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.

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