Clinical trial

BREAST SCAFFOLD

Introducing a sustainable solution to explant breast complications. Join us in pioneering a new era of Scaffold-Based Soft Tissue Regeneration.

TRIAL HAS COMMENCED

Models shown in the image are for illustrative purposes only and not intended to guarantee the aesthetic results shown. Designed by Freepik

Announcement: Our Breast Scaffold Trial has now commenced.

PIONEERING A SUSTAINABLE APPROACH

Thank you for your interest in our clinical research trial.
We are pleased to announce that our innovative study into breast implant revision surgery using scaffold-based tissue regeneration has now commenced.

Initial enrolment is currently limited to patients who have already been evaluated at our Breast Implant Check Clinics or who have had consultations with our surgeons at Macquarie University (MQ) and Integrated Specialist Health Care Research Foundation (ISHCERF). Eligible patients will have received a unique access token, which is required to complete the Expression of Interest (EOI) form

This staged rollout ensures that we can safely and efficiently begin the trial with patients already known to our clinical team. External expressions of interest are now open, and we encourage you to register if you wish to be considered for participation or participation in future trials.

Yes, I Have A Token

Models shown in the image are for illustrative purposes only and not intended to guarantee the aesthetic results shown. Designed by Freepik

ABOUT THE CLINICAL TRIAL

Research Project Title:

Clinical trial evaluating PCL Breast Scaffold implantation with autologous fat grafting and mastopexy/breast reduction for breast implant revision.

HREC Project Number:	19238
Protocol Number:	2025-BRV-005 Version 2 30.10.25
Principle Investigator (PI):	Prof. Anand Deva (Sydney)
Coordinating PI:	Prof. Owen Ung (Brisbane)
Purpose of the Study:	Safety and performance of the absorbable PCL Breast Scaffold
Recruitment Status:	Actively Recruiting

EMPOWER A NEW YOU. EMPOWER OTHERS.

This clinical study is exploring a pioneering approach to breast revision surgery that uses a biodegradable, 3D-printed scaffold made from polycaprolactone (PCL), paired with autologous fat grafting (AFG), fat sourced from your own body. This method is designed to restore breast volume and shape naturally, following the removal of implants.

For many individuals affected by complications such as capsular contracture, rupture, deformity, or pain caused by silicone breast implants, choosing not to replace them doesn’t mean giving up on reconstruction. This trial investigates a safer, implant-free solution, one that works in harmony with the body to support healing, structural integrity, and aesthetic outcomes.

NATURALLY ABSORBED

The scaffold absorbs over about four years and is replaced by your own tissue.

TGA APPROVED

TGA approved PCL implantable scaffolds used medical devices.

ONGOING CARE

You will be supported every step of the way pre and post operation.

OPERATIONAL SUCCESS

A 19-patient feasibility trial with two-year follow-up after scaffold and fat grafting.

NATURALLY ABSORBED SCAFFOLDS

The scaffold is naturally absorbed over approximately four years, though individual factors may influence this timeline, and it is gradually replaced by your own tissue. It is made from an approved biomaterial, polycaprolactone, used in TGA-approved 3D scaffolds and sutures that have been safely utilised in clinical practice for decades.

Throughout your journey, we will be with you at every step to support a smooth and successful experience.

A 19-patient feasibility trial with two-year follow-up, completing in December 2025 in Brisbane, has shown promising early results, prompting expansion to additional sites across Australia and Europe.

LEADING TRIAL PHYSICIANS

Introducing the two pioneers leading this clinical trial. Accomplished in Plastic & Reconstructive Surgery, these distinguished professors are at the forefront of innovation in their field. With a wealth of expertise and global recognition, their transformative contributions have advanced surgical techniques and patient care. Explore their biographies below to learn more about their lasting impact on the field.

Plastic & Reconstructive Surgeon

Prof. Anand Deva

Discipline head in Plastic & Reconstructive Surgery at the Faculty of Health and Medical Science at Macquarie University.

Read Bio

Breast & Endocrine Surgeon

Prof. Owen Ung

Professor of Surgery, University of Queensland,Director of the Metro North Comprehensive Breast Cancer Institute (CBCI) and Program lead for the Breast Reconstruction at the Herston Biofabrication Institute (HBI).

Read Bio

To qualify for the Breast Scaffold Trial (Clinical trial evaluating PCL breast scaffold implantation with autologous fat grafting for breast implant revision surgery) please ensure you meet the following criteria at minimum (additional criteria will be reviewed with you to confirm your eligibility if you are interested):

You are planning to undergo breast implant removal
You possess private health insurance that covers the necessary item numbers (45523, 45534, 45535, 45551, 45558).
You can commit to attending follow-up visits over a 5 year period, including periodic imaging.
You are a non-smoker.

Participants in this trial will have the scaffold component of the surgery covered by the trial sponsors. However, costs associated with the breast implant removal, and concurrent mastopexy, or breast reduction procedures if applicable, will be your responsibility.

If you meet these criteria and are interested in participating, please click on the Expression Of Interest (EOI) button to complete the required details.

Please note that meeting these initial eligibility criteria does not guarantee participation. Final participation will be determined following the submission of your EOI and/or initial consultation.

To take part, you must meet the inclusion criteria below. Please note: A detailed assessment to determine your eligibility will be conducted post submission of your expression of interest.

Planning surgery for breast implant removal, breast reduction, or mastopexy
Private health insurance that includes item numbers 45523, 45534, 45535, 45551, 45558
Non-smoker
BMI between 20–30 (exceptions may apply based on medical review)
Not pregnant or planning pregnancy within 5 years

Prior radical mastectomy or chest wall soft tissue removal
Breast or chest wall radiation
Infection in the breast region within the past 12 months
Diagnosed with BIA-ALCL or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
Uncontrolled diabetes or known immune deficiencies
Serious medical conditions impacting safety or wound healing
Unable to undergo MRI scans
Pregnant or breastfeeding or planning to become pregnant within 5 years of the breast surgery
History of smoking (you may still be eligible, subject to review)
Allergy to polycaprolactone
Unable to give informed consent

If eligible, participation will involve:

Initial consultation – no cost.
Clinical assessment including medical history, imaging (MRI, mammography, ultrasound), photography, and 3D scanning
Breast implant removal and concurrent mastopexy/reduction procedures if applicable (costs covered by you/your private health insurer)
Scaffold insertion and fat grafting (provided at no cost by the study)
Follow-up assessments over 5 years, including:
- Ultrasound surveillance at 1 week
- Follow-up MRI scans at, 6 and 12 months (free of charge)
- 3D volumetric imaging (Vectra) at 3 months, 6 months, 1- 2- 3- and 5-years.
Reimbursement for travel and parking at each follow-up appointment
No cost for additional care required due to scaffold or fat grafting complications

While we cannot guarantee any individual benefit, participating in this trial may offer:

An improved cosmetic appearance of the native breasts without the use of a permanent silicone implant
Enhanced overall wellbeing and self-confidence
A reduced need for multiple fat injection sessions compared to traditional methods

This research also contributes to developing safer, more effective reconstruction options—potentially benefiting future patients undergoing breast reconstruction after cancer, trauma, or congenital conditions.

By avoiding silicone implants, this approach may help eliminate known risks such as rupture, capsular contracture, implant malposition, or breast implant-associated lymphoma (BIA-ALCL).

All medical care related to the scaffold procedure and clinical trial will be provided at no cost to you. Your standard breast surgery (e.g., implant removal) will attract regular costs, which may be subsidised by your health fund if medically indicated. Please to more detail in FAQs outlined below.

Initial Consultation

Your initial consultation will last approximately 45 minutes. After the initial consultation, all subsequent appointments will be bulk-billed, meaning there will be no out-of-pocket costs for you moving forward.

During this consultation, the surgeon will review your medical history and specific needs, provide detailed information about the scaffold trial, clarify any associated costs, and arrange for any necessary screening tests.

Surgery Costs

The estimated cost of the surgery itself ranges from $7,500 to $20,000. This variation depends on the complexity of your individual case and the procedures required. For example, a patient requiring a breast explant, breast reduction, and mastopexy may expect the cost to be closer to $20,000. In contrast, a patient needing only an explant or a breast reduction would likely see costs closer to $7,500.

Please note that the trial sponsor will cover the costs for the scaffold, autologous fat graft (AFG), and any imaging.

The trial process begins with applicants filling out an Expression of Interest (EOI). Upon approval by the Principal Investigator, participants undergo an initial consultation involving a comprehensive assessment of medical history, demographics, and photography, alongside informed financial consent. Screening tests such as pathology, ultrasound (US)/mammogram, and MRI are ordered at this stage. Subsequently, participants undergo reviews at 1 week, 3 months, 6 months, 12 months, 2-, 3-, 4-, and 5-years, which include ultrasound, MRIs and 3D imaging at some visits to monitor progress and outcomes throughout the trial period.

There are two locations in Australia that have been authorised to conduct the clinical trials.

New South Wales
Macquarie University Hospital & ISHCERF Centre, NSW, Australia

Queensland
Royal Brisbane and Women’s Hospital (RBWH), Brisbane, Australia

This clinical trial is conducted at:

Macquarie University and ISHCERF Centre
Principal Investigator: Prof. Anand Deva
Sponsored by: BellaSeno Pty Ltd (Study Sponsor)

Yes. This study has been reviewed and approved by the Macquarie University Human Research Ethics Committee.

Contact:

ethics.secretariat@mq.edu.au
+61 2 9850 4430

The study follows the National Statement on Ethical Conduct in Human Research (2023) to ensure your rights, safety, and wellbeing are protected throughout the process.

Every surgery carries some risks. Our top priority is to safely remove your existing implants and replace them with an absorbable scaffold, designed to integrate naturally with your own tissue.

Possible concerns include:

The appearance, size, and feel of your breasts may be different from what you’re used to with implants.
You may feel dissatisfied with the cosmetic result, which could cause emotional distress.
As with any surgical procedure, there are standard risks such as infection, healing complications, or scarring.

A detailed list of potential risks will be provided to you before you consent to participate. Your wellbeing will be closely monitored with regular assessments and questionnaires. You’ll always have support from the study team.

If new findings emerge that might affect your safety or change the way we run the study, your doctor will discuss these with you. You may choose to:

Continue with the study and sign an updated consent form
Withdraw from the study and return to your regular care

In some cases, your doctor may recommend withdrawal from the trial in your best interest.

Yes, but you must inform your study doctor about any medications, supplements, or alternative therapies you are using or begin to use during the study.

If you need medications related to side effects or symptoms during the trial, they will be provided at no cost. Any out-of-pocket costs from your GP or pharmacy will be reimbursed if directly related to the study.

You can withdraw at any time—before or after surgery.

If you withdraw after scaffold placement:

You are not required to have the scaffold removed but can discuss options with an independent surgeon if you wish.
Any post-withdrawal complications from the scaffold will still be managed at no cost to you.
Information collected up to the point of withdrawal will be retained to ensure proper scientific analysis, unless you state otherwise before giving consent.

If you are considering participating in another clinical trial, please speak to the study doctor first.

Yes. The trial may be paused or stopped if:

New safety concerns are identified
Unexpected device complications arise
You become pregnant during the study period

In any of these cases, your care will continue, and your doctor will support you through the next steps. If the scaffold is already placed, it may be left in place unless removal is necessary.

This trial is not compatible with pregnancy. If you become pregnant during the study, your participation will be stopped for safety.

There is no evidence that the scaffold material (PCL) is harmful to unborn babies, but its safety in pregnancy has not been studied. For this reason, we recommend using a reliable form of contraception during the trial. Your doctor can help you choose the most suitable option.

In the event you become pregnant during the study, your care will continue, and your doctor will support you through the next steps.

If your previous silicone implant capsule is still present, it will be removed and sent for pathology testing during your scaffold surgery.

If any lesions or unusual findings are discovered:

Your participation in the trial may be ended for safety reasons.
The scaffold may remain in place unless your doctor recommends otherwise.

Your privacy and confidentiality are strictly protected.

Personal health information will be de-identified and stored securely.
Only authorised study staff and relevant health authorities will have access.
Some health information and images may be shared with the study sponsor overseas or scaffold manufacturer (outside Australia), always under strict confidentiality rules.
You have the right to access or correct your information at any time.

Some information about your participation will be added to your hospital medical record, such as consent documentation and surgical details.

Models shown in the image are for illustrative purposes only and not intended to guarantee the aesthetic results shown. Designed by Freepik

Submit Your Expression of Interest

Clinical Trial: Scaffold-Based Soft Tissue Regeneration After Breast Implant Complications
at Macquarie University & ISHCERF Centre

We invite you to submit an Expression of Interest (EOI) below to begin your application or
register for future trial opportunities. Please note, to proceed to the EOI form, you will need the unique access token already provided to eligible patients.

This information will help us determine your eligibility for the clinical trial and allow us to
contact you for the next steps. Please read our Privacy Policy.

Yes, I Have A Token

TRIAL LOCATIONS

New South Wales:

Macquarie Plastic and Reconstructive Surgery Suite 301, 2 Technology Place Macquarie Park NSW 2109

Integrated Specialist Healthcare Education and Research Foundation (ISHCERF), Suite 2, Level 1, 531-533 Kingsway Miranda NSW 2228,
Australia