Allogeneic and Alloplastic Augmentation Grafts in Nipple-Areola Complex Reconstruction: A Systematic Review and Pooled Outcomes Analysis of Complications and Aesthetic Outcomes.

BACKGROUND: With advancements in materials engineering, many plastic surgeons have looked to allogeneic tissue and alloplastic materials as a possible source of structure for long-lasting nipple-areola complex reconstruction. Furthermore, in light of the recent mandate from the Food and Drug Administration restricting the marketing and direct indication of acellular dermal matrices (ADMs) in breast reconstruction, we sought to highlight the overall safety and efficacy demonstrated in the existing literature surrounding all alloplastic materials in nipple-areola complex reconstruction. In this study, the authors conduct a systematic review and pooled outcomes analysis on allogenic and alloplastic implant materials utilized to achieve long-lasting nipple projection stratified by specific material used and respective outcomes. METHODS: A comprehensive systematic review on allogenic and synthetic materials data utilized in nipple reconstruction was conducted utilizing Medline/PubMed database. Articles were stratified by (1) alloplastic material, as well as (2) objective and patient-reported outcomes. RESULTS: A total of 592 nipple-areola complexes on 482 patients were featured in 15 case series. In all studies, alloplastic or allograft material was utilized to achieve and maintain nipple projection. Subjective measurements revealed a patient satisfaction rate of 93.3% or higher with the majority of patients being very satisfied with their reconstruction. The alloplastic and allograft implants analyzed had an overall complication rate of 5.3% across all materials used. The most common complication reported was flap or graft necrosis with a pooled rate of 2.5%. Overall, the Ceratite implant presented with the highest complication rate (18%) including flap/graft necrosis (13%) and extrusion of the artificial bone (5%). Other rigid implants such as the biodesign nipple reconstruction cylinder reported complications of extrusion (3.6%), projection loss requiring revision (2.5%), wound dehiscence/drainage (1.5%), flap or graft necrosis (1.0%) and excessive bleeding (0.5%). ADM implants had reported complications of both insufficient projection (0.8%) and excessive projection (1.6%), which required surgical revision. Injectable materials had minimal reported complications of pain during injection (0.8%) with Radiesse and a false-positive PET scan result (0.8%) with DermaLive. CONCLUSIONS: Allogeneic and alloplastic grafts are a reliable means of achieving satisfactory nipple projection, with a relatively low overall complication profile. The use of Ceratite (artificial bone) led to the highest complication rates. Further clinical studies are necessary to better understand the feasibility and longer-term outcomes of the use of allogeneic and synthetic augmentation grafts to improve nipple projection. LEVEL OF EVIDENCE III: 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.