Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Device not returned.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: oper orthop traumatol 2021 · 33:318¿330: https://doi.Org/10.1007/s00064-021-00721-y.
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It was reported in a journal article with title: hiatal reduction with the 'puborectalis sling': a multicenter randomized controlled trial.This study aims to report medium- term results of a multicenter randomized controlled trial investigating this procedure (prolapse repair).A total of 192 women undergoing prolapse repair at the discretion of the surgeon with a pre-operative hiatal area on valsalva of = 30cm2, were recruited to a prospective multicenter rct which compared pop surgery alone or pop surgery with pr sling.Mean age at operation was 58 (27-83).Mean body mass index was 29 (15-48).94 (47%) had a previous hysterectomy, 58 (29%) a previous incontinence or prolapse procedure.Primary outcome was prolapse recurrence on popq and ultrasound at 2 years.The pr sling was inserted after completion of prolapse repair, via bilateral groin and perianal incisions of 2 cm in length.A tunnel was created digitally below the anococcygeal raphe, connecting the two perianal incisions.A 3cm x 25 cm strip of polypropylene mesh (johnson & johnson/ethicon, somerville nj), was passed through this tunnel with the help of an angled clamp.A curved stamey needle (90 degree curvature) was inserted through the obturator foramen to exit in the ipsilateral perianal incision, allowing retrieval of the mesh sling.Needle insertion was performed under digital guidance (vaginal and rectal).The mesh was secured to the periosteum of the inferior pubic rami using absorbable sutures.192 patients were evaluated at least once post-operatively, with 181 having 4d translabial ultrasound.At 1.9 (range, 0.1-6.7) years, there was an average reduction of 9 cm2 (range 32.6 to -13.8) cm2 reduction in hiatal area from a mean pre-operative hiatal area of 42.1 (30 ¿ 68.1) cm2.Reported complications included n=1 compartment syndrome of the thigh, n=1 rectal perforation requiring prs removal, n=1 chronic pain, n=32 symptoms of prolapse, n=8 symptoms of incontinence, n=35 obstructed defecation, n=34 bladder descent, n=21 rectal descent, n=56 vaginal lump or bulge, n=150 clinical prolapse recurrence, n=38 recurrence beyond hymen and n=84 sonographic prolapse recurrence.In conclusion, while there were no significant differences for satisfaction, symptoms of prolapse and popq findings at an average follow-up of 1.9 years, we found a lower rate of anal incontinence in women after prs.Bladder and rectal descent on imaging as well as prolapse on ultrasound was reduced, the latter highly significantly.Reduction of hiatal area on valsalva was much more pronounced after prs, confirming published observational data.
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