Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy

Inclusion Criteria: * Female 18 years or older * A candidate for both arms of the study involving immediate breast reconstruction post-skin sparing mastectomy (unilateral or bilateral) DTI with the use of Strattice™ Reconstructive Tissue Matrix (TM), 2 stage with use of Tissue Expander through exchange to Implant without support of a mesh or autologous tissue) * An American Society of Anesthesiologists (ASA) Physical Status Classification of 1 or 2 * Estimated life expectancy \> 3 years * Able and willing to return for all scheduled and required study visits * Able to provide written informed consent for study participation Exclusion Criteria: * Clinically significant systemic disease, as determined by the Investigator, which could affect study participation or study results * Received neo-adjuvant, inductive chemo-therapy (except Herceptin, or other targeted therapy) within 4 weeks prior to mastectomy * Previous radiation therapy to either breast at any time * Predicted permanent implant size that is greater than or equal to 500 grams (gms), per Investigator assessment * Body mass index (BMI) \<17 or \> 30 * Co-morbid factors which predispose to postoperative infection, e.g. diabetes, collagen vascular disease, chronic steroid (except inhalers)/immunosuppressant use, immune deficiency, or co-existent infection * Pregnant or lactating * 3rd degree ptosis * Prior breast surgery including breast reduction, augmentation, mastopexy, quadrectomy, and partial mastectomy with reduction of the skin envelope * Prior use of a device (mesh or matrix) in the Breast * Concomitant unrelated condition of breast/chest wall/skin that, as determined by the investigator, could adversely affect the surgical outcome (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum) * Planned autologous tissue flap in addition to prosthetic implant * Use of permanent expander implants such as Becker expanders or the Natrelle™ Permanent expander 150 * Current alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction * Currently enrolled or plans to enroll in another clinical trial unless it is: a registry, a retrospective study, a neo-adjuvant chemotherapy trial (as long as the chemotherapy regimen has been stopped 4 weeks prior to mastectomy), or a hormone/anti-hormonal therapy trial * Any of the conditions identified within the labelled contraindications, i.e. sensitivity to porcine derived products or polysorbate 20.