(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Additional information was requested and the following was obtained: does the surgeon believe that ethicon products (pds ii suture) involved caused and/or contributed to the post-operative complications described in the article? yes.Pds was responsible for the complications described in table 5 under the absorbable suture columns.However, there are minor and expected complications.Does the surgeon believe there was any deficiency with the ethicon products (pds ii suture) used in this procedure? no.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number no.The following information was requested but unavailable: patient demographics.Citation: international urogynecology journal; doi: https://doi.Org/10.1007/s00192-020-04244-1.(b)(4).
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It was reported via journal article: "title: a randomized controlled trial of permanent vs absorbable suture for uterosacral ligament suspension" authors: joseph t.Kowalski; rene genadry; patrick ten eyck; catherine s.Bradley citation: international urogynecology journal; doi: https://doi.Org/10.1007/s00192-020-04244-1.The aim of this retrospective study was to compare absorbable suture to permanent suture for uterosacral ligament suspension (usls) as measured by pelvic organ prolapse quantification (pop-q) point c at 12-month follow-up.Between october 2016 and november 2017, 44 patients were enrolled in the study.The patients were divided into two groups either absorbable 0 polydioxanone suture (pds; ethicon) (n=22; mean age=62.1 years; mean bmi 28.4 kg/m^2) or permanent polytetrafluoroethylene (n=22; mean age=63.6 years; mean bmi 29.7 kg/m^2).During the procedure, when absorbable suture was used, the suture was placed through the full thickness of the anterior and posterior vaginal walls.Reported complications included de novo stress urinary incontinence (sui) (n=?); persistent sui (n=?) requiring urethral bulking injection; persistent urgency incontinence (n=?); worsened urgency incontinence and recurrent urinary tract infection (n=?); at 6 weeks follow-up: apical suture exposure (n=15) in which one patient was treated with topical estrogen; abnormal vaginal discharge (n=4); vaginal spotting (n=5); patient can feel sutures (n=1); any complication (n=17).At 12 months follow-up: apical suture exposure (n=1); abnormal vaginal discharge (n=1); vaginal spotting (n=1); dyspareunia (n=1); any complication (n=2).In conclusion, the study demonstrates that absorbable suture is non-inferior to permanent suture for prolapse outcomes at 12-month follow-up.Additionally, there were no differences in intervention-related adverse outcomes.
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