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. 2025 Jun 27;29(1):216.
doi: 10.1007/s10029-025-03398-5.

Evaluation of the effectiveness and safety of the ultralight, non-resorbable Optomesh® ULTRALIGHT surgical meshes for surgical treatment of hernias based on open and laparoscopic techniques - a retrospective analysis

Marcin Włodarczyk  1 , Łukasz Dziki  1 , Inez Bilińska  1 , Jarosław Szpunar  2 , Krzysztof Konopka  3 , Piotr Kasprzak  4 , Magdalena Tokarska  5 , Agata Kraj  6 , Paulina Łąpieś  6 , Witold Sujka  7
Affiliations

Evaluation of the effectiveness and safety of the ultralight, non-resorbable Optomesh® ULTRALIGHT surgical meshes for surgical treatment of hernias based on open and laparoscopic techniques - a retrospective analysis

Marcin Włodarczyk et al. Hernia. .

Abstract

Background: According to global data, hernia surgery is the most commonly performed elective surgical procedure. The primary factor that can lead to the development of a hernia is weakening of the abdominal wall. The only effective method of treating hernias, regardless of their type, is surgery. In the following clinical study, a retrospective - prospective analysis was performed. The aim of the study was to determine, based on open and laparoscopic techniques, the effectiveness and safety of Optomesh® ULTRALIGHT surgical meshes made from cuts of stabilized monofilament polypropylene knit fabric recommended for reconstructive surgical procedures to fill and/or strengthen soft tissue defects in the treatment of various types of hernias.

Methods: The study included 171 patients, aged 22 to 70 years, who met the inclusion and exclusion criteria specified in the clinical trial plan, including 20 women and 151 men. During surgery, the vast majority of hernias were operated using the Lichtenstein surgical technique (132 patients). The other operations were performed using the Rives-Stoppa technique (23) and laparoscopic TAPP, TEP technique (16).

Results: The results were collected from intraoperative data and data collected during 2 follow-up visits after the procedure. The presented data collected during interviews with patients concern the frequency of recurrences, pain sensation in the first days after the procedure, discomfort associated with mesh implantation and pain sensation according to the VAS scale. These parameters will help to assess the therapeutic value of this type of implants intended for surgical treatment of hernias. Interviews at the second follow-up visit confirmed the patients' long-term, satisfactory reception in terms of comfort and average pain sensation.

Conclusions: The Optomesh® ULTRALIGHT implant is not only effective and safe but also imperceptible to the patients.

Keywords: Clinical study; Hernia mesh; Laparoscopic surgery; Lichtenstein; Rives-Stoppa; TAPP, TEP technique; Ultralight mesh.

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Conflict of interest statement

Declarations. Institutional Review Board Statement: 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. Informed Consent Statement: The study is based on generated and analyzed archival data. None of the data required obtaining the patient’s Informed Consent Form. Conflict of interest: 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.

Figures

Fig. 1
Fig. 1
Optomesh® ULTRALIGHT polypropylene mesh implants intended for surgical treatment of hernias (a) L-Pore type, (b) S-Pore type, (c) M-Pore type
Fig. 2
Fig. 2
Image of a Rives-Stoppa repair using SUBLAY placement of the Optomesh® ULTRALIGHT L-Pore mesh
Fig. 3
Fig. 3
View of the Optomesh® ULTRALIGHT mesh variant: S-Pore, TAPP repair
See this image and copyright information in PMC

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