Metro North Health surgeons in Brisbane recently carried out a world-first trial of new technology replacing a woman’s silicone breast implants with 3D printed bioresorbable scaffolds that use the body’s natural regenerative capabilities.
The technology is based on over 10 years of fundamental and preclinical research led by Professor Dieter Hutmacher and an interdisciplinary team from QUT, the Herston Biofabrication Institute, Metro North Health’s Comprehensive Breast Cancer Institute, German-based medtech company BellaSeno, and many other partners, who set out to provide a safer alternative to permanent silicone implants.
Professor Hutmacher and his team used cutting-edge 3D printer technology to develop the biodegradable scaffold that guides the biological regeneration of a woman’s breast.
The 80 per cent porous scaffold is made from the same group of medical grade biomaterials used in dissolvable sutures by millions of patients every day.
The Metro North Health surgeons explanted a silicon implant which 46-year-old patient Moana Staunton received more than a decade ago and implanted the 3D printed biodegradable scaffold in combination with the patient’s own tissue in the same surgery session.
Director of the Comprehensive Breast Cancer Institute Owen Ung and Director of the Herston Biofabrication Institute Michael Wagels, both Metro North Health surgeons, joined forces for the ground-breaking procedure which was undertaken on 23 June 2022.
Metro North Health’s Professor Owen Ung said Moana was just one of many women who had experienced breast implant illness, noting a range of unexplained symptoms she believed were linked to her implants.
“In Moana’s case, she was experiencing dizziness and generally feeling unwell, and we’ll often see patients who believe their silicone implants may be making them ill,” Professor Ung said.
“But it’s not just those experiencing complications from their implants that will benefit, as we roll out our clinical trial in patients just like Moana. We will be moving into further studies for those who have experienced cancer, changing the lives of women who require a mastectomy and have limited reconstructive options until now.
“We are still in Phase One of clinical trials, but this work has hugely promising implications for women all over the world.”
The way the technology works is that the scaffold acts as a structural guiding template for the patient’s own tissue – in effect, it involves tissue growing around the scaffold, forming new breast tissue over time.
The scaffold is completely replaced by a patient’s new tissue after 3-4 years in a natural process similar to what happens with bioresorbable sutures.
Once dissolved, the patient’s own newly formed tissue will remain where the scaffold once was.
The solution aims to prevent the complications or illnesses that occur as a result of silicone breast implants.
Professor Hutmacher said the original research and design on the additive manufacturing – 3D printing – of biodegradable scaffolds started more than 20 years ago at the National University of Singapore.
“We originally focused on scaffold guided bone regeneration. That technology is commercialised by ASX listed medtech company Osteopore, of which I was also a founder and shareholder,” Professor Hutmacher said.
“We also had the idea that the technology would work with soft tissue.
“With my start as Professor and Chair for Regenerative medicine at QUT and my appointment as Hans Fischer Senior Fellow at the Institute for Advanced Studies at the Technical University of Munich (TUM), the late Professor Jan Thorsten Schantz and I started a scaffold guided breast tissue engineering program.
“This program was originally funded by TUM and QUT. A couple of years later we were awarded an Advance Queensland grant which allowed us to start preclinical studies.”
The research team received $705,000 in Advance Queensland funding in 2016 to develop an innovative Additive Biomanufacturing Technology Platform – the core 3D printer technology.
Professor Hutmacher said the Advance Queensland funding was essential for developing the printer technology and to perform the all-important preclinical studies.
“Breast reconstruction represents a major problem in the field of plastic surgery. Unfortunately, currently available clinical treatments and silicone-based filler materials for breast reconstruction following tumour removal sometimes yield unsatisfying results.
“Reconstructions using silicone-based implants may lead to complications such as fibrous capsule formation around the implant. In some cases, this may be associated with pain, soft tissue irritation via capsular contracture and lead – from a cosmetic point of view – to an undesirable appearance to the breast, while autologous fat tissue transplantation is associated with a high risk of tissue shrinkage, fat necrosis and/or oil cyst formation.
“The impetus has been gradually moving towards tissue engineering and regenerative medicine, which promise a complete regeneration of natural breast tissue using a biodegradable implant.
“So, we looked to additive printing of scaffolds as a potential solution. Our challenge was that our solution has to be economical, be reasonably quick while meeting stringent function requirements – such as strength stability, could degrade naturally over time – and could assist new tissue formation.”
Professor Hutmacher said additive manufacturing had already revolutionised industries, such as industrial design, aerospace and automotive.
“It has just started to also revolutionise health care.”
He said it would take another decade to get to the same level as other industries. But the outlook was good.
“We’re getting there as evidenced by this clinical trial. This is good news, providing hope for a lot of people.”
He said he was recently awarded a National Health and Medical Research Council (NHMRC) Senior Investigator grant, allowing him to work on the next clinical challenge.
“That is to load the scaffolds with antibiotics and innovative antibacterial coatings as well as load the scaffolds with chemo drugs for lumpectomy cases in which the tumour is removed and not the entire breast.”
Metro North’s Phase One clinical phase trial will recruit 15-20 eligible patients and will run until they each have two years of follow up.