The Australian Breast Device Registry (ABDR) is the first clinical quality registry to capture data on breast devices and procedural details across Australia. We speak with Prof Susannah Ahern, academic lead at the ABDR and A/Prof Gillian Farrell, plastic and reconstructive surgeon and one of the clinical leads, on the key findings from the ABDR annual report.

As the ABDR moves towards maturity, the data are becoming more valuable for breast device safety monitoring. What were the key findings from the 2019 annual report?

The 2019 ABDR Annual Report includes data on breast devices implanted, revised and removed in private and public health service facilities across Australia between 2012 – 2019. In 2019, 277 sites and 563 individual surgeons participated in the ABDR.

The ABDR collects and reports information related to two main patient cohorts – patients having breast reconstructions (for cancer, developmental deformities or risk-reducing indications) which comprises approximately 30% of total surgeries, with the remainder being patients having cosmetic (augmentation) procedures. Opt-out rates for the ABDR are just over 1%, which is extremely low and represents excellent community support for the ABDR.

As at December 2019, 49,563 patients were participating in the ABDR, an addition of 11,960 patients in 2019. We found a reduction in the number of patients having breast implant procedures of about 4% from the previous year, with these being predominantly from a reduction in aesthetic procedures. We also found that the proportion of textured implants used has reduced since 2018 for both reconstructive (25-30% reduction) and augmentation (30-40% reduction).

How has the ABDR improved our understanding of specific breast device performance and best surgical practice to give patients optimal outcomes? Have any gaps been identified?

Until the ABDR, data on breast devices and procedural details had never before been captured across Australia.

The most common complications for all breast implant surgeries in the 2019 Annual Report were capsular contracture, device malposition and device rupture. Other complications are less common. Revisions due to complications are more common in patients having surgery due to reconstruction indications, rather than for augmentation.

Aggregate data for intraoperative techniques, surgical plane and incision site and other surgical elements such as fat grafting and drains have been reported in the 2019 Annual Report for surgeons to compare their own clinical practices. The data collected is quite comprehensive and provides the ABDR with a lot of information that can identify current trends and also potential implants that are underperforming in comparison to others. Moreover, the data forms are regularly updated to align with current clinical practice.

What is the ABDR’s role in assisting the TGA with the suspension of implants with risk of BIA-ALCL and rapid identification of patients with those implants?

Clinical registries take a number of years before they can be effective early warning systems for device issues. As the ABDR matures, the capture rates of device surgeries undertaken nationally have increased and now stands at approximately 75-80%, enabling us to work towards reporting device outcomes in the next few years.

The ABDR works closely with the TGA, is a member of the TGA Breast Implant Expert Working Group and relays TGA device suspensions and alerts on the ABDR website.
The ABDR provides a long term, secure record for device recipients who want details of their implants, which we can provide to them, if they are registered with the ABDR. Medical records in Australia only need to be kept for up to seven years. Many patients contacted the registry directly to learn whether their implants were on the suspended list.

In 2019, the registry facilitated health care providers to rapidly identify their patients with the suspended implants in the registry, so they could contact patients and offer a clinical review.

How does the Breast-Q IS work and what strategies are used to increase patient participation?

The BREAST-Q IS survey has been specifically designed to measure patient experiences with their breast implants in the registry setting. Five questions, selected to reflect device performance and to monitor implanted breast devices, are sent to patients 1, 2 and 5 years post surgery.

A Patient Explanatory Statement sent to patients following their procedure informs them that the registry may contact them following their procedure. The Breast-Q IS survey is delivered by text message, phone call, email or post depending on patient preference and the available contact details. Patients can always contact us if they have questions about the Breast-Q IS or the registry generally.

What trends were seen from the Breast-Q in terms of patient satisfaction at Years 1, 2 and 5? How are you using patient reported outcome measures as a potential early safety signal?

The aggregate data showed that only a minority of patients following breast reconstruction experienced pain and tightness most or all of the time. Overall, for patients with breast reconstruction, satisfaction was generally high and this was maintained for the 5 years. For patients with breast augmentation, satisfaction was highest at 12 months, and reduced slightly over the 5 years.

Two major projects on patient-reported outcome measures (PROMs) data in the registry are underway: 1. to understand how patient reported outcomes on the look, feel and rippling of their breasts at various time points provides a benchmark of device performance; and 2. to learn how patient reported outcomes may reliably predict future revision surgery.

The ABDR is helping to lead the way for breast registries in other countries. Why is it important that international breast registries work together for the early detection of potential breast-implant related problems?

The ABDR is a founding member of the International Collaboration of Breast Registry Activities (ICOBRA) that brings together breast device registries internationally with the aim of monitoring and improving breast device safety and patient outcomes. An internationally agreed and comparable minimum data set was established, made up of standardised and sound data that reflected global best practice.

An analysis of more than 800,000 de-identified patients with more than 200,000 permanent breast implants from registries in Australia, the Netherlands, Sweden and United States is likely to be published this year to improve implant monitoring internationally. The major outcomes reported were nationwide coverage, patient- and implant characteristics, use of infection control measure, and cumulative revision incidence. This real-world data drives evidence-based decision making to improve patient health outcomes.

How many surgeons are currently enlisted? In addition to helping an important public health initiative, what are the benefits to surgeons of contributing to the ABDR?

As of March 2021, the ABDR has 561 surgeons participating in the registry, representing about 95% of eligible surgeons in Australia. The registry is overwhelmingly supported by surgeons from all three clinical craft groups performing breast device surgery.

Surgeons derive multiple benefits from their contribution to the ABDR. The registry is a secure, long-term repository of device information, so surgeons can be confident they can access their contributed data as needed.

This is particularly useful in the case of device recalls, suspension or revision surgery. The ABDR can provide surgeons with individual patient device and procedural details, including surgeries undertaken at specific health facilities upon request.

The ABDR also generates annual individual reports that provide surgeons a record of their own breast device procedures, which they can compare to the national aggregate data in the annual report.

Further, participating in the ABDR is a RACS (Royal Australian College of Surgeons) recognised audit activity. Our records, annual reports and ongoing research is working towards benchmarks of best clinical practice.

What are the goals of the ABDR for 2021 and beyond?

We have a lot of plans for 2021! We are going to build a new database which will allow surgeons to enter data online and to be able to access their own patient data and reports so it will provide a lot more functionality for them.

We are also doing more work on data linkage with state and national datasets to continue to improve our understanding of the proportion of breast devices that are recorded on the ABDR.

We are working to review how the ABDR PROMs (Breast-Q IS) relate to the clinical and device information in the ABDR.

We also plan to link with the Cancer Registry to make sure that we have captured any new diagnoses of BIA-ALCL related to devices that have been included in the ABDR.
And we are gearing up our engagement with the surgeons again in 2021 with a webinar about the Annual Report and presentations at the Royal Australian College of Surgeons conference in Melbourne in May.

Any other messages or observations you’d like to share?

The ABDR is a very large health initiative that is supported by the vast majority of plastic, breast and cosmetic surgeons and their patients. The registry can provide patients and their surgeons with information about individual implanted devices and facilitates, upon request, faster communication between healthcare providers and their patients in the event of TGA device alerts.

We encourage all Australian surgeons to register all their breast device procedures with the ABDR, including explants, to help drive continuous improvements in care and patient safety.

We are very happy for surgeons and researchers to approach us with requests to use de-identified ABDR data to support research into breast implant surgery that will improve patient outcomes. AMP

About the ABDR

The Australian Breast Device Registry (ABDR) is a clinical quality registry (CQR) led by Monash University with the purpose of tracking the long-term safety and performance of breast implants and breast tissue expanders; identifying and reporting on possible trends and complications associated with breast device surgery; and identifying best surgical practice to improve patient health outcomes. The ABDR provides consumers and their families peace of mind that the long-term safety and performance of the device is being tracked and monitored while they continue with their lives.

The ABDR was established in 2015 with funding from the Commonwealth Department of Health, after a successful pilot funded by the Australasian Foundation for Plastic Surgery. This is the fourth annual report released by the ABDR in its five years of operation. The ABDR works in partnership with Australian patients, health service managers in public and private systems, theatre teams, surgeons and clinical craft groups. The ABDR is tasked with collecting, analysing and reporting data on all breast device surgery taking place across Australia. This type of surgery takes place in a wide variety of clinical settings and the ABDR captures data from public hospitals, private hospitals and private day surgeries nationwide.

To ensure high quality data, the ABDR is a patient opt-out registry. All patients presenting to participating hospitals with a participating surgeon should be included in the registry, and there are no exclusion criteria. The patient can, however, choose to opt out. The registry includes any person undergoing surgery that involves the insertion of a breast implant, tissue expander, repositioning of a breast implant, repositioning of a tissue expander, replacement of a breast implant, replacement of a tissue expander, removal of breast implant, and/or removal of tissue expander

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