The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe

Inclusion Criteria: * Be female, greater or equal to 18 years of age * Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant * Be willing to undergo mastectomy with healthy, well vascularized skin flaps anticipated by the surgeon * Be in good health other than breast pathology and be suited to general anesthesia and planned treatments Exclusion Criteria: * 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 any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability * 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