LTFU of PCL Breast Scaffolds Used in 2021-BRV-004

Primary outcomes

• Assessment of moderate and severe device-related (probable and causal) AEs rate [Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]: Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time

Secondary outcomes

• Breast revision surgery rate [Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]: Number of breast revision surgeries categorized by reason and time
• Rate and severity of all AEs related to device and/or procedure [Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]: Number of AEs categorised by relationship with device and/or procedure (possible, probable, causal), severity and type over time
• Total breast volume retention (3D Imaging) [Assessed at 3- and 5-years after implantation of the PCL Breast Scaffold]: Total breast volume primarily assessed through 3D imaging. Supportive data generated by: * Dynamic contrast enhanced Magnetic Resonance Imaging (DCE-MRI) * Breast anthropomorphic measurements taken with tape measure or the Vectra imaging system (Sternal notch to nipple (SN-N), Nipple to inframammary fold (N-IMF), Overbust measurement, Underbust measurement, Chest circumference at highest projection) * Digital photos
• Assessment of patient satisfaction, quality of life, body image, and psychological well-being using the validated BREAST-Q questionnaire [Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]: Patient-reported outcomes will be measured using the validated BREAST-Q questionnaire. Results are reported as a transformed score range from 0 to 100, with higher scores reflecting a better outcome.
• Assessment of patient satisfaction, quality of life, body image, and psychological well-being using a 5-point Likert scale questionnaire [Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]: Patient-reported outcomes will be measured through a 5-point Likert scale questionnaire. Scores range from 1 to 5, with higher scores indicating better outcomes.
• Assessment of device user experience using a 5-point Likert scale questionnaire [Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]: The 5-point Likert scale questionnaire is administered to the PI. Scores range from 1 to 5, with higher scores indicating greater surgeon satisfaction.
• Assessment of suitability of mammography after scaffold implantation [Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]: Visibility of glandular breast tissue; visibility of all regions of interest required for effective screening; any interference caused by the scaffold that may affect the sensitivity and specificity of the diagnostic method; visibility of the scaffold or regenerated tissue; visibility of any findings previously detected by (DCE-)MRI; and visibility of any liquid formation or seroma, if present.

Other outcomes

• Technical possibility of MRI for tracking scaffold degradation [Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]: Visibility of ongoing degradation compared to previous visit through DCE-MRI
• Assessment of suitability of US (if medically indicated) screening after scaffold implantation [Only if medically indicated between 3 and 5 years after implantation of the PCL breast scaffold.]: Visibility of all regions of interest required for effective screening; any interference caused by the scaffold that affects the Color Doppler US reporting; visibility of the scaffold or regenerated tissue; visibility of any findings previously detected by DCE-MRI; and visibility of any liquid formation or seroma, including estimation of US-based calculated volume when present.
• Biopsy, if clinically indicated, will be used for assessment of: tissue viability, tissue composition, tissue vascularisation, inflammatory response [Reccomended 3 years after implantation of the PCL Breast Scaffold]: Assessments include tissue viability (presence of viable cells and observation of any necrotic tissue), tissue composition (tissue type, presence of calcifications or oil cysts), tissue vascularization (presence of blood vessels), and inflammatory response (presence of inflammation and whether it is acute or chronic)

Sex: Female

Inclusion Criteria:

* Patients implanted with at least one PCL Breast Scaffold who took part in the 2021-BRV-004 study.
* Patients who provide written informed consent to participate in this study.

Exclusion Criteria:

* Patient unwilling and unable to comply with the study requirements.

• Professor Owen Ung, Principal investigator, Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)