Breast Implant Revision
Conditions
Keywords
Breast scaffold, PCL scaffold, Long-term Safety and Performance, Absorbable Implant, Regenerative Medicine, PCL breast scaffold, Mammography screening
Brief summary
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.
Interventions
None listed
Sponsors
BellaSeno Pty Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Contacts
CONTACTProfessor Owen Ung
PRINCIPAL_INVESTIGATORProfessor Owen Ung
Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
Outcome results
None listed