The short life cycle of a surgical device - Literature analysis using McKinlay׳s 7-stage model

McKinlay׳s seven stages model was useful to describe TVT Secur׳s truncated life cycle. TVT Secur, fully approved and licensed according to all jurisdictional requirements, generated many descriptive cohort studies but more rigorous RCT evidence appeared only half way through its life cycle. Device discontinuation meant that the stage of erosion and discreditation described by McKinlay occurred after TVT Secur was no longer available. We suggest that careful premarket evaluation of safety and effectiveness might decrease the need for commercial discontinuation of devices, and that post-marketing evaluation is a crucial mechanism to protect patients from harm.