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54
Any attempt to implement a classication of meshes for hernia surgery has to
explain its right to exist [17]. For example, Klinge and Klosterhalfen’s classication
is made up of 6 classes, in order to include the largest part of products available on
the market.
We need it for our own quality control, to learn whether a new device is equiva-
lent or improved compared to a previous similar device, at least in terms of safety
and effectiveness; moreover, some devices may be related to more adverse events
than others. There is an ongoing discussion about new regulations for the approval
of medical devices, stressing the necessity for an intensied pre- and post-market
surveillance [18].
Moreover, the possibility to group different implanted meshes into comparable
cohorts through a classication allows the comparison among devices, supporting
the surgeons during decision on the best approach for each patient and in each
situation.
6.2.2 How toDescribe Meshes
Since it is essential to understand the characteristics of the hernia repair materials
prior to implantation, we should be able to make comparison among them through
tests or laboratory investigations.
Many parameters to describe a mesh are currently available. Each company can
choose independently which test to use to describe their products. We can sum-
marise standards and methodologies of investigation as follows:
• Biomechanical characterization [6, 16, 19] as elasticity, strength, and stiffness
– suture retention,
– tear resistance,
– uniaxial and biaxial tensile testing, ball burst,
• Porosity, pore size [20]
– from very large (>2000μm) to microporous (<100μm)
• Weight, prosthetic density [20]
– heavyweight (>90g/m
2
)
– lightweight
– ultra-lightweight (<35g/m
2
)
• Texture
– monolament, multilament, mixed structure, or polymer
– knitted or woven
• Shape
– at
– pre-shaped, 2D/3D structure
• Structural mesh component
– permanent
– absorbable synthetic
– biological tissue-derived
D. P. Greco and C. Abbati
55
• Biomaterial [7]
– simple: made of one pure biomaterial
– composite: made of two or more different layers, one of which is simple,
while the other(s) are non-resorbable or resorbable
– combined: made of two materials knitted or woven together; both materials
may be non-resorbable, or with only one lament resorbable
– coated: with extracellular matrix, antibacterial substances, metals, nitric oxide
– biological: non-cross-linked or cross-linked
6.2.3 How toStudy Meshes
During preclinical studies, meshes are studied on animal models, considering the
mechanical environment and function of the animal abdominal wall in different
species.
Studies can be conducted on intact abdominal wall or in models, where a lesion
similar to a hernia had previously been created. Of course, there are a number of limi-
tations which should be considered when interpreting results and conclusions from
the studies that have utilized animal model to examine abdominal wall mechanics.
Among invivo experimental models to study infection or microbiological stud-
ies to investigate bacterial adherence [21], SEM (scanning electron microscope) is
the most employed method.
Imaging is an essential tool to study the mesh/host interface in each phase of the
process, both before implantation, after surgery while the mesh is part of the abdom-
inal wall, and also post-explantation. It is particularly useful for dening the degra-
dation of the polymer over time (Fig. 6.1), especially in the case of explants, through
various techniques:
• Observation with the electron microscope,
• Traditional pathology
• Radiology, MRI for coated meshes
Fig. 6.1 SEM scan 0.1mm
30.0KV 1.63E2: corrosion
of polypropylene ber after
contact with bacteria. From
Greco DP, Forti D.Le
protesi nella chirurgia
erniaria moderna [19].
[Reproduction authorized
byDr D. P. Greco]
6 Biomaterials inAbdominal Wall Surgery
56
The technique of mesh implants visualization with MRI has been recently
introduced [22]; the combination of iron-loaded meshes with MRI gives the possi-
bility to delineate the mesh implant in detail. This might help to improve hernia
treatment in two ways: on the one hand, potential mesh-related complications can
be assessed accurately and adequate treatment can be initiated, on the other hand,
surgeons can learn about regular postsurgical mesh behavior and characteristics.
This mesh is made of polyvinylidenuoride monolaments and, to provide MR vis-
ibility, tiny iron particles have been embedded into the base material, resulting in a
mesh concentration of 99% polyvinylidenuoride and 1% Fe
3
O
4
.
The most important experience on explanted mesh from human is by Klinge and
Klosterhalfen’s [17] (Table6.4). Their studies have also been the basis of one of the
most up-to-date classications. Together with the German Medical Technology
Association, they planned to provide this classication on the webpages of the her-
nia societies.
The introduction and use of a shared and worldwide adopted classication may
permit to identify common standards for mesh characterization, and to tailor patients
therapy.
Moreover, the constitution of national or international registries for abdominal
wall hernia surgery, which of course has to include information about the type of
mesh, will account also for quality control of these devices, more than classica-
tion. Few examples already exist in some countries [23] and is still under develop-
ment an international online platform for registration and outcome measurement of
ventral abdominal wall hernia repair, EuraHS [24].
6.3 Host andMesh
6.3.1 Implant andInflammatory Reaction
The intensity and duration of host mesh reaction depend on type and quantity of the
material being used. Primary response is the formation of a layer of palmitic pro-
teins such as albumin, IgG, and brinogen around the mesh material, immediately
after implantation. Around a week after implantation, the population of mononu-
clear phagocytic cells differentiates into macrophages. These cells secrete a wide
number of effectors which help to modulate the biological response. The inamma-
tory reaction seals the foreign body in an epithelioid granuloma. In the presence of
indigestible prosthetic material, the macrophages coalesce into foreign-body giant
cells. The nal stage of the biological response is the synthesis of connective tissue.
A collagen network is produced for around 21 days. As a consequence of this
remodeling, its mechanical strength increases progressively until ~6months after
performing the surgical wound (see Table6.5). However, at the end of this period,
the newly formed tissue only has 80% of the normal mechanical strength of the skin
or fascia. Other properties, such as its elasticity or energy absorption capacity, will
be even lower [25].
D. P. Greco and C. Abbati
57
12345678
9101112131415161718192021
primary response
cellular
differentiation,
collagen network
collagen
modifications,
synthesis of
connective tissue
Six
months
Table 6.5 Inammatory phases, mesh/host interface
6 Biomaterials inAbdominal Wall Surgery
58
6.3.2 Complications andUndesirable Effects
A wide variety of complications or undesirable effects may occur after hernia repair.
The abdominal wall is a complex system, and not always after an intervention it is
possible to restore the elasticity and total function [11, 21, 26]. The mesh implant
has reduced recurrences, but some outcomes can be qualied as direct complica-
tions of the mesh. Modern meshes belong to the class of biomaterial, physically and
chemically inert and stable, nonimmunogenic and nontoxic. In contradiction to their
features, the biomaterials trigger a wide range of adverse response in vivo. The
response depends both from the biomaterials and from the host.
We can differentiate between short- and long-term complications [11, 15], as
shown in Table6.6. Many of the recent technological innovations have been devel-
oped trying to prevent these complications, in particular related to infections, in the
attempt to preserve mesh grafts without removing it [27–30].
6.4 Conclusions
How to choose the correct mesh? The large number of products available makes it
clear that none of them is an ideal t. EBM indicates that the surgeon has to look for
a lightweight mesh, with large pores and minimal surface area [11, 31, 32]. Ideally,
it should be a monolament, as for inguinal hernia. For incisional hernia instead, the
choice is still more difcult and depends on many factors as:
• Surgical technique
– Open
– Laparoscopic
• Host infection risk
– Low
– Medium
– High
• Surgical eld
– Clean
– Contaminated
– Infected
• Budget [33]
Table 6.6 Distribution of
complications over time
Short term
Long term
Seroma ×
Shrinkage ×
Fibrotic bridging ×
Recurrence ×
Pain × ×
Infection × ×
Fistula ×
Degradation ×
Adhesion ×
D. P. Greco and C. Abbati
59
Table 6.7 presents data from a competitive tender held in Italy. It shows that
sometimes there appears to be no correlation between price and complexity of a
mesh. Critical budget restricts the choice to few products, making it difcult to cus-
tomize and tailor treatments according to the risk factors both of the patient and of
the procedure.
Some open questions remain:
• The absence of a classication universally recognized, also by the manufactur-
ers, to describe in the same manner so different meshes
• The difculty of understanding the host–mesh interface of covered or complex
meshes, which can vary greatly depending on different clinical situations
• The lack of strong evidence to support the choice of a certain mesh among so
many in each specic situation; this often leads to self-making decisions.
Regarding decision making, it is mandatory for future development to collect
clinical data through Registries, as indicated by the European Commission’s
Recommendation 2013/172/EU [34]. This effort will help to combine different
experiences, in particular concerning complex meshes (covered, combined, coated),
that are not part of routine surgery of individual operating units with specic
indications.
The introduction of registries will provide a network among several institutions
and hospitals, supporting the surgeons to select the best prosthetics, and the compa-
nies to select satisfying research plans.
The choice of material is critical to success in hernia repair. It is necessary for the
development of novel materials or coatings. Ideally, fully biodegradable hernia
meshes possessing improved host interactions will become commonplace in the
Table 6.7 Mesh costs in Italy
Description
Dimensions
U.M.
(item)
Range
Min.– Max. (€)
Non-absorbable macroporous mesh for inguinal
and incisional hernia and abdominal wall
reconstruction
6.5×11/13cm 1 220 290
7.5×15cm 1 280 370
10/11×15cm 1 290 390
15×15cm 1 290 390
20×30cm 1 680 900
IPOM-like composite mesh for laparoscopy 7–8×12–15cm 1 270 350
10–
11×14–15cm
1 380 500
14–
15×18–20cm
1 680 900
18–
20×23–25cm
1 750 1000
20–
25×30–33cm
1 1350 1800
Non-absorbable lightweight macroporous mesh
for inguinal and incisional hernia
5–6×10–11cm 1 23 30
8–10×15cm 1 26 35
15×15cm 1 38 50
30×30cm 1 75 100
6 Biomaterials inAbdominal Wall Surgery
60
future. Today the search for this ideal biomaterial has to start from real data to be
collected in a short time from several centers and from a correct information on
implanted material. Furthermore, it requires multidisciplinarity, both in terms of
analysis and of approach, which includes the incorporation of new emerging disci-
plines, such as nanoengineering or microinformatics, for the design and develop-
ment of intelligent devices [27, 35]. The problem of sustainability remains, and we
wonder if these products will manage to be safe for the patient and compatible with
the budget at the same time.
References
1. Czerny V.Beiträge zur operativen Chirurgie. Stuttgart: Verlag Von Verdinand Enke; 1878.
2. Read RC.Milestones in the history of hernia surgery: prosthetic repair. Hernia. 2004;8(1):8–14.
3. Goepel R. Uber die verschliessung von bruchpforten durch einheilung geocuhtener fertiger
silberdrahtnetze. Verh Dtsch Ges Chir. 1900;9:174–9.
4. Aquaviva D, Bounet P.Cure d’une volumineuse eventration par plaque de Crinol. Extr. Bull.
Soc. Chir. Marseille. 1944; as cited by Zagdoun J, Sordinas A, L’utilisation des plaques de nylon
dans la chirurgie des hernies inguinales, Academie de Chirurgie, Se`ance du 1959;25:747–54.
5. Moloney GE, Gill WG, Barclay RC.Operations for hernia; technique of nylon darn. Lancet
Lond Engl. 1948;2(6515):45–8.
6. Brown CN, Finch JG.Which mesh for hernia repair? Ann R Coll Surg Engl. 2010;92(4):272–8.
7. Coda A, Lamberti R, Martorana S.Classication of prosthetics used in hernia repair based on
weight and biomaterial. Hernia. 2012;16(1):9–20.
8. DeBord JR.The historical development of prosthetics in hernia surgery. Surg Clin North Am.
1998;78(6):973–1006.. vi.
9. EU Hernia Trialists Collaboration. Repair of groin hernia with synthetic mesh: meta-analysis
of randomized controlled trials. Ann Surg. 2002;235(3):322–32.
10. Klinge U, Klosterhalfen B, Schumpelick V.Vypro (R): a new generation of polypropylene
mesh. In: Bendavid R, etal., editors. Abdominal wall hernias: principles and management.
NewYork: Springer; 2001. p.286–91.
11. Klosterhalfen B, Junge K, Klinge U.The lightweight and large porous mesh concept for hernia
repair. Expert Rev Med Devices. 2005;2(1):103–17.
12. Freudenberg S, Sano D, Ouangré E, Weiss C, Wilhelm TJ.Commercial mesh versus Nylon
mosquito net for hernia repair. A randomized double-blind study in Burkina Faso. World J
Surg. 2006;30(10):1784–9.. discussion 1790.
13. Sørensen CG, Rosenberg J.The use of sterilized mosquito nets for hernioplasty: a systematic
review. Hernia. 2012;16(6):621–5.
14. Sanders DL, Kingsnorth AN, Stephenson BM.Mosquito net mesh for abdominal wall hernio-
plasty: a comparison of material characteristics with commercial prosthetics. World J Surg.
2013;37(4):737–45.
15. Amid PK. Classication of biomaterials and their related complications in abdominal wall
hernia surgery. Hernia. 1997;1(1):15–21.
16. Deeken CR, Lake SP.Mechanical properties of the abdominal wall and biomaterials utilized
for hernia repair. J Mech Behav Biomed Mater. 2017;74:411–27.
17. Klinge U, Klosterhalfen B.Modied classication of surgical meshes for hernia repair based
on the analyses of 1,000 explanted meshes. Hernia. 2012;16(3):251–8.
18. Challoner DR, Vodra WW.Medical devices and health--creating a new regulatory framework
for moderate-risk devices. N Engl J Med. 2011;365(11):977–9.
19. Greco DP.Valutazione Morfologica. In: Greco DP, Forti D, editors. Le protesi nella chirurgia
erniaria moderna. Milano: Medical Economics; 1996. p.23–8.
D. P. Greco and C. Abbati
61
20. Kalaba S, Gerhard E, Winder JS, Pauli EM, Haluck RS, Yang J.Design strategies and applica-
tions of biomaterials and devices for hernia repair. Bioact Mater. 2016;1(1):2–17.
21. Junge K, Binnebösel M, Rosch R, Jansen M, Kämmer D, Otto J, etal. Adhesion formation of
a polyvinylidenuoride/polypropylene mesh for intra-abdominal placement in a rodent animal
model. Surg Endosc. 2009;23(2):327–33.
22. Hansen NL, Barabasch A, Distelmaier M, Ciritsis A, Kuehnert N, Otto J, etal. First in-human
magnetic resonance visualization of surgical mesh implants for inguinal hernia treatment.
Investig Radiol. 2013;48(11):770–8.
23. Kyle-Leinhase I, Köckerling F, Jørgensen LN, Montgomery A, Gillion JF, Rodriguez JAP,
etal. Comparison of hernia registries: the CORE project. Hernia. 2018;22(4):561–75.
24. EuraHS.European Registry of abdominal wall hernias [Internet]. http://www.eurahs.eu. Cited
9 July 2018.
25. Elango S, Perumalsamy S, Ramachandran K, Vadodaria K.Mesh materials and hernia repair.
Biomedicine. 2017;7(3):16.
26. Klinge U, Klosterhalfen B, Ottinger AP, Junge K, Schumpelick V.PVDF as a new polymer for
the construction of surgical meshes. Biomaterials. 2002;23(16):3487–93.
27. Pérez-Köhler B, Bayon Y, Bellón JM.Mesh infection and hernia repair: a review. Surg Infect.
2016;17(2):124–37.
28. Carbonell AM, Cobb WS.Safety of prosthetic mesh hernia repair in contaminated elds. Surg
Clin North Am. 2013;93(5):1227–39.
29. Novitsky YW. Biology of biological meshes used in hernia repair. Surg Clin North Am.
2013;93(5):1211–5.
30. Stremitzer S, Bachleitner-Hofmann T, Gradl B, Gruenbeck M, Bachleitner-Hofmann B,
Mittlboeck M, etal. Mesh graft infection following abdominal hernia repair: risk factor evalu-
ation and strategies of mesh graft preservation. A retrospective analysis of 476 operations.
World J Surg. 2010;34(7):1702–9.
31. Uzzaman MM, Ratnasingham K, Ashraf N.Meta-analysis of randomized controlled trials
comparing lightweight and heavyweight mesh for Lichtenstein inguinal hernia repair. Hernia.
2012;16(5):505–18.
32. Rutegård M, Gümüsçü R, Stylianidis G, Nordin P, Nilsson E, Haapamäki MM.Chronic pain,
discomfort, quality of life and impact on sex life after open inguinal hernia mesh repair: an
expertise-based randomized clinical trial comparing lightweight and heavyweight mesh.
Hernia. 2018;22(3):411–8.
33. Bower C, Roth JS. Economics of abdominal wall reconstruction. Surg Clin North Am.
2013;93(5):1241–53.
34. 2013/172/EU: Commission Recommendation of 5 April 2013 on a common Framework for a
unique device identication system of medical devices in the Union Text with EEA relevance
[Internet]. 2013. Report No.: 32013H0172. http://data.europa.eu/eli/reco/2013/172/oj/eng.
Cited 9 July 2018.
35. Ehrlich G, Hu F, Lin Q.Intelligent implants to battle biolms. ASM News. 2004;70(3):127–33.
6 Biomaterials inAbdominal Wall Surgery
63
© Springer Nature Switzerland AG 2019
D. P. Greco, E. Borgonovi (eds.), Abdominal Wall Surgery,
https://doi.org/10.1007/978-3-030-02426-0_7
D. P. Greco (*)
Day&Week Surgery Unit, Ospedale Niguarda Ca' Granda, Milano, Italy
e-mail: dalilapatriziagreco@gmail.com
C. Abbati
Department of Surgery, Niguarda Hospital, Milan, Italy
University of Milan, Milan, Italy
7
Care Settings
DalilaPatriziaGreco andClaudiaAbbati
7.1 Introduction
Care settings are dened as the organizational modalities through which health care
services are delivered.
Different features characterize each level of care:
• Minutes of care per head (nurse-to-patient ratio)
• Length of stay
• Care delivery methods
There is an increasing need for health care services, not reducible nor foresee-
able, determined both by the ageing population and the advent of chronicity [1].
Whatever health model is adopted, Beveridge, Bismarck or mixed models, the
nancial contribution remains the same or can slightly increase in time, being
related to GDP [2].
The recent global economic crisis has highlighted the economic pressure on wel-
fare choices even in the G8 countries.
Concern about limited economic resources has driven towards an evolution of
conventional hospital stay, involving pre- and post-operative time, introducing new
regimes, including Day Surgery, and new pathways, the so-called fast track and
ERAS [3–5]. Evidence-Based Medicine validates these choices [6].
64
At present, the only strategy to increase the number of available medical ser-
vices, without increasing costs, is by improving organizational policies and proce-
dures. Lean analysis of current clinical pathways allows for this [7].
7.2 Surgical Pathway
Clinical Pathway is a methodology and a complex intervention for the mutual
patient-care management and organization of care, for a well-dened group of
patients; it is based on EBM guidelines, best practice and patient expectations
[8–10].
The surgical pathway nowadays in the majority of countries including Italy
has quite eliminated the preoperative hospital stay for elective surgery. This has
been replaced by pre-surgical management that, through clinical assessment
(clinical evaluation of surgical complications) and careful patient selection,
allows to reduce preoperative hospitalization without affecting quality or safety
[11, 12].
The adoption of ERAS guidelines and best practice [13, 14] helps to shorten
hospital stays and decrease use of expensive care areas, as intensive care units.
Traditionally, British and American Health System (NHS; Medicare, Medicaid)
includes these care settings:
• Outpatient surgery
– Ofce-based surgery
– Ambulatory surgery
• Inpatient surgery
– Conventional hospitalization
– Intermediate intensive care
– Intensive care
In Italy, day surgery was introduced for the rst time in 1985 (Law No. 595/1985),
from the Anglo-Saxon medical culture.
The integration of these models into the Italian framework was conditioned by
the wide availability of hospitals across the country. Accordingly, the rst Italian
experience with day surgery encouraged the development of other forms of hospital
care, specic to surgical activities [15]. Table 7.1 shows which models are ofcially
recognized today and differences between them.
The outpatient clinic care can be classied into different organizational struc-
tures [16]:
• Hospital-integrated (operates in conjunction with the inpatient business),
• Hospital-separated (operates in the hospital as an independent station),
• Satellite-care (operates as an autonomous business entity on the hospital
grounds).
D. P. Greco and C. Abbati