BIOCHROMADERM® PMCF STUDY

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.