How Australian woman will be offered state-of-the-art breast implants with ‘NATURAL tissue’ – after safety fears over traditional silicone models
- A new, safer alternative to silicone breast implants has been unveiled
- Australian surgeons are at the forefront of the important breakthrough
- Patients will be left with own natural tissues two years after insertion
A safer alternative to silicone breast implants has been unveiled and Aussie surgeons are at the forefront of the breakthrough.
The world-first surgery was done at Brisbane‘s Metro North Health hospital, 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.
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.
A safer alternative to silicone implants has been unveiled and Australian surgeons are at the forefront of the breakthrough (stock image)
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.’
Prof Ung said the research 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.
Common breast implant complications
Breast pain and sagging
Changes in nipple and breast sensation
Breast asymmetry (one side is a different size or shape to the other)
Displacement of implant
Can cause cancer in very rare cases
Source: NSW Health
‘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,’ he 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.
The development follows the closer scrutiny of closer of doctors who perform breast implant surgery, in a bid to protect women after decades of dangerous methods and bungled operations.
Robust new guidelines, issued by NSW Health in March, emerged as the Australian regulator launched a wide-ranging review of the billion dollar cosmetic surgery industry.
‘We have seen class actions, breast implant illness and women dealing with ongoing pain,’ Anand Deva, head of plastic and reconstructive surgery at Macquarie University, told Nine newspapers.
‘These guidelines put a bottom line on safety. Doctors need to get proper, educated, informed consent from patients and make sure women have regular check-ups so problems are picked up early,’ he said.
‘Too many patients regret implants.’
A 3D printed scaffold breast implant is seen during the announcement of a world-first surgery in Brisbane, paving the way for women worldwide who require breast reconstructions
An investigation revealed last year that serious safety and hygiene breaches were also made in medical facilities that left women in extreme pain.
Former president of the Australian Society of Plastic Surgeons Mark Ashton said it is vital that patients are made more aware of the potential risks.
He said that the industry lacked transparency on the qualifications of medical practitioners and that anyone with a medical degree, a GP or dermatologist can say they are a cosmetic surgeon.
Plastic surgery experts say women need more protection from unskilled medical practitioners
‘There is no transparency that some doctors are just unskilled in certain types of operations. We hope guidelines like these will be implemented Australia-wide,’ he said.
‘Guidelines are helpful, but they aren’t legally enforceable. We need AHPRA (Australian Health Practitioner Regulation Agency) to have real teeth to punish outliers in cosmetic care who are performing surgery outside the guidelines of accepted medical care.’