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

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.

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.

What this study is about