An Open, Multi-center Study Evaluating Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast

简要总结

主要结局

次要结局

• to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS.(24 months)
• To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.(24 months)
• to evaluate pain experience during injection under local anesthesia.(during injection)
• To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary.(2 weeks)
• to study the implant duration and localization as documented by MRI.(24 months)
• to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire.(24 months)
• To evaluate any difficulties with the interpretation of the mammography image(s)or ultrasonography due to the presence of the implant 24 months after the initial treatment(24 months)
• Re-treatment phase: To evaluate the safety documented by physical examination and by adverse events reported up to 24 months after re-treatment and by mammography and ultrasonography examinations 15 and 39 months after re-treatment.(39 months)
• Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.(2 weeks)
• Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 24 months after last treatment between subjects that have received only one treatment and subjects that have received re-treatment.(24 months)
• Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 12 and 24 months after initial treatment between subjects that have received only one treatment and subjects that have received re-treatment.(24 months)
• Re-treatment phase: To evaluate any difficulties with the interpretation of the mammography image(s) or ultrasonography due to the presence of the implant 24 and 48 months after the initial treatment (15 and 39 months after the re-treatment).(48 months)
• Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment.(24 months)
• Re-treatment phase: To evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS up to 24 months after re-treatment.(24 months)
• Re-treatment phase: To evaluate, up to 24 months after re-treatment, the subjects satisfaction with her breast and general appearance using a subject questionnaire.(24 months)
• Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia.(During re-injection)
• Re-treatment phase: To evaluate if there are differences in esthetic improvement, subject satisfaction and implant duration, after re-treatment compared to after initial treatment. The visits up to 9 months will be compared.(9 months)