Suitable candidates for implantation of the Acticon® prosthesis may be male or female. The specific cause and duration of incontinence are not criteria. Patients should be past adolescence and may suffer from severe fecal incontinence as a result of:

• Congenital anorectal abnormalities
• Trauma-induced injuries
• Neurologic dysfunction
• Postoperative complications

Patients who have failed a previous incontinence treatment may be a candidate. Patients who presently have a colostomy and require a continence device prior to stoma closure also may be considered as candidates for the Acticon prosthesis.

Indications
All patients considered for implantation should have had a thorough history and physical, including an anorectal examination. Additional diagnostic tests which may be performed include anorectal manometry, endoanal ultrasound, and EMG (PNTML). These tests should confirm severe fecal incontinence. Additionally, patients should:

• Be an acceptable risk for surgery or general anesthesia
• Have sufficient dexterity and mental capacity to operate the prosthesis
• Have the mental and psychological ability to understand the implications of a prosthetic implant

Contraindications
Implantation may be contraindicated due to one or more of the following circumstances:

• This device is contraindicated in patients whom the physician determines to be poor candidates for risks associated with surgical procedures and/or anesthesia due to the patient's medical history (physical and mental conditions).
• This device is contraindicated in patients with fecal incontinence complicated by an irreversibly obstructed segment of bowel.
• This device is contraindicated in patients with an active infection.

A complete list of warnings, precautions and contraindications is available in the Instructions for Use.