Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

Exclusion Criteria

• •Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.
• •Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.
• •Axillary dissection planned as part of the breast lesion surgery.
• •History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.
• •Skin retraction at the breast to be operated.
• •Infection of the surgical site confirmed pre-operatively by clinical examination.
• •Abnormal blood sugar and glycosylated hemoglobin.
• •Hard smoker (more than 10 cigarettes a day).
• •Acute or chronic severe renal insufficiency (creatinine values \>180 μmol/l).
• •History of severe asthma or allergies (including allergy to anesthetics or contrast media).
• •Autoimmune disease.
• •Subjects who are known to be carriers of BCRA mutation.
• •Inability to undergo MRI or allergy to contrast media.
• •Systemic infections in an active phase.
• •Immunocompromised patients (HIV).
• •Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study.
• •Subject who has participated in another interventional study within the past 3 months.
• •Subject who received immunosuppressant therapy in the last 3 months.
• •History of substance abuse (drug or alcohol).
• •Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).