MAUDE Adverse Event Report: ETHICON INC. PROLENE 3D PATCH MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Unspecified Infection (1930); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.Citation: int urogynecol j (2013); 24:963¿968.Doi 10.1007/s00192-012-1953-2.No additional information available.If further details are received at a later date a supplemental medwatch will be sent.Adverse events associated with tension free vaginal tape device reported via mw # 2210968-2021-05108.

Event Description

It was reported in a journal article with title: repeat versus primary slings in patients with intrinsic sphincter deficiency.The aim of this retrospective cohort study is to evaluate the outcomes of repeat compared with primary slings in a cohort of patients with a urodynamic diagnosis of sui with isd.It was also our goal to determine any factors associated with an increased risk for sling failure, as well as any differences in outcomes between tension free trans-obturator and retropubic slings and tensioned pubovaginal slings.Between march 2003 to october 2010, a total of 637 female patients who underwent surgical treatment of sui with isd with a synthetic sling were included in the study.557 patients (mean age = 68.1±12.1 years; bmi = 27.4±5.1) had a primary sling placed, and 80 patients (mean age = 65.9±9.8 years; bmi = 26.9±4.8) underwent a repeat sling procedure for recurrent sui.Of the 637 slings, 132 (21 %) were tension-free mid-urethral trans-obturator slings (monarc), 174 (27 %) tension-free mid-urethral retropubic slings (anterior ivs and tvt (ethicon)), and 331 (52 %) tensioned pubovaginal slings placed at the bladder neck (prolene patch (ethicon) and i-stop).Reported complications included unsuccessful / not cured / failure (n=?) which required reintervention and underwent at least one in-office urethral bulking procedure during follow-up; subjective urgency/mui (n=?); de novo urgency (n=?); positive empty supine stress test (n=?); postoperative voiding dysfunction (n=?); bladder outlet obstruction (n=?) which required sling transection; infection of the synthetic sling or sutures (n=?) and underwent sling removal.In conclusion, in women with isd, repeat slings are associated with lower success rates compared with primary slings.Pubovaginal slings resulted in the highest success rate compared with both trans-obturator and retropubic slings.

• Brand Name: PROLENE 3D PATCH MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): J-PAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11913109
• MDR Text Key: 266909750
• Report Number: 2210968-2021-05109
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention