World-first breast implant trial in Australia aims to provide safer alternative to silicone

Moana Staunton was struggling with the health complications of breast implants when her doctor asked a surprising question: Did she want to be the first person in the world to try a new technology that could one day revolutionize breast reconstruction and cosmetic surgery?

Key points:

Surgeons in Brisbane have performed a worldwide procedure to replace silicone implants with a bioresorbable scaffold.Over the next two years, the scaffold will dissolve, leaving the patient with breasts made of her own tissue.The researchers hope that the technology will be used for breast implant replacements and reconstructions in the future

“I said yes,” says Ms Staunton.

“I wasn’t worried at all. I was excited. It wasn’t about being the first, it was about helping people who needed this procedure.”

Ms Staunton traveled to Thailand 11 years ago and got silicone implants with a friend.

Until recently, I absolutely loved them.

“We wanted to get our breasts done after we had our kids so we did. It turned out great,” she said.

But as she got older, her desire to keep the implants faded.

For years she suffered from symptoms such as brain fog and vertigo, which she believed were caused by the silicone implants.

“It became difficult to drive and to think,” he said.

Moana Staunton (right) hopes the research will help women who need reconstruction due to breast cancer.(Provided by: 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.

Ready to have 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 that she was looking to start human trials for a new technology where her old implants would be replaced by a soluble breast scaffold.

About five weeks ago, he became the first human to have the procedure, after successful tests on animals.

World’s 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 is made of the same material used for soluble points.

Space for play or pause, M for mute, left and right arrows for search, up and down arrows for volume.Play the video.  Duration: 28 secondsFrom a 3D printed scaffold to new breasts, here’s the procedure.

Surgeons insert the scaffold into the chest area and inject it with the patient’s own fat.

The scaffolding then acts as a net to help tie everything in place.

During the two years following insertion, the scaffold will completely dissolve.

A scientist holds a complex, plastic-looking scaffold in the shape of a chest.A medical-grade 3D printer is used to create the scaffold, which is inserted into the chest area.(ABC News)

In its place will be the patient’s 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 every year, and many women like Ms Staunton will suffer complications or illness after the procedure.

The trial is in its early stages, but Brisbane-based Professor Ung hopes the new technology could one day offer a safer, more natural alternative to silicone implants.

“I think it’s going to be a real game changer for women who will need treatment in the future. And then a real game changer for the surgeons who are providing that treatment,” Professor Ung said.

Since the surgery, Mrs. Staunton says all her strange ailments have disappeared and she feels great.

“My chest is light and I don’t get dizzy or anything like that anymore,” she said.

“Overall, it’s been an excellent and amazing experience for me.”

If Ms. Staunton remains healthy, doctors will enroll more women in Phase 1 of the trial, possibly expanding it to 15 to 20 otherwise healthy people.

He hopes the technology can help cancer patients in the future

This first phase of human trials is focused on people who have faulty implants that require removal.

“We’re removing problematic implants or restoring one after we’ve removed one with this new scaffold, which is a completely different technology,” Professor Ung said.

Professor Owen Ung smiles slightly in an indoor portrait.Professor Owen Ung says the technology could be a “game changer”.ABC News: Billy Cooper)

However, Professor Ung would like further trials to focus on women who required breast surgery due to cancer.

“The obvious long-term plan … is to help women who have had breast cancer, who need mastectomies, because that’s a huge clinical problem,” he said.

“There’s a need and we don’t have many other options.”

Ms Staunton has a family history of breast cancer and said helping cancer patients was possibly the main reason she took part in the trial.

“My mother died of breast cancer when she was 48, I’m 46 now. My sister has breast cancer,” she said.

“To me, this is a no-brainer for helping people with cancer.”

Doctors stress that there is still a long way to go before scaffolding technology is proven to be safe and effective.

Moana was photographed as a child, smiling in a photo with her mother.Moana Staunton’s mother died of breast cancer when she was 48.Provided by: Moana Staunton)

If the trial works, Professor Ung believes it could provide a more organic alternative for patients seeking breast augmentation or even reconstruction.

It could even reduce the chance of implant rejection.

“There are literally hundreds of thousands of women with silicone implants and silicone implants don’t last forever,” Professor Ung said.

“This is something that will be quite natural for women, it’s their own body tissue. And hopefully it will never need to be replaced.”

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 of the Herston Biofabrication Institute.

“It’s not the kind of thing we necessarily could have done 20 or 30 years ago when [dissolvable stitching] The product first became available because 3D printing technology simply did not exist,” he said.

Michael Wagles in a smart business suit, looking serious in a lab.Michael Wagels says the scaffolding will help keep the fat tissue in place.ABC News: Billy Cooper)

Professor Wagels was also part of a team that carried out a similar trial in patients with pectus excavatum, a common congenital chest problem where part of a person’s sternum sinks into the chest.

The success of this study has given him hope for this one.

“This is what we would call a bio-fabricated approach to the breast replacement problem,” he said.

“We’re trying to get … something that’s so innately part of the patient that eventually it goes away, and what’s left is the patient themselves or their own tissue,” he said.

The surgeon sees other possibilities for the technology

For now, the custom-made scaffolds must be manufactured in Germany, because Australia does not have a medical-grade 3D printing facility.

However, experts hope that medical advances like this will soon change that.

Close-up of a foot of a 3D printer.A medical-grade 3D printer, similar to this one, is used to create the scaffold.ABC News: Billy Cooper)

Plastic surgeon Mark Ashton, past president of the Australian Society of Plastic Surgeons, said the research was exciting work that made him proud to be Australian.

“These are people who literally think outside the square, think laterally,” said Professor Ashton, who was not involved in the trial.

“It took tissue engineering and 3D printing to develop a shape that truly reflects and individually matches the patient’s defect.”

However, 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 warned.

Professor Ashton sees a bright future for the technology in other applications.

“It also has broad implications in occult neck cancer or jaw defects,” he said.

“It has implications in road trauma and in people who have been in motorbike accidents and lost tissue in their lower limbs or other parts of their body.

“Anywhere we’re losing tissue and we’re looking to try to replace that tissue, that has tremendous potential.

“I think we’re seeing the beginning of a new paradigm, a new set of procedures and operations that really developed around this technology.”

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