Evidence map›Paper›PMID 42519399›Full record

ArticleJPRAS open2026

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.

Marc Thill, Evelyn Klein, Elke Nolte, Jan Forster, Christine Ankel, Claudia Gerber-Schäfer, Kristin Baumann, Anette Meiré, Christine Mau, Jens-Uwe Blohmer and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in JPRAS open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01885572 (National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01885572 nacompletednot on this map

National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)

TypeinterventionalSponsorPfm Medical Mepro GmbhRan2013 to 2021Enrolled267ConditionsBreast Reconstruction After MastectomyArmsTiLOOP Bra
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Marc ThillDepartment of Gynecology and Gynaecologic Oncology, Agaplesion Markus Hospital, Wilhelm-Epstein-Straße 4, 60431, Frankfurt am Main, Germany.
Evelyn KleinDepartment of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany.
Elke Noltepfm medical gmbh, Cologne, Germany.
Jan Forsterpfm medical gmbh, Cologne, Germany.
Christine AnkelCentre for Breast Diseases, Vivantes Hospital am Urban, Berlin, Germany.
Claudia Gerber-SchäferCentre for Breast Diseases, Sankt Gertrauden Hospital, Berlin, Germany.
Kristin BaumannClinic for Gynecology and Obstetrics, University Hospital Schleswig-Holstein, Luebeck, Germany.
Anette MeiréSt. Elisabeth Hospital, Cologne, Germany.
Christine MauHelios Hospital Berlin Buch, Berlin, Germany.
Jens-Uwe BlohmerDepartment of Gynecology with Breast Centre Charité, Berlin, Germany.
Andree FaridiCentre for Breast Diseases, Vivantes Hospital am Urban, Berlin, Germany.
Stefan PaepkeDepartment of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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: The following factors have been identified as increasing the risk of developing postoperative complications of implant-based breast reconstruction with a non-resorbable titanized polypropylene surgical mesh (TiLOOP® Bra): larger implants, age of 50 years or over, BMI of 25 kg/m

Indexed as

Breast implantsCohort studiesHumansLogistic modelsRisk factorsSurgical mesh

Identifiers

PMID42519399
PMCPMC13383859

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.