It all started with a crunch. An abdominal crunch. On a weighted ab machine at the college gym. I felt a strange twinge in my groin and thought to myself “that didn’t feel right.” Four years later, I was finally diagnosed as having an inguinal hernia.
How big a problem is it?
It turns out, one in four men will develop a hernia in their lifetime. Inguinal hernia repair is said to be one of the most common operations in general surgery. More than a million hernia repairs are performed in the USA each year, and approximately 800,000 of these repairs are for inguinal hernias. Due to differences in anatomy, men are nearly 10 times more likely than women to have an inguinal hernia.
“Back when I trained in the 1970s, we were taught never to use mesh.” – Dr. Robert Sewell, general surgeon
A brief history of hernia mesh
Prior to the late 1980’s, the vast majority of hernia repairs were done using sutures. Using mesh for hernia repair was a rarity. But in the 1990’s, mesh became increasingly more common alongside the advent of laparoscopic hernia repair, which can only be done using mesh. According to one USA study, suture repairs represented 94% of inguinal hernia surgeries in 1989. But by 2008, mesh repairs would come to represent 96% of inguinal hernia surgeries. The two surgical approaches to hernia repair flip-flopped in their predominance over the course of less than twenty years.
Before meeting with the general surgeon who would be performing my operation, I met with a physician assistant who explained aspects of the procedure to me. She said that mesh is the “gold standard” for hernia repair, that it is inert in the human body, and that it is a permanent implant. She also said that their goal, was that a year from now I would hardly remember having had the surgery. Time would tell, at least for me, that only one of these statements would turn out to be true.
The standard of care
If you are anything like me, you might assume that prior to surgical mesh being allowed on the market, studies must be conducted to ensure its safety. But this is actually not the case. A 2016 study published in the Journal of the American Medical Association explained as follows:
“The present study highlights the need to assess the long-term safety of interventions before making definitive conclusions about their benefits. Demonstration of long-term safety is required for drugs in the United States but not for some devices, such as hernia meshes, which are not subject to similarly strict documentation. In the United States, most hernia mesh is approved for use by the 510(k) mechanism. This requires only that these materials have similarity to existing products on the market without the need for clinical trials to demonstrate safety or efficacy. Thus, the complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization.”
In other words, the FDA does not require premarket safety studies for mesh, so these studies are not done, and consequently we do not know the long-term risks associated with mesh. This approach to safety reminds me of the lyrics to a song: “Night driving without headlights, wearing sunglasses too.”
My mother said to me, “Luke, you don’t want to have plastic implanted permanently into your body.” Incredulous, I thought to myself “What the hell does my mom know about medicine or surgery?” I trusted doctors and the medical profession. After all, they are the experts, right? What I would later find out in the years to come would forever change my view of the medical profession. Little did I know at the time, that my mother’s common sense would prove to be right after all.
The gold standard?
Most hernia and transvaginal mesh devices are made of a type of plastic called polypropylene (or a close variant of it). Material Safety Data Sheets of polypropylene explicitly prohibit “permanent implantation into the body.” In 2004, a subsidiary of Chevron that produces Marlex – a brand of polypropylene approved by the FDA – became concerned about medical use of its product and issued a warning that it must not be used for permanent implantation in the human body. When Chevron found out that their Marlex was being used in implantable medical devices (transvaginal mesh) they refused to sell their product to the medical device manufacturer saying, “We are simply not interested in this business at any price.” One might think this would stop medical device manufacturing companies from using polypropylene in their implantable medical devices. But sadly, such is not the case. So much for hernia (and transvaginal) mesh being the “gold standard.”
The surgeon repaired my inguinal hernia laparoscopically. He used a 6” x 6” piece of polypropylene mesh to repair what was a very small defect. The mesh stretched from my pubic bone to my hip. Admittedly, my health was not good before the surgery as I had taken many rounds of antibiotics in the previous two years. But after the surgery, with 36 square inches of polypropylene mesh in my body, my health would turn into a veritable train wreck (see this article written by a mesh-implanted patient to learn more about possible symptoms associated with foreign body response complications due to mesh).
“I can’t, in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body. It’s well known that its oxidatively unstable.” – Duane Priddy, plastics engineer and fellow of the American Chemical Society
Inert or not inert, that is the question
I was told by my doctor that mesh is inert in the human body. Thinking them to be the expert in the matter, I believed them. They were wrong. A 2012 study published in The Journal of Urology had this to say on the matter:
“Polypropylene in mesh form is commonly considered inert and without adverse reactions after implantation in humans. The literature suggests otherwise with reports of various degrees of degradation, including depolymerization, cross-linking, oxidative degradation by free radicals, additive leaching, hydrolysis, stress cracking and mesh shrinkage along with infection, chronic inflammation and the stimulation of sclerosis. Many substances added to polypropylene for various purposes during manufacture behave as toxic substances that are released during the degradation process. Based on available evidence the polypropylene used for surgical treatment of various structural defects is not inert after implantation in the human body.”
Additionally, polypropylene mesh increases oxidative stress in the body. A cursory search on Wikipedia states that in humans, oxidative stress is thought to be involved in the development of: ADHD, cancer, heart disease, Parkinson’s disease, Alzheimer’s disease, autism, chronic fatigue syndrome, depression, and the list goes on. The intensity of immunologic reactions, such as oxidative stress, seem to be directly related to the overall amount of polypropylene material implanted into the body, with heavy-weight meshes producing significantly higher oxidative stress than light-weight meshes.
So no, mesh is not inert in the human body. Rather, it degrades, shrinks, increases oxidative stress, releases toxic substances as it breaks down, and there are reports of infection and chronic inflammation, not to mention chronic pain.
Speaking of pain
Chronic pain is now recognized as one of the more significant complications of hernia surgery. Since early on, mesh has been implicated as a culprit in the development of chronic pain after inguinal hernia surgery – potentially causing both non-neuropathic (meshoma and fibrosis) and neuropathic (nerve entrapment) pain. According to one estimate, the risk of moderate to severe chronic pain after inguinal hernia surgery is around 10-12%.
Nine years after my initial inguinal hernia surgery, I finally decided to have a second surgery to have the mesh removed. Mesh removal is risky, and it is difficult to find surgeons who are experienced and willing to do it. Because my mesh was implanted laparoscopically, I opted to have it removed in the same manner. The surgery went well. Except that the surgeon was not able to remove all of it. He explained that the mesh surrounding my spermatic cord could not be removed without risk of causing damage to the many nerves in that area. Two years after this surgery, I still can feel the jagged edge of mesh on my pelvic floor, reminding me of its presence. But in some ways, I am lucky. For although mesh seems to have wreaked havoc on my health, at least I am not in chronic debilitating pain, for now.
Why use hernia mesh?
By now you might be wondering why hernia mesh is ever used at all in the first place. There are a couple reasons: 1) In the hands of your average surgeon, hernia reoccurrence rates are generally lower with mesh repairs compared to non-mesh repairs, and 2) When the tissues surrounding a hernia defect are grossly inadequate, it may be necessary to use mesh for proper support. There is a time and a place for surgical mesh but, until we have definitive studies showing it to be safe, mesh should be the exception rather than the rule. Note that mesh is rarely required in any primary direct inguinal hernia, and virtually never needed for primary indirect inguinal hernia repair.
There is a third reason why hernia mesh is used so frequently, and that is money. It is estimated that the global hernia mesh repair device market is worth about $3.8 billion USD. It should come as no surprise then, that hernia mesh manufacturers helped fund the new international guidelines for hernia repair. Under these new guidelines, non-mesh hernia repairs are only recommended where mesh is unavailable or where the patient specifically requests mesh not to be used.
Hindsight is 20/20
If I could do it all over again, I would have gone to the Shouldice Hernia Hospital in Ontario, Canada where they specialize in non-mesh hernia repairs and have a recurrence rate of less than 1% for primary inguinal hernias. If, for whatever reason, I could not travel to Canada then I would seek out a surgeon closer to home who specializes in non-mesh hernia repair. Lastly, I would find a surgeon who I trusted and felt comfortable with. That’s the advice I would give to my former self, if I could.
Hope for a better world
I have shared my story here in the hope that others will not have to suffer as I have suffered. I hope that you can learn from my naivety and the mistakes that followed from it. Surgical mesh is not a men’s issue or a women’s issue, as both are affected. The real issue is profiteering at any cost. Even the cost of human suffering. Through educating ourselves and becoming better informed, I hope we can alleviate suffering and create a healthier world for us all. Thank you for reading my story. And thank you for doing what you can to help create a better world.
For more mesh-related information visit the Mesh News Desk.