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Ethics, Economics And The Regulation And Adoption Of New Medical Devices: Case Studies In Pelvic Floor Surgery, Sue Ross, Charles Weijer, Amiram Gafni, Ariel Ducey, Carmen Thompson, Rene Lafreniere

Charles Weijer

BACKGROUND: Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.

METHODS/DESIGN: Our study involves three linked case studies using, as examples, selected pelvic …