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

Catalog Number PROMESHUNK

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

Patient Problems Erosion (1750); Granuloma (1876)

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.Citation: saudi med j (2010); 31(2): 180-184.(b)(4).

Event Description

It was reported in a journal article with title: mesh erosion after pelvic reconstructive surgeries.The aim of the study is to report an experience on the erosion of polypropylene mesh used in pelvic reconstructive surgeries, and to discuss the pathological changes of mesh erosion.This retrospective study involves 128 female patients (age range: 30-83 years) who received pelvic reconstructive surgeries with polypropylene mesh from may 2006 to may 2009.In the anteroposterior colporrhaphy, the vagina was dissected carefully, and the bladder was separated from the vagina.The paravesical fossa was opened on both sides, and the mesh was then introduced tension-free.The mesh was cut to a proper size (6 cm in width x 15 cm in length), and prepared under strict aseptic conditions.In the laparoscopic sacral suspension, the mesh was secured in the rectovaginal septum and vesicovaginal septum, and sutured periosteum above the first sacral vertebra with at least 3 permanent sutures.Prolene polypropylene mesh (ethicon) was used in all 128 patients.Reported complications included: a multinucleated giant cell and foreign-body granuloma was detected in the eroded tissue (n-1).In conclusion, most polypropylene mesh erosions occur within one year postoperatively.Removal of the mesh could be the best therapy for mesh erosion.

• 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; 982 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: 8920963
• MDR Text Key: 155213517
• Report Number: 2210968-2019-85982
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• 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