This study seeks to determine human host response to fetal bovine acellular dermal matrix (ADM) in staged implant-based breast reconstruction.
A prospective study was performed for patients undergoing immediate breast reconstruction with tissue expander placement and SurgiMend acellular fetal bovine dermis. At the time of exchange for permanent implant, we obtained tissue specimens of SurgiMend and native capsule. Histological and immunohistochemical assays were performed to characterize the extent of ADM incorporation/degradation, host cell infiltration, neovascularization, inflammation, and host replacement of acellular fetal bovine collagen.
Seventeen capsules from 12 patients were included in our study. The average “implantation” time of SurgiMend was 7.8 months (range, 2–23 months). Histological analysis of the biopsy of tissue revealed rare infiltration of host inflammatory cells, even at 23 months. One patient had an infection requiring removal of the tissue expander at 2 months. Contracture, inflammatory changes, edema, and polymorphonuclear leukocyte infiltration were rare in the ADM. An acellular capsule was seen in many cases, at the interface of SurgiMend with the tissue expander.
SurgiMend demonstrated a very infrequent inflammatory response. An antibody specific to bovine collagen allowed for direct identification of bovine collagen separate from human collagen. Cellular infiltration and neovascularization of SurgiMend correlated with the quality of the mastectomy skin flap rather than the duration of implantation. Future studies are needed to further characterize the molecular mechanisms underlying tissue incorporation of this product.
From the *Division of Plastic and Reconstructive Surgery, Department of General Surgery, and †Department of Pathology, Stanford University Medical Center, Stanford, CA.
Received October 31, 2012, and accepted for publication, after revision, November 15, 2012.
Conflicts of interest and sources of funding: Supported by TEI Biosciences Inc.
Reprints: Gordon K. Lee, MD, Division of Plastic and Reconstructive Surgery, Department of General Surgery, Stanford University Medical Center, 770 Welch Rd, Suite 400, Stanford, CA 94304-5715. E-mail: firstname.lastname@example.org.