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

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  • Breast Surgery
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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

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Authors and Affiliations

  1. Department of Breast Surgery, Plastic and Reconstructive Surgery Unit, Fondazione IRCCS Istituto Nazionale Tumori Milano, Via Venezian 1, 20133, Milan, Italy

    Secondo Folli

  2. Breast Surgical Unit, Morgagni – Pierantoni Hospital, 47100, Forlì, Italy

    Annalisa Curcio, Matteo Mingozzi, Federico Buggi & Francesco Marongiu

  3. Burns Intensive Care Unit and “Regione Emilia Romagna” Skin Bank, “M.Bufalini” Hospital, Cesena, Italy

    Davide Melandri, Elena Bondioli & Valeria Purpura

  4. Department of Clinical Medicine and Surgery, University of Naples “Federico II”, Via S.Pansini 5, 80131, Naples, Italy

    Nicola Rocco

  5. G.RE.T.A. Group for Recontructive and Therapeutic Advancements, Milan, Naples, Catania, Italy

    Nicola Rocco & Giuseppe Catanuto

  6. Multidisciplinary Breast Unit, Azienda Ospedaliera Cannizzaro, Catania, Italy

    Giuseppe Catanuto

  7. Romagna Cancer Registry, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Forlì, Italy

    Fabio Falcini

  8. Azienda USL della Romagna, Forlì, Italy

    Fabio Falcini

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  1. Secondo Folli
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  2. Annalisa Curcio
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  3. Davide Melandri
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  4. Elena Bondioli
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  5. Nicola Rocco
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  7. Fabio Falcini
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  11. Francesco Marongiu
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Corresponding author

Correspondence to Nicola Rocco.

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Folli, S., Curcio, A., Melandri, D. et al. A New Human-Derived Acellular Dermal Matrix for Breast Reconstruction Available for the European Market: Preliminary Results. Aesth Plast Surg 42, 434–441 (2018). https://doi.org/10.1007/s00266-017-1069-7

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  • DOI: https://doi.org/10.1007/s00266-017-1069-7

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