Fecal incontinence is the involuntary leakage of stool from the rectum and anal canal.  Fecal continence depends on a complex interplay of anal sphincter function, pelvic floor function, stool transit time, rectal capacity and sensation. The artificial anal sphincter has been investigated as a surgical treatment for severe fecal incontinence.  Existing treatment options for fecal incontinence include medical therapy, biofeedback techniques and surgery in selected individuals.

Note: Please see the following related documents for additional information:

• MED.00061 Biofeedback for Fecal Incontinence
• SURG.00056 Transanal Radiofrequency Treatment of Fecal Incontinence

Investigational and Not Medically Necessary:

The artificial anal sphincter is considered investigational and not medically necessary.

At this time, there is insufficient evidence in the published peer-reviewed literature to demonstrate the safety, efficacy or improved patient outcomes of the artificial anal sphincter as a treatment for severe fecal incontinence.  The available studies on this procedure include uncontrolled studies that found that surgical implantation of an artificial anal sphincter resulted in a reduction of fecal incontinence in some patients.  However, implantation of an artificial anal sphincter was also associated with a significant rate of serious complications including but not limited to infection, erosion of the device, injury during the surgical procedure, pain, constipation and incontinence.  The diversity and seriousness of complications that occur after artificial anal sphincter implantation and the high rate of explantation suggest that this device may not be as safe or effective a treatment of fecal incontinence as is a colostomy or other surgical options.  In addition to the safety concerns, the value of the published studies is limited by their small sample size, lack of a control or comparison group and limited periods of follow-up.

Fecal incontinence is the inability to control the bowels, which results in leakage of stool or gas. There are many causes of fecal incontinence, including injury from childbirth, injury from a previous surgery, nerve-related diseases, and age-related changes in muscle tone.

Management of fecal incontinence is provided in a tiered approach, beginning with lifestyle modification or pharmacologic therapy followed by selectively offering biofeedback and surgery to eligible individuals.  Selection of which treatment modality to be employed depends on a number of aspects, such as severity of symptoms, availability of methods and the individual's adherence to treatment.  Mild cases are frequently managed with antidiarrheal medication or fiber products.  Surgical intervention is usually reserved for severe cases of fecal incontinence. Surgical treatments include, but are not limited to sphincter repair, sacral nerve stimulation, and colostomy.

The artificial anal sphincter has been investigated as a surgical treatment for severe fecal incontinence.  During the surgical procedure, a cuff is placed around the upper anal canal and tubing from the cuff is directed along the perineum and connected to a pump which is placed just below the skin in the scrotum or labia.  Tubing is then used to connect the pump to a pressure regulating balloon that is implanted in the abdominal wall.  The balloon contains approximately 40 ml of radio-opaque solution and the control pump controls the transfer of fluid from the balloon to the cuff.  To use the sphincter, the person squeezes the pump which causes the fluid to be diverted from the anal cuff back to the balloon.  This allows the anal sphincter to relax so that defecation can occur.  Once defecation is complete, the fluid slowly returns to the cuff which results in the tightening of the anal sphincter and the achievement of continence.

Fecal incontinence: the inability to control the bowels, which results in leakage of stool or gas

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary: 

Peer Reviewed Publications:

1. Altomare DF, Dodi G, La Torre F, et al. Multicentre retrospective analysis of the outcome of artificial anal sphincter implantation for severe faecal incontinence. Br J Surg. 2001; 88(11):1481-1486.
2. Brown SR, Nelson RL. Surgery for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD001757. DOI: 10.1002/14651858.CD001757.pub2.
3. Christiansen J, Rasmussen OO, Lindorff-Larsen K. Long-term results of artificial anal sphincter implantation for severe anal incontinence. Ann Surg. 1999; 230(1):45-48.
4. Devesa JM, Rey A, Hervas PL, et al. Artificial anal sphincter: complications and functional results of a large personal series. Dis Colon Rectum. 2002; 45(9):1154-1163.
5. Finlay IG, Richardson W, Hajivassiliou CA. Outcome after implantation of a novel prosthetic anal sphincter in humans. Br J Surg. 2004; 91(11):1485-1492.
6. La Torre F, Masoni L, Montori J, et al. The surgical treatment of fecal incontinence with artificial anal sphincter implant. Preliminary clinical report. Hepatogastroenterology. 2004; 51(59):1358-1361.
7. Lehur PA, Glemain P, Bruley des Varannes S, et al. Outcome of patients with an implanted artificial anal sphincter for severe faecal incontinence. A single institution report. Int J Colorectal Dis. 1998; 13(2):88-92.
8. Lehur PA, Michot F, Denis P, et al. Results of artificial sphincter in severe anal incontinence. Report of 14 consecutive implantations. Dis Colon Rectum. 1996; 39(12):1352-1355.
9. Michot F, Costaglioli B, Leroi AM, Denis P. Artificial anal sphincter in severe fecal incontinence: outcome of prospective experience with 37 patients in one institution. Ann Surg. 2003; 237(1):52-56.
10. Michot F, Tuech JJ, Lefebure B, et al. A new implantation procedure of artificial sphincter for anal incontinence: the transvaginal approach. Dis Colon Rectum. 2007; 50(9):1401-1404.
11. Mundy L, Merlin TL, Maddern GJ, Hiller JE. Systematic review of safety and effectiveness of an artificial bowel sphincter for faecal incontinence. Br J Surg. 2004 Jun; 91(6):665-672.
12. O'Brien PE, Dixon JB, Skinner S, et al. A prospective, randomized, controlled clinical trial of placement of the artificial bowel sphincter (Acticon Neosphincter) for the control of fecal incontinence. Dis Colon Rectum. 2004, 47(11):1852-1860.
13. O'Brien PE, Skinner S. Restoring control: the Acticon Neosphincter artificial bowel sphincter in the treatment of anal incontinence. Dis Colon Rectum. 200043(9):1213-1216.
14. Parker SC, Spencer MP, Madoff RD, et al. Artificial bowel sphincter: long-term experience at a single institution. Dis Colon Rectum. 2003; 46(6):722-729.
15. Wong WD, Congliosi SM, Spencer MP, et al. The safety and efficacy of the artificial bowel sphincter for fecal incontinence: results from a multicenter cohort study. Dis Colon Rectum. 2002; 45(9):1139-1153.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Bisset AF. Artificial anal sphincter for faecal incontinence. In Bazian Ltd (Ed) STEER: Succinct and Timely Evaluated Evidence Reviews 2004; 4(3). Bazian Ltd and Wessex Institute for Health Research & Development, University of Southampton.
2. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Premarket approval letter. AMS Acticon™ Neosphincter. Approved December 18, 2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010020a.pdf.  Accessed on September 24, 2009.
3. Hayes Inc. Hayes Medical Technology Directory.  Artificial Anal Sphincter for Fecal Incontinence. Lansdale, PA. Hayes, Inc. August 2008.
4. Medical Services Advisory Committee. Placement of artificial bowel sphincters in the management of faecal incontinence: assessment report. Medical Services Advisory Committee (MSAC), 2003; MSAC application 1053:1099.

AMS Acticon™ Neosphincter
Artificial Anal Sphincter
Fecal Incontinence

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.