Clinical trial

BREAST SCAFFOLD

Investigating a scaffold-based approach for breast implant revision surgery and soft tissue regeneration.

Select a button below to learn more or register your interest.

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

RECRUITMENT CURRENTLY UNDERWAY
Expressions of interest are being accepted for this study and for future clinical research opportunities.

RESEARCH STUDY APPROACH TO BREAST REVISION SURGERY

ABOUT THE CLINICAL TRIAL

This clinical trial is investigating the use of an absorbable, 3D-printed scaffold made from polycaprolactone (PCL) in combination with autologous fat grafting (AFG) for breast implant revision surgery.

PCL is a biomaterial that has been used in a range of medical applications, including absorbable sutures. In this study, the scaffold is intended to provide temporary structural support while tissue develops within and around the scaffold.

The purpose of this research is to evaluate the safety and performance of this investigational approach in patients undergoing breast implant revision procedures.

As with all clinical research, the outcomes of participation are being studied and cannot be guaranteed.

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Submit Your Expression of Interest

Thank you for your interest in this clinical research study.

This study is investigating a scaffold-based approach for patients undergoing breast implant revision surgery.

If you would like to learn more about this clinical trial or receive information about future breast scaffold clinical research opportunities, you may register your interest below via the “Register Interest” button.

Once registered, you may be provided with a unique access token that enables you to proceed to the next stage of the screening process when appropriate.

If you have already received a token from the research team, you may use it to access the Expression of Interest (EOI) and screening questionnaire by selecting the “I have a token” button below.

The information you provide will assist the research team in assessing your eligibility and determining whether you may be suitable for further screening. Submission of an Expression of Interest does not guarantee eligibility or enrolment in the study. Please read our Privacy Policy prior to submitting your information.

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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

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