MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2022

Event Type  Injury  

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.H6 component code: g07002 ¿ device not returned h6 clinical code: e2402 ¿ low maximum urethral closure pressure citation: doi:10.1002/nau.25032.

Event Description

Title: midterm postoperative results of mid-urethral slings.Role of ultrasound in explaining surgical failures the objective of this study is to investigate the role of pf-us in patients with persistent or recurrent urinary incontinence (ui) symptoms after mus surgery for sui with a midterm follow-up.Between 2013 and 2015, a total of 245 patients with severe urodynamic sui who underwent mus surgery.Five patients were excluded for previous mus surgery.Finally, 87 women met the inclusion criteria.Eighty patients underwent tot-mus and seven patients rt-mus.In 28 patients, concomitant pop surgery was performed at the same time as mus placement.All mus surgeries were performed in a 1-day intervention with hospital discharge the same day.During the follow-up, three patients presented with voiding dysfunction and the pf-us, as part of the immediate postoperative protocol assessment, showed a mus which was too tight.Therefore, after this diagnosis, the mus was sectioned unilaterally a few weeks after surgery, and the symptoms in all three cases disappeared.One patient presented exposure of the mus to the vagina and another patient complained of chronic pelvic pain.In both, complete excision of the sling was performed, improving symptoms.Two of these four patients decided to be reoperated for sui symptoms.In these two patients, the failed tot-mus was removed, urethral mobility was assessed by pf-us after mus excision, and a new rtmus was performed.Regarding the symptoms of uui, up to 53% of patients had these symptoms at 5 years of follow-up, similar to the preoperative and 1-year follow-up visit (no statistically significant differences).In relation to urethral functional parameters, we observed a significantly lower mucp after surgery, with a progressive decrease during follow-up.The tot-mus procedure (monarc®) was performed following the method described by delorme and the rt-mus procedure (tvt-exact®) was performed according to the original technique described by ulmsten.Reported complications include voiding dysfunction (n=3), exposure of the mus to the vagina (n=1), chronic pelvic pain (n=1), sui symptoms (n=2), symptoms of uui/urgency urinary incontinence (53%), and low maximum urethral closure pressure (n=?).In conclusion, patients cured of sui had sonographically correct mus by pf-us.Less than one-third of cases of sui persistence or recurrence after mus surgery could be explained by a sonographically incorrect sling.Low urethral resistance and/or uui symptoms could help to explain the remaining failures.Complete functional and anatomic studies, including urodynamics and pf-us, should be performed before deciding on the next management strategy in patients with sui persistence or recurrence after mus.

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18847033
• MDR Text Key: 337012662
• Report Number: 2210968-2024-02514
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention