Overview

The objective of this clinical trial is to generate robust data that demonstrates clinical performance and safety of a polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) in women who seek a revision surgery of a breast implant used for breast augmentation. 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 of soft tissue reconstruction following breast implant revision?".

Participants will:

• Undergo removal of their existing silicone breast implant (if not 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.

Eligibility

Inclusion Criteria

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

1. Genetically female
2. Patients, age from 18 years old undergoing surgical revision of bilateral breast implants originally placed for cosmetic augmentation
3. Patients with a target volume that can be treated with the available catalogue of PCL scaffold sizes
4. Eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia)
5. Agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study
6. Agree to not undergo any elective cosmetic surgery on her breasts for a minimum of 3 years following implantation of the investigational device

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)
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