Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years

The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at 10 years. The primary objective is to evaluate the rate of women who had at least one re-intervention within the 10 years of follow-up. the secondary objectives are To evaluate the safety and performance outcomes of women who underwent breast augmentation and/or breast reconstruction using the Monobloc® - Silicone SoftOne® breast implants at 10 years Participants will have one follow-up visit during which data will be retrospectively documented at the following time points: preoperative visit, operative visit, follow-up 10 years

Inclusion Criteria: * Woman implanted with at least one Monobloc® - Silicone SoftOne® breast implants between 2011 to 2013 * Woman having received information and signed informed consent * Woman aged 18 years and older at the implantation * Woman affiliated to the health social security system Exclusion Criteria: * Pregnant or breastfeeding woman at the time of intervention * Woman under guardianship or curatorship * Woman under legal protection * Woman who refuses to participate * Woman unable to understand questionnaires * Woman with an active infection in the body at the time of intervention * Woman with a recent history of breast abscess at the time of intervention * Woman with an history of abnormal wound healing and scarring process * Woman with an immune system deficiency * Woman with a persistent or recurrent breast cancer * Woman with a lupus (e.g. acute disseminated lupus erythematosus) at the time of intervention * Woman with an uncontrolled diabetes or other disorder affecting wound healing at the time of intervention * Woman with tissue changes due to chest wall irradiation, skin grafts under tensile stress, or radical excision of the pectoralis major muscle. Woman with lymphorea at the time of intervention * Woman with a psychological instability characterized by inappropriate attitude or motivation at the time of intervention * Woman with lack of perception of the risks associated with the surgical procedure and the breast implant at the time of intervention * Woman with a benign or malignant breast tumor at the time of intervention * Woman with inadequate tissue coverage or tissue injury at the time of intervention * Woman with contraindication of non-emergent surgical procedures (biological, immunological, cardio-vascular