Scaffold-guided 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.

NCT Number	NCT07367698
Lead Sponsor	BellaSeno Pty Ltd
Conditions	Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
Enrollment	87 participants
Start Date	2026-02-13
Primary Completion	2032-01 (estimated)
Study Completion	2032-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-10