Breast Device Surgery in Australia: Early Results from the Australian Breast Device Registry

Self Cite

ver the past three decades, a lack of reliable implant data has had a negative impact on patients with breast implants Background: Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that has never been achieved yet. Methods: Real-world data from four currently active national breast implant registries were used. All permanent breast implants from the Australian, Dutch, Swedish, and American registries were included. A subpopulation present across all registries between 2015 and 2018 was subsequently selected, including only permanent breast implants inserted during primary surgery for breast reconstruction or augmentation in patients without previous breast device surgery. Nationwide coverage, patient and implant characteristics, infection control measures, and revision incidences were analyzed. Results: A total of 207,189 breast implants were registered. Nationwide coverage varied between 3% and 98%. The subpopulation included 111,590 implants (7% reconstruction, 93% augmentation). Across the registries, mean patient age varied between 41 and 49 years (P < 0.001) for reconstruction and 31 and 36 years (P < 0.001) for augmentation. Variation was observed in implant preferences across the countries and over the years. Infection control measures were most frequently registered in Australia. Cumulative revision incidence at 2 years ranged from 6% to 16% after reconstruction and from 1% to 4% after augmentation. Conclusions: For the first time, independent, national, registry-based data from four breast implant registries were combined. This is a powerful step forward in optimizing international breast implant monitoring, evidence-based decisionmaking, and patient safety.

“…22,23 In Australia, there is high use of intraoperative and postoperative antibiotics, but substantial regional variation in the use of other ICMs. 24,25…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Improving Breast Implant Safety through International Collaboration of National Registries – A Review of over 85000 Patients and 200000 Implants from Four Countries.

Becherer

Hopper

Cooter

et al. 2023

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“…Strengths of this study include the number of patients, length of follow-up, and high rates of participation by surgeons across Australia. 37 These are real-world data that reflect contemporaneous clinical practice. Limitations include the observational study design, which meant that we were unable to control for confounding factors or account for selection biases, particularly with regard to patient selection and reconstructive choice.…”

Section: Discussionmentioning

confidence: 99%

Comparing direct-to-implant and two-stage breast reconstruction in the Australian Breast Device Registry

Hoque¹,

Zhou²,

Gartoulla³

et al. 2022

Self Cite

Breast cancer affects almost 20,000 Australians annually, 1 and the national average rate of breast reconstruction is 18.3%. 2 For women undergoing mastectomy, the positive effects of breast reconstruction after mastectomy are well established. 2 Prosthetic breast reconstruction is either twostage expander/implant reconstruction or single-stage direct-to-implant (DTI) reconstruction. The choice of reconstructive method continues to spark debate. Proponents of DTI argue that it Background: There remains a lack of clarity surrounding the benefits, risks, and outcomes between two-stage expander/implant reconstruction and singlestage direct-to-implant (DTI) reconstruction. This study used a national data set to examine real-world outcomes of two-stage and DTI reconstructions. Methods: A cohort study was conducted examining patients in the Australian Breast Device Registry (ABDR) from 2015 to 2018 who underwent prosthetic breast reconstruction following mastectomy. DTI and two-stage cohorts after definitive implant insertion were compared. Rate of revision surgery, reasons for revision, and patient-reported outcome measures were recorded. Statistical analysis was undertaken using Fisher exact or chi-square, Wilcoxon rank sum, or t tests; Nelson-Aalen cumulative incidence estimates; and Cox proportional hazards regression. Results: A total of 5152 breast reconstructions were recorded, including 3093 two-stage and 2059 DTI reconstructions. Overall revision surgery rates were 15.6% for DTI (median follow-up, 24.7 months), compared with 9.7% in the two-stage cohort (median follow-up, 26.5 months; P < 0.001). The most common reasons for revision for DTI and two-stage reconstruction were capsular contracture (25.2% versus 26.7%; P = 0.714) and implant malposition (26.7% versus 34.3%; P = 0.045). Multivariate analysis found acellular dermal matrix use (P = 0.028) was significantly associated with a higher risk of revision. The influence of radiotherapy on revision rates was unable to be studied. Patient satisfaction levels were similar between reconstructive groups; however, patient experience was better in the DTI cohort than in the two-stage cohort. Conclusions:The ABDR data set demonstrated that DTI reconstruction had a higher revision rate than two-stage, but with comparable patient satisfaction and better patient experience. Capsular contracture and device malposition were leading causes of revision in both cohorts.

“…The National Breast Implant Registry (NBIR) is an example of a nationwide database that, despite having a narrow focus, facilitates real-time quality control for implant-based breast reconstruction. 15 As new health policies hold providers and manufacturers more accountable for patient outcomes, manufacturers could also consider discounting implants for providers who opt into the NBIR to incentivize outcome reporting and data collection. Building on the existing infrastructure for outcome reporting, similar registries could be developed for other plastic surgery procedures.…”

Section: Improving the Way We Measure Outcomesmentioning

confidence: 99%

Healthcare Value in Plastic Surgery Practice

Yang

Hyland

Tsai

et al. 2023

Summary: As value-based care gains traction in response to towering health care expenditures and issues of health care inequity, hospital capacity, and labor shortages, it is important to consider how a value-based approach can be achieved in plastic surgery. Value is defined as outcomes divided by costs across entire cycles of care. Drawing on previous studies and policies, this article identifies key opportunities in plastic surgery to move the levers of costs and outcomes to deliver higher value care. Specifically, outcomes in plastic surgery should include conventional measures of complication rates and patient-reported outcome measures to drive quality improvement and benchmark payments. Meanwhile, cost reduction in plastic surgery can be achieved through value-based payment reform, efficient workflows, evidence-based and cost-conscious selection of medical devices, and greater use of outpatient surgical facilities. Lastly, the authors discuss how the diminished presence of third-party payers in aesthetic surgery exemplifies the cost-conscious and patient-centered nature of value-based plastic surgery. To lead in future health policy and care delivery reform, plastic surgeons should strive for high-value care, remain open to new ways of care delivery, and understand how plastic surgery fits into overall health care delivery.