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About 15 years ago, an email from a PhD student with a bold idea dropped into the inbox of Professor Anand Deva.
“It said something like: I’ve got this idea about using an absorbable breast scaffold to encourage tissue regeneration,” Deva recalled.
The plastic and reconstructive surgeon had not yet become a beacon for women with breast implant complications. But they would soon come from across Australia and overseas with ruptures, infections and a constellation of symptoms linked to breast implant illness.
The student, Mohit Chayya, was pitching a solution for a problem that would soon inundate Deva’s practice: women with silicone breast implant complications, ruptures, infections and a constellation of breast implant illness symptoms.
“My reply was: Yeah, yeah, best of luck. Call me in 10 years when you’re ready for patient trials,” said Deva, the Head of Plastic and Reconstructive Surgery at Macquarie University.
A world-leading researcher in breast surgery complications and safety, Deva knew that there were myriad hurdles between idea and approved medical device.
But on Monday, Deva will use 3D-printed scaffolds for the first time on women who have never had silicone implants in a pivotal trial to assess their safety and performance.
“Now I’ve swooped in for the glory,” joked Deva of the trial sponsored by the scaffold’s medtech company, BellaSeno.
Forty-two Australian women have had their silicone implants replaced with the half-moons of white lattice, their bodies acting as bioreactors as the scaffold slowly dissolves, leaving behind their own regenerated fat tissue.
Ultimately, the researchers and Chayya – BellaSeno’s co-founder and chief executive – say they hope the scaffolds will offer breast cancer patients an alternative after lumpectomies and mastectomies.
“The end goal for us is to help patients like my grandma, who have no options,” Chayya said of his grandmother, Bansari, who lived with a deformity left by a lumpectomy to treat breast cancer in Gujarat, India.
“I could see the struggle that she had mentally and psychologically,” he said.
The scaffold’s crisscross pattern of bands and tiny filaments is made of a polymer called polycaprolactone, which has been used for decades in absorbable sutures used to stitch up wounds and surgical incisions.
“It’s 90 per cent porous,” Chayya said. The smallest size – 100 cubic centimetres – weighed 10 grams.
The procedure is similar to that of silicone implants, but with an extra step. The surgeon uses liposuction to harvest fat from the patient’s abdomen, buttocks or thighs and injects it into the scaffold, filling up to 50 per cent.
“Fat is a cocktail of a lot of really good cells – growth factors, small blood vessels and stem cells, which grow and multiply along the scaffold, filling up the remaining space,” Chayya said. The body gradually absorbs the scaffold over two to three years, leaving just the tissue.
“The regenerative process is incredible,” Deva said, “[unlocking] the body’s own capacity to heal and produce its own tissue with no footprint of the thing a year or two later.”
The lightness of the scaffold surprised trial participant Katrina Taylor as she palmed the device in Deva’s office.
Five months after undergoing the procedure, Taylor said she forgets they’re in there.
“If I touch [my chest], they feel firm because they haven’t absorbed yet … they look so natural,” she said.
Taylor was 36 when she got her first set of breast implants after having children. A decade later, they had ruptured, causing severe chest pain.
She would have two breast implant revisions. Then she developed a procession of alarming symptoms: pleurisy (inflammation of the membrane lining the lungs and chest wall) that caused stabbing pains, frequent migraines, fatigue, extreme hair loss, body rashes, sore joints, muscle weakness and bowel problems.
“I was 53 years old, and I felt like I was going crazy,” Taylor said. “No one could give me any answers, and I was at the stage where I thought: I don’t know if I can do this any more.”
Taylor recognised her symptoms in a news article about breast implant illness.
“I thought, I’ve got to have them out,” Taylor said. Within months of her explant surgery with Deva: “I was back to my normal self”.
Taylor was eager to take part in the trial: “If there’s something else that could give women other options, I wanted to help,” she said.
Reconstructive surgeon Professor Owen Ung has performed 19 breast augmentations with the BellaSeno scaffold on women who had silicone implants as part of a phase 1 safety trial with a two-year follow-up.
“These patients didn’t have an alternative because they were having all sorts of trouble with their implants,” said Ung, Director of the Comprehensive Breast Cancer Institute at Metro North Health.
“When you remove an implant, you don’t always go back to what you would have looked like beforehand,” Ung said. “Older women can be left with quite a big defect from where the implant used to be,” and not all women have enough fat for a fat transfer augmentation.
“I can see hundreds of thousands of women across the world having these.” Ung said.
The trial results – presented at an Australasian Society of Aesthetic Plastic Surgeons conference in Boston in May have not yet been submitted for peer review – found participants retained 83 per cent of their breast volume since their surgeries, and there were no serious adverse events.
Dr Tony Connell, a leading plastic and reconstructive surgeon in Perth, said the trial results were impressive, and he was hopeful that the scaffolds could be an invaluable option.
“There will be patients not suited for this who need more volume than the scaffolds can provide … but imagine if I could say to women: ‘we could take our implant out and safely put in a bio scaffold and your own fat’. It’s a very promising thing.”
First it was critical to ensure the researchers discovered what the scaffolds looked like with imaging to detect one of the most common cancers in women.
“It stands to reason that some women with scaffolds will get breast cancer, and we need to be able to investigate them in the same way we would anybody else,” Ung said.
A total of 106 women will take part in the pivotal trial, including three-monthly MRI scans.
Deva’s surgery on Monday marks the next step in safety and performance testing, expanding the trial to 53 women who have never had implants.
“We’re not there yet,” said Deva, also the Director of the Integrated Specialist Healthcare Education & Research Foundation (ISHCERF).
“No device should be rushed to market without adequate independent scientific and clinical evaluation,” he said, recalling the significant harm caused to women with transvaginal mesh, which bypassed rigorous clinical trials.
“This is not about replacing silicone implants, which serve the majority of women very well … It’s about giving them another option.”
Pending trial results and Therapeutic Goods Administration approval, Chayya hoped the scaffolds could be available for women after implant removal from 2028, followed by women who never had implants.
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