There have been numerous recent high-profile cases of 'surgical innovation' gone wrong, including vaginal mesh 1 , the da Vinci Robot 2 , and synthetic tracheas 3 . All were new developments in surgery that failed to reach their potential to benefit patients and surgeons, and instead caused harm. There is now urgent interest in how surgical innovation should be regulated.Surgical innovation has the potential to bring significant benefit to patients, and innovator surgeons are historically heralded as inspirational leaders, and courageous risk-takers 4 , who develop more efficient and more effective procedures and devices that improve patient outcomes.Currently, in the UK, surgeons are able to modify procedures, introduce procedures and devices, or use existing devices for new purposes with very little, if any, oversight. Guidance from the National Institute for Health and Care Excellence (NICE) is not followed 5 . Research itself is heavily regulated, and many UK hospitals have New Procedure Committees or Clinical Effectiveness Committees (or such like), providing an alternative 'research approval' process. They, in theory, monitor and authorize new procedures and new uses of devices 6,7 . Yet, if surgeons do not identify their practice as 'research', or do not self-identify as doing something 'new', these mechanisms fail, and practice goes unregulated and unmonitored.Compounding this, there are limited reporting mechanisms for failed innovations, and existing ones are underused [5][6][7] . Consequently, innovations associated with harms/risks go unreported (unless picked up by regulators, the coroner, and/or the media) and future innovators cannot learn from them, meaning mistakes may be repeated. Mandated (cardiac surgery) 8 and optional (e.g. arthroplasty) registries are designed to monitor standard (not innovative) procedures, and data capture is not routine. Although changes are occurring for the introduction of new devices, these are yet to be implemented. One challenge is defining what constitutes a new procedure, the associated risk, and what magnitude of modification/risk requires registration and/or regulation.There is currently much focus on regulating surgical innovation 9,10 to improve patient safety. We agree but, perhaps controversially, contend that the term 'innovation' should be eliminated.