MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR 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); Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580)

Event Date 06/12/2023

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2024-02507, 2210968-2024-02509, 2210968-2024-02510, 2210968-2024-02511.Citation: international urogynecology journal (2023);34:2573¿2580.Https://doi.Org/10.1007/s00192-023-05575-5.

Event Description

Title: the transvaginal mesh class action: a tertiary teaching hospital experience of all mid-urethral sling procedures performed between 1999 and 2017.This study is aimed at reviewing complications requiring readmission and re-operation of women who underwent a mid-urethral slings (mus) procedure using j&j, boston scientific (bs) or american medical systems (ams) devices at a single tertiary centre in melbourne, australia, from the time of their introduction until july 2017.Between 1999 and 2017, a total of 1462 women were identified as having a mus procedures for stress urinary incontinence (sui); of these, 1,195 (81.7%) had full patient records available.The median age at surgery was 56 (iqr 36¿76) years.Among these, 858 women had undergone 869 j&j mus procedures.Tvt and tvt exact (both retropubic) made up 75%, tvt-o and tvt-abbrevo (transobturator) the remainder.Tvt secur was also used in 5 patients but was excluded from the table owing to very low numbers.The median follow-up time from index surgery to chart review was 16 (iqr 4¿22) years.Reported complications include voiding dysfunction, recurrent sui, pain, mesh exposure, infection either of the surgical site or of the urinary tract, urinary urgency, de novo or persistent overactive bladder symptoms.In conclusion, this audit of all mus procedures performed at a tertiary centre confirms an overall low rate of readmission for complications and recurrent sui surgery; this justifies its continued availability with appropriate informed consent.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR 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: 18846748
• MDR Text Key: 337072408
• Report Number: 2210968-2024-02508
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K052401
• 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: 03/06/2024
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female