Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction

Inclusion Criteria: * Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant * Be female, between 18 and 65 years of age at the time of enrollment Exclusion Criteria: * Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study * Have undergone a skin reducing mastectomy * Have a BMI that is \<17 or ≥ 30 * Predicted implant weight more than 500 grams * Have a known allergy to silk * Have an abscess or active infection at any location within one month prior to surgery * Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study