WHAT IS THE 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 registry managed by Monash University.
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 one outcome of 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.
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.
Clinical registries are databases that systematically collect health-related information about patients who are treated with a particular surgical procedure or device ‑ in this case pelvic surgical mesh. The main purpose of a clinical quality registry is to monitor outcomes and report on quality of care. To do this, the APFPR will collect information from patients undergoing stress urinary incontinence (SUI) and pelvic organ prolapse (POP) procedures at participating health services in Australia. The APFPR primarily collects and analyses data from mesh insertion, revision and removal (explantation) procedures in Australia. Because clinical registries require individual health service approval, it may take some time before all health services in Australia that undertake these procedures are contributing to the APFPR.
It also collects information from patients before and after mesh implantation about their quality of life and ability to undertake everyday activities. Together with surgeon information, patient information can assist in determining factors that can lead to important changes resulting in better health outcomes. Over time we expect the APFPR to be as successful as the National Joint Replacement Registry (AONJRR), which commenced 20 years ago. The AONJRR has led to significant improvements in joint replacement outcomes, with the joint revision rate in Australia currently being the lowest on record due to data collection that has resulted in improvements in prostheses monitoring.
DATA SECURITY AND YOUR PRIVACY
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.
By taking part in the APFPR your health information will be used to produce data to monitor safety related to medical devices used in pelvic floor procedures. The APFPR complies with State, Territory and Commonwealth privacy laws.
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. 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 will review all publications prior to submission to ensure that no individual or identifying information is published.
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 in Australia, require ethical approval and governance sign-off at participating sites in order for recruitment and data collection to commence. The ethical requirements of this registry have been approved by the Human Research Ethics Committee of Monash Health under the National Mutual Acceptance Scheme (NMA) and Monash University Research Ethics Committee. Additional ethics approvals will be sought from participating sites that do not work under the NMA. This means that the registry will be carried out in accordance with 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.
Each year thousands of Australian women undergo pelvic floor reconstructive surgical procedure to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Approximately one quarter of these procedures involve the use of a surgical mesh product, with an estimated 150,000 mesh devices being implanted since 1998. As reported by the 2018 Senate Community Affairs Reference Committee Inquiry into the Number of women in Australia who have had transvaginal mesh implants and related matters, some women undergoing a mesh procedure suffered significant and devastating adverse events that were life-altering, however the Inquiry revealed it was difficult to ascertain just how many had undergone the procedure because of limited existing clinical data reporting systems for pelvic mesh. Following the Inquiry, the Senate Committee made 13 recommendations related to the establishment of a system for monitoring and reporting the number of devices implanted and patient outcomes including complications and adverse events. Specifically, it recommended the implementation of a registry for all high-risk implantable devices.
In April 2019 the Health Minister announced the Commonwealth Government would provide $2.3 million over three years to establish the APFPR to collect information about the safety of medical procedures and transvaginal surgical mesh devices which are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).