Suffering in Silence: Jim Shull from Synthetic Bard Hernia Mesh

Jane Akre
|
August 17, 2011

Lisa and Jim Shull

Jim Shull’s story started in September 2005. He had passed a kidney stone and went to see a urologist who ordered a CT scan to see if there were any more stones.

The urologist looked at the X-ray and told Jim he had a hernia.

“I don’t have a hernia I feel fine, I know the symptoms because I had a hernia as a teen,” he told the urologist in a 30 minute argument. But the urologist insisted so Jim went to a general surgeon. That doctor did the typical sports physical and said he had a small hernia about the size of a marble and it should be addressed.

Hernia surgeries are much easier today, you’ll be walking up steps in three days and back to work in two weeks,” he was told. So reluctantly, Jim scheduled the surgery at a surgical center near his home in Browns Mills, New Jersey.

Jim tells MDND when he woke up from anesthesia he was in a pain he had never felt before and he couldn’t stand up straight. He received Percocet and more pain medication and was sent home. By Christmas Eve he said he was doubled over, the groin was swollen and red and his left testicle was the size of a small baseball.

It’s all normal said the doctor’s office.

When the pain got too bad he went back to the doctor’s office and was told the site was infected. He was given morphine for pain in a pill form and antibiotics for the infection. At this point Jim tells MDND he couldn’t stand up, sit or lay down.

Another week goes by with assurances that this is normal. When the pain escalated, Jim and his wife, Lisa went to the emergency room.

He told the ER docs he had just had a hernia operation and it felt like “he left something inside of me, that’s how bad it hurts.”

X-rays followed and the hernia repair showed but nothing else. Instead, Jim received more morphine and another antibiotic. Returning to his original surgeon the first week of January, Jim says he still couldn’t stand up.

“I’m walking like the Hunchback of Notre Dame. He said it’s all part of the heeling process; you’re going to be fine. You’re not going to feel normal for a year.”

“You told me two weeks,” he told the doctor.

Now early in 2006, Shull, 42, with four children, had to return to work as a printer so the surgeon injected the incision with Novocaine. When it wore off, Jim says the pain was ten-fold.

“I called him back and said something is not right. It felt like a jagged instrument was trying to work its way out. The burning sensation was constant and today still is. It would just double me over.”

Give it another week he was told, even though he was losing weight and the pain kept getting worse.

Pain Management

Months passed and Jim shuffled between pain management doctors.

Seventeen shots of steroids and Marcaine from the surgeon to numb the pain followed 68 injections of nerve blocks, steroids and Novocaine. Another pain manager said he should take antidepressants.

“Doc, I’m not depressed I’m in pain,” he said. But despite his insistence Jim says he received 600 mg of Neurontin. When that didn’t work he was given time released morphine. When that didn’t work the Neurontin was upped to 800 mg.

When that didn't help, Jim was prescribed the drug, Lyrica, which is normally given to fibromyalgia patients. Jim took it only once.

“I thought I was going to have a heart attack, my heart was pumping fast, I couldn’t catch my breath and this was just the first dose. I told Lisa, I can’t take these; I think I’m going to die.”

By this time, Jim's mother brought a news item to his attention concerning the Kugel Mesh Hernia Patch made by Davol which had been recalled. Jim took the published papers back to his original pain management doctor as proof why he needed the mesh out.

“The doctor takes the paper and reads it and throws it at me. He said 'Go have the mesh taken out but you will come to me for the rest of your life because you have nerve damage,' ” Jim says he was told.

No Hernia?

By November 2006, Jim says he was still in intense pain and just wanted the mesh out. He went back to his original surgeon who during the conversation admitted he might have stitched some nerves together. When the surgeon left the room, Jim saw his surgical report.

The report said there was no Direct or Indirect hernia to speak of, so when he came back in the room Jim said “I’m going through all this and I never had a hernia?!"

The doctor said it was a fatty lipoma of the spermatic cord which is treated like a hernia.

By March 2007, Jim had found another surgeon to straighten up the nerve damage and to remove the mesh. The original surgeon had stitched up a nerve to the mesh so this surgeon cut and tied off the nerve but left the medical device inside, even though he had been directed by Jim to take it out.

“So now I still have this mesh inside of me and I’m regressing and I said I can’t live like this. I wanted to kill myself. I ended at 160 lb from 180 lb. My daughter thought I was a cancer patient.”

“I was the frog in the biology class” he says of his many procedures. “I can’t get these doctors to see it’s the mesh that’s the problem,” he says.

Finally, after three doctors said they couldn’t help him, Jim was referred him to Dr. William Meyers, Chairman of the Drexel University Department of Surgery. Jim told him what had gone on with tears rolling down his face.

Get the Mesh Out

“He said I know exactly what your problem is. I see three of these a week.”

From the films, Dr. Meyers could see Jim’s left groin was inflamed and full of fluid. There were 150 small rips and tears in the groin and a three inch gash in his pelvic floor. The mesh had hardened and was acting like a saw, cutting any time he made a sudden movement.

Surgery was scheduled again and afterward Jim says, “He apologized to me. I wish you could have come to me a year and a half sooner."

The rips and tears were fixed and Dr. Meyers said he got 98% of the mesh out which by that time he said looked like blue plastic tarps dipped in concrete which had hardened.

”Whoever put this in you, I didn’t see where there would be a hernia. You never needed an operation to begin with,” Jim was told by the surgeon.

Two years later after finally finding a surgeon who could help, he was still having sharp pain. Then the groin to thigh started to change color to a blotchy purplish brown. Dr. Meyers referred Jim to a neurologist who confirmed he had reflex sympathetic dystrophy, or chronic regional pain syndrome from the many surgeries and massive nerve damage. The condition is degenerative and likely would get worse, he was told.

His employer wants him to decide whether he should take permanent disability. Jim Shull is now 48 years old.

“All this for an operation I never needed” he tells MDND.

Spurs FDA Public Health Notification

It was only after his second consultation that Jim found he had been implanted with the Davol Bard PerFix Plug. Eventually he contacted the FDA’s Center for Devices and Radiological Health (CDRH) with his experienced.

“There were 1,000 complaints but they were sporadic over two years. They said 1,000 out of 7,000 operations a year is not enough to warrant to do anything.”

Shull encouraged the FDA/CDRH to issue its first Public Health Notification to the public about the side effects of mesh in October 2008.

“If I had known original surgeon was going to put something in me I would not have had the surgery. I think it was the mesh the whole time. The mesh migrated and then with all the scar tissue forming it encapsulated the mesh and then it hardened cutting the nerves.”

The financial cost has been staggering. The original surgery was $5,800. The next surgery was $12,800 and the third to remove the mesh was $128,000. Radiofrequency Ablation twice a year is $5,800 for each procedure.

Jim Shull credits his wife, Lisa for being his rock. “She hates that there is nothing she can do to help me. She feels hopeless. She sits there and watches me suffer.”

“All I can do is help prevent others from going through this. I wouldn’t wish this on my worst enemy.”

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