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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Genetically female
✓. Patients, age from 18 years old undergoing surgical revision of bilateral breast implants originally placed for cosmetic augmentation
✓. Patients with a target volume that can be treated with the available catalogue of PCL scaffold sizes
✓. Eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia)
✓. Agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study
✓. 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
✕. Based on the judgement of the Investigator, inadequate sites/ volume for harvesting the fat graft
✕. Medical history of any malignant condition in the breast or chest wall region
✕
What they're measuring
1
Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs aftersurgical revision of permanent breast implants within 12 months
Timeframe: Assessed at post-surgery, at 1 week and at 3-, 6- and 12-month post sugery