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

Preliminary Results

Secondo Folli, Annalisa Curcio, Davide Melandri, Elena Bondioli, Nicola Rocco, Giuseppe Catanuto, Fabio Falcini, Valeria Purpura, Matteo Mingozzi, Federico Buggi, Francesco Marongiu

Research output: Contribution to journalArticle

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 .

Original languageEnglish
Pages (from-to)434-441
Number of pages8
JournalAesthetic Plastic Surgery
Volume42
Issue number2
DOIs
Publication statusPublished - Apr 2018

Fingerprint

Acellular Dermis
Nipples
Mammaplasty
Mastectomy
Breast Neoplasms
Breast
Equipment and Supplies
Evidence-Based Medicine
National Institutes of Health (U.S.)
Thoracic Wall
Silicones
Legislation
Cadaver
Italy
Tobacco
Tissue Donors
Transplants
Skin
Wounds and Injuries
Therapeutics

Cite this

A New Human-Derived Acellular Dermal Matrix for Breast Reconstruction Available for the European Market : Preliminary Results. / Folli, Secondo; Curcio, Annalisa; Melandri, Davide; Bondioli, Elena; Rocco, Nicola; Catanuto, Giuseppe; Falcini, Fabio; Purpura, Valeria; Mingozzi, Matteo; Buggi, Federico; Marongiu, Francesco.

In: Aesthetic Plastic Surgery, Vol. 42, No. 2, 04.2018, p. 434-441.

Research output: Contribution to journalArticle

Folli, S, Curcio, A, Melandri, D, Bondioli, E, Rocco, N, Catanuto, G, Falcini, F, Purpura, V, Mingozzi, M, Buggi, F & Marongiu, F 2018, 'A New Human-Derived Acellular Dermal Matrix for Breast Reconstruction Available for the European Market: Preliminary Results', Aesthetic Plastic Surgery, vol. 42, no. 2, pp. 434-441. https://doi.org/10.1007/s00266-017-1069-7
Folli, Secondo ; Curcio, Annalisa ; Melandri, Davide ; Bondioli, Elena ; Rocco, Nicola ; Catanuto, Giuseppe ; Falcini, Fabio ; Purpura, Valeria ; Mingozzi, Matteo ; Buggi, Federico ; Marongiu, Francesco. / A New Human-Derived Acellular Dermal Matrix for Breast Reconstruction Available for the European Market : Preliminary Results. In: Aesthetic Plastic Surgery. 2018 ; Vol. 42, No. 2. pp. 434-441.
@article{60ea857915d24e3fac8ecf7dee22b2eb,
title = "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 .",
author = "Secondo Folli and Annalisa Curcio and Davide Melandri and Elena Bondioli and Nicola Rocco and Giuseppe Catanuto and Fabio Falcini and Valeria Purpura and Matteo Mingozzi and Federico Buggi and Francesco Marongiu",
year = "2018",
month = "4",
doi = "10.1007/s00266-017-1069-7",
language = "English",
volume = "42",
pages = "434--441",
journal = "Aesthetic Plastic Surgery",
issn = "0364-216X",
publisher = "Springer New York LLC",
number = "2",

}

TY - JOUR

T1 - A New Human-Derived Acellular Dermal Matrix for Breast Reconstruction Available for the European Market

T2 - Preliminary Results

AU - Folli, Secondo

AU - Curcio, Annalisa

AU - Melandri, Davide

AU - Bondioli, Elena

AU - Rocco, Nicola

AU - Catanuto, Giuseppe

AU - Falcini, Fabio

AU - Purpura, Valeria

AU - Mingozzi, Matteo

AU - Buggi, Federico

AU - Marongiu, Francesco

PY - 2018/4

Y1 - 2018/4

N2 - 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 .

AB - 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 .

U2 - 10.1007/s00266-017-1069-7

DO - 10.1007/s00266-017-1069-7

M3 - Article

VL - 42

SP - 434

EP - 441

JO - Aesthetic Plastic Surgery

JF - Aesthetic Plastic Surgery

SN - 0364-216X

IS - 2

ER -