BellaSeno’s Clinical Trial on 3D-Printed Breast Implants Shows Promising Early Results

Bioprinting firm BellaSeno has provided a public update on its ongoing clinical trial for resorbable breast scaffolding. The trial uses patients’ own fat with a 3D-printed scaffold, which gradually reabsorbs over three years, aiming for a fully natural breast reconstruction with no foreign materials left behind. This method offers a potential alternative to traditional breast implants, which introduce a permanent foreign object. BellaSeno’s approach could have broader applications in reconstructive procedures, with the potential to reshape the market for breast augmentation and reconstruction.

Approximately half of women receive breast reconstructions after mastectomies, while around four percent have breast implants in some countries. BellaSeno may be developing a procedure that is potentially safer, offering a more natural-looking and feeling breast, whether reconstructed or augmented. Beyond the financial potential, the company has the opportunity to make a significant positive impact. The FDA recently adopted a more stringent stance on implant safety, citing risks such as scarring, cases of non-Hodgkin’s lymphoma, and connective tissue diseases. If BellaSeno’s approach proves to be safer and more effective, both the company and women worldwide could benefit significantly.

Resorbable breast implants. Image courtesy of BellaSeno.

In its update, the company now describes how its correction procedures involve implanting polycaprolactone scaffolds. These scaffolds are manufactured centrally and then transported to the hospitals where the procedures are performed. While not fully customized, they are available in specific set sizes. Fat tissue is obtained from the abdomen or thighs through liposuction and is then injected into the scaffold during a two-hour operation. Currently, a two-year follow-up study is underway, and the company plans to provide more detailed results at the 93rd Annual Plastic Surgery Meeting.

The study is being conducted by BellaSeno’s Australian subsidiary and led by Professor Owen Ung, Professor of Surgery at the University of Queensland, alongside Dr. Matthew Cheng and Dr. Anand Deva, Professor at Macquarie University Health Sciences Centre. In this study, post-breast implant revision patients were treated with scaffolds. The company aims to assess patients’ quality of life and overall safety. The study followed 19 patients, with 12 available for a follow-up a year later. Thus far, there have been reports of infections and necrosis, but none of the complications typically associated with silicone implants, such as capsular contraction. The study also compared the overall breast volume when using the scaffold approach versus fat grafting alone. MRIs were used to evaluate the tissue, and the findings generally showed improved results and higher patient satisfaction.

New investigator-initiated clinical trials for BellaSeno’s resorbable implants. Image courtesy of BellaSeno.

“Our resorbable scaffold combined with an autologous fat graft offers a new solution. Over time, these scaffolds gradually resorb and allow the body to reconstruct natural tissue, resulting in a controlled, autologous regeneration process. This potentially results in a safer, more natural option which can be used in a broad range of indications, from aesthetic surgery for breast augmentation to breast cancer following mastectomy or lumpectomy,” said Tobias Grossner, BellaSeno´s Chief Medical Officer.

“Traditionally, breast augmentation and reconstruction have relied on silicone implants, which can lead to complications such as capsular contracture, implant rupture and, in rare cases, the development of breast implant-associated anaplastic large cell lymphoma,” contributed Professor Deva.

BellaSeno has been working towards making reconstructive surgery with 3D-printed PCL scaffolds a reality since 2015. Implementing this technology safely and effectively is a significant challenge, as it is capital-intensive and will take many more years to achieve widespread adoption. However, BellaSeno has substantial disruptive potential. If their results continue to hold up, the company could transform the breast implant market. This would mean that many women could be more satisfied with their bodies after life-changing procedures such as mastectomies. Millions of women worldwide could also benefit from increased safety, avoiding risks such as cancer and other adverse effects associated with traditional implants. Additionally, a more natural and safer option could provide greater peace of mind and satisfaction. The breast implant market is currently estimated to be worth around $3 billion. However, if BellaSeno’s procedures prove to be safer, more natural, and carry less stigma than breast implants, they could appeal to a broader range of women. Moreover, a similar approach could be applied to augment or reconstruct other parts of the body. BellaSeno’s work is fundamentally interesting, with the potential for significant implications in the field of reconstructive surgery.