Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery

Clinical Investigation Evaluating Medical Grade Polycaprolactone (PCL) Breast Scaffold Implantation in Conjunction With Autologous Fat Grafting for Breast Implant Revision and Primary Breast Augmentation Surgery

The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation and breast augmentation revision surgery following previous breast implant insertion. The material (PCL) has been in clinical use for many decades and is absorbable. This study follows the successful completion of a 2-year evaluation of the safety and feasibility of this technique performed by the Royal Brisbane and Women's Hospital (ClinicalTrials.gov ID: NCT05437757).

The main question it aims to answer is: "Is PCL Breast Scaffold with autologous fat graft a safe and effective method for soft tissue reconstruction following breast implant revision and for primary breast augmentation?".

Participants will:

• Undergo removal of their existing silicone breast implant (only for participants undergoing breast implant revision, if the implant has not been previously removed),
• Receive implantation of a PCL Breast Scaffold combined with autologous fat grafting (AFG), and
• Attend follow-up visits at 1 week, 3 months, 6 months, and annually for up to 5 years for clinical assessments and questionnaires.

Study Overview

• Status: Recruiting
• Conditions: Breast Implant Revision; Breast Augmentation Complications; Primary Breast Augmentation Surgery
• Intervention / Treatment: Device: Implantation of the PCL Breast scaffold with autologous fat grafting

• Study Type: Interventional
• Enrollment (Estimated): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Professor Owen Ung; Phone Number: +61 736460177; Email: owen.ung@health.qld.gov.au
• Study Contact Backup: Name: Professor Anand Deva; Phone Number: +61(2) 95252340; Email: anand.deva@ishc.org.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2109
      • Recruiting
      • Macquarie University Hospital
      • Contact: Professor Anand Deva; Phone Number: +61 295252340; Email: anand.deva@ishc.org.au
      • Principal Investigator: Professor Anand Deva
    • Sydney, New South Wales, Australia, 2145
      • Not yet recruiting
      • Westmead Hospital, Lakeview Private Hospital
      • Contact: A/Professor James French; Phone Number: +61 28850 8252; Email: drjamesfrench@gmail.com
      • Principal Investigator: A/Professor James French
      • Sub-Investigator: Professor Elisabeth Elder
  • Queensland
    • Brisbane, Queensland, Australia, 4029
      • Not yet recruiting
      • Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
      • Contact: Owen Ung Professor; Phone Number: +61 736460177; Email: owen.ung@health.qld.gov.au
      • Principal Investigator: Professor Owen Ung
      • Sub-Investigator: Professor Karin Steinke

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

To be eligible to participate in this clinical investigation, patients must meet ALL of the following criteria:

1. Genetically female
2. Patients with a target volume that can be treated with the available catalogue of PCL scaffold sizes
3. Eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia)
4. Agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study

5. Agree to not undergo any elective cosmetic surgery on her breasts for a minimum of 3 years following implantation of the investigational device

   Additional inclusion criteria applicable to the Revision Augmentation Cohort

6. Patients, age from 18 years old undergoing surgical revision of breast implants originally placed for cosmetic augmentation

Additional inclusion criteria applicable to the Primary Augmentation Cohort:

6. Patients, age from 18 years old undergoing primary augmentation surgery

Exclusion Criteria

Patients may not participate in the clinical investigation if they meet ANY of the following criteria:

1. Based on the judgement of the Investigator, inadequate sites/ volume for harvesting the fat graft
2. Medical history of any malignant condition in the breast or chest wall region
3. Medical history of BRCA 1 or BRCA 2 Mutation
4. Abnormal findings on diagnostic imaging in the breast(s) intended for treatment within one year of study enrolment
5. Prior history of infection in the breast in the preceding 12 months
6. Prior surgery involving the breast in the preceding 12 months (except any previous removal of silicone implant) including autologous fat grafting.
7. Breast feeding in the preceding 12 months
8. Any local infection or rash within or close to the surgical fields (harvest site(s) or breasts)
9. Medical history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
10. The patient has any disease, that is clinically known to impact wound healing ability
11. Known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency
12. Micro or macro angiopathia
13. Uncontrolled endocrine disorders
14. Clotting disorders, including thromboembolism
15. Known severe concurrent or intercurrent illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Investigator, compromise safety or compliance, or interfere with interpretation of study results
16. Polycaprolactone (PCL) allergy
17. Currently pregnant or breast feeding, or who are planning to become pregnant within 5 years after the breast surgery
18. Actively smoking or have a history of smoking (patient with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)
19. Actively using recreational drugs or have a history of use of recreational drugs (patients with a history of use of recreational drugs may still be eligible pending assessment by investigating team and documentation of rationale)
20. Known allergies to MRI contrast agents
21. Unable or unwilling to comply with the treatment protocol
22. Unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment
23. Currently enrolled or has plans to enrol in another clinical study that would interfere with this study, unless it is retrospective or observational

24. Any patient condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes, or would preclude participation in the study

    Additional exclusion criteria applicable solely to the Primary Augmentation Cohort:

25. Any prior surgery in one or both breasts that in the opinion of the PI could compromise the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Implantation of the PCL Breast scaffold with autologous fat grafting; Implantation of the PCL Breast Scaffold with autologous fat graft for breast implant revision or for primary breast augmentation surgery

Device: Implantation of the PCL Breast scaffold with autologous fat grafting; The PCL Breast Scaffold is implanted in a pre-pectoral pocket immediately following removal of the silicone breast implant in participants undergoing breast implant revision. For participants whose implants have been previously removed, or those undergoing primary breast augmentation, a pre-pectoral pocket is created. The use of a submuscular placement may be allowed at discretion of the PI. In conjunction with scaffold implantation, concurrent breast procedures may be performed on a case-by-case basis (e.g., Mastopexy,...). The PI will ensure accurate placement and secure fixation of the scaffold in the desired anatomical position. Autologous fat grafting (AFG) is then performed using fat cells harvested from the abdomen and/or thighs and injected into the implanted scaffold at the time of initial implantation. Then, wound closure and dressing will be conducted as per standard procedure. Sterile bandaging shall be initially applied and the wound reviewed daily whilst an inpatient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs after index surgery within 12 months	Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time	Assessed at post-surgery, at 1 week and at 3-, 6- and 12-month post sugery

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 post-surgery and at 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery
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 post-surgery, 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery
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-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery
Assessment of surgical usability and surgeon satisfaction using a 5-point Likert scale questionnaire	The 5-point Likert scale questionnaire is administered to the PIs performing the surgical procedure. Scores range from 1 to 5, with higher scores indicating a better usability and greater surgeon satisfaction.	Assessed at surgery and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery
Total breast volume retention (3D Imaging)	Total breast volume primarily assessed through 3D imaging. In case of immediate replacement, wight of the removed tissue and size of the removed silicone implant is also considered for total breast volume. Supportive data generated by: Dynamic contrast enhanced Magnetic Resonance Imaging (DCE-MRI);; Breast anthropomorphic measurements taken with tape measure or with 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 enrolment, surgery, and at 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-surgery
Assessment of patient satisfaction, quality of life, body image, and psychological well-being using validated questionnaires (BREAST-Q)	Patient-reported outcomes will be measured using the validated BREAST-Q questionnaire. The BREAST-Q Reconstruction module will be administered to participants of the Revision Augmentation Cohort, while the BREAST-Q Augmentation module will be administered to participants of the Primary Augmentation Cohort. Results are reported as a transformed score range from 0 to 100, with higher scores reflecting a better outcome.	Assessed at enrolment and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2026
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Breast Surgery; Regenerative Medicine; Primary Breast Augmentation; Implant Removal; Breast scaffold; PCL Scaffold; Absorbable Implant; Clinical Safety and Performance
• Other Study ID Numbers: 2025-BRV-005

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