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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: american journal of obstetrics & gynecology supplement to march 2017; s652. (b)(4).

 
Event Description

Journal article title : polypropylene mesh predicts mesh exposure after sacrocolpopexy independent of known risk factors: a retrospective case-control study. The purpose of this retrospective case-control study was to assess risk factors for mesh exposure in sacrocolpopexy patients and to determine if ultra lightweight polypropylene (restorelle ) mesh impacted rates of mesh exposure. From 2003 to 2013, sacrocolpopexies included 133 cases and 261 controls (controls were randomly selected and matched to cases in a 2:1 ratio). In these cases, prolene mesh were used including ethibond sutures utilized for vaginal mesh attachment and sacral attachment. Pds sutures were also used in vaginal cuff, vaginal mesh attachment and sacral attachment. Results of the analysis noted that pelvicol with prolene mesh were associated with increased mesh exposure. Pds sutures decreased rates of mesh exposure. The use of ethibond sutures in vaginal and sacral attachment increased the rates of exposure. Known risk factors for mesh exposure, including smoking, advance stage of prolapse, and non-absorbable braided suture (ethibond), were confirmed in the study. Both mesh choice and suture selection remained important independent predictors of mesh exposure with heavier meshes increasing and monofilament suture decreasing rates of mesh exposure.

 
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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 Key7749734
MDR Text Key116044604
Report Number2210968-2018-74901
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
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 Received08/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
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? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/03/2018 Patient Sequence Number: 1
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