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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MARLEX MESH

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MARLEX MESH Back to Search Results
Device Problems Material Erosion (1214); Extrusion (2934)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/1982
Event Type  Injury  
Event Description
Approximately 35 years ago i had double hernia surgery and had marlex mesh placed in my right side hernia repair. Sometime after surgery (i can't remember when it started) the mesh began to dissolve and appear on the surface of my skin around the surgical scar. It has been working out of my body until this present day. When it appears it looks similar to a large blackhead and nearly the same color. As it begins to come out i can squeeze around it and sometimes get it to come completely out. At times there may be two or three areas working out at the same time. This has been going on for approx. 35 years. I suppose my medical records would pin down the exact time. I haven't had any problems with the surgery and the repair has held up good. My only concern is this, will this deteriorating material inside me cause me any future problems and should i have this problem checked out by a physician. I know that there is a class action law suit against marlex but i have no interest in participating in that, i just need to know if i'm due some future problems because of the mesh breaking down inside me. Any advice to me from your agency would be much appreciated. You can contact me by email if you think it would be helpful and later by phone would be even more convenient for both parties. Thank you. (b)(6). P. S. The above date that i have given in the date the problem occured is just a wild guess. I do not take any medications. I am healthy.
 
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Brand NameMARLEX MESH
Type of DeviceMARLEX MESH
MDR Report Key6328932
MDR Text Key67505211
Report NumberMW5067869
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2017
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? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/11/2017 Patient Sequence Number: 1
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