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with Colleen Hutchinson

As we approach the season of annual hernia meetings and the debates that come with them, I am honing in on some critical hernia topics. I’d like to thank all of the contributors and Guy Voeller in particular for helping me navigate the world of mesh, which is the main focus of this month’s column.

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After reading this On the Spot, you will at least know what some of the experts think about mesh variants, based on their specialized experience and their knowledge of current and forthcoming data. In addition, I once again address the topic of standardization in hernia care. Last year (General Surgery News, February 2013, page 20), you read our contributors’ opinions on whether hernia treatment should be standardized and monitored via a Center of Excellence application, or at least via identification and definition of basic gold standards and standards of care. The question became clear: Is hernia care a field that demands an individualized approach to treatment, and therefore, one in which we really cannot implement generalized therapy approaches among subpopulations of hernia patients? This month, I target that question directly as I ask my colleagues to respond to the declaration that hernia treatment is something that, at this point, really cannot be standardized.

Read on for responses and let us know your thoughts on these issues as well by visiting this column online and sharing your thoughts. Don’t miss the Gut Reaction table on page 16, and as always, feel free to email me at colleen@cmhadvisors.com with any ideas for debate in hernia and other areas of general surgery.

Happy 2014!

—Colleen Hutchinson

P A R T I C I P A N T S
img-button David Chen, MD, FACS, is assistant clinical professor at UCLA Lichtenstein Amid Hernia Clinic, David Geffen School of Medicine at the University of California, Los Angeles.
img-button B. Todd Heniford, MD, is chief, Division of Gastrointestinal and Minimally Invasive Surgery; co-director, Carolinas Laparoscopic and Advanced Surgery Program; director, Carolinas Hernia Center, Charlotte; and clinical professor of surgery, University of North Carolina at Chapel Hill.
img-button Dmitry Oleynikov, MD, is professor of surgery and director of minimally invasive surgery at the University of Nebraska Medical Center, Omaha.
img-button Michael J. Rosen, MD, FACS, is associate professor of surgery and chief of the Division of GI and General Surgery at University Hospitals of Cleveland, Case Medical Center, and the director of the Case Comprehensive Hernia Center in Ohio.
img-button Michael G. Sarr, MD, FACS, is the J.C. Masson Professor of Surgery and vice chair of research in the Department of Surgery, Mayo Clinic in Rochester, Minnesota.
img-button Guy R. Voeller, MD, is professor of surgery, University of Tennessee Health Science Center, Memphis.

Statement:It is safe to place lighter-weight synthetic meshes in clean-contaminated or contaminated wounds.

Dr. Sarr: Disagree, but I am hearing about people who have placed lightweight, large-pore polypropylene in clean-contaminated cases, and even if a wound infection develops, it will granulate through. We need a study, but at the current time I would have to say “disagree.”

 

Dr. Voeller: Agree. There is no question that this is true. Randomized trials that have just been completed will show this to be safe. We at the University of Tennessee Health Science Center, and many other places, have been doing it for years. We especially like to use an onlay technique with fibrin glue for mesh fixation. Even if a wound infection develops, the lightweight mesh can always be salvaged by opening the wound and placing a wound vac [vacuum-assisted wound closure].

Dr. Rosen: Agree, so far. There is a large series of 100 patients with medium-term follow-up that suggests this is safe. We also are currently enrolling patients in a randomized controlled multicenter trial that hopefully will provide level 1 evidence on this question. However, there are some key technical points that allow one to place synthetic mesh in contaminated fields that should be carefully considered.

Dr. Heniford: On the fence. There is little clinical data that explore lightweight polypropylene mesh use in clean-contaminated and contaminated fields. Our lab data in animals show that lightweight polypropylene mesh has a reduced infection rate compared with the more traditional heavyweight mesh. Lightweight mesh is also more likely salvaged than its traditional, heavyweight counterpart if it becomes infected. But, in a recent paper presented at the Southern Surgical Association detailing outcomes in more than 750 complex ventral hernia repair patients, we found that synthetic mesh used in a hernia in which an enterotomy had occurred had significantly increased odds of a mesh infection. This data does not exclude its use, but it does give me some pause in using synthetic mesh in these fields.

Dr. Oleynikov: On the fence. There is new evidence to suggest that you can get away with this practice, but much remains to be worked out, such as how much is too much contamination and how to check the vascularity of the bed.

Dr. Chen: On the fence. I would agree, with caveats, depending on degree of contamination, type of mesh, position of mesh placement and the type of repair. I don’t have a problem placing lightweight mesh in the sublay position with a retrorectus repair for a clean-contaminated case. For a grossly contaminated case, there is a lot of mesh that is at risk and biologic [mesh] may still be safer. Soon enough, we will have some good data on this.

Statement:The market for biologics is dropping off; there are few indications for them based on current data; and generally, their outcomes are disappointing.

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Dr. Sarr: Agree. In my practice, biologic meshes are prolonged wound dressing. I never rely on a biologic mesh to span a defect and expect it to remain repaired. I think biologic meshes are best used to reinforce tenuous repairs or when a permanent prosthetic cannot be placed.

Dr. Rosen: Agree. I think, like all new medical devices that come on the market, there are many claims that are made that often do not pan out with long-term experience and data. The biggest problem with biologic mesh is it was initially priced to regenerate into fascia. We now know that does not happen. The current cost of this material and the disappointing long-term durability issues make other less expensive alternatives appealing. If biologic mesh companies could more reasonably price these materials for what they actually do, they might have a role in contaminated abdominal wall reconstruction.

Dr. Chen: On the fence. Biologic mesh is being more properly utilized for the right indications. When used with proper technique and selected for appropriate cases, the outcomes are good and it is good for us to have [biologic mesh] available. Like all tools in surgery, it has a role and a use but won’t correct for bad judgment or technique.

Dr. Heniford: Agree. In general, I agree, but there are a number of factors that go into its increased risk for failure. Our data do show a four to five times increased risk for recurrence when a biologic implant is used compared with when a synthetic mesh is used. The fact that these implants expand or stretch over time is disappointing. However, they are largely used in the most challenging surgical fields, and this fact does play a role in the increased recurrence rates. Certainly, if we expect these meshes to be the “be all and end all” and to behave like a synthetic, we will be disappointed. They must be accepted as different, and at times, very helpful. If you want something to behave as a synthetic, use a synthetic. Now, interestingly, the consideration of a synthetic, absorbable mesh has entered into the conversation. [See next statement.]

Dr. Oleynikov: Agree, this is a true statement, but only because we were asking too much of biologics, and not all biologics perform in the same way under similar conditions. Cost also has been a significant drawback.

Dr. Voeller: Agree. I was never a believer in the biologic mesh fairy tale. They were introduced without any clinical data. I never used the products because I did not believe the hype. Yuri Novitsky and others have confirmed what I believed—the scar that is formed has no good-quality collagen. Maybe there’s a role for salvage situations, but there are less expensive alternatives.

Statement:Biosynthetics, or new bioresorbable meshes, are the next best thing and will replace biologic mesh at a lower price and provide a better chance of leaving a ‘good’ scar and disappearing.

Dr. Sarr: Agree. The biosynthetics can be used in the same place that a biologic mesh is placed at a much cheaper price. Whether they have a better chance of leaving a good scar is unknown. I have used them; I like them; and they are much cheaper than biologic meshes.

Dr. Rosen: On the fence. Like biologic mesh, there are certainly early appealing results. Whether this will translate into long-term durability is unknown. However, the more reasonable price tag of some of these materials is encouraging.

Dr. Heniford: “Agree,” but we need to study these materials diligently. We completed an experiment that answers exactly this question in an animal study. In a blinded evaluation, we found that GORE BIO-A [Gore Medical] incorporates faster with greater cellular and vascular ingrowth and had significantly increased type I collagen deposition compared with Strattice [LifeCell], FlexHD [Ethicon] and Permacol [Covidien]. It did indeed leave a “good scar.” The data we have gathered from the biologic implants will provide a very good comparison among the absorbable synthetics.

Dr. Chen: On the fence. Let’s see what the long-term outcomes look like. It may not be “the next best thing,” but it is another good option that we have available. For the case in which you are just trying to get closure and bridge with biologic, this is definitely a more cost-effective alternative. For definitive repair, we need to see how these remodeled scars behave over time with regard to strength and recurrence rates. We will probably find that, like everything else when used with good technique, it will be effective (and hopefully cost-effective).

Dr. Oleynikov: On the fence. There is great promise from these engineered materials, but much remains to be worked out. The reabsorption characteristics vary significantly based on the tissue bed and use of these products.

Dr. Voeller: On the fence. We don’t have enough data on the biosynthetics at present. Only time will tell. I think they will replace the biologics as they are now doing since they are less expensive, but we don’t know if they will leave a good-quality scar plate.

Statement:Hernia care and treatment is something in medicine that, certainly at this point, by and large can’t be standardized.

Dr. Voeller: Agree. Even though there is a broad standardization, we do not have enough stratification data to tell us who benefits most from what type of repair. Hopefully, things such as the Americas Hernia Society Quality Collaborative will begin to allow more refined standardization.

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Dr. Oleynikov: Disagree. We have far more evidence for a number of hernia-related techniques and principles today than we did even five years ago. We can standardize many aspects of hernia repair today and should do so, as I see great variability in hernia repair principles that do not serve patients well.

Dr. Sarr: Agree. Several things are definite. A hernia-former [patient] needs a prosthetic mesh. A non–hernia-former may not, but the current use of component separation without a biologic mesh or without a permanent mesh for hernia-formers (obese or multiply recurrent hernias) is unconscionable, in my opinion.

Dr. Rosen: Disagree. First, we need definitions of what we are actually talking about. We desperately need a validated, easy-to-use classification system to allow unified reporting of outcomes and staging of hernia care. I think it is important to remember that one size will never fit all hernias. That is the fun of this field.

Dr. Chen: Agree, mostly. We definitely don’t want to take decision making, judgment and technique out of the hands of surgeons. Individual patient circumstances and surgeon expertise and experience are all important in surgical decision making. That being said, we need to look at collaborative experiences and outcomes to help direct better technique and standardize the low-hanging fruit.

Dr. Heniford: Disagree. There are indeed situations where we cannot fully standardize care, but through the use of true, well-designed, randomized studies, we can much better regulate and conform preoperative management, techniques and postoperative care for hernia operations, the most commonly performed operations in the world.

Contributor img-button
Question 1:
Mesh or no mesh for hiatal hernia?
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Question 2:
For a 2-cm umbilical hernia, laparoscopic repair is indicated.
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Question 3:
If you cannot bring the anterior rectus fascia together after a component separation, you should bridge the gap with a biologic, not a permanent, mesh.
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Question 4:
Obamacare is…
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Question 5:
Best advice to the community surgeon in clean-contaminated cases…
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Question 6:
Best advice to the community surgeon regarding sportsman hernia…
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Question 7:
The FDA’s approval process for medical devices is…
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Question 8:
The one thing residents and fellows forget most is…
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Question 9:
The one thing patients forget most is…
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Question 10:
The one thing I forget most is…
Dr. Rosen ‘No mesh’ ‘It certainly is easier than open. ’ ‘Depends on the wound class of the case and the goals of the surgeon/patient. But most of the time, permanent synthetic.’ ‘Why the U.S. government can’t do anything well. ’ ‘Do a good hernia operation. ’ ‘It doesn’t exist; let it go. ’ ‘Broken, but be careful what you wish for. See response on Obamacare.’ ‘Be prepared for every case.’ ‘You have to be part of the solution; there is no surgical magic. ’ ‘Use the electronic medical record.’
Dr. Oleynikov ‘Mesh for hernia 2 cm and greater ’ ‘Yes, especially in obese patients’ ‘I would use a permanent mesh and place onlay synthetic biologic over the defect. ’ ‘Not good for anyone’ ‘Use lightweight monofilament prolene mesh in the retrorectus po?cket. ’ ‘Don’t do it! ’ ‘Very slow’ ‘Patient factors determine outcomes far more than surgical technique. ’ ‘Personal responsibility’ ‘When there is a crisis, always check your own pulse first!’
Dr. Voeller ‘Mesh’ ‘Ventralex ST (Davol) open repair cheaper/better’ ‘Only in a salvage situation’ ‘A mess’ ‘Avoid biologics.’ ‘Find a true expert and learn.’ ‘Poor’ ‘To be humble’ ‘Respect is a two-way street.’ ‘I forgot.’
Dr. Heniford ‘Thickness of crus provides the answer.’ ‘Sure, lap-assisted is a good technique.’ ‘Permanent or expect to re-operate later’ ‘Scary…’ ‘Talk options with patient before surgery.’ ‘Fully understand the issues before operating.’ ‘Daunting, variable, a moving target’ ‘To get in their daily nap’ ‘Avoid Rosen’s operating room.’ ‘How truly thankful I should be’
Dr. Chen ‘Depends on size and the patient’ ‘Good for obese and incarcerated’ ‘Not necessary’ ‘An imperfect solution but a start’ ‘Biologic or retrorectus repair with lightweight mesh’ ‘Conservative management’ ‘A necessary evil’ ‘How lucky we are to do what we do’ ‘Perfection doesn’t exist.’ ‘How important it is to get home’
Dr. Sarr ‘Sometimes but usually not’ ‘No, too expensive; cheaper done open’ ‘Definitely not! Permanent mesh is indicated.’ ‘Too early to tell’ ‘Don’t place prosthetic mesh; consider reinforcing with biosynthetic mesh.’ ‘Refer to a sportsman hernia expert.’ ‘Too complicated’ ‘Place mesh sublay versus onlay, large pore versus small pore.’ ‘Hernias recur and hernias get infected.’ ‘Honesty in terms of recurrence’

img-button Colleen Hutchinson is a communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached at colleen@cmhadvisors.com.