Classification of surgical meshes and hernia registries
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LETTER TO THE EDITOR
Classification of surgical meshes and hernia registries F. Ko¨ckerling • D. A. Jacob
Received: 22 May 2012 / Accepted: 9 August 2012 Ó Springer-Verlag 2012
We thank U. Klinge and B. Klosterhalfen for the excellent modified classification of surgical meshes for hernia repair based on the analyses of 1,000 explanted meshes [1]. The authors have impressively demonstrated that, in the case of simple flat meshes, the weight, textile and effective porosity are of paramount importance in determining biological behavior in the body. Meshes with barrier function for intraperitoneal use or surface coating, meshes with films, 3D meshes and biologicals are classified separately by the authors. Already today, there are more than 166 different meshes on the market [2]. Nonetheless, each year, several new meshes are added. While thanks to approval with a CE mark within the European area or FDA approval in the USA, the safety, technical functionality and performance of each and every medical device are certified by the licensing authority, in general their clinical benefits are not evaluated through corresponding studies. In particular in the wake of the breast implants’ scandal, there is an increasing call for the systematic evaluation of the benefits (Health Technology Assessment) of medical devices [3]. The German Society of Surgery believes that clinical registries could play an important role in the evaluation of the benefits of medical devices since they quickly identify any irregularities related to individual devices [4]. In view of the plethora of meshes used in hernia surgery, Klinge et al. [1], too, believe that registries are the only means of identifying clinical differences between meshes. However, because of the vast number of meshes, they propose that
F. Ko¨ckerling D. A. Jacob (&) Department of Surgery and Center of Minimally Invasive Surgery, Vivantes Hospital Spandau, Neue Bergstr. 6, 13585 Berlin, Germany e-mail: [email protected]
the meshes be grouped together in the registries, for example, in accordance with the classification system suggested by them, so as to obtain greater numbers for the various classes of meshes [1]. Using such an approach, it would no longer be possible to identify an individual mesh in the registry and, as such, it would not be possible either to evaluate the benefits. In addition to the registries for hernia surgery that have been in place in Scandinavia for several years now, there are two further initiatives in the European region: Herniamed [5] and EuraHS [6]. In both registries, which collaborate with each other, each hernia operation is recorded, with precise details of the mesh and fixation systems used. New products that are placed on the market are entered into a product list. To facilitate product searches when entering data online, the meshes and fixation systems are classified according to manufacturer. Such an approach allows generation of clinical data for each medical device used for the cases recorded in the registry. In the Herniame
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