Włodarczyk, Marcin
Dziki, Łukasz
Bilińska, Inez
Szpunar, Jarosław
Konopka, Krzysztof
Kasprzak, Piotr
Tokarska, Magdalena
Kraj, Agata
Łąpieś, Paulina
Sujka, Witold https://orcid.org/0000-0003-0293-6681
Funding for this research was provided by:
TZMO SA (TZMO SA (PL))
Article History
Received: 12 February 2025
Accepted: 28 May 2025
First Online: 27 June 2025
Declarations
:
: Ethical review and approval were waived for this study because the scientific study conducted does not have the characteristics of a medical experiment and, in accordance with Polish law and Good Clinical Practice (GCP), is not subject to the opinion of the Bioethics Committee.
: The study is based on generated and analyzed archival data. None of the data required obtaining the patient’s Informed Consent Form.
: The study was conducted by hospitals and research units. Tricomed company has the status of a Research and Development Centre and the authors included in the publication are employed in the research and development sphere. The study was carried out in accordance with current regulations and under the supervision of monitors and are based on archival records. The manufacturer of Optomesh ® ULTRALIGHT was the initiator of the described study. Tricomed did not pay for any of the tests performed. The mesh itself was developed as part of a project financed by TZMO SA company. The research was carried out in three centers using procedures consistent with the standard and financed by the National Health Fund. The last three authors of the manuscript are employees of Tricomed, the manufacturer of the tested mesh. The remaining authors are renowned specialists in the field of hernia treatment and statistician from Lodz University of Technology. Specialists at the centers responsible for collecting data from patient records received payment from the mesh manufacturer. We declare that we had full access to the study data, conducted all data analyzes independently from the entity performing the procedures and without contact with patients, and take complete responsibility for the integrity and accuracy of the data contained in the manuscript.