The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or revision of breast augmentation or breast reconstruction.
The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended.
Genetic female subjects aged between 18 and 65 years old.
Subjects with a BMI >35.
Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.
Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer-related clinical studies.
Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.
Patients from centers participating to the study.
Cohort
Prospective
Breast augmentation surgery
Procedure/SurgeryThe procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
Breast reconstruction surgery
Procedure/SurgeryThe procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
Frequency and rate of implant rupture
Frequency and rate of capsular contracture Baker III-IV
Rate of the secondary surgical procedures required for correction of complications
Rate and frequency of local complications
These complications may be related to the device itself or to the surgical procedure: * Capsular contracture of Baker Grade I-II * Haematoma * Rupture * Seroma * Severe and continuing pain * Post-operative infection * Explantation as a result of infection * Implant displacement/extrusion * Implant misplacement/malrotation * Wrinkling/folds * Breast Implant Associate Anaplastic Large Cell Lymphoma * Breast Implant Ilness (BII)/ Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants (Asia) * Delayed or abnormal wound healing occurring within the first 3 months of surgery * Any other complications considered by the Investigator to be related to the device or surgical procedure
Patient satisfaction
This will be determined using a questionnaire assessing the qualify of life.
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