To make sure all the essential information has been entered, your medical records may be reviewed. This information will be recorded in a secure database.

To understand the outcomes associated with pelvic floor procedures, you may be invited to participate in questionnaires asking you about your outcomes of surgery such as urinary leakage, pain and discomfort during intercourse. Questionnaires are conducted before surgery, and again six, 12 and 24 months post-surgery. These questionnaires may be completed online, by mail, or by telephone with trained APFPR personnel. Questions are asked before and after surgery to determine surgery outcomes and distinguish between existing and new concerns. Data will only be accessed and provided to the registry once the 14-day opt out period has ended.

Do I have to take part?

This is an opt-out registry. This means that you need to tell us if you do not want to participate. If we do not hear from you, we may start collecting information about you. This may happen any time after two weeks from the date on your invitation letter.

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the registry at any stage and you can ask for your information to be deleted from the registry at any time. Please note however, if you choose to remove all your data from the registry, we will no longer have a record of you. This means that should you undergo additional SUI or POP related procedures in the future you may receive another invitation from the registry. For this reason, we prefer to keep a minimal amount of information to avoid recontact occurring. If you do NOT want your data to be entered onto the registry or would like to withdraw from the questionnaires component, you can opt out at any time by calling 1800 571 093 (toll free) or emailing apfpr@monash.edu and quote the office ID number on the letter.

Your decision whether to take part or not, will not affect your relationship with your treating hospital or specialist.

How will my information be used?

The surgical and patient reported outcomes of mesh procedures, including initial procedures and those requiring revision or mesh removal, will be used to provide safety and quality of care reports to hospitals, surgeons and government. As more data is collected more information can be analysed to not only inform surgical best practice, but to inform patients who are considering pelvic surgery with mesh to better understand the benefits and potential risks of these procedures. Importantly, analyses and public reports arising from the APFPR will contain no identifiable information about you.

Please note, while the APFPR will provide objective, credible information for consumers, it is not a substitute for clinical advice and management of medical and surgical specialists.

Will my information be safe? Who has access?

Monash University has established and managed clinical registries for 20 years. Monash currently operates more than 30 state and national registries including a number of large national registries. Monash University has the highest levels of data security and governance systems for sensitive data.

The APFPR complies with State, Territory and Commonwealth privacy laws, with your data permanently stored on infrastructure located in Australia. Data stored on this infrastructure is backed up daily. All traffic between the data collector’s personal device, the web server(s), the database server(s), and the file server(s) is encrypted, and accessed by trained, relevant APFPR personnel only.

 

We retain your contact details so that you can be contacted if required, such as for completion of a follow-up questionnaire, but also to provide information to you or your health professional on request. The APFPR will not release your identifiable information to any person or organisation, other than to your surgeon. Importantly, analyses and public reports arising from the APFPR will contain no identifiable information about you.

 

To ensure patient privacy any external access to information from the APFPR must adhere to strict protocols and procedures and have ethics approval. Registry data will be made available to external researchers (upon ethics approval) but only after all identifiable patient information has been removed. Additionally, the APFPR Steering Committee [link] will review all publications prior to submission to ensure that no individual or identifying information is published.

What are the benefits of taking part?

Your information will make an invaluable contribution to the future of Australia’s health system by helping to improve medical device awareness and facilitate patient-centred care and safety. This project is designed to safeguard the health of people undergoing procedures involving stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Information is collected in a simple and secure way, and provides peace of mind for participants that their procedure details are recorded. Details of your surgery including any device used, will be kept indefinitely on the registry, and can be accessed by yourself and your health providers should this information be needed in the future. As more information is collected, the data produced will be analysed to inform new patients who are considering pelvic surgery with mesh to better understand the benefits and potential risks of these procedures. Performance of these procedures, identified by data analysis, will also be made available via public annual reports and to the Therapeutic Goods Administration.

What are the risks?

 This registry will not have any immediate impact on the medical care you receive, however over time doctors will use the information from the registry to better understand devices and procedures that provide the best outcomes for future consumers. Should you feel distressed or uncomfortable when answering the questionnaires, you do not need to continue answering the questions. At any time, you can choose to withdraw from the registry or you can withdraw from the questionnaires only.

How is the APFPR is funded?

The registry is funded by the Commonwealth Department of Health.

Does it cost anything to participate?

There are no costs associated with participating in this project and participants are not paid.

Who governs the registry?

The APFPR is managed by the Clinical Outcomes data Reporting and Research Program part of Public Health and Preventive Medicine at Monash University. The operational team is led by Professor Susannah Ahern and Project Manager, Ms Joanne Dean. Clinical oversight and registry support is provided to the operational team by the APFPR Steering Committee.

The strategic direction and development of the registry is being overseen by the Steering Committee which monitors activities such as data quality, and establishes policies to address issues of clinical interest or significance that may arise, including those relating to quality of care and patient privacy. This committee meets quarterly and includes project investigators and stakeholder representatives from the Australian Government Department of Health; Therapeutic Goods Administration; Australian Commission on Safety and Quality in Health Care; consumer; and senior clinicians from key medical specialist societies and medical colleges involved in mesh procedures and removal.

The APFPR, like all clinical quality registries, must be approved by ethics committees and by each hospital at which data is collected. Further, the ethical requirements of this registry have been approved by the Human Research Ethics Committee of Monash Health. This registry will be carried out according to the National Statement on Ethical Conduct in Human Research (2018). This statement has been developed to protect the interests of people who agree to participate in human research studies.

How can I access my data?

In accordance with relevant national and/or state privacy and other relevant laws, you have the right to request access to the information collected and stored by the registry team about you. You also have the right to request that any information with which you disagree be corrected. Participants can apply to the Registry Coordinator to access their own data. However, all requests must be compliant with the Data Access and Publication Policy. Enquiries should be directed to the APFPR Project Team.

What is the role of the Therapeutic Goods Administration (TGA)?

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

The APFPR will work closely with the TGA to ensure that information about pelvic surgical mesh device performance is made available to inform decisions about device regulation.

The APFPR also supports new national requirements for credentialing of surgeons performing mesh procedures, by being an audit tool to assist surgeons to review their outcomes.

For more information visit the TGA transvaginal mesh hub.

Does the registry include input from consumers?

The APFPR has consumer representation on the Steering Committee to ensure that the aims and activities of the registry is informed at all times by the experiences and advice of women who have had mesh complications.

The APFPR actively engages with mesh-related consumer support groups through a targeted newsletter to provide consumers with updates regarding the activities and findings of the registry. We also invite feedback from individuals and community groups on our website regarding APFPR activities.

Why aren’t people with existing complications included on the register?

The Commonwealth and States/Territories are committed to supporting activities that lead to addressing the unmet needs of women afflicted with adverse events related to pelvic mesh implants, such as establishing specialist mesh assessment and removal clinics in many jurisdictions. These services were established specifically in response to the Senate Inquiry to provide highly specialised care to women who have already suffered complications from mesh procedures. For more information visit the Australian Commission on Safety and Quality in Health Care.

However, a significant finding of the Senate Inquiry was that identifying patients who have had complications in the past would be an extremely difficult task. It is estimated that up to 20,000 women per year have had pelvic mesh procedures.

Additionally, when a study relies on retrospective data it relies on existing medical records that have been collected for other purposes, and therefore may not contain the type of information required to measure quality of care or address safety concerns.

Due to these practical concerns, the APFPR was only ever established to collect prospective (new patient) data.

Patients who are yet to undergo corrective surgery as a result of existing mesh complications will be included in the APFPR data collection process at participating hospitals.

But didn’t the Senate Inquiry recommend an audit?

Yes, but the audit and the APFPR are different things.

Recommendation 11 from the Senate Inquiry committee requested that the Commonwealth, states and territory governments commission the Australian Commission on Safety and Quality of 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 Australian Government only noted this recommendation. It said: “The Government notes that the proposed retrospective audit of procedures presents several policy and implementation issues, and would be a matter for state and territory health departments and private health service providers. The Commission is not able to directly access individual patient health records, but could work with the public and private systems to coordinate such audits, if commissioned by state and territory governments. The Government recognises the importance of the recommendation to take stock of transvaginal mesh procedures to inform and improve the use of the devices. The Government recognises the challenges associated with effectively collecting this information, including: data being stored on paper-based records, lack of information held as to whether procedures involved mesh, time to examine non-electronic records, and lack of some records where these are over seven years old.”

Currently there is no uniform, systematic infrastructure for the collection, analysis and reporting of outcomes of surgical interventions for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in the Australian setting. Importantly, numbers and types of procedures are not readily available and the incidence of adverse events such as pelvic pain, mesh exposure and need for repeat surgery for these adverse events and recurrent incontinence and prolapse is not known. This is why the APFPR is being introduced.

Why is pelvic mesh still being used?

Pelvic surgical mesh products vary. Some can no longer be supplied in Australia, while others are still recognised as having a place in the treatment of pelvic floor disorders where native tissue procedures have not succeeded. The APFPR will collect information about pelvic mesh procedures to not only identify best practice but also highlight products or procedures that may need to be reviewed by the TGA.

Where can I access support?

Women who live with mesh-related complications should seek a referral from their GP for specialist services to assist the management of their clinical situation. There are also a number of patient-led support groups for people adversely affected by mesh-related procedures in Australia – please visit the Therapeutic Goods Administration’s Transvaginal (urogynaecological) surgical mesh hub for details of consumer support services in your area.

If you require immediate support please contact Beyond Blue 1300 224 636 or Lifeline 13 11 14.

If you are a person with lived experience and you wish to report historical mesh-related complications please visit the Therapeutic Goods Administration’s adverse events reporting web page.

How do I update or change my personal details with the registry?

It is important that we are able to keep in touch. If you need to update or change personal details with the registry please call 1800 571 093 (toll free) or email apfpr@monash.edu to let the APFPR Coordination Centre know.

More questions?

Contact the APFPR Coordination Centre 1800 571 093 (toll free) or email apfpr@monash.edu.