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.
Study Type
OBSERVATIONAL
Enrollment
650
The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
Dr Guillaume Lasserre
Villefranche-sur-Saône, France
RECRUITINGDScultp Clinic
Barcelona, Spain
RECRUITINGFrequency and rate of implant rupture
Time frame: 10 years
Frequency and rate of capsular contracture Baker III-IV
Time frame: 10 years
Rate of the secondary surgical procedures required for correction of complications
Time frame: 10 years
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
Time frame: 10 years
Patient satisfaction
This will be determined using a questionnaire assessing the qualify of life.
Time frame: 10 years
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