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

Device Problem Migration (4003)

Patient Problems Bacterial Infection (1735); Erosion (1750); Pain (1994); Urinary Tract Infection (2120)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported in a journal article with title: endoscopic laser vaporisation of prolene mesh extruded into the bladder.The purpose of this study is to present a case of bladder erosion by a prolene mesh inserted 4 years before as a cervix-abdominal suspension to cure and prevent vaginal prolapse and treat mixed urinary incontinence after abdominal hysterectomy for uterine fibromatosis and prolapse.She was already submitted twice to endoscopic bladder lithotripsy for bladder stones but still she was suffering of recurrent urinary tract infections and retropubic tenderness.During these procedures the presence of a mesh after removal of the stones was evident but not treated.Therefore we planned to endoscopically remove the mesh using thullium laser.During the procedure under general anesthesia we found presence of small recurrent stones on the posterior wall of the bladder lying over threads of a prolene mesh.After lithotripsy we continued to use the laser to disintegrate the prolene threads until they were disappearing into the thick bladder wall.The procedure was well tolerated and the patient discharged after 48 hours of bladder drainage without any complain.We reviewed the patient after 6 months, she was asymptomatic but still with bacteriuria.We found small remnants of prolene threads covered with little concretions that were again treated this time with holmium pulsated laser.After further 3 months the patient was still well and at cystoscopy we did not find any residual mesh or stones.Reported complications included recurrent urinary tract infection, retropubic tenderness, mesh erosion and bacteriuria.In conclusion, erosion of mesh into the bladder can happen after management of female stress urinary incontinence with suburethral sling.It is rare after suspension of the cervix or vaginal vault unless the suspension is made to the anterior abdominal wall.Management of this type of erosion is usually endoscopically performed with holmium laser.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: neurourology and urodynamics.2020 dec; conference: 44th annual congress of the italian urodynamic society please see article attached.If further details are received at a later date a supplemental medwatch will be sent.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: neurourology and urodynamics.2020 dec; conference: 44th annual congress of the italian urodynamic society please see article attached.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported in a journal article with title: endoscopic laser vaporisation of prolene mesh extruded into the bladder.The purpose of this study is to present a case of bladder erosion by a prolene mesh inserted 4 years before as a cervix-abdominal suspension to cure and prevent vaginal prolapse and treat mixed urinary incontinence after abdominal hysterectomy for uterine fibromatosis and prolapse.She was already submitted twice to endoscopic bladder lithotripsy for bladder stones but still she was suffering of recurrent urinary tract infections and retropubic tenderness.During these procedures the presence of a mesh after removal of the stones was evident but not treated.Therefore we planned to endoscopically remove the mesh using thullium laser.During the procedure under general anesthesia we found presence of small recurrent stones on the posterior wall of the bladder lying over threads of a prolene mesh.After lithotripsy we continued to use the laser to disintegrate the prolene threads until they were disappearing into the thick bladder wall.The procedure was well tolerated and the patient discharged after 48 hours of bladder drainage without any complain.We reviewed the patient after 6 months, she was asymptomatic but still with bacteriuria.We found small remnants of prolene threads covered with little concretions that were again treated this time with holmium pulsated laser.After further 3 months the patient was still well and at cystoscopy we did not find any residual mesh or stones.Reported complications included recurrent urinary tract infection, retropubic tenderness, mesh erosion and bacteriuria.In conclusion, erosion of mesh into the bladder can happen after management of female stress urinary incontinence with suburethral sling.It is rare after suspension of the cervix or vaginal vault unless the suspension is made to the anterior abdominal wall.Management of this type of erosion is usually endoscopically performed with holmium laser.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13565257
• MDR Text Key: 286162146
• Report Number: 2210968-2022-01200
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2022

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: 01/20/2022
• Initial Date FDA Received: 02/19/2022
• 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 Sex: Female