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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 Migration (4003)
Patient Problem Erosion (1750)
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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: am j obstet gynecol 2008;199:688. E1-688. E5; doi: 10. 1016/j. Ajog. 2008. 07. 029. (b)(4).

 
Event Description

It was reported in a journal article title : risk factors for mesh/suture erosion following sacral colpopexy the purpose of this prospective planned analysis was to identify demographic and surgical parameters associated with foreign body complications of abdominal sacral colpopexy (asc): specifically, mesh and suture erosion. Three hundred twenty two female patients with stress-continence stage ii to iv pelvic organ prolapse who underwent sacral colpopexy (concomitant burch colposuspension [n=157] and no burch colposuspension [165]). Graft material was sutured to both the anterior and posterior vaginal walls and then anchored to the anterior longitudinal ligament of the sacrum in such a way as to avoid tension on the anterior portion of the graft. Most of the asc were done using woven polyester (mersilene [42%]) and polypropylene (prolene or gynemesh [48%]). Sutures such as prolene and ethibond were used. Within the 2 years of surgery, there were 20 patients who developed mesh erosion. Three of the erosions involved suture only, while 17 had exposed mesh. Two of 3 patients with suture erosions healed after simple removal of suture. The third patient probably had suture erosion, but healing after suture removal has not been confirmed. Of the remaining 17, 13 patients underwent at least 1 surgery for mesh removal (n=2 resolved; n=6 persistent erosion; n=5 lost to follow-up) and 4 were managed without surgery (n=3 no resolution; n=1 lost to follow-up). Of these 20 cases of mesh erosion, 8 utilized prolene or gynemesh graft, 2 used prolene vaginal sutures, 1 used ethibond vaginal sutures, and 7 used ethibond sacral sutures. The statistically significant associations of expanded polytrafluroethylene (eptfe) mesh, concomitant hysterectomy, and smoking were strong ones, with ors ranging from 4-5, and the authors feel confident in these associations; but, as with all retrospective associations, this does not prove causation. Expanded ptfe mesh should not be used for sacral colpopexy. Concurrent hysterectomy and smoking are modifiable risks for mesh/suture 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 PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7753270
MDR Text Key116122244
Report Number2210968-2018-74927
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK962530
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 07/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/06/2018 Patient Sequence Number: 1
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