To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
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.
Study Type
OBSERVATIONAL
Enrollment
223
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Baptist Medical Center South
Montgomery, Alabama, United States
Shoals Plastic Surgery
Muscle Shoals, Alabama, United States
Tierney Plastic Surgery
Nashville, Tennessee, United States
Ascension/Seton Institute of Reconstructive Plastic Surgery
Austin, Texas, United States
Occurrence of Events
Occurrence of: infection, hematoma, seroma, capsular contracture, mastectomy skin flap dehiscence, mastectomy skin flap necrosis, expander/implant explantation, red breast syndrome, subsequent surgical interventions related to the breast reconstruction process
Time frame: From date of surgery through study completion, an average of 9 months
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Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
DHR Health
McAllen, Texas, United States