Abstract
BACKGROUND: Silicone breast implants have been widely used for breast augmentation and reconstruction. During this time, silicone breast implants have undergone several modifications to improve their safety, quality, and clinical performance. Complications such as reoperation, capsular contracture, and rupture are risks often associated with breast implants. OBJECTIVES: The authors conducted a retrospective study to analyze and report complication rates associated with Eurosilicone's (Eurosilicone S.A.S, Apt, Cedex, France) silicone gel-filled breast implants over a period of 5 years. METHODS: In this retrospective clinical study, 2151 women who underwent either breast augmentation or breast reconstruction with Eurosilicone breast implants were diagnosed. Data on early and late complications including implant removal (explantation/exchange), capsular contracture, and rupture were collected using questionnaires, completed by 39 surgeons across Italy. RESULTS: Of the 2151, only 60 patients (2.78%) required implant removal. Twenty-five patients experienced capsular contracture (Baker Grade III/IV), giving an actual rate of 1.2%. The actual rate of implant rupture confirmed by breast magnetic resonance images was 0.18% (4 implants). Six patients (0.27%) were diagnosed with breast cancer following breast augmentation, and local complications including hematoma (1 patient) and seroma (2 patients) were experienced. CONCLUSIONS: This retrospective clinical study involving Eurosilicone's round and anatomical textured silicone gel-filled mammary implants demonstrates an excellent safety profile through 5 years. Level of Evidence: 2.