Authors' recommendations: Polydimethylsiloxane injections are a minimally-invasive option in the treatment of VUR, faecal incontinence, periprosthetical leakage, UVFP, laryngeal cleft type I, and stomal leakage in continent diversion. All studies covered in this report have generally demonstrated the safety and efficacy of PDMS implants in treating these indications, although long-term and high level evidence is conspicuously lacking for most indications. The results of fifteen studies (including one systematic review, one RCT, and two comparative non-RCTs) indicated that PDMS implants are relatively safe in the treatment of VUR, with few serious complications or side-effects. While non-comparative studies showed a favourable cure rate, comparative and RCT studies indicated that PDMS injection generally yielded a roughly equal or slightly lower cure rate in comparison to treatment with Deflux® or extravesical reimplantation. In the treatment of faecal incontinence, three studies (including one RCT) demonstrated that PDMS implants were relatively safe, with complications generally resolved through proper positioning of injections or adjustments to needle gauge. Overall, marked or significant improvements in all outcome measures were reported, although no studies sought to compare PDMS treatment with other forms of treatment.Three studies demonstrated the safety and effectiveness of PDMS injections in the treatment of periprosthetical leakage. Although the level of evidence was relatively low and no comparisons were sought, the studies did suggest that PDMS implants were generally effective in sealing prosthesis leakage, with no complications or side-effects in the small patient samples used.Low level evidence for the efficacy and safety of PDMS implants in treating UVFP came from two studies. Both studies reported significant short-term improvements in outcome measures, with no safety issues.The results of a single case report suggested that PDMS injections were effective in treating one young patient with laryngeal cleft type I, carrying no complications or safety issues.Similarly, one case series indicated the effectiveness of PDMS injections in sealing stomal leakage in six patients. No complications or safety issues were reported. Overall, with the exception of PDMS implants in the treatment of VUR - which may have been superseded by Deflux® injections - more long-term, higher quality evidence is required to determine the value of PDMS injections in treating the indications outlined in this report.

Project Status: Completed

URL for project: http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/211ABF81A69CA39DCA2575AD0080F3DC/$File/Injectable%20Silicone%20Biomaterial%20Implants.pdf

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical

Contact Address: ASERNIP-S 24 King William Street, Kent Town SA 5067 Australia Tel: +61 8 8219 0900

Contact Name: racs.asernip@surgeons.org

Contact Email: racs.asernip@surgeons.org

Copyright: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S)