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

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