Introduction of New devices - an Ethical framework

Workshop 3

Aims & Objectives

Basic
180 minutes
Pelvic Floor
Ethics Surgical devices Meshes
All membersof ICS and IUGA
The purpose of this meeting is to consider the ethical dimension of introduction of new devices in the context of clinical and regulatory requirements. The introduction of meshes and tapes has brought benefits to pelvic floor surgery and continence care but raised many ethical issues. These include the ethical imperative to test new devices with RCTs before clinical introduction and the validity of other means of monitoring success and complications, such as registries. The ethical responsibilities of manufacturers and potential bias in trials will be discussed. Ethical aspects of training will be considered, as will the funding of new devices. The regulatory framework and implications for globalisation of new devices will be addressed.