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

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.

• 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 PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7749734
• MDR Text Key: 116044604
• Report Number: 2210968-2018-74901
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• 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 Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2018
• 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