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

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

Patient Problems Erosion (1750); Pain (1994); Insufficient Information (4580)

Event Date 03/09/2022

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.Citation: pelviperineology 2022;41(1):28-38; doi: 10.34057/ppj.2022.41.01.2022-1-5.Please see article attached.

Event Description

Title: is a softly knitted polypropylene tape a better choice than a laser cut polypropylene tape for the treatment of female urinary stress incontinence? the purpose of this study is to evaluate the feasibility, the safety, the cure rate, and postoperative pain of both procedures, as well as digital ability to palpate the implanted tapes and on physical examination.99 women suffering from urinary incontinence during physical exertion proved by clinical examination such as supine cough stress test were included in the study.The patients were randomized onto 1 of the 2 study groups, to have either a competitor serasis or tvt-abbrevo (ethicon).52 women (mean age 34.8 years, mean bmi 27.7 kg/m2) were assigned to tvt-abbrevo (ethicon) group and 47 women (mean age 51.7 years, mean bmi 26.8 kg.M2) to the competitor serasis group.The operations were performed under general anesthesia and the patients were discharged 8 hours after surgery.Reported complications included groin pain before hospital discharge (n=13), groin pain after hospital discharge (n=5) groin pain at 12 months postoperative (n=1), vaginal pain at intercourse (dyspareunia) at 1 month postoperative (n=1), vaginal pain at intercourse (dyspareunia) at 12 months postoperative (n=1), vaginal pain before hospital discharge (n=44), vaginal pain after hospital discharge (n=32), vaginal pain at 1 month postoperative (n=1), pelvis pain before hospital discharge (n=28), pelvis pain after hospital discharge (n=26), thigh pain before hospital discharge (n=15), thigh pain after hospital discharge (n=12), radiating pain before hospital discharge (n=12), radiating pain after hospital discharge (n=5), radiating pain at 1 month postoperative (n=1), palpation of a tape on physical exam at 1 month postoperative (n=36), palpation of a tape on physical exam at 12 months postoperative (n=7), tape erosion into the vaginal cavity (n=1), and tape failure (n=1).In conclusion, based on the results, serasis softly knitted polypropylene tape might be a better choice than tvt-abbrevo laser cut polypropylene for the treatment of female urinary stress incontinence due to less unfavorable outcomes.

• Brand Name: TENSION FREE VAGINAL TAPE - ABBREVO 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: 18884901
• MDR Text Key: 337417470
• Report Number: 2210968-2024-02866
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K100936
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2024
• 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): Other
• Patient Sex: Female