First results of a pre-planned interim analysis of a national multicenter Patient Reported Outcome Study (PRO-Bra) in breast reconstruction following mastectomy with titaniferously coated polypropylene mesh (TiloopBra)

Dr Stefan Paepke
Klinikum Rechts der Isar, Klinik und Poliklinik fuer Frauenheilkunde, Technische, Universitaet Muenchen, Germany


In the majority of interdisciplinary breast centres of Germany, implant-based, mesh-supported operations constitute a total of approximately 50-60% of reconstructive techniques. The vast majority of mesh-supported reconstructive breast surgery is performed with the titanised polypropylene mesh TiLoop®Bra [ Zoche H; 2014]. The BreastQ [Pusic AL; 2006] is the most valid and reliable measurement of quality of life aspects in important domains used in clinical routine.

Material and Methods:

Because the patient reported outcome is the most relevant factor reflecting the overall satisfaction from a patient perspective a prospective single arm non-randomised surveillance study with BreastQ-scales at 12 months as primary endpoint was conducted (2013). Overall 205 breasts of 153 pts. were treated between 12/2013 and 9/2015. A pre-planned analysis of the first 60 pts. with completion of the BreastQ after 6 months (secondary endpoint) was done.


Most frequent indication was BC. Almost all surgeries were primary reconstructions (96.6%) and nipple-skin-sparing mastectomies (97.1%). A expander exchange is planned for 20 pts. The most frequent incision was inframammary (n=115), followed by T-shaped (n=45). The average of the pts. was 50 y (19-77); BMI was 22 (17-33), 77.3% were non-smokers. Percentage of neoadjuvant chemotherapy was 23%, of prior radiotherapy was 12%. Radiotherapy showed no significant influence of the BreastQ. Severe events occurred in 46 cases. The most frequent complications were necrosis (n= 12), hematoma (n= 12); 9 pts. dropped out. The mean score of BreastQ was equal pre- and postoperative after 6 months (67+/-16 to 65+/-15); satisfaction with breast from 67+/-22 to 61 +/-14; psycho-social well-being from 71+/-17 to 73+/-18; sexual well-being from 62+/-17 to 60+/-19; satisfaction with outcome was 75+/-18 and satisfaction with surgeon 90+/-15. 88.3% were very satisfied, 10.0% somewhat satisfied, only 1.7% somewhat dissatisfied, 0% very dissatisfied.


The first analysis of the PROBra-study shows positive results in all outcome parameters. The study will continue until the complete recruitment of the pre-planned 267 pts. within a follow up of at least two years.