RecruitingNAINTERVENTIONAL

Scaffold-guided Breast Implant Revision Surgery

This study is testing a new procedure for women who need to have their breast implants revised, often due to complications or dissatisfaction with their previous surgery. Instead of another implant, this method uses a special dissolving 'scaffold' made from a safe material (PCL) combined with fat taken from your own body. This aims to help reshape and rebuild the breast tissue naturally. Researchers want to find out if this combination is a safe and effective way to help women undergoing breast revision surgery. The study involves removing old implants, if present, and then using this new technique. Participants will have regular check-ups for up to five years to monitor progress and safety.

At a glance

Status

Recruiting

Phase

Sponsor

BellaSeno Pty Ltd

Enrolment target

Start

13 Feb 2026

Estimated completion

01 Jan 2032

Breast Implant Revision Breast Augmentation Complications

What is this study about?

This study is about finding a new and effective way to help women who need to have their breast implants revised. Sometimes, after breast enlargement surgery, implants can cause problems or complications. This study is testing an approach that doesn't involve putting another artificial implant back in. Instead, it uses a combination of a special material called a 'scaffold' and your own body fat to reshape and rebuild the breast.

The scaffold is like a temporary framework that helps new tissue grow. It's made from a material called PCL, which has been used safely in medicine for many years and eventually dissolves away naturally in the body. Alongside this, doctors will use fat taken from another part of your body (a process called 'autologous fat grafting') to help create a more natural breast shape and feel. The main goal of this research is to see if this method is both safe and works well for women undergoing breast implant revision surgery.

This research follows a successful initial study that looked at the safety of this technique. Now, doctors want to gather more information to prove that it's a good option for people who need this type of surgery. They will closely follow participants for several years to make sure the method is safe, performs as expected, and provides good results.

Key takeaways

Tests a new method for breast implant revision using a dissolving scaffold and your own fat.
Aims to be a natural alternative to replacing old breast implants.
Involves surgery to remove old implants and place the new scaffold/fat graft.
Requires follow-up appointments for up to 5 years to monitor results.
Participation means no other cosmetic breast surgery for at least 3 years.
The scaffold material (PCL) has been used safely for many years and dissolves naturally.

Who may be eligible?

To join this study, you need to be a woman aged 18 or over who is having surgery to revise artificial breast implants that were originally put in for cosmetic reasons. You'll need to be generally healthy and able to have an MRI scan, meaning you shouldn't have any metal in your body that isn't compatible with MRI, and you shouldn't suffer from severe claustrophobia.

There are also some reasons why you wouldn't be able to join. For example, if you have a history of cancer in your breast area or have certain genetic mutations like BRCA1 or BRCA2. You also can't have had any breast surgery (other than implant removal) or infection in your breast within the last year, or have breastfed in the last 12 months. It's also important that your doctors can find enough fat in your body to use for the grafting part of the procedure.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older needing breast implant revision surgery?
Do you have enough body fat that could potentially be used for grafting?
Can you have an MRI scan (e.g., no incompatible metal in your body or severe claustrophobia)?
Do you have a history of cancer in your breast area or certain genetic mutations (like BRCA1/2)? (If yes, you likely can't join)
Have you had any other breast surgery (besides implant removal) or infection in your breast in the last year? (If yes, you likely can't join)
Are you willing to maintain a stable weight throughout the study and avoid other breast cosmetic surgery for 3 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have any existing silicone breast implants removed, if they haven't been taken out already. Then, during the same operation, the special PCL breast scaffold would be placed, along with fat that has been taken from another part of your own body.

After your surgery, you would need to attend several follow-up appointments. These would typically be at 1 week, 3 months, and 6 months after the operation. Following that, you'd have yearly check-ups for up to five years. During these visits, doctors and nurses will check on your recovery and how well the treatment is working. You'll also be asked to fill out questionnaires about how you're feeling and your satisfaction with the results. You'd also need to try and keep your weight stable (within 5%) throughout the study's duration.

Potential risks and benefits

Taking part in this study could offer the potential benefit of a new approach to breast revision surgery that uses your own tissue, potentially leading to more natural results without another artificial implant. However, as with any surgery, there are always risks, including infection, bruising, scarring, or complications related to the anaesthetic or the healing process. The long-term effects of this specific scaffold and fat grafting combination are what the study aims to understand fully. You should know that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Macquarie University Hospital
Verified postcode
Sydney, Australia· Recruiting
Westmead Hospital, Lakeview Private Hospital
Verified postcode
Sydney, Australia· Not yet recruiting
Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI)
Verified postcode
Brisbane, Australia· Not yet recruiting
Zealand University Hospital
Verified postcode
Roskilde, Denmark· Not yet recruiting
Evangelisches Krankenhaus Göttingen-Weende
Verified postcode
Göttingen, Germany· Not yet recruiting
Universitätsklinikum Münster
Verified postcode
Münster, Germany· Not yet recruiting

Common questions

What is a 'scaffold' in this surgery?

It's like a temporary framework, made from a safe, dissolving material, that helps your body grow new tissue to reshape the breast.

Where does the 'fat grafting' come from?

It's fat taken from your own body, typically from an area where you have a bit extra, and then carefully placed into the breast area.

How long will I be followed up after the surgery?

You'll have several check-ups over the first six months, then yearly visits for up to five years to make sure everything is going well.

Can I have another breast enlargement if I join this study?

No, you would need to agree not to have any other cosmetic breast surgery for at least three years after this procedure if you take part.

What if I change my mind about participating?

You are completely free to leave the study at any time, and this will not affect your future medical care in any way.

How to find out more

Professor Owen Ung

owen.ung@health.qld.gov.au +61 736460177 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.