Allograft vs Xenograft Bioprosthetic Mesh in Tissue Expander Breast Reconstruction: A Blinded Prospective Randomized Controlled Trial.

ABSTRACT

BACKGROUND: With the increased use of acellular dermal matrix (ADM) in breast reconstruction, the number of available materials has increased. There is a relative paucity of high-quality outcomes data for use of different ADMs. OBJECTIVES: The goal of this study was to compare the outcomes between a human (HADM) and a bovine ADM (BADM) in implant-based breast reconstruction. METHODS: A prospective, single-blinded, randomized controlled trial was conducted to evaluate differences in outcomes between HADM and BADM for patients undergoing immediate tissue expander breast reconstruction. Patients with prior radiation to the index breast were excluded. Patient and surgical characteristics were collected and analyzed. RESULTS: From April 2011 to June 2016, a total of 90 patients were randomized to a mesh group, with 68 patients (HADM, 36 patients/55 breasts; BADM, 32 patients/48 breasts) included in the final analysis. Baseline characteristics were similar between the 2 groups. No significant differences in overall complication rates were identified between HADM (n = 14, 25%) and BADM (n = 13, 27%) (P = 0.85). Similar trends were identified for major complications and complications requiring reoperation. Tissue expander loss was identified in 7% of HADM patients (n = 4) and 17% of BADM patients (n = 8) (P = 0.14). CONCLUSIONS: Similar complication and implant loss rates were found among patients undergoing immediate tissue expander breast reconstruction with HADM or BADM. Regardless of what material is used, careful patient selection and counseling, and cost consideration, help to improve outcomes and sustainability in immediate breast reconstruction.