The goal of this observational study is to: * To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; * To confirm the continued safety of BIOCHROMADERM®, * To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation * To assess the long-term performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 12 months post-pigmentation (Likert scale) * To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation * To assess fading (pigment retention potential) over 12 months * To assess the number of pigmentation adjustments needed per patient throughout the study duration * To assess patient's satisfaction/self-confidence evolution post-treatment, both in terms of general breast appearance and as to the specific dermo-pigmentation stage * To assess the correlation of the esthetic satisfaction/self-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation
Study Type
OBSERVATIONAL
Enrollment
115
Centre Oscar Lambret
Lille, France
NOT_YET_RECRUITINGHôpital de La Conception
Marseille, France
RECRUITINGInstitut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
NOT_YET_RECRUITINGTo confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation
Time frame: 3 months post-pigmentation
To confirm the continued safety of BIOCHROMADERM®
Time frame: 12 months
To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation
Time frame: 12 months
To assess the long-term performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 12 months post-pigmentation (Likert scale)
Time frame: 12 months
To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation
Time frame: 12 months
To assess fading (pigment retention potential) over 12 months
Time frame: 12 months
To assess the number of pigmentation adjustments needed per patient throughout the study duration
Time frame: 12 months
To assess patient's satisfaction/self-confidence evolution post-treatment, both in terms of general breast appearance and as to the specific dermo-pigmentation stage
Time frame: 12 months
To assess the correlation of the esthetic satisfaction/self-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation
Time frame: 12 months
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