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Updated: Jul 15, 2026

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Elastomer implants in faecal incontinence: a blind, randomized placebo-controlled study.

L Siproudhis1, J Morcet, F Lainé

  • 1Service des Maladies de l'Appareil Digestif, CHU Pontchaillou, Rennes, France. laurent.siproudhis@chu-rennes.fr

Alimentary Pharmacology & Therapeutics
|April 19, 2007
PubMed
Summary

Polydimethylsiloxane elastomer injections did not improve severe fecal incontinence in patients with internal anal sphincter impairment. The treatment showed no significant difference compared to saline injections in clinical outcomes.

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Area of Science:

  • Colorectal surgery
  • Gastroenterology
  • Biomaterials science

Background:

  • Severe fecal incontinence often results from internal anal sphincter dysfunction.
  • Existing treatments have limitations, necessitating novel therapeutic approaches.

Purpose of the Study:

  • To evaluate the efficacy and safety of polydimethylsiloxane elastomer implants for treating severe fecal incontinence.
  • To assess the impact on incontinence scores, quality of life, and adverse events.

Main Methods:

  • A randomized, double-blind study involving 44 women with severe fecal incontinence.
  • Participants received three injections of either polydimethylsiloxane elastomer or saline in the intersphincteric space.
  • Treatment success was defined as a Cleveland Clinic Florida-Fecal Incontinence score below 8 at 3 months.

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Main Results:

  • No significant difference in treatment success rates between the polydimethylsiloxane elastomer group (23%) and the saline group (27%) at 3 months (P = 0.73).
  • Mean Cleveland Clinic Florida-Fecal Incontinence scores remained similar between groups (11.7 vs. 11.4, P = 0.79).
  • The treatment was generally well-tolerated with no major adverse events reported.

Conclusions:

  • Polydimethylsiloxane elastomer implants are not effective for treating severe fecal incontinence due to internal anal sphincter impairment.
  • Further research may be needed to explore alternative biomaterials or treatment strategies.