Abstract
BackgroundThe use of acellular dermal matrix (ADM) for post-mastectomy reconstruction is considered by many surgeons to be an accepted component of surgical technique. Early clinical experience is described for SimpliDerm® - a novel human ADM (Aziyo Biologics, Silver Spring, USA), and AlloDerm® Ready-To-Use (RTU) - an established ADM (Allergan Medical, Irvine, USA).MethodsRecords were retrospectively reviewed from four sites between 2016 and 2021 of patients who underwent immediate, two-stage reconstruction with either SimpliDerm (n=38) or AlloDerm RTU (n=69) after mastectomy and were followed out to exchange to permanent implant(s), tissue expander(s) explant, or death.ResultsImmediate breast reconstruction with tissue expanders and ADM was performed on 107 patients (181 breasts). Overall mean patient age was 51.4 ± 12.4 years, and mean BMI was 28.0 ± 5.8 kg/m2. Significantly more patients in the SimpliDerm group were of Hispanic or Latino ethnicity (34.2% vs. 7.2%; P<.001). Reconstructions were predominantly prepectoral (82.3%). A total of 35 adverse events (AEs) occurred in 27 (25.2%) patients, with no difference in AE type, classification, or rates between ADM groups. No AEs were considered related to either ADM. The observed AE profiles and rates are similar to those published for other ADMs in immediate breast reconstruction.ConclusionsThere continues to be a need for additional clinically equivalent ADMs to provide physicians with more availability and options for their practice. This retrospective, multisite study describes comparable clinical outcomes with SimpliDerm and AlloDerm RTU through a median of 133.5 days (~four months) following immediate two-stage breast reconstruction.
Highlights
Acellular dermal matrices (ADMs) are used in approximately 60% of all breast reconstructions performed every year in the United States (US) [1]
Immediate breast reconstruction with tissue expanders and ADM was performed on 107 patients (181 breasts)
No adverse events (AEs) were considered related to either ADM
Summary
Acellular dermal matrices (ADMs) are used in approximately 60% of all breast reconstructions performed every year in the United States (US) [1]. Controversy remains with the use of ADM in breast reconstructive procedures [11], there continues to be a need for additional safety and efficacy data of available ADMs to provide greater accessibility, more physician choice, increased payer coverage, and to foster ADM innovation through improved design of newer products [9, 12]. In an effort to support the existing literature and introduce additional data on a new human ADM, we report a collective experience with two ADMs in immediate breast reconstruction (IBR). How to cite this article Tierney B P, De La Garza M, Jennings G R, et al (February 18, 2022) Clinical Outcomes of Acellular Dermal Matrix (SimpliDerm and AlloDerm Ready-to-Use) in Immediate Breast Reconstruction. Clinical experience is described for SimpliDerm® - a novel human ADM (Aziyo Biologics, Silver Spring, USA), and AlloDerm® Ready-To-Use (RTU) - an established ADM (Allergan Medical, Irvine, USA)
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