A safer alternative to silicone implants has been unveiled in a world-first surgery delivered by Metro North Health surgeons in Brisbane, paving the way for women worldwide who require breast reconstructions.
The procedure is based on decades of research with a clinical patient trial undertaken on Moana Staunton, who had her silicone implants removed and replaced with 3D printed "bioresorbable scaffold" on June 23 this year.
It is made from a medical-grade material known as polycaprolactone-PCL, and was inserted in the breast area and injected with Ms Staunton's own fat cells.
The scaffold will completely dissolve and metabolise, leaving patients with their natural tissues in the body two years after insertion, and was jointly made by Metro North and German medtech company BellaSeno.
Director of the Comprehensive Breast Cancer Institute Owen Ung said Ms Staunton is one of many women experiencing breast implant illness with a number of unexplained symptoms believed to be 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," Prof 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."
BellaSeno's co-founder and CEO Mohit Chhaya said the regenerative breast scaffold is a milestone in the group's plans to ultimately design and manufacture these implants in Australia.
"Our goal is to further advance novel products in the field of natural tissue and bone reconstruction, working with our key partners in Australia such as Metro North Health," Dr Chhaya said.
"This key milestone would not have been achievable without the outstanding efforts of the entire BellaSeno team and our scientific advisers over the past five years."
The clinical phase one trial with Metro North will recruit 15-20 eligible patients and will run until they each have received two years of follow up.
Australian Associated Press
