ArticleAnnals of surgery2018
The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes.
Article in Annals of surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.
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Who cites it
53 citing papers in PubMed, 1 synthesis or guideline pooled it, 93 citations in OpenAlex.
- Robotic-assisted primary ventral and incisional hernia repair: a comprehensive comparative analysis of rv-TAPP, r-Rives, and r-TARUP techniques.Journal of robotic surgery · 2025Pooled it
- Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue.Langenbeck's archives of surgery · 2018Trial
- Mesh-fixation combinations and chronic postoperative inguinal pain after laparoscopic groin hernia repair: nationwide cohort study.BJS open · 2026Article
- Smart responsive hydrogels combined with AI design for tumor therapy.Acta pharmaceutica Sinica. B · 2026Review
- Validating the mesh integration (MINT) index: a 3-month porcine study.Surgical endoscopy · 2026Article
- Evaluation of the safety and effectiveness of crural reinforcement with bio-aHernia : the journal of hernias and abdominal wall surgery · 2025Article
- Surgical treatment of rectus abdominis diastasis with concomitant abdominal wall hernias-perioperative outcomes of 11,658 cases from the Herniamed Registry.Hernia : the journal of hernias and abdominal wall surgery · 2025Article
- Similar recurrence rates among the 10 most used meshes for laparoscopic groin hernia repair: a nationwide register-based cohort study.Hernia : the journal of hernias and abdominal wall surgery · 2025Article
- Standardization of laparoscopic intraperitoneal onlay mesh repair for incisional hernia: Impact on clinical outcome and quality-of-life (LIPOM trial, NCT 02089958).Contemporary clinical trials communications · 2025Article
- Beyond Traditional Repair: Comparing eTEP and Open Sublay for Ventral Hernia Repair.Journal of clinical medicine · 2025Article
- Comparison of Laparoscopic eTEP-RS/TAR and IPOM Techniques for Ventral Hernia Repair.Journal of abdominal wall surgery : JAWS · 2025Article
- Adhesions After Laparoscopic IPOM-How Serious Is the Problem?Journal of abdominal wall surgery : JAWS · 2025Review
- Inguinal Hernia Repair Using Absorbable Biosynthetic Mesh Versus Permanent Polypropylene Mesh: A Preliminary Comparative Study of 1-Year Outcomes.Journal of abdominal wall surgery : JAWS · 2025Article
- Simultaneous incisional hernia repair and colorectal surgery: one or two-step procedure?Hernia : the journal of hernias and abdominal wall surgery · 2024Article
- PROsthetic MEsh Reinforcement in elective minimally invasive paraesophageal hernia repair (PROMER): an international survey.Updates in surgery · 2024Article
- Laparoscopic retromuscular hernia repair (LaHRR): a case-series of 17 patients treated with a novel technique for laparoscopic ventral hernia and diastasis repair.Surgical endoscopy · 2024Article
- Determining the value of the abdominal core health quality collaborative to support regulatory decisions.Hernia : the journal of hernias and abdominal wall surgery · 2024Article
- Repair of parastomal hernia after Bricker procedure: retrospective consecutive experience of a tertiary center.Hernia : the journal of hernias and abdominal wall surgery · 2024Article
- Biomechanical causes for failure of the Physiomesh/Securestrap system.Scientific reports · 2023Article
- Mesh-based inguinal hernia repairs in an integrated healthcare system and surgeon and hospital volume: a cohort study of 110,808 patients from over a decade.Hernia : the journal of hernias and abdominal wall surgery · 2023Article
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Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the role of registries in the postmarketing surveillance of surgical meshes.
backgroundTo date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database. This paper now presents the relevant data from the Herniamed Registry.
methodsThe present analysis compares the prospective perioperative and 1-year follow-up data collected for all patients with incisional hernia who had undergone elective laparoscopic intraperitoneal onlay mesh repair either with Physiomesh (n = 1380) or with other meshes recommended in the guidelines (n = 3834).
resultsPatients with Physiomesh repair had a markedly higher recurrence rate compared with the other recommended meshes (12.0% vs 5.0%; P < 0.001). In the multivariable analysis, the recurrence rate was highly significantly influenced by the mesh type used (P < 0.001). If Physiomesh was used, that led to a highly significant increase in the recurrence rate on 1-year follow-up (odds ratio 2.570, 95% CI 2.057, 3.210). The mesh type used also had a significant influence on chronic pain rates.
conclusionsThe importance of real-world data for postmarketing surveillance of surgical meshes has been demonstrated in this registry-based study. Randomized controlled trials are needed for premarket approval of new devices. The role of sponsorship of device studies by the manufacturing company must be taken into account.
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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.