Objective:To assess the role of registries in the postmarketing surveillance of surgical meshes.Background:To 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 Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries—Herniamed German Registry and Danish Hernia Database.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.Methods:The 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).Results:Patients 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.Conclusions:The 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.
The MILOS technique allows minimally invasive transhernial repair of incisional hernias using large retromuscular/preperitoneal meshes with low morbidity. The technique combines the advantages of open sublay and the laparoscopic IPOM repair.ClinicalTrials.gov Identifier NCT03133000.
Whereas for TEP the guidelines do not recommend mesh fixation on the basis of meta-analyses regardless of the defect size, for TAPP mesh fixation can be omitted only up to a defect size of 3 cm because of the paucity of studies on this topic. Hence, this study now seeks to explore this subject on the basis of prospective data from the Herniamed Hernia Registry. In the period September 01, 2009, to January 31, 2014, 11,228 male patients were operated on with the TAPP technique for a primary unilateral inguinal hernia and were followed up for 1 year. Mesh fixation was used for 7422 (66.1 %) of these patients and no mesh fixation for 3806 patients (33.9 %). Unadjusted analysis did not find any significant difference in the recurrence rate (0.88 % with fixation vs. 1.1 % without fixation; p = 0.259). Multivariable analysis of all potential influence factors (age, ASA, BMI, risk factors, defect size, mesh fixation, localization of defect, mesh size) did not identify any factor that impacted recurrence on 1-year follow-up. Only for medial and combined defect localization versus lateral localization was a highly significant effect identified (p < 0.001). With mesh fixation and larger mesh size, it was possible to significantly reduce the recurrence rate for larger medial hernias in this series (p = 0.046). For TAPP repair of an inguinal hernia, mesh fixation is not necessary in a significant number of patients. Patients with a medial and combined hernia are at higher risk of recurrence. In the patient series analyzed, it was possible to significantly reduce the recurrence rate with mesh fixation and larger mesh size for medial defects.
Objective: Based on an analysis of data from the Herniamed Registry, this study aims to identify all factors influencing the outcome in female groin hernia repair. Background: In a systematic review and meta-analysis of observational studies, female sex was found to be a significant risk factor for recurrence. In the guidelines, the totally extraperitoneal patch plasty (TEP) and transabdominal preperitoneal patch plasty (TAPP) laparo-endoscopic techniques are recommended for female groin hernia repair. However, even when complying with the guidelines, a less favorable outcome must be expected than in men. To date, there is no study in the literature for analysis of all factors influencing the outcome in female groin hernia repair. Methods: In all, 15,601 female patients from the Herniamed Registry who had undergone primary unilateral groin hernia repair with the Lichtenstein, Shouldice, TEP or TAPP technique, and for whom 1-year follow-up was available, were selected between September 1, 2009 and July 1, 2017. Using multivariable analyses, influencing factors on the various outcome parameters were identified. Results: In the multivariable analysis, a significantly higher risk of postoperative complications, complication-related reoperations, recurrences, and pain on exertion was found only for the Lichtenstein technique. No negative influence on the outcome was identified for the TEP, TAPP, or Shouldice techniques. Relevant risk factors for occurrence of perioperative complications, recurrences, and chronic pain were preoperative pain, existing risk factors, larger defects, a higher body mass index (BMI), higher American Society of Anesthesiologists (ASA) classification and postoperative complications. Higher age had a negative association with postoperative complications and positive association with pain rates. Conclusions: Female groin hernia repair should be performed with the TEP or TAPP laparo-endoscopic technique, or, alternatively, with the Shouldice technique, if there is no evidence of a femoral hernia. By contrast, the Lichtenstein technique has disadvantages in terms of postoperative complications, recurrences, and pain on exertion. Important risk factors for an unfavorable outcome are preoperative pain, existing risk factors, higher ASA classification, higher BMI, and postoperative complications. A higher age and larger defects have an unfavorable impact on postoperative complications and a more favorable impact on chronic pain.
Introduction In the update of the guidelines of the European Hernia Society, open Lichtenstein and endoscopic techniques continue to be recommended as the surgical technique of choice for repair of unilateral primary inguinal hernias in men despite the fact that a meta-analysis had identified a higher recurrence rate for TEP compared with Lichtenstein operation. The Guidelines Group had taken that decision because one surgeon in one of the randomized controlled trials included in the meta-analysis had had a very high recurrence rate. Therefore, this study based on registry data now compares the outcome of TEP versus Lichtenstein repair.Patients and MethodsThe analysis of the Herniamed Registry compares the prospective data collected for male patients undergoing primary unilateral inguinal hernia repair using either TEP or open Lichtenstein repair. Inclusion criteria were minimum age of 16 years, male patient, primary unilateral inguinal hernia, elective operation, and availability of data on 1-year follow-up. In total, 17,388 patients were enrolled between September 1, 2009, and August 31, 2013. Of these patients, 10,555 (60.70 %) had a Lichtenstein repair and 6833 (39.30 %) a TEP repair.ResultsOn multivariable analysis, the surgical technique was not found to have had any significant effect on the recurrence rate (p = 0.146) or on the chronic pain rate (p = 0.560). Nor did the complication-related reoperation rates differ significantly between the two techniques (p = 0.084). But TEP was found to have benefits as regards the postoperative complication rate (p < 0.001), pain at rest rate (p = 0.011), and pain on exertion rate (p < 0.001).SummaryIn the present registry study, no significant difference was identified in the recurrence rates between the TEP and Lichtenstein technique. TEP was found to have benefits compared with Lichtenstein repair as regards the postoperative complication rates, pain at rest, and pain on exertion.
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