Human Acellular Dermal Matrix (Epiflex®) in Immediate Implant-Based Breast Reconstruction after Skin- and Nipple-Sparing Mastectomy and Treatment of Capsular Fibrosis: Results of a Multicenter, Prospective, Observational NOGGO-AWOGyn Study

Abstract

<b><i>Background:</i></b> Over the last decades, the number of acellular dermal matrix (ADM)-assisted implant-based breast reconstructions (IBBR) has substantially increased. However, there is still a lack of prospective data on complication rates. <b><i>Methods:</i></b> We performed a non-interventional, multicenter, prospective cohort study to evaluate complication rates of a human ADM in patients undergoing an IBBR after skin- and nipple-sparing mastectomies. Patients with primary reconstruction (cohort A) and patients undergoing a secondary reconstruction after capsular fibrosis (cohort B) using the human ADM Epiflex® (DIZG gGmbH, Berlin, Germany) were enrolled in this study. Patients were followed-up for 12 months after surgery. <b><i>Results:</i></b> Eighty-four eligible patients were included in this study of whom 28 women underwent a bilateral breast reconstruction, leading to 112 human ADM-assisted reconstructions in total (cohort A: 73, cohort B: 39). In 33.0% of the reconstructed breasts at least one of the complications of primary interest occurred, including implant loss 7.1%, seroma 15.2%; infection 5.4%, rash 8.0%, and Baker grade III/IV capsular fibrosis 2.7%, with no statistically significant differences between the cohorts. Previous radiation therapy was significantly associated with occurrence of any postoperative complication (OR 20.41; <i>p</i> value 0.027). <b><i>Conclusion:</i></b> The rates of most complications were comparable to the rates reported for other ADMs with relatively low rates of capsular fibrosis and infections. The rate of seroma was increased in our study. Prior radiation therapy increased the risk of any postoperative complications. Therefore, the use of ADM in these patients should be considered carefully.

Wound Healing after Acellular Dermal Substitute Positioning in Dermato-Oncological Surgery: A Prospective Comparative Study

“…More data are currently available on their use in breast reconstruction after mastectomy, where ADMs are becoming routinely employed [ 39 ]. However, conflicting data are currently emerging from updated observations of ADM-specific side effects, therefore suggesting careful patient selection for ADM-based reconstructive surgery [ 40 , 41 ].…”

Patient-Reported Outcomes and Aesthetic Results after Immediate Breast Reconstruction Using Human Acellular Dermal Matrices: Results of a Multicenter, Prospective, Observational NOGGO-AWOGyn Study

“…From a patient’s perspective, improved quality of life and satisfaction with the surgical result are key outcomes of the breast reconstruction [16]. In our study, in addition to the previously reported complication rates [17], we prospectively assessed patient-reported outcomes, including patient satisfaction and quality of life, in patients who underwent an ADM-assisted immediate breast reconstruction after skin- and nipple-sparing mastectomy with or without prior breast reconstruction. In addition, surgeon satisfaction with the outcome and the aesthetic result judged by 2 independent external experts were assessed.…”

“…During follow-up, occurrence of complications, patient satisfaction, surgeon satisfaction, and quality of life (from 1 week after surgery onwards) were assessed and photographs were taken. Details on complication rates in the present study have been reported previously [17].…”

“…From a patient’s perspective, an improved quality of life and satisfaction with the surgical result are key outcomes of the breast reconstruction [16]. The aim of our study was not only to evaluate complication rates, which have been reported previously [17], but also to prospectively assess patients’ quality of life, patient and surgeon satisfaction, and the aesthetic outcome in patients undergoing an immediate human ADM-assisted breast reconstruction after skin- and nipple-sparing mastectomy.…”