Clinical Research Directory

Inclusion Criteria: * Female or male ≥18 years old, * Requiring the reconstruction of the nipple-areola complex following mastectomy, * Affiliated or beneficiary of a social security scheme, * Able and willing to provide written informed consent to study participation. Exclusion Criteria: * Known allergy to pigment ingredients * Active, recent or prior history of skin disease, chronic skin disease, history of hypertrophic scars, skin infection or skin inflammatory disease, * Patients carrying a prosthesis (especially cardiac), * Patients presenting with a coagulation disorder, * Patients scheduled for an MRI within 6 months following pigmentation, * Patients scheduled for a skin esthetic treatment close to the pigmentation zone (laser, peeling, abrasion, ...) shortly after pigmentation, * Existing medical condition or organ pathology close to the skin that the Investigator considers may put the patient at risk or compromise their participation in the study, * Pregnant or breastfeeding female, * Currently participating to another clinical trial or having participated to a prior clinical trial within 1 month prior to inclusion into the present one, * Personal strong objection to medical tattooing, * Psychiatric illness/social situations that would limit ability to consent and/or to compliance with study requirements, * Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision. Note: The recent use of permanent wrinkle or lip filling products close to the scheduled pigmentation zone (silicon, PTFE, ...) is a contraindication in the approved product IFU but is not relevant to the breast reconstruction indication.