MND, Jan. 6, 2014 ~ Transvaginal mesh has been used in women to shore up pelvic organs since the late 1990s but long before that, the same polypropylene mesh was used in the treatment of hernias.
In fact, it was thought that pelvic organ prolapse (POP) where the bladder, vagina, uterus or colon fall through the vaginal opening due to gravity and weak tissues, was a form of a hernia, so the transition was an easy one. Unfortunately for many recipients of mesh, the response has been less than optimal as had the reaction and response to the foreign object in the body.
Bruce Rosenberg, 49, is a prime example. He has turned his encounter with mesh into the nonprofit The National Meshoma Foundation and now helps others with injuries when he is able. He tells his story to Mesh News Desk editor, Jane Akre.
Celebrating his 40th
It started innocently enough. Bruce Rosenberg, his wife, Susan, and six-year-old daughter drove to Naples, Florida, the other side of the state from their Fort Lauderdale area home, to celebrate his 40th birthday. Bruce went to pick his daughter out of the pool when he says he felt a bump form. “It was a sudden twinge and felt like a bump, like a marble,” he tells Mesh News Desk.
Concerned, the family called their primary care physician who said, don’t worry it sounds like a hernia. It’s nothing.
Bruce had developed a left inguinal hernia, a small hole in the groin area that can grow with exertion, allowing the intestine to protrude through the hole and outside of the abdominal wall.
He consulted with a general surgeon who told him they use something called mesh to repair a hernia. Bruce was shown a Prolene Hernia System®, a medical device made by Ethicon, a division of Johnson and Johnson. The doctor rolled the soft mesh, crumpled it in his hand. Did Bruce have any questions?
“What happens if there is a problem with it? Can it be taken out?” The surgeon seemed bothered by the inquiries so referred him to the inventors of the Prolene Hernia System, a hernia repair group in Florida. There Bruce was told thousands of individuals had been implanted and only three people ever had any problems. That’s because they were put in wrong, he was assured.
“Of course it can be removed but we’ve never had to,” Bruce says he was told. He wasn’t told that nonabsorbable mesh is intended to remain indefinitely and is considered a permanent implant.
But this was a test site for Ethicon. Going to the right place would bring a better outcome with less pain and decrease any chances for complications, he reasoned.
Prolene Hernia System
The Prolene Polypropylene Hernia System is made of a petroleum-based plastic pre-shaped into a three-dimensional patch connected by short mesh cylinder. The fiber is nonabsorbable polypropylene filaments.
With more than one million hernia surgeries performed a year, and more than 700,000 involving an inguinal hernia repair, primarily in men, the mesh is thought to offer a stronger advantage over just suturing up the hernia.
Use of a bi-layer polypropylene mesh device (BPMD) for inguinal hernia repair began in 1998 and was the latest in a long evolution of material for hernia repair that included stainless steel, polyester, Dacron, Teflon and Marlex. In third world countries, where petroleum-based mesh is rare and expensive, mosquito-net cloth has even been used.
Pioneered first by Benjamin Pease in the 1950s and later Francis Usher, hernia repair mesh materials was originally made of polyethylene. Polypropylene came along in 1962, a result of petroleum-based plastics developed by Phillips Petroleum.
Non-mesh options are practiced by doctors at the Shouldice Hospital in Toronto using sutures and the Desarda suture repair originated in India as a mesh-free and tension-free procedure that pays attention to the body’s anatomy but polypropylene mesh is considered the standard for hernia repair.
Did His Homework
Bruce did his homework. As a caseworker he was used to deep investigations, chronicling and collecting data on cases of abuse on the geriatric population and neglected teens. As a probation and parole officer, he was trained in tracing documentation to its source to uncover the truth.
After he moved to Florida in 1977, Rosenberg attended the University of Florida and graduated in 1986. Growing up in Levittown and East Northport, on Long Island, NY, Rosenberg’s grandfather and great uncle had been major league baseball players, one playing for Chicago, the other for the New York Giants. Harry and Lou Rosenberg were paid $6 a game back in the 1930s. After their athletic careers ended, they opened up a gas station in Brooklyn.
Rosenberg wasn’t offered the Desarda technique or any no-mesh repair. He was shown a 6 by 4 cm Prolene Hernia System the day before his 40th birthday, August 19, 2004.His birthday party planned for the next day had to be cancelled.
Right after surgery, when Bruce woke up he says he says he knew something was wrong.
He tried to walk and felt like something was too tight, a stabbing pain. “It was driving me to my knees” he says. More pain meds followed and on the drive home, he asked his father to pull over on the side of the Florida Turnpike to call the surgeon. The doctor was annoyed. He said “it’s all in your head,” Bruce says today. Just go home and fill your prescription for oxycodone and you’ll feel better.
Hurricane Charley was hitting Florida and residents were battening down from the Category 4 storm. Despite that the doctor gave Bruce his cell phone number and said he’d be back to work on Monday. But that evening the pain grew worse and Rosenberg called the doctor. Again he was told it’s all in your head, you’re feeling anxiety, take two oxycodone every four hours, four times a day. Just double the dosage. That along with four Motrin four times a day was a pain med load on his 127 lb body. Bruce says he couldn’t get off the couch and the pain was emanating from somewhere deep like something was grabbing him from inside. He knew something was not right.
Within a few months Rosenberg had lost 30 pounds and says he was doubled over with terrible groin pain. He says of that time, “I couldn’t move. It was like I was on fire in the groin like a knife was stuck in the left side of my groin burning into the hip.”
By this time he could no longer function at work and was demoted becoming his assistant’s assistant.
“After 25 years as a social worker it was very demeaning,” he says. Bruce had to wear sweatpants to work because he could not tolerate the pressure from the waistband. He gave up his passion of restoring vintage cars. Because of the pain he could no longer bend over his watch repair desk, a skill he had learned from his grandfather or teach the skill to students at a nearby community school. A loving relationship with his wife was impossible. This is no way the pain is related to mesh, he says he was told by the implanting doctor.
Looking for Answers
Bruce spent the next two years looking for answers. He went to a dozen urologists, neurologists, gastroenterologists. The pain drove him to a dozen emergency room visits and he’d endured a half dozen CT and MRI scans.
“I was glowing in the dark from so much radiation,” he tells MND. It was later that he found out that CT can damage mesh. Polypropylene will degrade more rapidly when exposed to gamma radiation.
During the first session with a pain management specialist in January 2005, Rosenberg was told he had a “cigar” under his skin. Where the mesh was supposed to be flat, the prolene had rolled inside of his groin. Over time it stiffened and scar tissue began to grow, known as a keloid. The suture was popping out of his skin as his body tried to reject the mesh.
Surgery Number Two
After seeing blood on his shirt, Bruce went to his primary care physician who found something resembling fishing line sticking out of him. The doctor told he had a suture granuloma from the hernia repair, a condition Ethicon dubs “suture spitting.” Bruce called the company and Ethicon reportedly filed the adverse event as a problem with the vicryl suture.
The original surgeon put Bruce on the gurney and cut out what Bruce calls a “chunk of flesh” calling it an aberrant hair follicle. By January 2005 the same surgeon did an exploratory surgery and confirmed the mesh had folded over. He removed about one-quarter of the lateral overlay of the Prolene Hernia System Mesh and intentionally cut some nerves, Rosenberg says neurectomy is a standard treatment or mesh-related pain.
Why did he keep going back to the implanting physician? “He was the only one who would see me,” according to Bruce.
The weight loss continued. By January 2005, Bruce weighed 97 pounds and no one knew why. Prostatitis, it was thought. He was tested for AIDS and received a colonoscopy. At a local medical center he was given lines with solutions which caused his potassium levels to plunge to dangerous levels resulting in severe dehydration. He was rushed back into the ER to have potassium intravenously pumped back into him, resulting in a severe burning sensation at the infusion site.
“It’s not just the mesh problem,” he says. “You are subjected to the medical community and all the ills that come with it. All the misdiagnosis, they think I have MS, lupus, IBS, arthritis and give meds trying to get rid of the symptoms. Chronic misdiagnosis problems befall many patients. I was on eight pills three times a day – Zelnorm, Lyrica, Cymbalta, Trazadome, heart medications. All cause side effects that are worse than original problem.”
The Valentine’s Day card Bruce received on February 14, 2005 changed his life. By this time he couldn’t get out of bed, surgery had failed and he didn’t sleep through the night due to night sweats. The card came from his six-year-old. “Happy Valentine’s Day Daddy – I hope your hernia gets better.”
“For me a little kid, this shouldn’t be on her mind. It just floored me, I was already depressed. At that point I had a gun I couldn’t take the pain anymore and I was going to use it but I looked at pictures of her and my family and said I can do better than this, this can’t happen to others. I never took crap from anybody before, I’m a strong person. I put it down and took bullets out and threw them in canal behind my house at 3 in the morning. I put the gun back in the case. I just started typing.”
For the next two years, Rosenberg continued the round-robin of specialists looking for any answer as to why he was in pain and losing weight. The circle expanded to include rheumatologists, internists and neurologists. He says he saw 40 physicians in all and kept paying the co-pays even with insurance.
Finally in February 2006, Rosenberg walked into a strip mall in Deerfield Beach to meet with Dr. Randy Kimmelman of New Jersey Surgery. It took the general surgeon about ten seconds to identify the problem on the same CT scan the original surgeon had been shown.
“That’s your mesh there,” he said pointing to the scan. You probably need to have it removed. Your original surgeon is not identifying the problem because he’s afraid of being sued.
“He was the first person who truly identified what the problem was and told me I was not crazy,” says Bruce today.
Dr. Kimmelman told Bruce he used mesh all the time in his practice mostly with good outcomes, but said “when they’re bad, they’re really bad,” Bruce recalls.
Surgery Number Three
Dr. Kimmelman didn’t remove mesh but he recommended Dr. B. Todd Heniford, an Ethicon consultant and surgeon in North Carolina who was the “fixer” when others went wrong. But Bruce had already sought a consultation with Dr. Jeffrey Sedlack, a surgeon in Connecticut, whose website said he had removed more than 100 meshes.
During a March 2006 scan, he saw the mesh pushing on the bowel and another one there wrapped around the spermatic cord. In ten seconds, he put his finger on the same place in the CT scan as Dr. Kimmelman. “It has to come out. This is a meshoma,” Bruce was told.
A meshoma is a mesh contraction moving away from the pubic bone and inguinal ligament causing the mesh to wrinkle or ball up which can cause the recurrence of the hernia. In Bruce’s case, the meshoma had eroded through the peritoneum, the lining of the abdominal cavity.
Bruce recalls Dr. Sedlack asked if this was the scan he had shown his original surgeon. The doctor said the mesh should have been removed immediately before it caused additional injuries, trauma, psychological trauma and weight loss. The mesh is strangling your bowel, putting pressure on the bladder and crushing the spermatic cord and testicle. You could have avoided that if he had taken it out.
Surgery number three took place March 2, but there were complications. Removing such a large piece of mesh on a small body had created a defect, giant hole of six centimeters. Bruce says he sat up after surgery, his leg turned purple and his gut blew out. The sigmoid colon had herniated and was outside the abdominal wall like a piece of sausage.
Bruce recalls as he was being rolled into surgery a representative from Ethicon showed up. “I’m here to study your case,” Bruce was told. “I blew my stack. I’ve been calling you for months,” he said. “You’re only here to see if it’s your fault.”
The doctor said he wouldn’t do surgery if the rep couldn’t go in. Bruce agreed.
“My pain went away when the mesh was removed. Even though I had a huge hernia I felt great. I started gaining weight, didn’t have a bowel problem, no neurological problems. I even started having sex again and walked a mile every day. I got into great shape with a massive hernia pushing outside of the abdominal cavity.
Bruce had a recurrence of the hernia but now it was larger recurrence because of the mesh removal. This time he was referred to Dr. Todd Heniford, the last chance surgeon who would later become a specialist for Ethicon. If you go there I will come with you just to be by your side, said Dr. Kimmelman. Bruce says that’s exactly what he did.
Surgery Number Four
By this time Bruce Rosenberg was facing his fourth surgery. Since Dr. Kimmelman had recommended Dr. Heniford, Bruce chose him for what he hoped would be his final repair.
Dr. B. Todd Heniford, is a board certified surgeon at the Carolinas Medical Center in Charlotte, North Carolina where he also conducts studies for industry. At the time, a human trial was underway into Ethicon’s new lightweight mesh, Ultrapro. Bruce was enrolled in the human trial for Ultrapro. He was told the defect is too large for tissue repair and his body is too thin.
Bruce signed a waiver that he would not take Ethicon to court.
This time around the outcome was expected to be different. The theory was the lightweight mesh would call less inflammatory response so in July 2006 Dr. Heniford spent a half hour just cutting out adhesions to his mesh. Since his sigmoid colon was herniated outside of the abdominal cavity, to put Bruce back together the surgeon implanted a 30 cm square sheet of Ultrapro, about the size of a piece of notebook paper.
The giant mesh today covers his entire abdomen from the belly button down. His bladder had to be lifted out of his body to place the mesh. He was literally wrapped in mesh now. A second surgeon had to be called in a urological surgeon to remove the testicle which had been damaged by the first removal.
At first Bruce says he felt good but as the month wore on, the pain came back, chronic groin pain, sexual dysfunction, neurological, gastrointestinal problems, just not to the extent as originally.
“I called Heniford and he refused to see me,” Bruce told MND. I called repeatedly and made about 20 attempts to call him to discuss I’m still having pain, is there something I can do?”
Despite the promises of the less mesh the less mess, Bruce was experiencing inflammation; he had trouble moving and still could not have sex. “My local doctor tried to call there. The nurse said she spoke with him (Dr. Heniford) and said to tell you there must be something else wrong with you.”
“I had multiple scans and MRI even after that to see what was wrong. I started to lose weight again. I weigh 107 pounds now. I’m 49 years old.”
American Hernia Society
For some reason, Dr. Sedlack was not done with Bruce.
He reached out to the injured man and brought him to the American Hernia Society meeting in February 2008 in Scottsdale, Arizona. There he introduced him to another man who had experienced terrible hernia complications, Dr. Elliott Miller. The pair was joined by Bill Smith from Dallas, also hernia mesh injured, who had been researching his systemic response after being implanted with a Marlex mesh which Bruce says made him deathly ill.
The exhibition booth and table cost the group $3,000. Bruce sold one of the cars he had fixed to fund the trip. On the table of the fledgling foundation were handmade signs which said National Meshoma Foundation, a nonprofit he had formed a week before. Behind them on the wall was a blow up of the Topix website where hernia mesh patients share their horror stories. On the table was a Rubbermaid container full of hundreds of vials of Bruce’s medication he had been prescribed over the past two years, about $12,000 worth. The sign said “Patient meds one year after mesh complications.”
Rosenberg’s implanting physician approached the table.
“Bruce what are you doing?” Bruce told him, “I’m here to educate people about mesh complications.” There is no such thing, said the doctor.
Despite being ostracized by some at the conference, Rosenberg found some support among leading physicians present including Dr. Bruce Ramshaw and Dr. Robert Bendavid of Shouldice Hospital who hugged Bruce and said it’s about time somebody talked about this.
Apparently they too had been talking about these problems for years. In fact in 2008, Dr. Ramshaw did a presentation showing pictures of degrading polypropylene mesh from the explants he was documenting at the University of Missouri.
“I interviewed 60 surgeons and asked them about their patients and it was all consistent; I send them away I don’t know what to do with them. I send them to pain management they all said.”
The National Meshoma Foundation
The newly formed National Meshoma Foundation focused on research, education and outreach. Bruce says he spent seven nights a week researching and slept no more than four hours a night for three years.
“I spent every night on the internet, libraries, book stores, met with doctors and interviewed them. I went to hernia conferences and just kept pouring into it.”
His research started with Benjamin Pease and continued to Dr. Parvez Amid, of the Lichtenstein Hernia Institute and himself a developer of mesh products. He dove into industry-funded studies and retrieved early evidence that red flags concerning mesh had been waving since the days of Pease. He saw industry videos extolling the virtues of lightweight mesh.
He even paid for a few patients to go to Dr. Ramshaw for a consultation by selling a few antique cars.
As word spread, Rosenberg was brought in to consult with law firms and bring his research. And thousands of patients found Bruce on the Topix page looking for a direction, any direction.
Patients responded, “It’s amazing what you do,” “You’re a Godsend,” “You saved my life.”
Before the internet, patients were turned away when there were complications, says Bruce. As a result, no one has any idea how many people died from septic erosion in the bowel.
Despite two hemorrhagic strokes at age 35, Bruce kept learning and listening.
He says there is a consistent theme among mesh-injured patients – many express frustration that there is nothing worse than being denied you’re actually in pain. Patients reported feeling crazy, suicidal, depressed due to the fact that no one believes the cause and extent of their pain, especially when they look normal on the outside. He would later learn it could happen to him. At this writing, his wife has decided to file for divorce.
Rosenberg said he had repeatedly called the U.S. Food and Drug Administration throughout 2006 and was told the agency had never heard of this problem. Bruce knew for a fact that many mesh sufferers had called to file an “adverse event report.” Still the FDA insisted it had never been called about this problem. There is no such thing as the contraction of mesh. Polypropylene is not plastic.
An Office of Criminal Investigation case was opened against several larger manufacturers to determine if polypropylene could degrade in the body. That case is still opened.
Unlike the FDA’s warning that transvaginal mesh complications are not rare and the benefits of its use may not outweigh the risks, a notification posted on the agency’s website in July 2011, hernia mesh has not received such a warning. The FDA’s hernia mesh page says:
“The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh.”
This is perplexing because besides the well-publicized Composix Kugel mesh recall of several lots, which was later put back on the market, there have been very few recalls of hernia mesh with the exception of a few manufacturing lots recalled over mislabeling, sterility or counterfeit mesh issues.
The only other large hernia mesh recall was in September 2005 by LifeCell Corporation over its AlloDerm mesh. It was determined that about one-quarter of those implanted with the donated human/cadaver skin mesh had complications including infection and rejection.
Ethicon’s Prolene Hernia System remains on the market. Marlex, the Phillips Petroleum plastic was made into Hula Hoops in the 1950s. It is still used for inguinal hernia repair. #
*Editor’s Note– In transvaginal mesh litigation, MDL PTO #66 orders Defendant Ethicon to produce backup data on hernia products and on Ethicon’s decision to redesign them to move from “a heavyweight small pore design to a lighter-weight, larger pore hernia mesh…” including documentation on Prolene, Prolene Soft Vypro, Proceed and Ultrapro and including research conducted by Dr. Heniford, among others (Klosterhalfen, Klinge). Dr. Heniford later made a video extolling the virtues of lightweight mesh. Plaintiffs’ attorneys say much of that evidence was not preserved by Ethicon.