Mesh News Desk is preparing a series of stories on hernia mesh as litigation begins to focus on this polypropylene medical device. It is the same material that has been made into pelvic mesh and caused hundreds of thousands of complications worldwide.
Complications are similar between pelvic and hernia mesh patients. Now a leading hernia surgeon specialist is seeing an increase in requests for hernia mesh removal. Mesh News Desk talked to Dr. Shirin Towfigh, of Beverly Hills Hernia Center.
She also manages HerniaTalk.com a forum for discussion.
In her center, Dr. Towfigh generally has 13 percent of her hernia practice dedicated to mesh removal. Last year, that number increased to 22 percent. An even larger percentage of patients are requesting that the medical device be removed.
In a published study last month, (here), Dr. Towfigh and colleagues reported on 105 hernia meshes that they removed. Most were in males (58%), with an average pain score of five out of 10. Pain and infection were the most common reasons for mesh removal in the groin and abdomen, respectively.
Dr. Towfigh opened the Beverly Hills Hernia Center in 2013, where she treats hernias and hernia-related complications. Trained as a general surgeon, she tells Mesh News Desk that hernias are not a “sexy topic” of discussion, unlike other specialties such as trauma or cardiac surgery. As a result, despite being one of the most common operations performed, it gets little funding for research and is one of the poorest reimbursed operations in general surgery.
Mesh-based hernia repair first became popular in the 1980s. Interestingly, mesh removal has also been performed since then, but there is still no specific code to bill for mesh removal, she tells MND. This may be secondary to the American Medical Association’s lag in addressing less common procedures.
Dr. Towfigh says mesh repair for inguinal hernia was invented to reduce recovery pain, improve recurrences, and turn a previously inpatient procedure into an outpatient procedure. This was the main contribution of Dr. Lichtenstein, who invented the Lichtenstein onlay mesh inguinal hernia repair.
Q: You’ve been performing hernia repairs since 2002 as a general surgeon and exclusively dedicated your practice to hernias since 2008. What are the trends in mesh removal requests, as you’ve seen over the years? Do more patients want their mesh removed, for example?
Dr. Towfigh: “I have patients who call my office requesting their mesh be removed: Some believe their mesh has been recalled. Some are told their mesh needs to be removed because they saw an ad for a hernia lawsuit. Some are afraid they will have a future mesh-related problem.
“These are not reasons for mesh removal. The large majority of patients do fine with mesh with no long-term complications. In the US, we perform about one million hernia repairs every year.
“Nevertheless, even though a small percentage of patients have a hernia or mesh-related complication, the whole number of patients with complaints can be high. Part of our role as surgeons is to understand our patients’ complaints and to objectively and compassionately explain to them why they would benefit from an operation such as mesh removal and also when they have no indication for mesh removal.
“A growing proportion of my practice includes mesh removal. In fact, one in four of my operations is for mesh removal. I also like to share my experience in this realm, to make sure whatever I learn is disseminated to other surgeons. See the December paper published here.
“When writing our most recent paper, I wasn’t so surprised that my volume of mesh removals had increased. What surprised me was the growing proportion of patients I treated who were showing a systemic reaction to their hernia mesh. Last year, they made up 1/3 of the mesh removal patients I treated. We were not seeing this trend before.
“The patients who were showing signs and symptoms of mesh reaction tended to be young and female. We are now focusing our research on doing a deep dive into this rare, but seemingly growing population of patients, to learn more about them.”
Q: Since I understand more than 80-90 percent of mesh is synthetic, is polypropylene the problem?
Dr. Towfigh: “No, that is not what my data showed. We specifically analyzed whether polypropylene was more represented in mesh-related complications than other mesh materials, such as polyester, ePTFE, and biologics. We did not find polypropylene to stand out disproportionately among them.
“I’d like to believe I am open-minded about what we do know and don’t know about mesh and its interactions with the human body. If a patient presents to me with a clear story that implicates the mesh as a cause of their symptoms, and extensive workup has not shown any other cause for their symptoms, then I will offer mesh removal to help them. If the story is not clear, I work with an allergist/ immunologists and with rheumatologists who can help me further workup patients before they are subjected to mesh removal.
“We don’t have specific blood testing to detect for mesh allergy or reaction. The testing we do have has not been validated for mesh reactions. Also, insurance does not pay for most of them. For a patient who requires allergy or immunologic testing, they often must pay out of pocket to have it performed.”
Q: What about biofilms?
Dr. Towfigh: “Biofilms are a product of bacterial infections. The discussion about biofilms is related to mesh infection. Biofilm is one way that bacteria prevent antibiotics, for example, to penetrate their domain. It is not a bi-product of mesh itself.”
Prolene Hernia System explant from Rosenberg, 1.5 years
Q: Can mesh be removed? What percentages go wrong and have to be removed for whatever reason?
“Absolutely, mesh can be removed. As with any operation, there are risks and benefits. In the case of mesh removal, there may risks of injury to whatever the mesh may be adherent to–such as bladder, nerves or major vessels–in the process of removing the mesh. Ideally, we remove mesh without sacrificing most tissue.
“Hernia mesh removal is not a common operation and is not indicated for the vast majority of patients. In the US, only a handful of us surgeons perform it on a notable basis. We do not have an accurate number to quote regarding the need for mesh removal, as we do not have a national database that tracks this problem. I suspect mesh removal occurs in less than 1% of the patients who undergo hernia repair.”
Q: How long does it take to experience a problem with mesh, if at all?
“For inguinal hernia repairs, most mesh-related problems will present themselves in the first weeks to months after hernia surgery. Rarely, patients may have mesh reactions that present three to seven years later. We don’t have a good understanding of what are these reactions. In our study, we see foreign body reactions that manifest as rash, joint pain, swelling, chronic fatigue, brain fog, fever, malaise. One recent publication using FDA data showed a possible very slight correlation between breast implants and autoimmune diseases. The same has not been shown with other implants, such as joint replacements, cardiac stents, pacemakers, aortic valves, vascular grafts, and so on.
“For abdominal wall hernia mesh repairs, the risks of infection and intestinal obstruction may present early on, such as the first couple of months after hernia surgery, or may present years later. Again, the overall risk is low, and depends on the type of operation performed, risks associated with the patient (e.g., obesity, diabetes, nicotine use, emergency operation, etc.), type of mesh implanted, where it is implanted, etc.”
Q: What about the adage – the more mesh the more mess?
“It’s a catchy comment, but what does that really mean? Most of us hernia surgeons believe that, in general, less mesh is better than more mesh. But are we talking about less size of the mesh, or less density and weight, or that overall it’s best to limit how much mesh is used as part of our hernia surgery practice?
“I’ll give you some examples: Physiomesh (Ethicon, Inc.) was removed from the market because it was too lightweight and could not withstand the pressures of larger hernias and bridging repairs performed laparoscopically. That is a situation where less mesh is not better. Also, we know that when using mesh, size matters. Implanting smaller-than-recommended mesh sizes will more likely result in pain and a hernia recurrence. That is another example of less mesh being worse.
“On the other hand, most mesh cause inflammation. Less of it causes less inflammation, which can translate into less pain and less reactions to it. But a recent study (here) showed more pain with lighter-weight mesh . We probably don’t need as much mesh as we put in, especially in the US. Fortunately, some companies are making mesh with less overall synthetic in it. The results of using those mesh seem promising.”
Q: What kind of mesh do you use?
“I tailor the type of mesh to the needs of each of my patients. When I use mesh, they can be polypropylene, polyester, hybrid, or biologic material.”
Q: Can we predict who will have a complication?
“That’s the million dollar question, isn’t it? To date, we can only predict risks of having complications based on what we know from retrospective studies of populations as well as our own experience. So, for example, the risk of a mesh infection in an obese diabetic patient who smokes is much higher than in the opposite type of patient. But that does not imply that a thin athlete has no risk, or that an obese diabetic smoker will have a mesh infection.
“In my practice, my patient and I do have an honest discussion about risks and benefits of operations. I try to tailor my discussion as much as I can to the patient’s specific needs. For example, I am more likely to recommend a tissue-based inguinal hernia repair in a young, thin female patient, especially if they have a personal history of lupus or fibromyalgia. I don’t have Level 1 scientific evidence to support this recommendation. Most such patients will likely do just fine with a standard mesh repair.
“I am hopeful that with more attention to mesh-related risks, we will have more data to support surgical recommendations. In the meantime, my colleagues and I will continue to study these issues in hopes of gaining and sharing our knowledge, with the goal of helping patients.”
Q: So you will do a non-mesh repair?
“Absolutely. For both inguinal and abdominal hernias, there are non-mesh options for many patients. For inguinal hernias, my patients may be eligible for Shouldice, Bassini, Marcy, McVay, Nyhus, and other types of tissue repairs.
“I also teach my residents and fellows how to do a high-quality tissue repair, so that they can incorporate it in their future practices, too.”
Q: How does hernia mesh compare to pelvic mesh?
“We’ve been using hernia mesh much longer than pelvic mesh. We have not experienced the same incidence or degree of complications that have been reported with pelvic mesh. The area and type of structures against which we place hernia mesh is very different than pelvic mesh. As a general surgeon, it seems to me that placing mesh near mobile structures in the pelvis may be more problematic. Also, the technique is often transvaginal, which means it is not perfectly sterile. Almost all hernia repairs with mesh are performed in sterile settings.
“From what I understand, there may have been an inadequate training of gynecologists to perform many of the mesh-related operations in the pelvis, specifically the ones for urinary incontinence. Meanwhile, there are highly gifted and talented gynecologists and urologists who are trained to treat pelvic floor diseases and do a great job with excellent results, including in their use of mesh. These trained experts don’t experience nearly the amount of complications that less trained general gynecologists may have. The consequence is that because of the pelvic mesh-related complications, trained surgeons are unable to offer mesh-based procedures that can help their patients because so many patients have been hurt.”
Q: We see on the MAUDE database (FDA) sepsis and deaths associated with hernia mesh. Are we connecting the dots?
“As with any operation, sepsis and death are potential complications. The MAUDE database cannot clearly assess whether a death or sepsis is primarily due to the associated mesh-based operation. It’s typically not the mesh itself that causes sepsis.
As with any implant, mesh can get infected if bacteria seed it. This can occur from problems unrelated to the hernia repair, such as a tooth abscess, a bout of diverticulitis, or a colonoscopy. More commonly, the mesh is infected as a complication of the mesh-based hernia repair operation itself. This may be due to a wound infection or an injury to intestine, as examples. Sometimes these are preventable infections, but often the infection is not preventable. To die from sepsis due solely to a mesh infection is very rare, as the combination of antibiotics and mesh removal can cure that problem. We had no deaths from mesh removal in our published study, as an example.”
Q: Should mesh go through a premarket approval that involves clinical trials before it is marketed?
“I like the idea of categorizing hernia mesh to be a higher-risk device that requires premarket clinical trials for new mesh as well as requiring post-market surveillance of patients who have mesh implanted.
“Of course, the immediate effect will be higher cost of the mesh implant, which will be passed on to the consumer. Hernia surgery is already one the lowest reimbursed operations not only to the surgeon but also to the hospital or surgical facility. Meanwhile, insurance companies do not change their level of reimbursement if the surgeon chooses to use a cheaper or more expensive mesh implant. Medicare and private insurers pay each facility a set price per hernia repair.
So, the situation may be that the facility gets paid $1,500 for an open inguinal hernia repair operation. That must cover the cost of the surgical instruments, sutures, drapes, gloves, facility’s overhead, the surgical technologist’s and nurses’ time, as well as the mesh implant. If the mesh now costs more, in the range of let’s say $700-$3000, then performing inguinal hernia repair will not be economically feasible.”