Australia was as affected by the mesh crisis as other markets, and the Australian class action suit against Johnson and Johnson of more than 1350 women made it one of the largest mesh class action suits of that period.¹ The broad response by the Australian Commonwealth and state governments to support mesh-affected women concluded a senate enquiry with 13 recommendations, including implementation of a national clinical quality registry for all high-risk implantable devices for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

The Australasian Pelvic Floor Procedure Registry (APFPR) tangibly reflects the bravery of these women and aims to redress past system failures. The APFPR’s development has been well documented,^2,3 and the APFPR was established in 2019, with data collection commencing in 2021. At the time of writing, 44 hospitals and 73 clinicians are participating. Led by clinicians, the APFPR unites urologists, gynecologists, urogynecologists, and colorectal surgeons and consumers in design and governance. Adoption of the APFPR into New Zealand is planned for 2025.

Regarding mesh in Australia, midurethral SUI slings, sacrocolpopexy, and rectopexy are in widespread use; transvaginal mesh for prolapse is limited to clinical trials and a special access scheme. While the impetus for the APFPR’s development was mesh outcomes, adding selected nonmesh procedures in 2024 has provided denominators and comparisons. The dataset aims to provide comprehensive risk-adjusted outcomes while minimizing the burden of data collection, capturing physician-reported outcomes at 6 to 12 months and patient-reported outcomes at 6, 12, and 24 months.

The registry collects 3 categories of procedures based on indication: SUI, POP, and SUI + POP. Approximately 70% of procedures are primary (the first for a particular indication), and 30% are subsequent (those that follow a primary procedure, including for recurrence or complication management). Figure 1 lists the procedures that are in the scope of the registry.

Early Outcomes of the APFPR

Analysis of the first 1519 procedures in 1412 patients that were entered included the following.

• SUI primary procedures
  • A total of 867 procedures were recorded, comprising mesh slings (58%), bulking agents (32%), and native tissue (10%). Of the latter, 41% were rectus fascial slings, 27% Burch colposuspension, and 13% fascia lata slings; in 19% of procedures identified as native tissue the procedure was not known. Ninety-five percent of bulking injections used Bulkamid. The Australian Register of Therapeutic Goods contains a limited selection of mesh slings; the most commonly recorded in the APFPR for primary procedures is the Gynecare TVT Exact (73%), followed by Gynecare TVT Abbrevo and Gynecare TVT.
  • Outcomes are good, with clinician-reported improvement for mesh slings (96%), native tissue procedures (93%), and bulking agent procedures (74%; Figure 2).
• POP primary procedures
  • Of 98 primary POP only and 83 primary POP + SUI procedures, the most commonly recorded procedure was sacrocolpopexy with mesh (54% and 41%, respectively), followed by sacrohysteropexy with mesh (40% and 28%, respectively).
  • There is no purpose-designed sacrocolpopexy product on the Australian Register of Therapeutic Goods, with the most common being off-label use of Tilene Mesh products and a high proportion of “unknown” devices.
  • These primary POP procedures reported extremely high rates of improvement after both POP mesh (100%) and POP + SUI procedures (98%; Figure 2).
• Subsequent SUI and POP procedures
  • The most common reason given for a subsequent SUI or POP procedure is recurrence (of the condition), followed by mesh excision.
  • Procedures performed for recurrent SUI most often used a bulking agent (48%), followed by a mesh sling (29%) or fascial sling (14%). SUI subsequent procedures performed for nonrecurrence reasons were most commonly sling division (81%).
  • Mesh excision procedures for both SUI and POP were usually transvaginal partial excision rather than total removal or extravaginal excision.
  • Subsequent POP procedures performed due to recurrence were most commonly sacrocolpopexy with mesh (73%), followed by sacrospinous colpopexy with mesh (16%).
  • Postoperative outcomes were less favorable than for primary procedures, with 77% improvement after surgery for recurrent SUI, but only 27% improvement following mesh excision procedures. Of the latter, 40% reported no improvement, and 33% felt worse (Figure 2).
  • Ninety-four percent of patients felt improved after procedures to treat recurrent POP. In contrast, for mesh excision procedures, only 29% thought they had improved, while 71% had not (Figure 2).

These early data highlight that revision procedures are associated with poorer outcomes compared with primary procedures; the first operation remains the best opportunity for success. With registry growth, the dataset will allow correlation of risk factors and clinical assessment with outcomes and contribute to evidence-based guidelines regarding the long-term efficacy of mesh implants and the management of recurrent prolapse.

The APFPR is in the early stages of collecting patient-reported outcomes data at 6, 12, and 24 months and is including these data in health service reports. It aims to also include patient-reported outcomes data alongside clinical data in publicly available reports and in research in the future.

Conclusion

The APFPR is a fundamental and evolving resource for the care of Australians with pelvic floor disorders, informing patient-centered care with real-time evidence regarding clinical best practices.

Funding: The Australasian Pelvic Floor Procedure Registry is funded by the Australian Government Department of Health and Aged Care.