The SurgiMend PRS Retrospective Study

Inclusion criteria

• The patient has reviewed the ethics-approved consent form and has provided consent for data collection
• Subject is a female over the age of 18 at the time of index surgery (mastectomy)
• Subject had mastectomy performed for cancer or as a cancer prophylaxis
• The surgical plan included one of the following approaches:

• Immediate unilateral or bilateral prepectoral DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skinreducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
• Immediate unilateral or bilateral submuscular DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skin-reducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
• If subject received bilateral breast reconstruction, the subject must have received the same surgical technique for both breasts including the implantation of SurgiMend® PRS or SurgiMend® PRS Meshed
• If subject received unilateral breast reconstruction, there was no surgical intervention on the contralateral breast within 12 months post-operatively
• Subject underwent mastectomy (index surgery) at a minimum of 24 months prior to study initiation at site

Exclusion criteria

• The surgical plan included muscle flaps to supplement the breast mound
• The reconstruction plan included hybrid implant coverage with another type of mesh (e.g., use of another mesh or ADM in addition to SurgiMend®)
• Subject had received prior breast augmentation, mastopexy, or breast reduction surgeries (does not include breast biopsy)
• Subject was a user of any nicotine products (cigarettes, chewing tobacco, vapor, etc.) (within 6 weeks before index surgery)
• Subject had uncontrolled Type I or Type II diabetes (HbA1C >9)
• Subject had previously undergone radiation therapy to the chest wall prior to index surgery
• Subject had been diagnosed with advanced stage disease (stage 3 or 4, or inflammatory cancer)