Title: medium term outcomes of tvt-abbrevo for the treatment of stress urinary incontinence: efficacy and safety at 5-year follow-up.The aim of the present study is to evaluate the efficacy and safety of the tvt-a procedure in women with pure sui at 5-year follow-up.Between june 2014 and december 2017, all women who were referred to our urogynecological department complaining of pure sui symptoms were prospectively enrolled in our study.A total of 50 women with urodynamic suis who met the inclusion criteria and underwent gynecare tvt-abbrevo (ethicon) implantation were enrolled in the study.Reported complications are persistent of voiding dysfunction, recurrent uti, de novo overactive bladder (oab), asymptomatic vaginal mesh exposure and symptomatic vaginal mesh exposure.In conclusion, the 5-year follow-up results of this study demonstrated that tvt-a is a safe and effective option for treatment of sui with a very low rate of post-operative groin¿thigh pain.
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(b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.An attempt has been made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.H6 component code: g07002 ¿ device not returned.Citation: medicina 2022, 58, 1412.Https://doi.Org/10.3390/medicina58101412.
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