Breast cancer is one of the most common forms of cancer among women. A mastectomy, i.e. the removal of the breast, is often recommended as part of cancer treatment. Many women who opt for this procedure have to deal not only with the physical consequences of surgery but also, in the longer term, with a huge amount of psychological stress. In Germany, measures taken to restore the breast form part of one of the most common surgical reconstruction procedures. Traditional reconstruction measures, however, continue to be accompanied by countless complications and side effects, including severe fibrotic reactions to exogenous implants, the emergence of capsular contracture that gives the breast an unnatural appearance and also tissue loss. This results in more stress for the patient and the need for additional, costly corrective surgery.
The company BellaSeno GmbH is working with partners to develop an innovative procedure that avoids the above-listed drawbacks of breast reconstruction while restoring the breast tissue in a natural way. In order to do this, state-of-the-art 3D manufacturing processes are combined with established biocompatible materials and surgical techniques.
With the help of 3D laser scanning, the patient's breast area is first evaluated and measured. Software is then used to turn these measurements into a computer model which the treating physician can use to model the implant. Finally, a 3D bioprinter produces the implant using medical grade polycaprolactone (mPCL) – a biodegradable polymer already used in various kinds of surgical applications. These novel implants are placed in the body in exactly the same way as conventional products. The porous structure encourages the surrounding tissue to form blood vessels. This approach is complemented by an autologous fat transfer procedure (injecting the patient's own fat under the skin). Tissue regeneration is stimulated; firstly, as the implant's pores give the adipose cells plenty of space and dimensional stability and, secondly, because the vascularization gives cells a direct nutrient supply. The scaffold gradually degrades as the tissue regenerates, ultimately being replaced with natural breast tissue.
Various development stages are yet to be completed before this procedure can be applied to patients. BellaSeno GmbH is being supported here by the Fraunhofer Institute for Cell Therapy and Immunology. The institute is responsible for evaluating safety in accordance with ISO 10993 and for developing a clean-room based ISO 13485 compliant manufacturing process for the production of BellaSeno implants. Dresden-based company GeSim mbH will further develop the manufacturing technology with an eye to optimizing production rate and capacity. Leipzig University is also involved in the project, carrying out preclinical, long-term studies to review the toxicology and biocompatibility of the implants, while their mechanical properties are being simulated and validated by the company Leichtbau-Zentrum-Sachsen GmbH.