The SurgiMend PRS Retrospective Study

Study Overview
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Brief Summary
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The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.

Official Title
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A Multi-Center, Retrospective Review of Implant-Based Post Mastectomy Breast Reconstruction Utilizing SurgiMend® Collagen Matrix in Prepectoral and Submuscular Surgical Approaches

Conditions
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Reconstructive Surgical Procedures

Intervention / Treatment
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* Device: SurgiMend PRS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SurgiMend PRS|SurgiMend® PRS and SurgiMend® PRS Meshed are intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® PRS and SurgiMend® PRS Meshed are specifically indicated for plastic and reconstructive surgery, including breast reconstruction.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of SurgiMend | The primary endpoint of this study is the proportion of patients who did not require additional surgical interventions at or associated with the site of the original reconstruction within 12 months after SurgiMend® PRS or SurgiMend® PRS Meshed implantation. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of SurgiMend | The secondary endpoint of this study is the occurrence of relevant (S)AEs within 12 months of SurgiMend® PRS or SurgiMend® PRS Meshed implantation. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction