(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products ( prolene polypropylene mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? citation: neurourology and urodynamics.2018;37:278¿283; doi: 10.1002/nau.23288.(b)(4).
|
Title: long-term follow-up of anterior vaginal repair: a comparison among colporrhaphy, colporrhaphy with reinforcement by xenograft, and mesh the purpose of our retrospective study was to evaluate the long-term outcomes of three different techniques for anterior compartment repair: transvaginal anterior colporrhaphy (ac) alone, transvaginal ac with reinforcement by porcine xenograft, and transvaginal anterior repair with the use of a polypropylene mesh (prolene).From nov2000 to may2015, 109 patients surgery for pelvic organ prolapse with either transvaginal ac (n=42; mean age sd of 65.5 [9.8] years), transvaginal ac with reinforcement by using porcine xenograft (ac-p) (n=19; mean age sd of 67.2 [6.6] years) or transvaginal ac with prolene mesh (ac-m) (n=48; mean age sd of 64.5 [8.6] years).In ac-m group, self-tailored prolene mesh was placed without anchoring sutures in a tension-free manner after the midline vaginal incision and vaginal epithelium separation from the underlying fibromuscular layer.Complications in ac-m group included pain (n=2) treated with pain killers with persistent medical treatment; extrusion (n=8) associated with temporary urinary retention (n=1) and pelvic pain (n=1) treated with surgical revision (for all extrusions), clean intermittent catheterization (extrusion with temporary urinary retention) and prescription of pain killer with persistent medical treatment (extrusion with pelvic pain), hematoma (n=1) and urinary retention (n=3) treated with clean intermittent catheterization.Additionally, recurrences from this group was reported in 8 patients.This study evaluated long-term outcomes to anterior vaginal repair over a period of more than 5 years in all the groups.The data showed that anterior vaginal repair with mesh and xenograft did not improve significantly objective and subjective outcomes.Rather, prosthetic device use leads to higher rate of complications.
|
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.It was reported that this device is not malfunction reportable.Therefore, this medwatch report 2210968-2018-76235 is not reportable.Additional information was requested and the following was obtained: were the cases discussed in this article previously reported to ethicon? no that was not reported.Does the surgeon believe that ethicon products ( prolene polypropylene mesh) involved caused and/or contributed to the post-operative complications described in the article? no, we believe that is not related to the kind of the mesh.Does the surgeon believe there was any deficiency with the ethicon products involved? no there was no deficiency with ethicon product involved.
|