SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy

Inclusion Criteria: * Patient is at least 18 years of age * Patient is female * Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS * Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy \& reconstruction) * Patient utilized a textured expander only * Patient utilized a smooth gel permanent implant only * Patient has agreed and is able to comply with the study follow-up requirements * Patient or guardian has provided consent for participation Exclusion Criteria: * Patient is undergoing single-stage breast reconstruction * Patient is undergoing a delayed reconstruction * Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant. * Patient is undergoing planned reconstruction using autologous tissue * Patient has a known hypersensitivity to collagen or bovine derived materials * Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study * Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)