BellaSeno GmbH announced promising preliminary data from its clinical trial evaluating 3D-printed resorbable breast scaffolds at the 93rd Annual Plastic Surgery Meeting in San Diego, CA. The study, led by Professor Owen Ung, explores the use of medical-grade polycaprolactone (mPCL) scaffolds in women undergoing breast implant revision surgery.
The open-label, single-arm study (NCT05437757) involved replacing silicone implants with mPCL breast scaffolds filled with approximately 50% autologous fat graft. Key endpoints included safety, performance (volume sustenance), and patient satisfaction.
Enhanced Volume Retention and Safety Profile
Scaffolds were successfully implanted in all 19 patients. After a 12-month follow-up of the first 13 patients, the data analysis of the first 10 patients demonstrated significantly higher breast volume sustenance (80%) compared to autologous fat grafting alone (60%, literature control). Furthermore, MRI imaging confirmed good soft tissue retention at 12 months. Notably, there were no reports of explantations, infections, necrosis, or complications typically associated with silicone implants, such as capsular contraction.
Improved Patient-Reported Outcomes
Patient-reported outcomes revealed significant improvements in breast satisfaction, sexual well-being, and psychosocial well-being compared to pre-operative baselines, indicating a positive impact on patients' quality of life.
A Groundbreaking Option?
Professor Owen Ung stated, "We are excited by these results, which suggest that protected autologous reconstruction (PAR) using fully resorbable mPCL breast scaffolds to protect the fat graft by shielding it from the forces of surrounding tissue pressure could become a groundbreaking option for women seeking breast implant revision, augmentation or reconstruction." He added that this approach could provide predictable, natural, long-lasting results while eliminating the risks associated with permanent implants. The company plans to expand the study into an international multi-center trial.
Addressing the Limitations of Silicone Implants
Professor Anand Deva highlighted the limitations of traditional silicone implants, which can lead to complications such as capsular contracture, implant rupture, and, in rare cases, breast implant-associated anaplastic large cell lymphoma. BellaSeno's resorbable scaffold combined with an autologous fat graft offers a novel solution, allowing the body to reconstruct natural tissue over time. PD Dr. med. Tobias Grossner, Chief Medical Officer of BellaSeno, stated that this approach potentially results in a safer, more natural option for a broad range of indications, from aesthetic surgery to breast cancer reconstruction.
This clinical trial builds upon previous preclinical research and a successful first-in-human study for pectus excavatum correction using the same scaffold technology, which received EU Market Authorization in 2023. The study team will continue to monitor patients to assess the long-term safety and performance of the mPCL scaffolds.
