Melodi Matrix™ in Breast Reconstruction

Inclusion Criteria:

• Female.

• Age 22 or older at the time of enrollment.

• Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic)with immediate two-stage post-mastectomy alloplastic prepectoral breastreconstruction.

• Is able to and willing to comply with the study requirements and providing informedconsent.

Exclusion Criteria:

• Has prior history of neoadjuvant radiotherapy.

• Has had prior history of failed tissue expansion or breast implantation at theintended reconstruction site.

• Has an active abscess or infection requiring antibiotics anywhere in their bodywithin 30 days.

• Has a Body Mass Index (BMI) < 14 or > 40.

• Is pregnant or is nursing; or plans to become pregnant during the course of thestudy.

• Has any connective tissue/autoimmune disorder or rheumatoid disease.

• Has known allergies to study device materials.

• Is participating in another interventional research study that may interfere withstudy endpoints.

• Has limited life expectancy or co-morbid conditions, social/psychological problems,or cognitive impairments that precludes participation.

• Has a medical condition or is taking medications that would result in elevated riskand/or affect the validity of the study.

• Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomyskin flap thickness or viability) for immediate, two-stage post-mastectomyalloplastic prepectoral reconstruction in any breast.