MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMSH PS 4INX6IN; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	GPSL
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928); Prolapse (2475); Unspecified Kidney or Urinary Problem (4503)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Title: clinical outcome and urodynamic changes of tailored transvaginal mesh surgery for pelvic organ prolapse: a mid-term 40 months follow-up the aim of this retrospective study was to evaluate the changes in clinical outcome and urodynamic parameters after tailored anterior transvaginal mesh (atvm) surgeries in a mid-term follow-up.Between november 2011 and december 2015, a total of 160 women (mean age of 64.1 ± 9.5 years; mean bmi of 24.7 ± 2.8 kg/m2) with stage ii pelvic organ prolapse (pop) who underwent atvm surgeries were included in the study.The data reviewing timeframe was until december 2021.Clinical and urodynamic diagnoses regarding urinary symptoms were evaluated before and after the operation.A polypropylene mesh (gynemesh ps nonabsorbable prolene soft mesh, gpsl 10 cm x 15 cm, ethicon, us) was used and trimmed to a central diamond shape (7 x 6 cm) with two sets of paired arms.The anterior vaginal wall was sutured in two layers without trimming the redundant portion using a vicryl 1-0 suture.Concomitant posterior repair with posterior transvaginal mesh surgery (ptvm), perineorrhaphy, or apical suspension was performed as needed.The median follow-up interval was 40 months.Reported complications include voiding dysfunction (n=10), overactive bladder syndrome (n=45), stress urinary incontinence (n=68), bladder outlet obstruction (n=4), detrusor underactivity (n=6), bladder oversensitivity (n=128), detrusor overactivity (n=17), urodynamic stress incontinence (n=82), recurrent advanced pelvic organ prolapse (n=18), and mesh extrusion (n=24).In conclusion, in women with advanced cystocele, the atvm surgery provides a favorable anatomic reduction outcome with an acceptable mesh extrusion rate.The atvm provides an anti-incontinence effect, both in subjective symptoms and objective parameters, but this effect might decline after postoperative 2 years.
Additional Manufacturer Narrative
(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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: journal of the formosan medical association (2022;121:2424-2429.Https://doi.Org/10.1016/j.Jfma.2022.07.011.

• Brand Name: GYNECARE GYNEMSH PS 4INX6IN
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19771738
• Report Number: 2210968-2024-07352
• Device Sequence Number: 15482646
• Product Code: OTO
• UDI-Device Identifier: 10705031037731
• UDI-Public: 10705031037731
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: GPSL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female