, Volume 23, Issue 8, pp 969-970
Date: 03 Jun 2012

While we wait for a new regulatory framework for surgical mesh

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Gynaecologists have since the 1990s used surgical mesh for transvaginal repair of pelvic organ prolapse (POP) [1]. During the past decade, introduction of new mesh and surgical “kits” (surgical mesh products that includes tools to aid in the delivery and insertion of the mesh) has been endless and ongoing. This situation has three main reasons (1) the current premarket notification program for clearance of surgical mesh, which (2) the mesh manufacturers have used to bring new products on the market without clinical data on efficacy and safety, and (3) the willingness of many gynaecologists to adopt new untried and unproved techniques into clinical practices.

The FDA cleared the first surgical mesh product specifically for use in POP in 2002 [1]. The clearance process for new surgical meshes follows the principles instituted for class II medical devices, a large group which includes a variety of devices like medical lasers, magnetic resonance imaging devices, hard contact lenses and batt ...