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In-\/exclusion criteria were predefined according to the PICOS scheme. The Institute of Health Economics risk of bias (RoB) tool assessed studies' internal validity. According to the Grading of Recommendations, Assessment, Development and Evaluation approach, the strength of evidence for safety outcomes was rated. A qualitative synthesis of the evidence was used to analyse the data.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The evidence consists of eight prospective single-arm, before-after studies (166 patients) fulfilling the inclusion criteria for assessing clinical effectiveness and safety of implantable bulking agents. FI severity statistically significantly improved in five of seven studies rated by the Cleveland Clinic FI Score and in three of five studies measured by the Vaizey score. Statistically significant improved disease-related QoL was found in one of five studies measured by the FI QoL Score and in one of two studies rated by the American Medical Systems score. Procedure-related adverse events occurred in 16 of 166 patients (i.e., intraoperative complications, anal discomfort and pain). Device-related adverse events occurred in 48 of 166 patients, including prostheses\u2019 dislodgement and removed\/extruded prostheses. Studies were judged with moderate\/high RoB. The strength of evidence for safety was judged to be very low.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Implantable bulking agents might be an effective and safe minimally invasive option in FI treatment if conservative therapies fail. FI severity significantly improved, however, effects on QoL need to be explored in further studies. Due to the uncontrolled nature of the case series, comparative studies need to be awaited.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12876-022-02441-4","type":"journal-article","created":{"date-parts":[[2022,8,17]],"date-time":"2022-08-17T12:02:54Z","timestamp":1660737774000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7734-0682","authenticated-orcid":false,"given":"Lucia","family":"Gassner","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Wild","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melanie","family":"Walter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,8,17]]},"reference":[{"key":"2441_CR1","doi-asserted-by":"publisher","first-page":"2161","DOI":"10.1111\/codi.15277","volume":"22","author":"CA Leo","year":"2020","unstructured":"Leo CA, Leeuwenburgh M, Orlando A, Corr A, Scott SM, Murphy J, Knowles CH, Vaizey CJ, Giordano P. 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