Breast Cancer Clinical Trial
A Retrospective Breast Reconstruction Study
Summary
To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
Full Description
This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.
A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.
Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.
Eligibility Criteria
Inclusion Criteria:
Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.
Exclusion Criteria:
Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
Female patient who underwent delayed breast reconstruction procedure.
Female patient who underwent revision of previous breast reconstruction procedure.
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There are 5 Locations for this study
Montgomery Alabama, 36116, United States
Muscle Shoals Alabama, 35661, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78731, United States
McAllen Texas, 78504, United States
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