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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Urinary Retention (2119); Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/21/2022

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 ¿ pop stage, cystocele, and rectocele the single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2024-02845, 2210968-2024-02846 and 2210968-2024-02847 citation: https://doi.Org/10.1016/j.Ejogrb.2022.11.014.

Event Description

Title: can obesity impact mesh exposure rate after mid-urethral sling operation? medium term follow-up the objective of this study is to study mesh exposure rates among obese (bmi = 30 kg/m2) vs non-obese women after mid-urethral sling (mus) operation.Between april 2014 to april 2021, a total of 120 obese patients and 172 non-obese patients who had mid-urethral sling surgery.The median age at the time of surgery was 61 years, (59.8 ± 10.8 years in the obese group vs 61.8 ± 12.3 years in the non-obese group, p =.15).Ages ranged from 33 to 87 years.During the study period, 292 patients underwent mus surgery for sui.262 underwent tvt-obturator, 13 mini-sling tvt, and 17 retro-pubic tvt.Two cases of post-operative mesh exposure occurred among the obese group compared to 14 cases in the non-obese group.In three cases, estrogen treatment was the definitive solution for the exposure.There were no other significant differences in the intraoperative or post-operative complications between the obese group and the non-obese group, which include the need for blood transfusion (no cases), urinary tract infection (6 vs 3 cases), the need for rehospitalization -1-month post-operative (5 vs 3 cases) and postoperative urinary retention (7 vs 3 cases).Pop stage, cystocele, and rectocele levels were significantly higher in the non-obese group.No patient in either group had repeat mus surgery related to failed or new sui symptoms during the study period.The study cohort included all women who underwent mus surgery for sui during the study period, including tvt-o (gynecare, ethicon), tvt-abbrevo (gynecare ethicon), and retro-pubic tvt-exact (gynecare, ethicon).All of the mus surgeries were done by our three urogynecology unit surgeons.Reported complications for each groups: obese group: -post-operative mesh exposure (n=2) -urinary tract infection (n=3) -postoperative urinary retention (n=4) -rehospitalization (n=3) -pop stage, cystocele, and rectocele (n=?) non-obese group: -post-operative mesh exposure (n=14) -urinary tract infection (n=6) -postoperative urinary retention (n=7) -rehospitalization (n=5) -pop stage, cystocele, and rectocele (n=?) in conclusion, this follow-up after mus surgery showed an association between obesity and lower rate of mesh exposure.Further research is needed to evaluate correlations between estrogen and mesh exposure.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• 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: 18881572
• MDR Text Key: 337414294
• Report Number: 2210968-2024-02845
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K033568
• 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

• Date FDA Received: 03/11/2024
• 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: 02/20/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention