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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Urinary Tract Infection (2120)

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.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title: anterior colporrhaphy versus repair with mesh for anterior vaginal wall prolapse: a comparative clinical study.The purpose of this study was to compare the clinical effectiveness of anterior colporrhaphy versus mesh repair as surgical management of anterior vaginal prolapse.A total of 44 patients underwent surgical repair for anterior vaginal wall prolapse (cystocele) and were included in the study.Of which, 23 patients received anterior colporrhaphy (group 1) and 21 patients received soft gynemesh ps mesh (group 2).In group 2, the patients had mesh repair where the development of vesicovaginal space was done as before, followed by reflection of the vaginal wall laterally.Then a trapezoid piece of single-layered prolene mesh was fashioned to fit the defect from the urethrovesical junction anteriorly to the vaginal apex posteriorly.The mesh was anchored to the underlying connective tissue at the lateral limits of the previous dissection with interrupted tension free polyglactin sutures stitched to the mesh¿s four corners and mid-lateral edges.Mesh anchoring was checked by trying to mobilize it by atraumatic forceps.In group 2, reported complications included urinary infection (n-3) and mesh erosion (n-1).It was concluded that the use of polypropylene mesh for vaginal prolapse repair is superior to classical anterior repair in terms of anatomic and functional outcomes.The mesh repair is simple, relatively safe on a short-term basis, and appears to be an effective method of preventing recurrence with high success rate and low local morbidity.

• 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.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7485028
• MDR Text Key: 107440011
• Report Number: 2210968-2018-72578
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2018
• 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