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

This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.

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