The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with autologous fat grafting (AFG) in the 2021-BRV-004 clinical trial (ClinicalTrials.gov ID: NCT05437757). In addition, this study will investigate the suitability of mammography in the subset of patients that fall into the national breast screening age category - individuals aged 40 years and older. The main questions this study aims to answer are: * "Is the PCL Breast Scaffold combined with autologous fat grafting a safe and effective method of soft-tissue reconstruction following breast implant revision?" * "Is mammography a suitable follow-up screening and diagnostic tool for patients implanted with the PCL Breast Scaffold?" Participants will attend annual follow-up visits from 3 to 5 years after PCL Breast Scaffold implantation for clinical assessments and patient-reported outcome questionnaires.
Study Type
OBSERVATIONAL
Enrollment
19
Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
Brisbane, Queensland, Australia, Australia
Assessment of moderate and severe device-related (probable and causal) AEs rate
Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Breast revision surgery rate
Number of breast revision surgeries categorized by reason and time
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Rate and severity of all AEs related to device and/or procedure
Number of AEs categorised by relationship with device and/or procedure (possible, probable, causal), severity and type over time
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Total breast volume retention (3D Imaging)
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
Time frame: Assessed at 3- and 5-years after implantation of the PCL Breast Scaffold
Assessment of patient satisfaction, quality of life, body image, and psychological well-being using the validated BREAST-Q questionnaire
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.
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Assessment of patient satisfaction, quality of life, body image, and psychological well-being using a 5-point Likert scale questionnaire
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.
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Assessment of device user experience using a 5-point Likert scale questionnaire
The 5-point Likert scale questionnaire is administered to the PI. Scores range from 1 to 5, with higher scores indicating greater surgeon satisfaction.
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Assessment of suitability of mammography after scaffold implantation
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.
Time frame: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
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