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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Insufficient Information (4580)

Event Date 12/02/2023

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.Related events captured via 2210968-2024-02671.Citation: bjog.2023;00:1¿8.Doi: 10.1111/1471-0528.17738.Https://pubmed.Ncbi.Nlm.Nih.Gov/38126201/.

Event Description

Title: rates of subjective and objective cure, satisfaction, and pain 10¿20 years after tension-free vaginal tape (tvt) surgery: a retrospective cohort study the aim of this multicentre, retrospective cohort study is to investigate the long-term subjective and objective cure rate, satisfaction rate and persistent pain 10 and 20 years after tvt surgery, with a comparison between the 10-and 20-year cohorts.A secondary aim was to evaluate the associations between subjective cure and satisfaction in women with high bmis, compared with lower bmis.A total of 1210 women (age at surgery was 46.4 (9.2) years) who underwent tvt surgery in norway over two periods of time were included in the study.These women undergoing surgery between 2001 and 2006 were considered for the 20-year follow-up cohort (n=783), and women who had surgery in 2011 and 2012 were considered for the 10-year follow-up cohort (n=427).In the 10-year cohort 12.7% (54/426) had transobturator tapes, versus 5.5% (53/783) in the 20-year cohort.The remaining had retropubic tapes.No mini slings were used.Gynecare tvt¿ (johnson & johnson, new brunswick, nj, usa) was the only option for the 20-year cohort.In 2011¿2012 this was still used in most hospitals, but also other tapes, such as gynecare tvt exact® (johnson & johnson) or advantage fit¿ (boston scientific, marlborough, ma, usa) were available.Reported complications include voiding difficulties (n=?), >1 urinary tract infection (n=?), persistent pain associated with surgery (n=?), persistent or recurrent stress urinary incontinence (n=?), pain, infection, or other complication requiring removal of part or all of tvt (n=?), tape exposure (n=?), and pain at palpation along tvt (n=?).In conclusion, tension-free vaginal tape (tvt) provided high rates of subjective and objective cure at 10 and 20 years after surgery, with no significant difference between the two cohorts.Although 3%¿5% of women experienced persisting pain, most women were satisfied with tvt surgery.Obesity was associated with a lower cure rate.

• Brand Name: TENSION FREE VAGINAL TAPE 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: 18860542
• MDR Text Key: 337182815
• Report Number: 2210968-2024-02670
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K974098
• 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: 03/07/2024
• 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
• Patient Sex: Female