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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Tissue Injury (4559)

Event Date 10/10/2005

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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. .

Event Description

It was reported in a journal article with title: presence of prolene mesh in vagina.This study aimed to describe the clinical case of a patient presenting complications after the implantation of a prolene mesh as reinforcement for the correction of a recurrent cystocele.A (b)(6) year old female patient with history of previous cystocele repair with prolene mesh was included.Vaginoscopy which showed a fragment of calcified mesh extruding from the vagina.Cystomanometry and pressure-flow: normal sensitive-motor behavior during the study.Leakage observed upon coughing.Normal voiding phase.Since this is a patient with type iii sui with a fixed urethra on examination, it was decided to implant a remeex-type adjustable-tension sling and perform partial excision of the mesh extrusion at the anterior vaginal level.Reported complications included recurrent cystocele, urinary incontinence and vaginal erosion.In conclusion, the use of mesh for the repair of cystoceles has the advantage of providing greater support to the colporrhaphy and avoiding recurrences.Nevertheless, it may present complications as in our reported case with mesh migration, fistula, infection, or intolerance.

• 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: 11871157
• MDR Text Key: 253823192
• Report Number: 2210968-2021-04911
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2021

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: 04/28/2021
• Initial Date FDA Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR