Safety

Safety and performance data collected through our robust Post-Market Surveillance System confirm that SmoothSilk^®/ SilkSurface^® contributes to superior post-operative outcomes, with patients reporting fewer high- and low-risk complications. In particular, the data demonstrates a very low (less than 1 %) capsular contracture rate in patients with SmoothSilk^®/SilkSurface^®.
Additionally, this surface has been associated with a healthy tissue capsule formation and a significantly low expression of pro-inflammatory immune factors, key for optimal patient recovery and a lower risk of post-operative complications associated with excessive and prolonged inflammation.