William J. Casey, III, M.D.

This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.

The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Retrospective Arm.

The purpose of this study is to evaluate the safety and effectiveness of the Mentor MemoryGel® larger size ultra high profile breast implants for patients who are undergoing primary or revision reconstruction surgery.

The purpose of this study is to identify the prevalence of malnutrition and patients most at risk for nutritional deficiency within those presenting for plastic surgery and how it may affect their clinical outcomes.