Breast Device Surgery in Australia: Early Results from the Australian Breast Device Registry.
Adolescent
Adult
Aged
Anti-Bacterial Agents
/ therapeutic use
Australia
Breast
/ abnormalities
Breast Implantation
/ adverse effects
Breast Implants
/ adverse effects
Breast Neoplasms
/ surgery
Female
Humans
Middle Aged
Prophylactic Mastectomy
/ statistics & numerical data
Registries
Reoperation
/ statistics & numerical data
Silicone Gels
Young Adult
Breast device registry
Breast device surgery
Breast reconstruction
Cosmetic augmentation
Journal
Journal of plastic, reconstructive & aesthetic surgery : JPRAS
ISSN: 1878-0539
Titre abrégé: J Plast Reconstr Aesthet Surg
Pays: Netherlands
ID NLM: 101264239
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
04
05
2020
revised:
03
03
2021
accepted:
13
03
2021
pubmed:
2
5
2021
medline:
16
11
2021
entrez:
1
5
2021
Statut:
ppublish
Résumé
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. To report on breast device surgery characteristics across Australia. 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. 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. 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.
Sections du résumé
BACKGROUND
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
OBJECTIVE
To report on breast device surgery characteristics across Australia.
METHODS
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 33931327
pii: S1748-6815(21)00125-X
doi: 10.1016/j.bjps.2021.03.035
pii:
doi:
Substances chimiques
Anti-Bacterial Agents
0
Silicone Gels
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2719-2730Informations de copyright
Copyright © 2021 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest None.