"PRO-BRA"-Study

National, Multicentre Post-Market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titanised Polypropylene Mesh (TiLOOP® Bra)

This national, multicentre post-market surveillance study examined the titanised polypropylene mesh implant TiLOOP® Bra which is already on the market. TiLOOP® Bra is intended for the support, reinforcement and bridging of body's own tissue in reconstructive and plastic-aesthetic breast surgery, e.g. after breast cancer.

Method

Between December 2013 and July 2016, 269 patients were enrolled in a prospective, single-arm, multicentre study. The patients underwent a skin-sparing, nipple-sparing or modified radical mastectomy followed by primary or secondary breast reconstruction with the titanised mesh TiLOOP® Bra.

Study objectives

Primary Enpoint

  • Assessment of the quality of life after plastic-reconstructive surgery: 
    Comparison pre- and 12 months postoperative using the Breast-Q questionnaire reconstructive

Secondary Endpoint

Status of the study

Completed

Study centers

  • Agaplesion Markus Krankenhaus, Frankfurt am Main
  • Charité Campus Mitte und Benjamin Franklin, Berlin
  • Helios Kliniken, Berlin 
  • Klinik für Frauenheilkunde und Geburtshilfe, Lübeck 
  • Klinikum rechts der Isar, München
  • Sankt Gertrauden-Krankenhaus, Berlin
  • St. Elisabeth Krankenhaus, Köln
  • Vivantes Kliniken am Urban, Berlin  

Independent experts to assess the cosmetic outcome: 

  • Klinik für Frauenheilkunde und Brustzentrum, Universitätsmedizin Greifswald 
  • Rems-Murr-Klinikum Winnenden

Further study details

Publication