Porcine Acellular Peritoneal Matrix in Immediate Breast Reconstruction: A Multicenter, Prospective, Single-Arm Trial.

Abstract

Use of biological implants such as acellular dermal matrices in tissue expander breast reconstruction is a common adjunct to submuscular implant placement. There is a paucity of published prospective studies involving acellular matrices. The authors sought to evaluate a porcine-derived acellular peritoneal matrix product for immediate breast reconstruction. A prospective, single-arm trial was designed to analyze safety and outcomes of immediate tissue expander-based breast reconstruction with a novel porcine-derived acellular peritoneal matrix surgical mesh implant. Twenty-five patients were enrolled in this industry-sponsored trial. Patient demographics, surgical information, complications, histologic characteristics, and satisfaction (assessed by means of the BREAST-Q questionnaire) were evaluated. Twenty-five patients (44 breasts) underwent mastectomy with immediate breast reconstruction using tissue expanders with acellular peritoneal matrix. Sixteen reconstructed breasts experienced at least one complication (36 percent). Seroma and hematoma occurred in one of 44 (2.3 percent) and two of 44 breasts (4.6 percent), respectively. Wound dehiscence occurred in four of 44 breasts (9.1 percent). Three subjects experienced reconstruction failure resulting in expander and/or acellular peritoneal matrix removal (6.8 percent); all failures were preceded by wound dehiscence. Histologic analysis showed cellular infiltration and product resorption. Results of the BREAST-Q demonstrated a level of postoperative patient satisfaction consistent with results in the available literature. Prepared porcine-derived acellular peritoneal matrix is a safe adjunct in immediate two-stage tissue expander-based breast reconstruction. Further studies are required to determine efficacy compared to current commercially available acellular matrices. Therapeutic, IV.