Invited Response on: Comment on “The First use of Human-Derived ADM in Prepectoral Direct-to-Implant Breast Reconstruction after Skin Reducing Mastectomy.”

Abstract

Dear editor, We would like to thank you for giving us the chance to further discuss some aspects of our work. In response to the issues raised by your letter, we would like to give some clarifications. 1. To the best of our knowledge, this was the first description of the use of human-derived Acellular Dermal Matrix (hADM) in prepectoral direct-to-implant (DTI) Breast Reconstruction (BR) after Skin-Reducing Mastectomy (SRM). We know that other authors have already described ADM-assisted prepectoral DTI after SRM, nevertheless none has ever employed a hADM and therefore our title should be considered as correct [1]. 2. Regarding the statement that ADM produced outside Europe cannot be used and commercialized in our country, we would like to clarify that this happens only with hADM, which was precisely the reason that pushed us into developing a valuable and cost-effective device. Indeed, ‘‘according to the European legislation [European Community (EC) directive 2004/23/EC], companies producing hADMs outside the EC are not allowed to commercialize them in Europe, hADMs being ‘‘human products’’ and not ‘‘medical devices,’’ so being ruled by European legislations on transplants. This legal issue prevents European women from benefiting from the use of hADMs, even though most evidence in the literature shows optimal outcomes in breast reconstruction using this kind of product; hADM characteristics lead to better and easier integration of the ADM in the host tissues when compared with porcineor bovine-derived products [2–13]. The skin bank of the AUSL ROMAGNA 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 Acellularizzata) from the Italian National Transplant Center and National Health Institute [2–4, 8–13]’’. We already reported our preliminary results of MODA application in a previous article about DTI-BR following nipple-sparing mastectomy for breast cancer treatment, which we invite you to consult for more details [2, 3]. Furthermore, since you were also interested in the related additional costs of ADMs, we suggest you consult an even recent paper we have just published where we described our technique to employ an autologous dermal patch taken from the contralateral matching breast reduction procedure to be used in place of the ADM when performing prepectoral DTI-BR following SRM [14]. 3. Regarding the 4D pocket performed by vertical incisions at the lower border of the fascia profunda and the pectoralis major muscle, although this might be considered a valid option in selected cases, we personally believe that in the era of conservative surgery, in which many efforts are made by surgeons in performing least invasive but effective surgeries, proposing as innovative approach a technique that employs old strategy as subpectoral pocket (with the related morbidity caused by harvesting chest wall muscles) should be considered obsolete instead, and in contrast with the conservative trend [15]. Indeed, & Francesco Marongiu [email protected]