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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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