A national collaborative cohort study (coordinated by NWBRC) investigating the current surgical management of breast cancer in patients with previous breast augmentation with implants.
Background
Breast augmentation is the most commonly performed cosmetic procedure worldwide. New cancer and DCIS diagnoses in this cohort will increase as this population increases and ages. The presence of an implant poses several challenges including achieving margins with breast conserving surgery (BCS), management of the implant, capsule and contralateral breast, and implications of adjuvant treatment. The single published UK series (using iBRA data) includes only patients that underwent a mastectomy implant-based reconstruction. There are no national guidelines or a consensus opinion regarding management of these patients.
Study Scope and Aims
To establish what UK practice currently exists for women who have a diagnosis of breast cancer or DCIS after previous breast augmentation with implants. This will enable us to establish best practice, assess safety data, offer patients information regarding outcomes, and inform future prospective studies.
Study population
The target population is women >18 who have had previous cosmetic breast augmentation with implants and have had surgical treatment for invasive cancer or DCIS any time after January 2011 (provided they have three months of follow up data).
Patients with previous history of breast cancer or DCIS or previous risk-reducing breast surgery are excluded.
Methods and Primary Outcomes
Northwest Breast Research Collaborative and Mammary Fold Academic and Research Committee are coordinating a national collaborative study. Patients will be identified by searching the National Breast Screening System using a bespoke algorithm, and symptomatic patients will be identified by searching MDT and theatre databases. Data will be entered into a REDCap database.
Primary outcomes include BCS rate for tumour size and method of reconstruction. Secondary outcomes include management of existing implant, capsule, contralateral breast, and complications.
Authorship and recognition
The study is open to any doctor working in a UK breast unit. Entry of five patients onto the REDCap database will ensure a participant gets listed as a collaborative author on any subsequent publications or presentations as per Northwest Collaborative authorship guidelines.
Ethical approval
All collaborators will need to register their participation in the study locally as a quality improvement project. Formal ethical approval is not required as this is deemed to be an assessment of current practice, as confirmed formally with the Health Research Authority.
Current progress
The study launched in November 2022 and has 9 breast units nationally participating to date.
Steering Committee
Benjamin Baker – Post-CCT fellow in plastic surgery (Lead)
Hud Shaker – ST8 in breast surgery
Shaneel Shah – CT2 in Gen Surg
Kristin Manor – JCF in Gen Surg
Naz Arafin – Surgical Trials Research Co-Ordinator
Megan Bydder – Consultant Radiologist
Rajiv Dave – Breast Surgeon
James Harvey – Breast Surgeon
Cliona Kirwan – Prof of Surgical Oncology and Breast Surgeon
Have any questions or interested in taking part?
Please contact the study team at bcaba.northwest@gmail.com
nwresearch.org 