First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer

Inclusion criteria

• Criteria related to pathology:
• Female patient over 18 Years old
• Patient who required autologous breast reconstruction:
• Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
• Breast reconstruction after unilateral preventive total mastectomy
• or delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with a tissue expander implantation
• or conversion from implant-based to autologous reconstruction: Patient who had a breast implant during a previous reconstruction after total mastectomy for cancer, and who needs to change it.
• For patient with active cancer: Patient with early-stage cancer (stage 0, I or II, with tumor size \< 50mm, without lymph-node involvement) needing oncological management that does not required radiotherapy after surgery on the breast area or on the flap donor site
• Patient who required Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion; or implant removal for patient undergoing autologous conversion, or expender removal for patient undergoing differed reconstruction.
• Autologous reconstruction using Lateral Intercostal Perforator (LICAP) flap or an intercostal thoracic artery perforation flap (LTAP) if oncological conditions do not allow for LICAP harvesting.
• Patient medically fit for surgery without significant comorbidities
• Breast cup-size less than D
• Body mass index \>20 kg/m2 or patient for whom sufficient flap volume is expected according to surgeon's assessment
• Adequate hematopoietic functions
• Criteria related to population:
• Subjects who have given free, informed and written consent to participate in the study;
• Patient able to answer questionnaires, able to communicate in the language of the study country;
• Subjects affiliated to a social security schema or entitled to a social security scheme.
• Non-inclusion Criteria:
• Pathology related criteria:
• Patient undergoing bilateral reconstruction
• Patient undergoing bilateral preventive mastectomy
• Patient undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation
• Previous history of radiotherapy on the breast area or on the flap donor site
• Previous history of breast or axillary surgery that does not allow fat flap dissection
• Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI
• Body mass index \>30 kg/m2
• Taking medication for weight loss at the time of inclusion visit
• Presence of major medical conditions that may compromise patient's health and healing
• Diabetes and a history of gestational diabetes
• Active smoking
• Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease)
• Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination
• Allergy to anesthetics or contrast media
• Immunocompromised patient (HIV) or patient used immunosuppressants
• Population related criteria
• Pregnant patient
• or breastfeeding patient or woman who has nursed a child three months within inclusion
• Participation in a clinical trial in the 3 months prior to the initial visit
• Predicted unavailability during study.
• Patient deprived of liberty or under guardianship.
• Patient unable to give consent
• Medical device related criteria
• Allergy to any of the components of the medical device.

Exclusion criteria

• Positive or suspicious extemporaneous sentinel node biopsy
• Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler
• Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment