BIOCHROMADERM® PMCF STUDY

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.