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www.abc.net.au/news/2022-08-04/world-first-breast-implant-reconstruction-trial-in-brisbane/101267356
World-first breast implant trial in Australia aims to provide safer alternative to silicone
By the Specialist Reporting Team's
Penny Timms and national medical reporter
Sophie Scott
Posted 2h ago2 hours ago
Moana Staunton is the first woman to trial the technology.(ABC News: Billy Cooper)
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Moana Staunton was struggling with health complications from breast implants when her doctor asked a surprising question: Did she want to be the first person in the world to trial a new technology that might one day revolutionise breast reconstruction and cosmetic surgery?
Key points:
- Brisbane surgeons have performed a world-first procedure replacing silicone implants with a bioresorbable scaffold
- Over the next two years the scaffold will dissolve, leaving the patient with breasts made of their own tissue
- Researchers hope the technology will be used for breast implant replacement and reconstructions in future
"I said yes," Ms Staunton says.
"I wasn't worried at all. I was excited. It wasn't about being the first, it was about helping people who needed to have this procedure."
Ms Staunton travelled to Thailand 11 years ago and got silicone implants with a friend.
Until recently, she absolutely loved them.
"We wanted to have our breasts done after having our children and so we did. We came out of that great," she said.
But as she got older, her desire to keep the implants faded.
For years she suffered from symptoms including brain fog and vertigo, which she believed were caused by the silicone implants.
"It was getting hard to drive and hard to think," she said.
Moana Staunton (right) hopes the research will help women who need reconstructions due to breast cancer.(Supplied: Moana Staunton)
Ms Staunton then discovered hers were part of a potentially faulty batch and had been recalled.
Doctors also recommend removing or replacing breast implants after about a decade.
Set on getting them removed, Ms Staunton sought the advice of Owen Ung, a Brisbane-based breast and endocrine surgeon at Metro North Health, and director of the Comprehensive Breast Cancer Institute.
After discussing her options, Professor Ung explained he was looking to start human trials for a new technology where her old implants would be replaced with a dissolvable breast scaffold.
About five weeks ago, she became the first human to have the procedure done, following successful animal trials.
World-first procedure could be a 'game changer'
In simple terms, scientists use a 3D printer to create a scaffold that looks like an intricately woven breast implant.
It's made from the same material used for dissolvable stitches.
Surgeons insert the scaffold into the breast area and inject it with the patient's own fat.
The scaffold then acts as a web that helps bind everything in place.
Over the two years after insertion, the scaffold will completely dissolve.
A medical-grade 3D printer, similar to this one, is used to create the scaffold.(ABC News: Billy Cooper)
In its place will be the patient's own newly-formed tissue and collagen, which should prevent the fat from being reabsorbed into the body — a common problem with fat grafting.
Thousands of Australians get silicone breast implants each year, and many women like Ms Staunton will experience complications or illness after the procedure.
The trial is in early stages, but the Brisbane-based team Professor Ung hopes the new technology could one day provide a safer and more natural alternative to silicone implants.
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"I think it will be a real game changer for women who are going to need treatment going forward. And then a real game changer for the surgeons that are delivering that treatment," Professor Ung said.
Since the surgery, Ms Staunton says all her strange illnesses have gone and that she's feeling great.
"My chest is light and I don't have vertigo or anything like that anymore," she said.
"Overall, it's been an excellent, amazing experience for me."
If Ms Staunton remains problem-free, doctors will include more women in the phase one trial — potentially expanding it to 15 to 20 people who are otherwise healthy.
Hopes technology could help cancer patients in future
This first phase of human trials is focused on people who have faulty implants that require removal.
"We are either removing problematic implants or restoring after one has been removed with this new scaffold, which is an entirely different technology," Professor Ung said.
Professor Owen Ung says the technology could be a "game changer".(ABC News: Billy Cooper)
However, Professor Ung would like subsequent trials to concentrate on women who required breast surgery due to cancer.
"The obvious long-term plan … is to help women who've had breast cancer, who need mastectomies, because that's an enormous clinical problem," he said.
"There's a need and we don't have a lot of other options."
Ms Staunton has a family history of breast cancer, and said possibly helping cancer patients down the track was the main reason she took part in the trial.
"My mother passed away from breast cancer when she was 48, I'm now 46. My sister has breast cancer," she said.
"For me, this is a no-brainer to help people with cancer."
Doctors stress there is still a long way to go before the scaffold technology is proven to be safe and effective.
Moana Staunton's mum died with breast cancer when she was 48.(Supplied: Moana Staunton)
If the trial does work, Professor Ung believes it could provide a more organic alternative for patients looking for breast augmentation or even reconstruction.
It could even reduce the chance of rejection of the implant.
"There are literally hundreds of thousands of women out there with silicone implants and silicone implants don't last forever," Professor Ung said.
"This is something that's going to be quite natural for women, it's their own body tissue. And will hopefully never need replacing."
The trial is the result of decades of research that originated in Australia, says plastic surgeon Michael Wagels, a key member of the research team and clinical director with the Herston Biofabrication Institute.
"It's not the kind of thing that we could necessarily have done 20 or 30 years ago when the [dissolvable stitching] product was first available because the 3D printing technology simply didn't exist," he said.
Michael Wagels says the scaffolding will help keep fat tissue in place.(ABC News: Billy Cooper)
Professor Wagels was also part of a team that performed a similar trial on patients with pectus excavatum — a common congenital chest issue where part of a person's breastbone is sunken into their chest.
The success of that study has provided him with hope for this one.
"This is what we would call a bio-fabricated approach to the problem of breast replacement," he said.
"We're trying to achieve ... something that is so innately part of the patient that it ultimately disappears, and what's left is the patient themselves, or their own tissue," he said.
Surgeon sees other possibilities for technology
At the moment, the custom-made scaffolds have to be made in Germany, because Australia does not have a medical grade 3D printing facility.
However, the experts hope medical advances like this one will soon change that.
A medical-grade 3D printer is used to create the scaffold, which gets inserted into the breast area.(ABC News)
Plastic surgeon Mark Ashton, a past president of the Australian Society of Plastic Surgeons, said the research was exciting work that made him proud to be Australian.
"This is people thinking literally outside of the square, thinking laterally," said Professor Ashton, who was not involved in this trial.
"It's taken tissue engineering and 3D printing to develop a shape that actually mirrors and individually matches the patient's defect."
Though, fat grafting or inserting the scaffold into an area that has undergone radiation therapy will be much more difficult and will need to be carefully considered, he cautioned.
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Professor Ashton sees a bright future for the technology in other applications.
"It also has wide-ranging implications in hidden neck cancer or jaw defects," he said.
"It has implications in road trauma and people who've had motorbike accidents and lost tissue in their lower limbs or other parts of their body.
"Anywhere where we do lose tissue and we are looking to try and replace that tissue, then this has enormous potential.
"I think we are seeing the start of a new paradigm, a new series of procedures and operations which really developed around this technology."
(20min delay)