Clinical Study to Investigate the Effectiveness of the TOPAS Sling System to Treat Fecal Incontinence (TRANSFORM)

Inclusion Criteria:

Subject is/has:

1. An adult (>/= 18 years) female.
2. FI symptoms for a minimum of 6 months.
3. Failed two modalities of conservative therapies such as Dietary Modification, Pharmacologic Intervention, or Pelvic Floor Muscle Training.
4. <50 years old OR if >/= 50 years old, has had a negative cancer screening examination of the colon according screening guidelines (colonoscopy or barium enema + flexible sigmoidoscopy) within the past 3 years prior to informed consent date. (Note: if not done, the investigating physician must provide written justification for not having this exam and must be following the American Cancer Society Guidelines).
5. FI episodes ≥ 4 in 14 day period.

Exclusion Criteria:

Subject is/has

1. Unable or unwilling to sign Informed Consent Form or comply with study requirements.
2. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by AMS.
3. Allergic to polypropylene.
4. Pregnant or planning a future pregnancy.
5. Less than 12 months (365 days) postpartum.
6. Pelvic prolapse >/=1 cm beyond the hymen (Stage III & IV)
7. Had stress urinary incontinence (SUI) or anterior repair within 3 months (90 days) prior to TOPAS Sling System implantation.
8. Had a hysterectomy, Sphincteroplasty, or Posterior surgery within 6 months (180 days) prior to TOPAS Sling System implantation.
9. Had rectal surgery (such as rectopexy) within 12 months (365 days) of TOPAS Sling System implantation.
10. Planning pelvic surgery within 12 months (365 days) post implant
11. Current Grade III or IV hemorrhoids.
12. Neurological or psychological condition as cause of FI such as MS, dementia, brain tumor.
13. Diagnosed Inflammatory Bowel Disease (for example, ulcerative colitis or Crohn's disease).
14. Chronic, watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence.
15. Severe chronic constipation, including obstructive defecatory disorder.
16. External full thickness rectal prolapse.
17. A history of laxative abuse within the past 5 years.
18. Had previous rectal resection.
19. Active pelvic infection, perianal or recto-vaginal fistula.
20. Congenital anorectal malformations or chronic 4th degree lacerations and cloacae.
21. History of therapeutic radiation for cancers of the pelvis.
22. Currently implanted with a sacral nerve stimulator.
23. Contraindicated for surgery or having any condition that would compromise wound healing.