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Multicenter Study
. 2018 Dec;268(6):1097-1104.
doi: 10.1097/SLA.0000000000002326.

The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes

Ferdinand Köckerling  1 , Thomas Simon  2 , Martin Hukauf  3 , Achim Hellinger  4 , Rene Fortelny  5 , Wolfgang Reinpold  6 , Reinhard Bittner  7
Affiliations
Multicenter Study

The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes

Ferdinand Köckerling et al. Ann Surg. 2018 Dec.

Abstract

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 Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database.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.

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Conflict of interest statement

The authors report no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Flowchart of patient inclusion.
FIGURE 2
FIGURE 2
Recurrence rate and mesh type (P < 0.001).
See this image and copyright information in PMC

Comment in

References

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