MESSAGE FROM THE VICE PRESIDENT, LIASION, FDA/CDRH...
Hello to all my fellow meshies
I would like to speak a little about myself first. I am a 46 year young man who resides in Browns Mills, NJ. I am married to a wonderful woman who has stuck by my side thru my entire ordeal with my mesh nightmare. I have 4 wonderful children, they are all grown with the youngest being 17. I will soon become a Grandfather as November 4th is my daughters due date, this is our first and we are very excited.
In 2005, I was operated on for a supposed Left Inguinal Hernia, during my consultation with the surgeon; I argued with him that I did not feel that I had a hernia. I explained to him that I had a Right side Inguinal when I was a teenager and that I knew what all the symptoms of a hernia were. I explained to him that I would rather just take a wait and see approach, instead of surgery. His answer to me was that I indeed had a hernia, but that it was small, only about the size of a marble. He then explained to me that I was still young and I would heal very quickly. He stated that I would be walking up stairs in three days and back to work in two weeks as if nothing happened. He told me that technology has come a long way and that a hernia operation is very routine and my healing time would not be like the 4 weeks I had when I was a teenager. Never once did he state anything about placing an implant inside of me, I thought it would be repaired the same way as they did when I was a teen with a pure stitch repair. So, I relented and had the surgery. When I awoke in the recovery room, I knew something was horribly wrong. I remembered what my hernia as a teen felt like and this was 1000 times worse. The pain and the swelling were horrible. The nurses gave me Percocet, but that didn’t help and they sent me home and told me to give it a couple of days. Within a couple of days, the swelling and pain had increased three fold and became infected. I called my surgeon only to remember that he left on vacation after my surgery, so I met with his partner. He told me that it was indeed infected. He gave me a prescription for antibiotics and a prescription for morphine for the pain.
None of this medication helped, at my post-op visit, I explained the horrible pain I was in, only for the surgeon to tell me everything was normal and was to be expected. He then gave me another prescription for the pain and sent me on my way with a release to go back to work. Well, the pain never relented and I kept going back to him because I couldn’t tolerate the pain while working. At my second post-op visit, I explained the same to him about the pain, with his response being the same, but this time he elected to inject me groin with Novocain and a steroid. As soon as the Novocain wore off the pain came right back. This went on for a year with him. After a year he said that he wanted to go back in and that he thought he may have stitched up some nerves or a bundle of nerves. I asked if he could do it Laporoscopically, he told me NO. I then asked for my records so that I could have a second opinion. It was at this point, at 11 months post-op did I learn from reading my medical records with him, that he had put a Synthetic Mesh inside of me (Perfix Plug and Patch) and that I was right all along, I did not have a hernia. In his own words, “there was no direct or indirect hernia to speak of and no sac from a hernia”. So elected to remove a fat deposit and then perform the hernia operation anyway.
I then found another surgeon that told me that what I was going through a nerve that was stitched up when he was closing me up from the first operation. This surgeon told me that once the nerve is affected it would have to be ligated, cut and tied. So I had the single neurectomy done, which did not help with my pain. I was then sent to pain management. During my pain management stint I had approximately 70 shots in my groin along with many different combinations of powerful pain medicines and anti-depressants. None of these procedures worked.
During all of this time I was doing my research and found that Synthetic mesh is a horrible product. It took almost 2 years after the first surgery to find a surgeon that knew what was happening to me. But all the damage had already been done. This third surgeon was able to get all of the mesh out of me, but he told me the damage was irreversible. He told me that the mesh and plug had contracted and balled up on itself and hardened. He told me that the hardened mesh was acting like a saw inside of me and when it balled up it took all of the nerves with it. He told me that he had to repair a 3 inch tear in my pelvic floor and there were hundreds of smaller rips and tears of only some that he could repair.
While I was doing all of my research, I came across this wonderful woman, her name…Lana Keeton. When I thought all hope was lost she lifted me up and made me want to help others. I found Lana approximately 2 years ago and we have been working together since. I had told her that I was willing to be the FDA contact as I had already been speaking with a prominent doctor at the CDRH. I was able to schedule 3 conference calls with the FDA/CDRH so that myself and Lana could prove to them that these products were bad and harming people very badly. I have complete documentation, as does Lana, stating that the FDA/CDRH know there is a problem with mesh.
It was due to my diligence and Lana’s support of me, that I was finally able to get the CDRH to put out the public health notification for the use of synthetic mesh in the use of Pelvic Organ Prolapse and Urinary Incontinence. That was a huge win for us at that time but we still did not get the public health notification for the use of mesh in Hernias. To this day, I am still fighting for our cause to have these horrible products removed from the market. Now that there has been an administration change at the FDA, I have to almost start all over again. So the FIGHT IS ON AGAIN!!!
Lana and I feel that to move forward with the website, we should be adding information about the use of mesh in hernia repairs. Within the website we will have a separate part for the hernia side of meshes and their inherent complications. There are many, many people who are suffering the complications of mesh for hernias. They are lost and looking for help and answers also.
THIS IS WHAT WE DO; THIS IS WHY WE ARE HERE. To help all of the sufferers of these products find answers and get pointed in the right direction. I hope to be able to write at least a quarterly letter for the website or write, when new information becomes available.
To Lana, I would like to say thank you, if it were not for you…I would have quit…Now because of you, I will not stop until we win…
and WE WILL WIN!!!
Thanks to everyone here who are members, we need to keep helping our own and not back down from the fight that we have in front of us. It will be long and it will get ugly, but we will win.
God bless all, and feel better
Jim
James P. Shull, Vice-President, Liasion, FDA & CDRH
Truth in Medicine Incorporated
Browns Mills, NJ
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