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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, 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 Key8920963
MDR Text Key155213517
Report Number2210968-2019-85982
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
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 Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPROMESHUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/22/2019 Patient Sequence Number: 1
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