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Published in: Hernia 2/2018

01-04-2018 | Comment

Comment to: What is the evidence for the use of biologic or biosynthetic meshes in abdominal wall reconstruction. F. Köckerling, N. N. Alam, S. A. Antoniou, I. R. Daniels, F. Famiglietti, R. H. Fortelny, M. M. Heiss, F. Kallinowski, I. Kyle-Leinhase, F. Mayer, M. Miserez, A. Montgomery, S. Morales-Conde, F. Muysoms, S. K. Narang, A. Petter-Puchner, W. Reinpold, H. Scheuerlein, M. Smietanski, B. Stechemesser, C. Strey, G. Woeste, N. J. Smart

Author: G. Voeller

Published in: Hernia | Issue 2/2018

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Excerpt

The authors of the manuscript evaluating the use of biological or biosynthetic meshes for AWR are to be commended for a fairly exhaustive review of the data regarding this subject. While I am not a big fan of consensus statements and guidelines such as these because people (especially non-physicians) interpret them as gospel, they can serve a useful purpose in letting us know the state of the science. Biological implants were first used for hernia repair in the late 1990s. While the biologic meshes cost about 3–10 times more than synthetic meshes, most were approved using the 510(k) process which requires that the biologic meshes only had to show “substantial equivalency” to a predicate device, i.e., their inexpensive synthetic counterparts that had been in use since the 70s. Human acellular dermal matrix was a little different in that it did not even have to have 510(k) approval since it was classified as a human tissue transplant. While not approved by the FDA for use in the contaminated or clean–contaminated case, these are the patients where these products found their footing. Most surgeons were taught to not use synthetic meshes in these situations and a niche for biologics was thus “preselected” more or less without any clinical data. The main conclusion one can reach from the present work as well as many other review-type articles on this subject is that the data is not extremely rigorous. However, I think it is important to read the wording of the authors’ conclusion, i.e., “The routine use of biological and biosynthetic meshes cannot be recommended”. The key word in this statement it seems to me is “routine”. Hundreds of thousands of patients have had these products placed, many times successfully. While we know that macroporous synthetic meshes work well in the inguinal area and in the uncomplicated incisional hernia, it can be a different story in the patient requiring complex AWR with contamination. In these situations, getting the abdomen closed and the fistulas healed may be more important than hernia recurrence and are not “routine” situations by any metrics. Avoiding the risk of synthetic mesh erosion into viscera and other issues with synthetic meshes may be more important than avoiding a recurrence that can be addressed at a later date. More and more studies are showing macroporous synthetic meshes can be safely used in certain contaminated situations, however, the type of infecting agent, complexity of the reconstruction and good quality studies are lacking to help us stratify our patients to the best mesh to use in these complex situations. While there is a fervor for the use of macroporous synthetic meshes in these complex cases, it needs to be tempered based on the situation the surgeon faces until we have more good quality data. It is very difficult to do high-quality level one studies in this complex hernia arena and often times the results only lead to more questions instead of answers. This is why quality collaboratives such as the AHSQC from the AHS and other registries are very important to give us real-world data both with biologic meshes as well as synthetic meshes. Both biologic (biosynthetic) and synthetic meshes have their advantages and disadvantages. Synthetic meshes are under vigorous attack from the class action lawyers and are far from perfect. While “routine” use of biologic (biosynthetic) mesh is not supported by rigorous data as the present manuscript shows, the concept of what I call a “magic mesh” that produces a strong, long-lasting repair of a hernia and then disappears is certainly the holy grail of hernia repair. …
Metadata
Title
Comment to: What is the evidence for the use of biologic or biosynthetic meshes in abdominal wall reconstruction. F. Köckerling, N. N. Alam, S. A. Antoniou, I. R. Daniels, F. Famiglietti, R. H. Fortelny, M. M. Heiss, F. Kallinowski, I. Kyle-Leinhase, F. Mayer, M. Miserez, A. Montgomery, S. Morales-Conde, F. Muysoms, S. K. Narang, A. Petter-Puchner, W. Reinpold, H. Scheuerlein, M. Smietanski, B. Stechemesser, C. Strey, G. Woeste, N. J. Smart
Author
G. Voeller
Publication date
01-04-2018
Publisher
Springer Paris
Published in
Hernia / Issue 2/2018
Print ISSN: 1265-4906
Electronic ISSN: 1248-9204
DOI
https://doi.org/10.1007/s10029-018-1736-x

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