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

Long-term Follow-up Study to Evaluate the Long-term Safety and Performance of PCL Breast Scaffolds Used for Breast Implant Revision Surgery in 2021-BRV-004

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 Overview

• Status: Not yet recruiting
• Conditions: Breast Implant Revision

• Study Type: Observational
• Enrollment (Estimated): 19

Contacts and Locations

• Study Contact: Name: Professor Owen Ung; Phone Number: +61 736460177; Email: owen.ung@health.qld.gov.au

Study Locations

• Australia
  • Queensland, Australia
    • Brisbane, Queensland, Australia, Australia, 4029
      • Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
      • Contact: Professor Owen Ung; Phone Number: +61 736460177; Email: owen.ung@health.qld.gov.au
      • Principal Investigator: Professor Owen Ung
      • Sub-Investigator: Professor Karin Steinke
      • Sub-Investigator: Dr Michael Wagels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who took part in the 2021-BRV-004 study, meet the eligibility criteria and provide informed consent to participate in this study

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PCL Breast Scaffold Follow-up Group; Participants from the 2021-BRV-004 study receiving long-term follow-up assessments at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast revision surgery rate	Number of breast revision surgeries categorized by reason and time	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	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	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.	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.	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.	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.	Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical possibility of MRI for tracking scaffold degradation	Visibility of ongoing degradation compared to previous visit through DCE-MRI	Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold
Assessment of suitability of US (if medically indicated) screening after scaffold implantation	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.	Only if medically indicated between 3 and 5 years after implantation of the PCL breast scaffold.
Biopsy, if clinically indicated, will be used for assessment of: tissue viability, tissue composition, tissue vascularisation, inflammatory response	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)	Reccomended 3 years after implantation of the PCL Breast Scaffold

Collaborators and Investigators

• Sponsor: BellaSeno Pty Ltd
• Investigators: Principal Investigator: Professor Owen Ung, Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Mammography screening; Regenerative Medicine; Breast scaffold; Absorbable Implant; PCL scaffold; Long-term Safety and Performance; PCL breast scaffold
• Other Study ID Numbers: 2025-BRV-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No