Hernia Mesh Injured Patient Jim Shull Testifies on FDA’s Lax Oversite of Medical Devices

Feb 16th, 2012 | By | Category: Op-Ed

Jim Shull

February 15, 2012 ~ Testimony of James Shull
U.S House Committee on Energy and Commerce/Subcommittee on Health

My name is Jim Shull and I am from Browns Mills, New Jersey. I would like to thank you for allowing me the opportunity to speak here today.

My story goes back to 2005 when I was told I had a hernia. I was told that I was young and would recover quickly. I was told I would be walking up stairs in 3 days and back to work in 2 weeks.

I awoke in the recovery room from the surgery in excruciating pain, the nurses gave me some pain medication and told me I would be fine and sent me home. Two days later I was in such pain that I couldn’t stand up straight or barely walk. I called my surgeons office and he told me to meet him at the hospital Emergency Room. He took me in to an examination room, looked at the surgical site and told me that it was very infected. He prescribed an anti-biotic and Morphine for the pain but, nothing seemed to help. The infection was so bad that I had streaks running down my groin; I was still very swollen, bruised and in severe pain.

I continued to call the surgeon over the next 2 weeks only for him to tell me that I am just a slow healer. Quite a difference from walking up stairs in 3 days, like he told me before the surgery. As time went on I was still in unbearable pain. At my 6 week follow up I explained again to my surgeon that the pain was unbearable, so, he decided to inject my groin with Novocain, right thru the incision and sent me back to work.
The pain I was feeling, was as if there was a sharp object left inside of me. My boss told me that I couldn’t be at work if I couldn’t stand up straight and walk, so, he sent me home. After continuously going back to the surgeon he decided to send me to Pain Management, where over the course of 6 weeks the pain doctor injected my groin upwards of 70 times with steroids and Novocain.

Nothing would help the pain so I decided to investigate myself. The internet is a wonderful tool to launch an investigation. I googled complications from hernia surgery and was amazed at what I found.

It was only then that I figured out that a Hernia Mesh kit must have been put inside of me. I went back to the surgeon and explained what I found. Only then did he tell me that he had put a Synthetic Mesh inside of me and told me that, it was not the mesh, because the mesh is inert and my problem has to do with the nerves in my groin. I tried to go back to work because I couldn’t afford not getting a paycheck, but the pain was so unbearable that I ended up in the ER. The doctor in the ER did a CT scan only to find nothing. That is because the mesh is transparent and cannot be seen on X-rays. The doctor in the ER told me that I probably had Diverticulitis and that I needed to follow up with a GI specialist. That test came back negative also.

I decided to get a second opinion from another surgeon and asked if he could remove the mesh from inside of me. He told me that he couldn’t remove the mesh but could do an exploratory surgery to see if the nerves were stitched up. This surgeon did cut and tie off one of the nerves in my groin and thought that it would ease my suffering. After returning to him for 6 weeks in unbearable pain he told me that there was nothing else he could do for me. So I was on my own. I continued to be in unbearable pain and still tried to work. I continued to try to find a surgeon who knew what was happening to me.

I finally did find a surgeon in another state and he agreed to see me. When he examined me he told me that he knew exactly what was wrong with me but to be sure sent me to have an MRI. I went back to this surgeon and he showed me the problem. There it was a hardened synthetic mesh. This surgeon told me that he has been removing these products for 20 years because of problems similar to mine.

So finally after almost 2 years of unbearable pain I found someone who could give me some answers. The surgery to remove the mesh took 3 ½ hours. When I awoke in the recovery room, the surgeon was at my bedside. He told me that he was sorry and that I would be in pain for the rest of my life.

The surgeon explained to me that he had removed a balled up piece of concrete from my groin, that the mesh had hardened and balled up, and had encapsulated the other 2 main nerves in my groin. In order to get the mesh out the nerves had to be severed. He explained to me that the mesh was so hard, that when I moved it was acting like a saw and cutting into the surrounding tissue. I had a 3 inch gash in my pelvic floor along with hundreds of smaller cuts and tears.

In 2008 I was diagnosed with a degenerative nerve condition, which I believe was caused by the mesh. The pain that I suffer through on a daily basis consists of constant burning and sharp pains in my groin and upper thigh. My groin and upper thigh are a purple and brown color because of the nerve condition I now have. It is a constant battle every day. I must take three strong medications Oxycontin, Percocet, and Tramadol just for the pain alone. Every 6 months I have to have radio frequency ablation done at the spinal level were the nerve roots are located. This just to relieves 50 percent of the burning. It is very uncomfortable for me to sleep at night without the help of medication.

Because of this product I am no longer able to work as a printer. I loved my job; where else can you take 12 different components and put them all together and make what I considered art. I am now on New Jersey State Disability, which is about to run out. I have applied for Social Security Disability but have not heard back from them yet.

When I was a teenager, I had a hernia. That hernia was not repaired with mesh, but was stitched back together – 34 years later and I still have no problems with that repair, while the repair that I had when I was 42 went bad immediately and I now face a lifetime of pain and struggles because of it.

All of this I have to go thru because of a piece of hernia mesh that was supposed to be inert and not cause any problems. The mesh that was put inside of me caused so much damage that none of the nerves will ever be able to be repaired and will never grow back. I live a life of pain because of a product that never had any kind of clinical trials and slipped through the back door of what you know as the 510K process based on the use of predicate devices. Did you know that the mesh that was inside of me used only sutures as a predicate device? I am left disabled because the FDA considered surgical mesh equivalent to sutures and allowed it to be implanted in patients like me.

After years of people reporting problems and investigations in to synthetic meshes, the FDA published a Public Health Warning. Unfortunately, the warning was only for Synthetic Trans-vaginal meshes that are used in woman for Pelvic Organ Prolapse, Incontinence and Bladder Slings, which have caused problems every bit as terrible as mine.

There was no Public Health Notification for the Hernia Meshes. Which are just as tragic and cause horrible complications for men and woman alike. In my research I found that in the United States alone there are 750 thousand to 1 million hernia surgeries each year. Failing to address the hernia mesh issue puts too many people in danger. I think synthetic mesh should not be on the market because it is unsafe and I have proudly taken the challenge to work to prevent this from continuing to happen to others.

In closing I would just like to say that I am only one face in thousands of people that this has happened to and the sad part of it all is that I feel that I may be one of the lucky ones. This committee can change the laws to improve the safety of medical devices and put patients first. Surgical mesh and other medical devices should be tested for safety before they are allowed to be implanted into people like myself. We also need a national system to track what happens to patients like me after devices are implanted, to catch these problems as soon as possible.
Thank you.

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15 Comments to “Hernia Mesh Injured Patient Jim Shull Testifies on FDA’s Lax Oversite of Medical Devices”

  1. Nonie Wideman says:

    As another mesh victim my heart goes out to you, thank you for sharing your story and advocating to get these toxic meshes off the market, hopefully as more people come forward to tell their stories we will gather stength in numbers as God Knows they put a lot of mesh in thousands of men and women alike……

    • Tammy says:

      I am also a victim of mesh and in constant pain. In ky it is very hard to get pain meds even because the doctors are afraid of getting in trouble. What kind of doc and what test are performed to know if the pain is from nerve damage?

  2. Kathleen says:

    I am so sure there are so many out there that have your similar story and are told it is not the mesh. I am so sorry you have had to go through so much. At least it is out BUTt now you have the aftermath. Same here TVT-O. Thank you so much for speaking out!

  3. D, Summers says:

    Thank you so much for speaking out. I too have two mesh implants inside of me. I have already have had 8 surgeries and am awaiting surgery number 9. I rode over 1400 miles round trip and was in surgery when the doctor saw I was too infected to have the mesh removed. I am going to pain management and taking 17 pills a day. My local pain management dr. says the pain and infection will not go away until tjhe mesh is removed but the surgeon says if he goes in to remove the mesh with the infection I have it will get in my bloodstream and kill me. I have had the mesh implants for 4 years. I want it out. The pain never goes away even with all of my medication. I want my life back.

  4. DJ says:

    Dear D Summers, I am pretty sure that Dr Raz at UCLA, world reknowned urologist, female pelvic reconstruction specialist, and mesh- removal expert (women go to him from all over the US and the world) is usually of the same opinion as your pain management doctor. The mesh must be removed to get rid of the infection. I have a friend who developed a chronic clostridium infection because she had been on antibiotics for over a year due to an area on her abdomen that would swell and become bruised looking whenever she went off of them. She was in pain, chronically fatigued, and had developed other medical problems after her mesh surgery years ago, including diabetes and high blood pressure. Tests showed inflammation of her major organs, including her colon and something going on with her pancreas. The urologist there (not the one who put the mesh in) said her mesh was fine and a surgeon told her that she needed to see internal med doctor again because her problems were medical, not surgical. She ended up going across the country to see Dr Raz, who told her that her problems definitely were from the mesh and that she needed it out as soon as possible. Her internal medicine doctor then refused to give her a medical clearance for surgery because he thought she was too sick. Dr Raz called this doctor himself and apparently told him that the mesh was the cause of her issues and that he was going to proceed with the surgery without his medical clearance. The mesh was severely infected and stuck all over her colon and other areas. Two weeks after surgery, my friend said she was feeling better than she had felt in YEARS, was no longer needing insulin for the diabetes, and she had to go off her blood pressure meds because it started running too low! TRUE story!

  5. DJ says:

    Jim, I truly wish I could change things for you. Thank you so much for sharing your story, speaking with the FDA, and trying to prevent this from happening to others. An on-going medical tragedy for far too many unsuspecting and undeserving people….

  6. jabora says:

    Would some one tell me if there is a law suit concernin hernia mesh.. as a child i had a hernia.. then in 2008 had surgrey again in 2009 this last one was last year 2011.. and I hurt seem like a hard board inside of me an from time to time it hurt.. if I cough it really hurt the doctor who did it in 2011 put a mesh inside of me … He was very nice .. now i found out he left the medical field … Why do I turn??

  7. terry bedson says:

    i have had twelve operations on my left groin the hospital who performed the first six of these operations denied putting any mesh inside me, i changed hospitals and have had six operations to remove multiple polyproplene meshes, my last operation was in germany where dr georg arlt removed the last of the mesh i underwent a neuroctomy of the genitofemoral nerve, and had a 4x3x3 rock hard meshoma removed plus three clips of a tubular structure ,plus another mesh which which was a polyproplene ultrapro mesh i have got both meshes in a jar and have got color pictures of the clips and meshes removed, i have now been dismissed from the pain clinic as they said they can do no more .i am now awaiting to see a vascular consultant because i might have damage to my femoral artery.keep up the good work if i can do anything to help i will

    • Eden says:

      Terry, did the final mesh removal make you better or worse? Was Dr. Arlt the most helpful doctor? Did he cause damage when he removed your mesh? I hope you see this and can answer my questions. I have mesh in me and must have it removed soon…it is killing me.

  8. s larsen says:

    We need to all call and place reports of hernia mesh and complications it has caused us. Our lives are not better they are a thousand times worse. I am filing the paperwork it may not help me but if i can save one person from filing it is worth it.

  9. s larsen says:

    Call the FDA to fill out paperwork. I left that out sorry.

  10. Julianne says:

    I need names of surgeons who will remove without putting more mesh in.

  11. Mabel Davis says:

    I had the hernia mesh in 2008 and kept having pain. I kept going back to that dr and he kept saying its not the mesh.Said I was seeking pain meds and wasting away and looked like someone was aaddicted to crystal meth
    I was living in pain. ..throwing up….and bile…back and forth to the er then my blood pressure started going up I never had high blood pressure. I finally had a covering Dr in my primary care who finally believed me and sent me to another dr. He looked at the same records tests my other dr had and seen something different long story short I had mesh stuck to my main artery and if he removed it I woukd die. So he went in took out 3/4 of it and had to leave the other piece but the pain is gone just every now and then it will hurt or pull but not as bad as it did. I got my color back and im able to live again. After 3 surgeries I thank god someone finally believed me.

    • Jane Akre says:

      I’m glad you found a doctor who listened and was curious enough to explore further. He likely saved your life… how many don’t do that and write off the patient. It’s very sad and it happens every day.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.