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

Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy

This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.

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)