The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes.

Abstract

To assess the role of registries in the postmarketing surveillance of surgical meshes. 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 Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database.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. 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). 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. 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.