TiLOOP®​ Bra Pocket supported pre-pectoral breast reconstruction: 12 months follow-up results from a prospective observational study

Objective Safety and breast aesthetics of direct-to-implant techniques are well recognized. Pre-pectoral techniques add a new dimension supported by the next generation of titanized mesh-pockets with high biocompatibility.

Material and Method A prospective international, multicentre observational investigation (PRO-Pocket-Trial clinicaltrials.gov: NCT03868514) is performed in 12 clinical centres in Germany and Austria. Patient reported outcome after TiLOOP®​ Bra Pocket supported prepectoral breast reconstruction is assessed by the Breast-Q questionnaire. Furthermore, complications are documented. The results of the 12 months follow-up are presented.

Results From 06/2019 until 02/2021, 311 (age 23-80) patients with TiLOOP®​ Bra Pocket supported breast reconstructions were included. The mean BMI was 24.6 ± 4.5 kg/m². The most frequent indication for surgery was invasive ductal carcinoma followed by increased breast cancer risk. Breast-Q data are available for 261 patients. The mean score of the scales “satisfaction with breasts” and “psychosocial well-being” increased by 8.0±28 and 7.1±22.1 points, respectively, from prior surgery to 12 months FU. The mean score for “sexual well-being” increased by 3.3±23.0 points, while the mean score for “physical well-being chest” decreased by 2.1±15.3 points. Currently, 6.8% seroma, 5.2% capsular fibrosis, 3.6% wound healing disorders, 3.4% infections, 2.3% necroses, and 2.5% bleedings (needing revision) are documented.

Conclusion Use of TiLOOP®​ Bra Pocket enables a new standard of pre-pectoral reconstructive techniques preserving the natural anatomy, thereby avoiding adverse effects associated with submuscular reconstruction and minimizing postoperative pain. Patient-reported outcome showed postoperative increased satisfaction with breast and psychosocial well-being.

Interessenskonflikt

Ich erkläre als korrespondierender Autor, dass ich oder einer bzw. mehrere meiner Ko-Autoren während der letzten 3 Jahre wirtschaftliche oder persönliche Verbindungen im oben genannten Sinne hatten:; Interessenskonflikt Details: Christine Ankel:; honoraria for lecture and or consulting as well as travel reimbursements from pfm medical AG, Köln; Andree Faridi:; Honorare für Vortragstätigkeit, operative Workshops und Ausbildungsoperationen von pfm medical AG, Köln; Sherko Kümmel: Member of advsiory Board (past 36 months):Novartis, Roche pharma, Genomic Health, Pfizer,Lilly, Amgen, MSD, pfm medical, Celgene, Astra Zeneca, Daiichi Sankyo, Somatex, Sonoscape,Seagen,Exact Science, Gilead as well as honoraria for presentations; Dr. Christine Mau: Referententätigkeit: Agentur für Arbeit, MG-Screening Berlin, Lilly, Novartis, Pfizer, Roche, Seagen; Fortbildungskosten: Roche; Beraterhonorar: Lilly, Myriad, Roche, Seagen; Dr. Stefan Paepke: Beratung, Unterstützung von Fortbildungen und Reisekostenunterstützung durch:; Grünenthal, lnvitrocue Europe, HC 21; Medtronic, Neodynamics, Novusscientific, pfm medical, sysmex und Roche in der Finanzierung von Fortbildungen (Klinik); Prof. Marc Thill:; Advisory Board: Agendia, Amgen, AstraZeneca, Aurikamed, Becton/Dickinson, Biom‘Up, ClearCut, Clovis, Daiichi Sankyo, Eisai, Exact Sciences, Gilead Science, Grünenthal, GSK, Lilly, MSD, Norgine, Neodynamics, Novartis, Onkowissen, Organon, Pfizer, pfm Medical, Pierre-Fabre, Roche, RTI Surgical, Seagen, Sirius Pintuition, Sysmex; Manuscript support: Amgen, ClearCut, Clovis, pfm medical, Roche, Servier; Travel expenses: Amgen, Art Tempi, AstraZeneca, Clearcut, Clovis, Connect Medica, Daiichi Sankyo, Eisai, Exact Sciences, Hexal, I-Med-Institute, Lilly, MCI, Medtronic, MSD, Neodynamics, Norgine, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, Seagen; Congress support: Amgen, AstraZeneca, Celgene, Daiichi Sanyko, Hexal, Neodynamics, Novartis, Pfizer, Roche, Sirius Medical; Lecture honoraria: Amgen, Art Tempi, AstraZeneca, Clovis, Connect Medica, Eisai, Exact Sciences, Gedeon Richter, Gilead Science, GSK, Hexal, I-Med-Institute, Jörg Eickeler, Laborarztpraxis Walther et al., Lilly, MCI, Medscape, MSD, Medtronic, Novartis, Onkowissen, Pfizer, pfm medical, Roche, Seagen, StreamedUp, Sysmex, Vifor, Viatris; Trial Funding: Endomag, Exact Sciences; Trial honoraria: AstraZeneca, Biom’Up, Celgene, Clearcut, Neodynamics, Novartis, pfm medical, Roche, RTI Surgical

Publication History

Article published online:
15 June 2023