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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Insufficient Information (4580)

Event Date 01/01/2023

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.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: journal of gynecologic surgery; volume 39, number 5, 2023; doi: 10.1089/gyn.2023.0026.Please see article attached.

Event Description

Title: ichiorectal sinus formation associated with mesh exposure remote from transobturator sling placement.This study reports a case of ischiorectal sinus formation associated with mesh exposure from transobturator sling placement.13 years after having an uncomplicated tension free vaginal tape¿obturator (tvt-o; ethicon) placed for stress urinary incontinence, a 49 year-old woman was treated conservatively for vaginal exposure of the right sling arm, pelvic pain, and dyspareunia.4 years later and 3 months prior to being seen, she experienced intermittent swelling of the right side of the perineum and glute, difficulty sitting, and back pain.Palpation of the exposure reproduced her dyspareunia.A tender subcutaneous induration was identified medial to the right ischial tuberosity measuring 1 x 2 cm.Magnetic resonance imaging revealed that she had a 5-cm long sinus tract along the anterior margin of the right pubococcygeus muscle and inferiorly into the perineum and medial glute without cutaneous extension.A combined groin and vaginal dissection were performed to explant the sling and debride the fistula tract.The distal end of the mesh had retracted below the level of the adductor muscles, and, with further exposure, the sinus tract was found behind the inferior pubic ramus with a flexible probe.After extensive dissection, the remaining mesh was removed, and the tract was debrided with a flexible channel cleaning brush with polypropylene bristles.A disposable pulse-lavage system was also utilized.A drain was placed into the dependent portion of the wound and the remainder of the wound was closed primarily.The patient was discharged on the same day and was prescribed oral levofloxacin and metronidazole to take for 2 weeks.At her follow-up, there was resolution of the gluteal induration, tenderness, and back pain; and she only experienced occasional stress-urinary incontinence.Reported complications included vaginal exposure of the right sling arm, pelvic pain, and dyspareunia at 13 years postoperative, gluteal induration, tenderness, and back pain, distal end of the mesh retraction below the level of the adductor muscles leading to ischiorectal sinus formation at 17 years postoperative, and occasional stress-urinary incontinence.In conclusion, in my patient, the location and the time course of the exposure as well as weak bacterial virulence may have led to the migration of the distal end of the mesh arm favoring the development of the ischiorectal fossa sinus tract (as well as her nonacute presentation) rather than the more commonly reported groin abscess.

• 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: 18884855
• MDR Text Key: 337417103
• Report Number: 2210968-2024-02865
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 03/12/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female