The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

Exclusion Criteria

• •The subject must not:
• •Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
• •Have a known allergy to silk
• •Have collagen-vascular, connective disease, or bleeding disorders
• •Have a Body Mass Index (BMI) that is greater than or equal to 35
• •Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
• •Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer
• •Have smoked within the last 12 months
• •Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
• •Be pregnant, lactating, or expecting to be within the next 24 months
• •Have concomitant unrelated condition of breast/chest wall/skin
• •Have an abscess or infection at the time of surgery
• •Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
• •Have had a prior soft tissue support device implanted in the breast
• •Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.