Fecal incontinence: mid-term efficacy and safety of Sphinkeeper™ implantation

Dear Editor, Fecal incontinence (FI), a prevalent disorder severely impairing quality of life, has long posed a formidable challenge in the field of colorectal surgery. A recently published multicenter retrospective cohort study conducted jointly by seven European medical centers systematically evaluated the mid-term efficacy and safety of Sphinkeeper™ (SK) implantation for the treatment of refractory FI[1]. The findings showed that postoperative incontinence symptoms were considerably reduced: all aspects of quality of life showed consistent improvement, the median Cleveland Clinic Incontinence Score (CCIS) dropped from 12 to 7, and the time to postpone defecation increased from 8 to 18 s. Notably, its therapeutic efficacy seems to be independent of the integrity of the anal sphincter, and the rate of good implant location reaches 91.9%. We would like to express our gratitude to the research team for providing valuable mid-term evidence. With a prudent academic attitude, we put forward several suggestions for academic discussion and further exploration: Although the study demonstrated significant improvements with SK compared to baseline, it lacked an active control group (e.g., other implantable bulking agents, sacral nerve modulation). The absence of direct comparisons makes it difficult to precisely define SK’s relative advantages and cost-effectiveness within the existing FI treatment spectrum[2]. Therefore, future head-to-head comparative studies are needed to provide stronger clinical guidance[3]. The 3-year follow-up verified the mid-term safety of the procedure; however, for permanent implants, long-term risks such as biocompatibility issues, implant migration, degradation, or local tissue reactions (e.g., the degree of fibrous encapsulation) still require extended monitoring. Therefore, the long-term follow-up data are very important. We eagerly anticipate the authors’ long-term follow-up findings. While the study demonstrated the effectiveness of SK implantation at the group level, individual responses varied considerably. Currently, there is a lack of objective predictors (e.g., specific anorectal manometry patterns, imaging characteristics, or neurophysiological markers[4]) to identify which patients will derive the maximum benefit from SK implantation. Exploring such predictive biomarkers will facilitate the realization of individualized precision treatment. To sum up, this study methodically verified the mid-term safety, effectiveness, and continued quality of life improvement linked to SK implantation for refractory FI. Meanwhile, resolving present constraints through prospective controlled studies, extended follow-up, and the investigation of efficacy predictors would strengthen the evidence base and assist more patients.