Challenges faced in the clinical application of artificial anal sphincters.

Fecal incontinence is an unresolved problem, which has a serious effect on patients, both physically and psychologically. For patients with severe symptoms, treatment with an artificial anal sphincter could be a potential option to restore continence. Currently, the Acticon Neosphincter is the only device certified by the US Food and Drug Administration. In this paper, the clinical safety and efficacy of the Acticon Neosphincter are evaluated and discussed. Furthermore, some other key studies on artificial anal sphincters are presented and summarized. In particular, this paper highlights that the crucial problem in this technology is to maintain long-term biomechanical compatibility between implants and surrounding tissues. Compatibility is affected by changes in both the morphology and mechanical properties of the tissues surrounding the implants. A new approach for enhancing the long-term biomechanical compatibility of implantable artificial sphincters is proposed based on the use of smart materials.