SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

Inclusion Criteria: * Negative nicotine test at screening visit * Previous augmentation with silicone-filled or saline-filled breast implants requiring Revision Augmentation surgery for increased nipple:inframammary fold distance * Well vascularized skin flaps that can be approximated without tension Exclusion Criteria: * BMI (Body Mass Index) that is ≥ 30 kg/m2 * Active smoker or have smoked within 6 weeks prior to screening visit * Pregnant or nursing * Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy * Carcinoma of the breast * Previous mastectomy or lumpectomy * Abscess or infection in the body at the time of enrollment * Had any disease, including uncontrolled diabetes (e.g., HbAIc \> 8%), that is clinically known to impact wound healing ability. For example: collagen-vascular, connective tissue or autoimmune disorders (e.g., Systemic Lupus, Rheumatoid Arthritis, Scleroderma) * Subjects with diagnosed diabetes must have HbAIc ≤ 8% within 3 months of enrollment * Showed tissue characteristics that were clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration * Had, or was under treatment for, any condition that may have constituted an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems) * History of prior implantation of any surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) in the breast * Implantation of any non-SERI® surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) during the study period * Product contraindications for use of SERI® Surgical Scaffold per the supplied package insert (e.g., hypersensitivity to silk)