TY - JOUR
T1 - Breast Device Surgery in Australia
T2 - Early Results from the Australian Breast Device Registry
AU - Vishwanath, Swarna
AU - Pellegrini, Breanna
AU - Parker, Emily
AU - Earnest, Arul
AU - Kalbasi, Saeid
AU - Gartoulla, Pragya
AU - Elder, Elisabeth
AU - Farrell, Gillian
AU - Moore, Colin
AU - Cooter, Rodney D.
AU - Ahern, Susannah
AU - McNeil, John J.
AU - Hopper, Ingrid
N1 - Funding Information:
We gratefully acknowledge the Australian Commonwealth Department of Health for funding the Australian Breast Device Registry . We are also grateful to Marie Pase for work on the data. IH is supported by a National Health and Medical Research Counci l fellowship.
Publisher Copyright:
© 2021 British Association of Plastic, Reconstructive and Aesthetic Surgeons
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/10
Y1 - 2021/10
N2 - Background: The Australian Breast Device Registry (ABDR) is a clinical quality registry designed to monitor the performance of breast devices; and the quality and safety of breast device surgery. Objective: To report on breast device surgery characteristics across Australia. Methods: Participants were registered patients in the ABDR from 2012 to 2018. Results are described using percentages, mean and median. Revision rates were calculated using survival analysis methods. Results: A total of 37,603 patients were registered and had undergone reconstruction (post-cancer 15.1%, risk-reducing mastectomy 3.4% and developmental deformity 2.4%) or cosmetic augmentation (74.7%) procedures. The majority of breast implant devices were silicone filled with textured surface (reconstruction 74.0% and augmentation 64.0%). Sub-pectoral plane was the most common for both reconstruction (60.1%) and augmentation (76.6%) procedures. For reconstruction surgery, the most common surgical incision was previous mastectomy scar (44.0%) and inframammary (31.8%), and for augmentation, it was inframammary (83.4%). Intraoperative/postoperative antibiotic usage for reconstruction was 85.8% and augmentation was 89.4%. Revision incidence due to complication at 12 months post-cancer reconstruction was 5.1%, risk-reducing reconstruction 5.7% and developmental deformity implants 4.5%. Revision incidence due to complication at 12 months after augmentation procedure was 1.1%. Patient-reported outcome measures (PROMs) indicate high levels of satisfaction at 1 year for augmentation and reconstruction procedures. Conclusion: We report on early data from the ABDR and reflect on the uptake of the registry by surgeons and patients. The registry also benefits from international collaborative approaches to addressing challenges and is committed to facilitate international post-market surveillance.
AB - Background: The Australian Breast Device Registry (ABDR) is a clinical quality registry designed to monitor the performance of breast devices; and the quality and safety of breast device surgery. Objective: To report on breast device surgery characteristics across Australia. Methods: Participants were registered patients in the ABDR from 2012 to 2018. Results are described using percentages, mean and median. Revision rates were calculated using survival analysis methods. Results: A total of 37,603 patients were registered and had undergone reconstruction (post-cancer 15.1%, risk-reducing mastectomy 3.4% and developmental deformity 2.4%) or cosmetic augmentation (74.7%) procedures. The majority of breast implant devices were silicone filled with textured surface (reconstruction 74.0% and augmentation 64.0%). Sub-pectoral plane was the most common for both reconstruction (60.1%) and augmentation (76.6%) procedures. For reconstruction surgery, the most common surgical incision was previous mastectomy scar (44.0%) and inframammary (31.8%), and for augmentation, it was inframammary (83.4%). Intraoperative/postoperative antibiotic usage for reconstruction was 85.8% and augmentation was 89.4%. Revision incidence due to complication at 12 months post-cancer reconstruction was 5.1%, risk-reducing reconstruction 5.7% and developmental deformity implants 4.5%. Revision incidence due to complication at 12 months after augmentation procedure was 1.1%. Patient-reported outcome measures (PROMs) indicate high levels of satisfaction at 1 year for augmentation and reconstruction procedures. Conclusion: We report on early data from the ABDR and reflect on the uptake of the registry by surgeons and patients. The registry also benefits from international collaborative approaches to addressing challenges and is committed to facilitate international post-market surveillance.
KW - Breast device registry
KW - Breast device surgery
KW - Breast reconstruction
KW - Cosmetic augmentation
UR - http://www.scopus.com/inward/record.url?scp=85116540703&partnerID=8YFLogxK
U2 - 10.1016/j.bjps.2021.03.035
DO - 10.1016/j.bjps.2021.03.035
M3 - Article
C2 - 33931327
AN - SCOPUS:85116540703
SN - 1748-6815
VL - 74
SP - 2719
EP - 2730
JO - Journal of Plastic, Reconstructive and Aesthetic Surgery
JF - Journal of Plastic, Reconstructive and Aesthetic Surgery
IS - 10
ER -