A New Human-Derived Acellular Dermal Matrix for Breast Reconstruction Available for the European Market: Preliminary Results.

ABSTRACT

INTRODUCTION: The introduction of acellular dermal matrices (ADMs) contributed to the growing diffusion of direct-to-implant breast reconstruction (DTI-BR) following mastectomy for breast cancer. According to specific legislations, European specialists could not benefit from the use of human-derived ADMs, even though most evidence in the literature are available for this kind of device, showed optimal outcomes in breast reconstruction. The Skin Bank of the Bufalini Hospital (Cesena, Italy) obtained in 2009 the approval for the production and distribution of a new human cadaver-donor-derived ADM (named with the Italian acronym, MODA, for matrice omologa dermica acellulata) from the Italian National Transplant Center and National Health Institute. We report preliminary results of MODA application in direct-to-implant breast reconstruction following nipple-areola complex (NAC)-sparing mastectomy for breast cancer treatment. MATERIALS AND METHODS: We prospectively enrolled all women undergoing NAC-sparing mastectomy for breast cancer and DTI-BR in our breast surgical unit from June 2015 to January 2017. We enrolled a selected population without previous chest wall irradiation, not being heavy tobacco smokers or diabetic, with a BMI < 30 kg/m2 and requiring less than 550 cc silicone implants. We assessed short-term outcomes, defined as postoperative complications presenting in the first 30 postoperative days and long-term outcomes at 6 and 12 months. RESULTS: From June 2015 to January 2017, we treated 56 breasts. At a mean follow-up of 14 months, we observed only two minor complications described as limited wound dehiscences, conservatively managed with complete resolution without implant exposure or re-intervention. CONCLUSIONS: Our preliminary results show very good performance of MODA in direct-to-implant breast reconstruction following NAC-sparing mastectomy for breast cancer treatment. This is particularly relevant for the European market, where no other human-derived devices are available for breast reconstruction due to regulatory restrictions. LEVEL OF EVIDENCE IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .