Bielefeldt K. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration. World J Gastrointest Pharmacol Ther 2016; 7(2): 294-305 [PMID: 27158546 DOI: 10.4292/wjgpt.v7.i2.294]
Corresponding Author of This Article
Klaus Bielefeldt, MD, PhD, Division of Gastroenterology, University of Pittsburgh Medical Center, 200 Lothrop St. Pittsburgh, PA 15217, United States. bielefeldtk@upmc.edu
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Systematic Reviews
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastrointest Pharmacol Ther. May 6, 2016; 7(2): 294-305 Published online May 6, 2016. doi: 10.4292/wjgpt.v7.i2.294
Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration
Klaus Bielefeldt
Klaus Bielefeldt, Division of Gastroenterology, University of Pittsburgh Medical Center, Pittsburgh, PA 15217, United States
Author contributions: Bielefeldt K contributed to the manuscript.
Conflict-of-interest statement: The author has no conflict of interest.
Data sharing statement: Technical appendix and dataset are available from the corresponding author at bielefeldtk@upmc.edu.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Klaus Bielefeldt, MD, PhD, Division of Gastroenterology, University of Pittsburgh Medical Center, 200 Lothrop St. Pittsburgh, PA 15217, United States. bielefeldtk@upmc.edu
Telephone: +1-412-8647087 Fax: +1-412-6489378
Received: December 19, 2015 Peer-review started: December 22, 2015 First decision: February 22, 2016 Revised: February 23, 2016 Accepted: March 14, 2016 Published online: May 6, 2016 Processing time: 123 Days and 3.6 Hours
Core Tip
Core tip: Sacral neuromodulation can improve fecal incontinence refractory to other treatments. However, adverse events are very common and often require additional operations. Many of the reported patient concerns surface early after stimulator implantation, respond to changes in stimulation parameters and may thus be considered a part of the routine maintenance of this treatment modality. Nonetheless, rates of surgical re-interventions are high and increase over time. Physicians counseling patients about this treatment for fecal incontinence should emphasize the likely need for such secondary surgeries and consider emerging non-invasive treatment options. In addition, prospective studies should compare less invasive paradigms, such as transcutaneous stimulation, with permanently implanted devices to more clearly define their differential impact.
