For this year’s “The Art of Herniology,” I worked closely with Ajita Prabhu, MD, a surgeon at the Cleveland Clinic in Ohio, to develop a column that focused mainly on mesh—a timely topic right now given the recent research and outcomes. I would like to thank all of the contributors for their efforts, especially Dr. Prabhu, for their hard work and time to make this a compelling installment. Don’t forget to check out the Gut Reaction table as well for some quick candid thoughts from these contributors. Feel free to email me at colleen@cmhadvisors.com with any ideas for debate in hernia and other areas of general surgery. Thanks for reading!
—Colleen Hutchinson
Colleen Hutchinson is a medical communications consultant at CMH Media, based in Philadelphia. She can be reached at colleen@cmhadvisors.com.
Expert Panelists
Statement: If surgeons knew how to close the fascia properly after a primary laparotomy, there would be far fewer hernias and no need for prophylactic mesh.
Dr. Prabhu: Agree. We have some pretty good data to support that 4:1 closure with smaller needles significantly decreases the occurrence of hernia after a primary laparotomy. The vast majority of surgeons in the United States, including myself, were trained to take 1-cm bites with 1-cm travel, so likely it will take time for the message to diffuse that there is a better way to close the fascia. The first part is learning the proper technique; the second part is practicing that technique. We need to maintain the same level of technical rigor at the end of the case as we do during the key portions of the operation. I suspect this is often overlooked.
Dr. Adrales: Disagree. There will still be a role for prophylactic mesh for some patients. There is excellent evidence from Europe to support the 4:1 sutured closure of elective laparotomy for hernia risk reduction. However, we do not have ample evidence for this type of closure in emergency cases or obese patients. There is evidence to support mesh augmentation in emergent laparotomy closure. Additionally, patient factors such as aneurysmal disease and stomas will continue to affect hernia rates unfavorably, prompting mesh placement. There is also evidence to suggest that failure of early wound healing contributes to incisional hernia. This deficit in the early inflammatory stage of healing may facilitate hernia development regardless of fascial closure technique.
Dr. Fischer: Disagree. Most surgeons know how to optimally close abdominal fascia during laparotomy; however, the patients we treat and perform abdominal operations on have risk factors that lead to increased risk of herniation despite optimal suture technique. The addition of mesh can support tissue healing and prevent gapping of fascial closures, thereby improving fascial wound healing and reducing the risk of hernia formation. Currently, there are no data that directly compare optimal suture-based closure to prophylactic mesh, but certainly studies like that would help clarify these issues. It is likely the case that a combination of both techniques used in the right patients will help optimize its use.
Dr. Rosen: Agree. There is high-level evidence that a 4:1 suture-to-wound length ratio significantly decreases incisional hernia formation. However, it does add extra time to the case and has not been universally accepted by most surgeons. Sadly, the fascial closure part of most cases is performed without the attending faculty in the room, which is a prime missed teaching opportunity that could result in significant reduction in patient morbidity from hernia formation and repairs.
Dr. Poulose: Disagree. In general, surgeons try to do their best with the information available. We are just beginning to understand how big a problem this is and what we can do about it. Many patients could benefit from changes to our usual technique for primary laparotomy closure, and some might benefit from prophylactic mesh. I don’t think a one-size-fits-all approach is going to work. Our job is to figure out what would be best for the patient sitting in front of us, to help advise him or her appropriately.
Dr. Voeller: Disagree. As we know, recent studies from Europe show that small bites closure with a proper suture to wound length ratio has been shown to decrease the incidence of incisional hernias. The average body mass index in these studies was not typical of a lot of the American population. While I hope it applies to the, on average, more obese American population, we do not know if this is the case. I don’t know that anything much can be done in the smoker with poor tissues, in those with poor collagen-like aneurysm formers, and in the obese person other than prophylactic mesh to decrease hernia formation. I would agree with the statement if the word “far” was removed.
Statement: Prophylactic mesh will prevent many hernias in the future, and although some patients might experience harm from the mesh, the benefits outweigh the risks.
Dr. Fischer: Agree. Much of the data from our European colleagues has validated the answer to this question; specifically, multiple RCTs across large populations show benefit for prophylaxis, including the PRIMA trial. These studies show that the addition of mesh reduces the risks of hernia occurrence following open abdominal surgery. Although the majority of studies show minimal risks—mostly the risk of seroma formation—there is always significant concern around the potential morbidity and risk associated with a prophylactic intervention. While there may be risks, it seems that these risks will be justified given the significant opportunity to improve the unfavorable epidemiological trends of incisional hernia formation.
Dr. Prabhu: Disagree! While prophylactic mesh may have the potential to help some patients, the unavoidable consequence of some patients coming to harm due to a procedure, which was performed in absence of an existing problem, is to me unacceptable. Mesh complications are often very serious and can be devastating for patients. While patients may consent to the placement of a prophylactic mesh when told it may decrease their risk for hernia formation, I seriously doubt that they would do so if they knew how severe the complications may be if they were to occur. They depend on us to guide them, and we need to do so responsibly.
Dr. Rosen: On the fence. There is certainly mounting evidence that in randomized controlled trials (RCTs), the use of prophylactic mesh reduces incisional hernia formation rates. However, most of these studies are underpowered to assess the harm associated with placing mesh in many patients who ultimately would not have needed the prosthetic. We have certainly learned from hernia surgery that in most patients mesh performs well, but we know that in some cases it can cause significant patient harm from infection, erosions and chronic pain. It is critical that all surgeons and patients understand that the threshold at which we will accept a negative outcome for a patient is not the same when treating a disease versus trying to prevent something from happening. In the latter, there are many patients who will receive a treatment (mesh) and never develop a hernia in the first place. For these patients, I am not sure we know what an acceptable failure rate is, but I would presume it should be very low.
Dr. Voeller: Agree—as long as the mesh used and the location of the mesh is selected properly. The mesh used should be a macroporous mesh and the studies show both onlay and retrorectus placement of the mesh are effective. As long as the mesh is midweight, macroporous, and kept out of the abdomen, any harm should be minimal. This is especially true if the onlay position is chosen for mesh placement; if you were to get a wound infection and have to open the wound, negative pressure wound therapy will heal the wound without mesh loss and with minimal morbidity. Prophylactic mesh is where a moderately priced “magic mesh” that gives a durable result and then disappears would be a big advance.
Dr. Poulose: On the fence. Basically, we don’t know if the benefits of prophylactic mesh outweigh the risks. Most of the studies so far have focused on the benefits, which are encouraging. But we need much more work quantifying the risks, especially in groups of patients who may be more prone to low-rate catastrophic complications (mesh infections, fistula formation, bowel obstruction, etc.). RCTs are very good at determining the efficacy of prophylactic mesh. What is very difficult to obtain from an RCT is how much harm comes to people in the form of low-rate catastrophic complications. This is something we need to determine to see if the benefits outweigh the risks.
Dr. Adrales: On the fence. Just as hernia repairs should be tailored to the individual patient and hernia defect, broad application of a single method of hernia prophylaxis is not likely to be the best solution. For patients at higher risk for incisional hernia, mesh augmentation is reasonable. As discussed at the 2017 International Symposium on Incisional Hernia Prevention [in San Francisco], there is currently no definitive consensus on which groups of patients would receive the most benefit and where the prophylactic mesh should be placed (e.g., onlay, sublay). Even higher-risk patients may find that the benefit does not outweigh the risk of mesh. An individualized, patient-centered approach is needed.
Statement: Surgeons should be reimbursed for placing prophylactic mesh.
Dr. Fischer: Agree. The act of reinforcing the abdominal fascial closure with mesh represents a discrete, significant procedural service rendered by a physician and, therefore, should be represented and billed as such. Currently, mechanisms are underway and a category 3 code has been developed, approved and supported by the AMA and the American College of Surgeons (0437T). Success of efforts to advance this code to a recognized Category I Code will be contingent upon sufficient evidence in the published literature demonstrating efficacy, and upon expected use of the code and this technique throughout the United States.
Dr. Voeller: Agree. It adds time to the operation and will save a lot of money in the long run if the cost of an incisional hernia is avoided.
Dr. Prabhu: On the fence. This is the ultimate conflict of interest. Paying surgeons to place prophylactic mesh incentivizes surgeons to place devices that will in some cases fail and in others may even harm the patients. On the other hand, there is a return on investment argument that can also be made. Placing mesh takes time, effort and skill. If surgeons feel that their efforts aren’t rewarded, they will likely be unwilling to place a prophylactic mesh even if evidence supports that it’s the right thing to do. For the time being, for my practice, the risk outweighs the benefits of placing prophylactic mesh, reimbursement or not.
Dr. Rosen: On the fence. I think if a surgeon used a large-pore polypropylene mesh as has been described in most RCTs and typically adds only $50 to the case, they have reasonable grounds to be reimbursed. If they use biologic or absorbable synthetic materials, then I would consider that experimental and they should not be reimbursed.
Dr. Adrales: Agree. There are indications for prophylactic mesh, and this should be appropriately reimbursed to allow surgeons/hospitals to apply mesh augmentation when indicated. Collectively, surgeons will have to be careful to apply this responsibly with evidence-based guidance—that continues to evolve—and tracking of outcomes.
Dr. Poulose: On the fence. Depends—at the time of stoma creation, we have reasonable information that the potential harm is acceptable given the morbidity of parastomal hernia formation. For primary laparotomies, I don’t think we are there yet, especially given the availability of the small bites technique. (It would be ideal to be reimbursed for this.) If you look at the steps needed to obtain reimbursement around a product, you can see what needs to be done: 1) We need a category 1 CPT [Current Procedural Terminology] code; 2) to get the category 1 CPT code, the use of prophylactic mesh needs to be “on-label”; 3) to get an on-label indication, you need data to support a regulatory claim with the FDA; and 4) for prophylaxis it’s going to come down to adequately quantifying the risk for low-rate catastrophic complications.
Statement: While synthetic mesh has been used in RCTs in Europe for prophylactic mesh, in the United States it is likely and appropriate that absorbable synthetic and biologic mesh will be utilized, particularly in the setting of contamination.
Dr. Poulose: Disagree. Much more information is needed to help figure this out. Some of the questions we need to answer include: Do absorbable synthetics and biologics reduce the chance of long-term low-rate catastrophic complications compared with permanent synthetic meshes? Are there particularly high-risk groups of patients for whom the threshold for prophylactic mesh placement is different? Patients undergoing initial stoma creation come to mind. We need to all come together and figure this out collaboratively to help our patients improve their quality of life and minimize harm.
Dr. Adrales: Agree. The easy access to absorbable synthetic and more expensive biologic mesh along with the current litigation climate in the United States leads me to expect that there will be greater use of nonpermanent mesh for hernia prophylaxis, particularly for contaminated cases. Is this the right approach? The European data (PRIMA, RCT of mesh augmentation after abdominal aortic aneurysm repair, PREVENT and others) are compelling for use of lightweight polypropylene mesh. However, the STOMAMESH trial showed no difference in colostomy parastomal hernia incidence with prophylactic mesh. I will await the results of the PREBIOUS trial for absorbable synthetic mesh augmentation.
Dr. Prabhu: Disagree! This is the part where we need to really consider what we are there to do as surgeons. In the setting of contamination, we need to treat the patient for the problem they have rather than concerning ourselves with problems they may have in the future. To add a potentially very expensive (and unnecessary) device into the mix, which has not yet been thoroughly investigated for this use, doesn’t pass the commonsense test for me. The same is true for clean cases. Simply put, we don’t know enough about how those devices behave to suggest that we should use them for hernia prophylaxis in absence of good level I data.
Dr. Fischer: Agree. It is important to note that much of the literature demonstrates significant benefit from prophylactic mesh; however, these studies primarily demonstrate efficacy with synthetic mesh. Population profiles of countries that performed these randomized trials in Europe and beyond are vastly different than the relatively more comorbid and higher-BMI population seen in the United States. For these reasons and because of our medical and legal environment, it is likely that surgeons will favor absorbable mesh constructs to reinforce the abdominal wall, particularly if onlay approaches are adopted. The onlay approach that places the mesh one anatomic plane away from the outside world demonstrated high levels of efficacy in the PRIMA study, and this represents potential additional reason to consider nonpermanent mesh in higher-risk patients with a risk of wound healing events.
Dr. Rosen: Sadly agree. I think this is a major sticking point for the use of prophylactic mesh in the United States. In most trials from outside the United States, the patients who benefit the most from prophylactic mesh are those at “high risk” for hernia formation. These tend to be patients undergoing complex operations, those with multiple comorbidities and/or with the presence of contamination. Currently in the United States, there is a tendency to use nonpermanent meshes. There is certainly evidence to support these practices in the setting of incisional hernia repair. However, these meshes are expensive, and the lack of reimbursement for these materials would make it cost-prohibitive in most systems for prophylactic usage. Likewise, in the absence of long-term data that these other products do not in fact improve outcomes, I think it is inappropriate for individual surgeons outside of standardized protocols and studies to be experimenting with these products in this setting.
Dr. Voeller: Agree. They will be used. I think the biosynthetic and biologics have a better chance of being used here in the United States, where cost constraints, etc., are not as tough as in Europe. Is it appropriate? Probably so, since class action lawsuits are scaring away patients and some surgeons from synthetic products, and placing them prophylactically opens up a new can of worms. As more surgeons and lawyers in the United States understand that macroporous synthetic meshes can be used safely with contamination, they will be used, however. As we know, the durability of the biosynthetic and biologic products is the question, and studies will need to be done. Right now, long-term durability is the question with these products.
| Gut Reaction | ||||||
 Benjamin Poulose, MD |  Gina Adrales, MD | Guy Voeller, MD | John Fischer, MD | Ajita Prabhu, MD | Michael Rosen, MD | |
|---|---|---|---|---|---|---|
| International Hernia Collaborative (Facebook group) | Cool Facebook group | Hernia friends | Great communication tool when used properly | Highly innovative platform for sharing ideas | Keeping Up With the Kardashians | Great potential, but a dangerous weapon in the wrong hands |
| Most significant recent technological advance in hernia repair | Transversus abdominis release (performed correctly) | Minimally invasive complex AWR (extraperitoneal, roboTAR, etc.) | Not the robot | The concept of prophylactic mesh and work from our European colleagues | Marlex | Americas Hernia Society Quality Collaborative |
| The use of the term “sports hernia” | Inguinal disruption/ core muscle injury | Misnomer | Terrible term—replace with core muscle injury | Incredibly confusing | Surrogate for “can be lots of stuff” | Charlatan |
| Favorite book | Revelation Space by Alastair Reynolds | East of Eden by John Steinbech | The Big Short by Michael Lewis; Outliers by Malcolm Gladwell | Into the Wild by John Krakauer | Life of Pi by Yann Martel | Lonesome Dove by Larry McMurtry |
| Favorite movie | Star Trek II: Wrath of Khan | Shawshank Redemption | Monty Python’s Holy Grail / Rear Window / Pulp Fiction | Shawshank Redemption | The Princess Bride | Rocky |
| All hernia surgeons should be engaged in a quality improvement program for hernia care | Americas Hernia Society Quality Collaborative | Yes! | The Americas Hernia Society Quality Collaborative. Join! | A great idea | Yes! | Yes, if you actually want to get better and know your outcomes. |
| Most challenging issue hernia surgeons face today | Long term follow-up | Increasing hernia complexity but declining reimbursement and support | Mesh versus no mesh | Treating the diverse and unique types of hernia we see and practice | No consistency in disease/complication definitions, treatment or follow-up | Getting good data to make informed decisions |
| My mentors | Jeff Ponsky, Mike Rosen, Mike Holzman | Grateful for multiple mentors for different work/life areas | Louis Britt, MD, deceased UTenn chairman/Eugene Mangiante, MD | My patients | Oof! There are so many! Rosen and Heniford | Jeff Ponsky taught me leadership, academic excellence, and to maintain family balance. |
| 2017 Todd Heniford tweet: “If studying your outcomes closely doesn’t make you uncomfortable, you are probably not doing it right.” | Todd is usually right | Right on! | AHSQC. Join! | Starting to feel uncomfortable myself | Exactly! | Preach!!! |