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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
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.
 
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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.
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 Key7485028
MDR Text Key107440011
Report Number2210968-2018-72578
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 04/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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