MAUDE Adverse Event Report: MARLEX MESH

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.

• Brand Name: MARLEX MESH
• Type of Device: MARLEX MESH
• MDR Report Key: 6328932
• MDR Text Key: 67505211
• Report Number: MW5067869
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 84