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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON (PROLENE) HERNIA MESH

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ETHICON (PROLENE) HERNIA MESH Back to Search Results
Device Problems Entrapment of Device (1212); Material Frayed (1262); Material Too Rigid or Stiff (1544)
Patient Problems Erythema (1840); High Blood Pressure/ Hypertension (1908); Nerve Damage (1979); Pain (1994); Weakness (2145); Hernia (2240); Discomfort (2330); Injury (2348); Depression (2361); Shaking/Tremors (2515)
Event Date 04/12/2014
Event Type  Injury  
Event Description
Lifting boiler caused panels at work. I felt a sharp stabbing pain in my right groin. A place where i have had a hernia repair back in 2002 with two pieces of prolene mesh made by ethicon. The company failed to take me for medical help with an on the job injury timely. The following day i was taken into the bay city hospitals emergency room where it concluded a possible hernia. I told the doctors of the previous mesh in me and they directed me to a hernia surgeon for further evaluation. Took me until (b)(6) of 2014 to find a surgeon willing to evaluate me. The original surgeon (b)(6) refused to treat me when he seen my condition and him finding out it was a (b)(6) case. He stated "they don't pay, i won't get paid so i will not see you. Leave my office" my mother was witness and asked him how he could be so inconsiderate and neglectful. In (b)(6) i found (b)(6). Surgeon out of (b)(6). When he opened me up he found the mesh had shrunk, encased itself around all of my arteries spermatic cord and the inguinal canal. He had also stated that the mesh had become hard and brittle inside, causing an edge to curl up and act as a razor continuously cutting my insides and my nerves. That was the debilitating pain i was feeling. Unfortunately the mesh had become part of my insides meaning he was unsuccessful in removing any of it and stated he did all he could do. I was under anesthesia for 6 hours and was becoming a risk for further surgery time. Instead the only thing he could do was cut the defective piece of mesh out and place a parietex pro grip mesh over the top of the defective mesh to act as a barrier between the jagged shriveled, broken mesh and stop it from causing further damage. It has cut all of my nerves inside, wrapping itself around my spermatic cord causing debilitating, lifelong, permanent damage to my nerves in my groin and parts of my leg. Mainly the ilioinguinal nerve. Its a main nerve running through that region of the body. Everyday i suffer and am told the only treatment for me is shots directly into the ilioinguinal nerve itself. Very painful, very temporary and extremely expensive pain shots, that only improve my quality of life for literally 3 days. The first two days are spent on the couch with an ice pack because it is so painful to have a 4 inch needle stuck into a nerve in your groin. I urge you to ban these hernia meshes. I have no quality of life. Depressed all the time. This permanent injury consumes me at all times and even disrupts my relationships as its painful to have sex. I am (b)(6) and have a lot of years ahead of me. Sometimes i cannot work due to pain and suffering. I was told by my doctors i should be on disability or pick a career that requires no physical dependencies. I can't sit for long periods of time, stand for too long, lift no more than 40 pounds for the rest of my life nor can i have any more surgeries. (b)(6) nor can i afford it at (b)(6). I don't know what my future holds, but i do know that this mesh is the worst thing that has ever happened to me and the pain causes my blood pressure to rise where my face is red and i shake. I also know that in 2000 the fda did studies on this mesh, two years before being placed in me and because degeneration and chronic inflammation only happened in 33% of the study group it was cleared for use as a hernia repair device. I really wish it had not been. Everyday that i suffer, my family suffers with me. I feel with all the evidence that i have found at how terrible this mesh is and how i am just one out of the hundreds of thousands that silently suffer. Please reconsider ever allowing a polypropylene mesh or any mesh for that matter to ever be used again.
 
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Brand NameHERNIA MESH
Type of DeviceHERNIA MESH
Manufacturer (Section D)
ETHICON (PROLENE)
MDR Report Key6279056
MDR Text Key65940966
Report NumberMW5067474
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 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/19/2017 Patient Sequence Number: 1
Treatment
RX MEDS: MOTRIN 800MG FOR CHRONIC INFLAMMATION.
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