(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.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? if yes, provide details of event and specific product code.Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date and type of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions.Are the product code and lot numbers available for ethicon devices used? citation: dis colon rectum.2017; 60: 178 186.Doi: 10.1097/dcr.0000000000000710.[(b)(4) - fu 2017.Pdf].
|
It was reported in journal article: ¿title: risk factors for recurrence after laparoscopic ventral rectopexy¿ authors: cherylin w.P.Fu, m.B.B.S, m.Med, f.R.C.S.Ed; andrew r.L.Stevenson, m.B.B.S, f.R.A.C.S citation: dis colon rectum.2017; 60: 178 186.Doi: 10.1097/dcr.0000000000000710.The objectives of this retrospective cohort study aimed to evaluate factors contributing to recurrence after laparoscopic ventral rectopexy (lvr).A total of 231 patients underwent lvr and were included in the study.All of the procedures were performed by or under the direct supervision of a single surgeon experienced in the lvr technique.The procedure was fully laparoscopic, and either a synthetic mesh or a biologic graft was used.The method of fixation of the graft to the sacral promontory used was pds sutures in 41 patients and the type of mesh used were prolene and ultrapro synthetic mesh in 32 patients.It was also noted that modifications to the technique evolved throughout the study period.Reported complications included pelvic abscess which required laparoscopic wash-out, rectovaginal seroma/hematoma, vaginal discharge, wound hernia, wound infection, and recurrent prolapse which required redo lvr, sutured transanal mucosectomy and plication, sacral nerve modulation, ligation of hemorrhoids, stoma, and prosthetic sphincter augmentation.It was reported that the authors identified certain technical aspects of lvr that can contribute to failure and recurrent prolapse: inadequate apposition of the mesh/graft to the lateral and anterior surfaces of the rectum, especially at the midrectum, resulting in inadequate rectal suspension and recurrent internal prolapse or rectoanal intussusception, slippage of mesh attachment from the sacral promontory, which may be attributed to excessive tension on the mesh or poor anchoring technique to the sacral promontory, and the distal part of the mesh/graft being too narrow, resulting in inadequate support of the lateral aspects of the rectum and pelvic floor.It was concluded that recurrent prolapse after lvr is multifactorial and risk factors are both clinical and technical.The use of biologic grafts was associated with lower recurrence as compared with synthetic mesh.
|