Complication rate after implant-based breast-reconstruction with support of a synthetic non-resorbable titanized polypropylene mesh (TiLOOP® Bra): Analysis of the 2-year follow up from the prospective multicentre PRO-BRA trial

Background: Specific patient characteristics and certain cancer treatments increase the risk for postoperative complications in implant-based breast reconstructions. It is therefore essential to identify those risk factors and analyse their contribution to the outcome. Methods: Implant-based breast reconstruction with support of synthetic non-resorbable titanized polypropylene surgical mesh (TiLOOP® Bra) was performed in 269 patients during the prospective, multicentre PRO-BRA cohort trial (clinicaltrials.gov: NCT01885572, DRKS: DRKS00005342). Secondary endpoint was the evaluation of the postoperative complication rate 24 months after breast reconstruction. Univariable and multivariable logistic regression analyses were performed to identify specific factors (e.g. BMI, age, radiotherapy, chemotherapy, implant size) increasing the risk for complications. Results: In 362 breast reconstructions the following factors were identified in univariable logistic regression to be associated with an increased risk for distinct complications: Implant volume, BMI (complication irrespective of type, seroma, wound complications), adjuvant radiotherapy (capsular fibrosis), Charlson Comorbidity Index (first complication, seroma), age (seroma), transverse/vertical incision (wound complications), and adjuvant chemotherapy (infection/inflammation). Multivariable logistic regression identified neoadjuvant chemotherapy as significant risk factor for the occurrence of complications. Conclusion: or over, adjuvant radiotherapy, as well as neoadjuvant and adjuvant chemotherapy. These factors must be considered when selecting patients for this type of breast reconstruction and should form part of a thorough patient information.