According to the International Society for Aesthetic and Plastic Surgery (ISAPS), breast augmentation surgery represents one of the leading aesthetic surgical procedures in the world, with about 1.35 million of first breast augmentation surgeries and about 280,000 breast surgery revisions performed in 2014. In the same year, we estimated that around 230.000 people underwent reconstructive surgery after mastectomy (tumor resection), in order to improve the results of the intervention. These figures do not yet consider the 5 to 10 million women worldwide who have already breast implants that will need to be substituted.
Today, the most common treatment for breast tissue defects makes use of silicone implants. This technique does not reconstruct the lost fat, but only replace it and therefore does not represent a permanent solution. In fact, they need additional surgical interventions to be replaced approximately every 10/15 years. Silicone implants technology is more than 35 years old and brings with it a number of risks, among others their rupture (approx. 30% of incidence), leakage and capsular contracture.
Several scientific studies and researches claim that innovative biomaterials, used as a graft substitute, could offer a good solution for the issues identified in reconstructive and aesthetic surgery, but today this option is limited to small defects mainly due to the insufficient vascularization of the materials used to fill tissue defects. Vascularization is the ability to promote blood vessel penetration and formation in a tissue. Without vascularization, nutrients and oxygen cannot reach the cells inside the scaffold, rapidly causing tissue necrosis and consequently volume loss.
REGENERA, developed by Tensive, is a versatile bioactive and bioabsorbable polymeric scaffold characterized by an interconnected open-pore structure and an internal 3D micro-vascular channel network. The combination of these factors enables, after implantation in-vivo, cell penetration, early vascularization and maturation of stable and viable autologous tissue inside the scaffold. This innovative prosthesis aims to restore a totally natural breast to oncological patients who experienced reconstructive surgery after lumpectomy (tumor and part of surrounding tissue resection) or mastectomy (total breast removal), solving the current problems related mostly to the use of silicone implants.
