A New Human-Derived Acellular Dermal Matrix for Breast Reconstruction Available for the European Market: Preliminary Results.
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
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['Folli|Secondo|S|', 'Curcio|Annalisa|A|', 'Melandri|Davide|D|', 'Bondioli|Elena|E|', 'Rocco|Nicola|N|http://orcid.org/0000-0001-6941-7873', 'Catanuto|Giuseppe|G|', 'Falcini|Fabio|F|', 'Purpura|Valeria|V|', 'Mingozzi|Matteo|M|', 'Buggi|Federico|F|', 'Marongiu|Francesco|F|']
D062088:Acellular Dermis D000328:Adult D000368:Aged D018427:Breast Implants D001943:Breast Neoplasms D015331:Cohort Studies D004954:Esthetics D005260:Female D005500:Follow-Up Studies D006801:Humans D007558:Italy D016462:Mammaplasty D015414:Mastectomy, Subcutaneous D008875:Middle Aged D011182:Postoperative Care D012189:Retrospective Studies D016896:Treatment Outcome D014945:Wound Healing
Breast reconstruction Acellular dermal matrices Alloplastic tissue Breast implants Human acellular dermal matrices