When does the 'learning curve' of innovative interventions become questionable practice?

Demand for less invasive surgical intervention has increased in recent years resulting in surgeons occasionally being pressurised into adopting new techniques before evidence of safety and efficacy has been established. Unlike pharmaceutical research, most innovative surgical procedures enter surgical practice without regulatory oversight. This anomaly was recently highlighted in the 'Bristol Report' resulting in a recommendation that unproven therapies or surgical techniques be subjected to ethical overview or independent oversight. When a novel technique is introduced, the surgeon will find himself/herself gaining proficiency and experience on suitable patients. Hence the surgeon embarks on a 'learning curve'. A learning curve can be defined as a graphic representation showing the relationship between experience with a procedure and outcome. Studies demonstrate that learning curves generally 'flatten out' as experience increases, resulting in fewer complications and less of a need to convert to the standard procedure. In addition to lack of regulatory oversight, it is this learning curve that gives rise to many ethical and legal dilemmas. This paper considers the ethical issues relating to a surgeon's candour and clinical equipoise, the legal standard of care in a negligence action and the ethical and legal implications regarding risk disclosure during informed consent. The paper concludes by considering a more patient centred approach where new and innovative therapies are being considered in order to ensure good medical practice and avoid litigation for allegations of negligence or breach of human rights.