MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration (4003)

Patient Problems Erosion (1750); Urinary Tract Infection (2120); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Citation: int urogynecol j (2005) 16: 165¿167; doi 10.1007/s00192-004-1229-6.Adverse event 6 months post op for ethibond suture reported in medwatch # 2210968-2019-78450.Adverse event 2 months after the last treatment for prolene mesh reported in medwatch # 2210968-2019-78451.Adverse event 2 months after the last treatment for ethibond suture reported in medwatch # 2210968-2019-78452.(b)(4).

Event Description

It was reported via journal article: "title: complications of synthetic graft materials used in suburethral sling procedures".Authors: kwong-pang tsui, soo-cheen ng, yi-torng tee, guang-perng yeh, gin-den chen citation: int urogynecol j (2005) 16: 165¿167; doi 10.1007/s00192-004-1229-6.This study aimed to present four unusual cases of women using different synthetic materials and the complications occurred.In the first case, a (b)(6)-year-old female patient with urodynamimc stress incontinence and uterovaginal prolapse stage ii who underwent a pubovaginal slingplasty using a patch of prolene mesh with 1-0 ethibond as suspension material.She presented with chronic urinary tract infections 6 months postoperatively.Cystoscopy revealed ethibond thread in the right side of the bladder in which it was cut using an endoscopic scissor.Two months after the last treatment, symptoms of urinary tract infection relapsed and during second cystoscopy, ethibond thread was found to be migrated into the bladder and the right end of the prolene mesh eroded.She underwent reconstruction of the anterior vaginal wall in which the lower end of the ethibond was pulled out of the paravaginal fascia and the prolene mesh was removed simultaneously.The patient was followed up regularly and she remained continent.The transabdominal procedures for the removal of the synthetic materials were difficult because the meshes caused a severe fibrosis to the surrounding tissues or the posterior rami of the pubic ramis.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8255214
• MDR Text Key: 133358698
• Report Number: 2210968-2019-78451
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2019

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: 01/04/2019
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR