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478
K. El-Hayek and M. Kroh
Absorbable Fasteners
Though transfascial suture fi xation is the most common method to
secure mesh, there is a trend toward fastening devices such as tacks.
These devices are more common in laparoscopic repair but are also
used during open repair. The technology has evolved and includes
medical skin staples, helical fasteners, and other specialty tacking
devices [
24, 25 ] . Tack fi xation of mesh during laparoscopic hernia
repair has the advantage of being relatively easy to dispense and to
secure the mesh, but the depth of penetration into the soft tissue is
limited by the design of the tack, the thickness of mesh being used, and
the adequacy with which the tack is seated into the abdominal wall.
These concerns have prompted many surgeons to use tacks in conjunction
with transfascial suture fi xation, with the idea that the tacks will help
position the mesh for ultimate transfascial suture placement. Tacks also
keep the periphery of the mesh annealed to the abdominal wall until
re-peritonealization takes place, a process that typically takes 7–10 days
[ 6 ] . The suture is then designed to stabilize the mesh for robust tissue
ingrowth and durable mesh fi xation. With mesh products that allow for
fast and signi fi cant tissue ingrowth, some authors have proposed not
using transfascial suture fi xation, though studies have shown increased
rates of hernia recurrence when PTFE mesh is used without suture
fi xation [ 12 ] . However, composite materials may allow better tissue
ingrowth resulting in accelerated healing times and stronger repairs
[ 26 ] . Other authors have shown that use of tacks as an adjunct or
replacement for sutures reduces time and possibly even postoperative
pain [ 22 ] .
Permanent metallic fi xation devices work well in securing the mesh
long enough for reperitonealization and stabilization. However, concerns
exist about leaving these permanent materials in place. Complications
such as adhesions to metallic tack heads and tack migration from the
abdominal wall into the viscera have been shown to result in small bowel
obstruction and even perforation [ 27– 30 ] . Such complications have led
to the development of absorbable fi xation devices. There are currently
three companies with absorbable fi xation systems on the market:
Covidien (AbsorbaTack™), Bard Davol (SorbaFix™, PermaSorb™),
and Ethicon (Securestrap™).
Covidien: AbsorbaTack™
The Covidien AbsorbaTack™ was released in 2008. There are both
long and short 5-mm versions of the delivery system for use in
479
43. Absorbable Fixation Materials: A Critical Appraisal
laparoscopic and open repair. These devices have 15 or 30 tacks for the
long delivery system and 20 tacks for the short delivery system. There is
no pilot tip in this design for engaging soft tissue. The fasteners are
composed of poly(glycolide-co- l -lactide) (PGLA) and have a tapered
screwlike tip. There is a 1.0-mm head with a total length of 5.1 mm. A
signi fi cant absorption period occurs at 3–5 months via hydrolysis into
glycolic and lactic acid, which are then metabolized completely by
12 months. When in vitro shear strength was tested by Covidien,
AbsorbaTack™ screws had 39 lbf initially, which ultimately degraded to
19 lbf at 8 weeks [ 31 ] .
Bard Davol: SorbaFix™ and PermaSorb™
The Bard Davol SorbaFix™ was released in 2009. A 5-mm delivery
system is used with either 15 or 30 fasteners. Fasteners are composed
of poly( d , l )-lactide (PDLLA) and are shaped with a blunt screwlike
tip. The head length is 0.8 mm with a 6.7-mm total length. There is a
sharp pilot tip on the delivery system that is needed for engaging tissue.
Material degradation involves a process of hydrolysis and enzymatic
metabolism. Sixty days postimplantation, the fastener maintains 100%
of original strength, while degradation is nearly complete at 1 year.
Preclinical, company-based studies revealed that burst strength
remained seven times higher than the intra-abdominal pressure
requirement at 56 days [ 32 ] .
The Bard Davol PermaSorb™ is another option for hernia fi xation
and differs mainly in design when compared to SorbaFix™. The
PermaSorb fasteners are also made of PDLLA but are con fi gured with
two staggered hooklike projections off a central shaft to allow for a mesh
and tissue fi xation. Because the fasteners are composed of the same
material as SorbaFix™, the absorption pro fi les are similar.
Ethicon: Securestrap™
The Securestrap was released by Ethicon in 2011. A 5-mm delivery
system is used with 25 total fasteners. These fasteners are designed in a
strap-like con fi guration with fi xation points on both sides. When fully
deployed, there is a low-pro fi le area exposed which is designed to limit
foreign body reaction. Ethicon sponsored studies revealed that the
Securestrap™ maintained signi fi cant shear strength in relation to angle
of deployment. Absorption occurs via a hydrolysis and metabolism
mechanism [ 33 ] .
480
K. El-Hayek and M. Kroh
Fibrin Sealants
Interest in adhesive products for hernia fi xation stemmed from a desire
to limit the foreign body reaction following placement of mesh and
permanent suture in hernia repair. The fi rst materials used were synthetic
cyanoacrylate-based glues, and while they showed promise for hernia
fi xation, they were also associated with cytotoxicity, carcinogenicity, and
severe tissue in fl ammation [
34– 37 ] . Due to these unwanted side effects,
the use of nonsynthetic fi brin sealant products has been recommended in
lieu of synthetic-based glues. Baxter Healthcare offers two such options
for fi brin sealant products: Tisseel™ and Artiss™.
Baxter Healthcare: Tisseel™ and Artiss™
Tisseel™ and Artiss™ are adhesive agents procured from human
fi brinogen and thrombin. An initial formulation of Tisseel™ received
FDA approval in 1998, while an upgraded formulation received approval
in 2006. Artiss™ was approved for use in 2008. The concentration of
human thrombin is 500 IU/ml in Tisseel™ and 4 IU/ml in Artiss™. When
mixed with human fi brinogen, these preparations mimic the fi nal stage of
blood coagulation pathway. Tisseel™ is indicated as an adjunct to
hemostasis in several operations including those involving cardio-
pulmonary bypass as well as treatment of splenic injury following trauma.
It is also indicated for use as an adjunct to prevent anastomotic leakage in
colonic anastomoses. Indication for use of Artiss™ is limited to prepared
wound beds for patients undergoing autologous skin grafting. There is no
indication for hemostasis. Fibrin sealant use in hernia repair is considered
“off-label”; however, investigators have studied it in both animal and
human trials [ 38, 39 ] . It is important to note that while these sealants are
considered absorbable, there is a small risk of human disease transmission
as they are procured from human plasma.
Clinical Use of Absorbable Fixation Materials
Inguinal Hernia Repair
The typical method of mesh fi xation in open repair of inguinal hernia
is that of direct suture. In a large cohort study, Novik et al. studied the use
of permanent suture, long-term absorbable suture (i.e., PDS), and short-
term absorbable suture (i.e., Vicryl) fi xation of mesh in over 80,000
481
43. Absorbable Fixation Materials: A Critical Appraisal
Lichtenstein herniorrhaphies [ 40 ] . This group found that there was no
advantage in using permanent versus long-term absorbable suture in
terms of hernia recurrence. However, the use of short-term absorbable
suture was associated with a twofold increased risk of hernia recurrence
versus long-term absorbable or permanent suture, discouraging use of
short-term absorbable sutures for open hernia repair.
For laparoscopic inguinal herniorrhaphy, the discussion regarding
mesh fi xation is more controversial, with multiple questions regarding
type and extent of fi xation [ 41 ] . Lau performed a randomized trial
comparing mechanical stapling versus fi brin sealant in patients
undergoing bilateral endoscopic totally extraperitoneal inguinal
hernioplasty (TEP). In this study, he found a signi fi cant reduction in
postoperative analgesics in the fi brin sealant group; however, there was a
higher incidence of postoperative seroma in this group when compared
to the mechanical staple group (17.4% vs. 5.3%) [ 42 ] . Because of such
fi ndings, investigators began to study non fi xation in laparoscopic inguinal
hernia repair, hoping to fi nd equivalent outcomes with less pain and
seroma. A multicenter, blinded, randomized trial by Taylor et al. sought
to evaluate this postulate. In this study, investigators learned that
following unilateral repair, the non fi xated group had signi fi cantly less
groin pain. Likewise, following bilateral repair when each side was
randomized to fi xation or non fi xation, the non fi xated side was more
comfortable than the fi xated side (47% vs. 9%; P = 0.006). When more
than six tacks were used, there was also greater pain than when six or
fewer tacks were used (40% vs. 22%; P = 0.008) [ 43 ] .
Incisional/Ventral Hernia Repair
Data regarding absorbable fi xation methods during open ventral
hernia repair is relatively sparse, being limited to animal studies and
small case series. A comparative study by Grommes et al. in a porcine
ventral hernia model tested nonabsorbable suture, absorbable suture,
fi brin glue, and non fi xation of retrorectus mesh implantation. In this
study, there was no mesh dislocation or migration, and tensile strength of
mesh integration was similar in all four groups. The technique of this
repair did require fascial re-approximation in front of the mesh [ 44 ] .
Similar to laparoscopic inguinal hernia repair, a signi fi cant controversy
exists in relation to mesh fi xation during laparoscopic ventral hernia
repair. There are several key differences that make mesh fi xation a more
complex discussion in laparoscopy. While hernia sac excision and
482
K. El-Hayek and M. Kroh
abdominal wall dissection is common in open repair, often the hernia sac
and abdominal wall tissue are not disturbed during laparoscopic repair.
Such differences allow for different variety of mesh choice for open
repair, as intraperitoneal exposure of the mesh can be avoided. During
laparoscopy, the mesh is typically placed in an intraperitoneal position,
with at least one aspect exposed to viscera. For this reason, mesh selection
becomes paramount. First, in order to limit intraperitoneal complications
such as adhesions or fi stulae, anti-adhesive barriers should be employed
on the visceral side of the mesh [ 6 ] . Also, signi fi cant overlap of 3–5 cm
around the defect is important to allow for adequate ingrowth and to
compensate for possible mesh shrinkage, as the area covering the defect
will not be in contact with any tissue in many cases [ 17 ] .
In a porcine model of hernia repair comparing absorbable tacks to
metal tacks, Duffey et al. showed equivalent mesh incorporation with
both permanent and absorbable fasteners. In this model, transfascial
fi xation was not used [ 45 ] . Hollinsky et al. studied mesh fi xation via
transfascial fi xation, a permanent fastener (Covidien ProTack™), and
two absorbable fasteners (Covidien AbsorbaTack™, and I-Clip™) in
rats. Retention strength was signi fi cantly higher (8.7 N/cm [ 2 ] ) in the
transfascial fi xation group than that of ProTack™ (5.6 N/cm [ 2 ] ) or
AbsorbaTack™ (5.7 N/cm [ 2 ] ). The authors also found that the I-Clip™
had poor retention strength, while the ProTack™ was associated with
signi fi cantly more adhesions [ 46 ] .
In humans, signi fi cant debate regarding increased postoperative pain
with use of transfascial fi xation led several investigators to compare this
approach with alternative fi xation materials. Beldi et al. found that pain at
6 weeks was signi fi cantly higher when transfascial fi xation sutures were
used compared with tacks in a series of laparoscopic hernia repairs. While
recurrence rates were similar at 6 months, this group did note that mesh
shrinkage was also greater with metal tack fi xation [ 47 ] . Morales-Conde
proposed a “double-crown” technique using permanent fasteners and
reported a 2.14% recurrence rate after 140 repairs [ 48 ] . Wassenaar et al.
also compared three groups of patients who underwent laparoscopic ventral
hernia repair: those with absorbable sutures and tack fi xation, those with
double-crown tack fi xation and no sutures, and those with nonabsorbable
suture with tack fi xation. These investigators found no difference in
postoperative pain or quality of life scores at 2 weeks, 6 weeks, and 3 months
postoperatively [ 49 ] . Likewise, Nguyen et al. showed equivalent narcotic
usage, hospital stay, and return to work in patients who underwent either
primarily transfascial fi xation versus primarily tack fi xation [ 50 ] .
483
43. Absorbable Fixation Materials: A Critical Appraisal
Conclusion
Based on a critical review of the literature, there are still many
unanswered questions regarding the use of absorbable fi xation materials.
Two inseparable factors for successful hernia repair are mesh selection
and mesh fi xation, and inappropriate choice of either can lead to operative
failure. Currently, absorbable fi xation methods appear to show promise,
but further study needs to more clearly evaluate the device ef fi cacy
against proposed bene fi ts of less foreign material. Future studies should
be aimed at areas such as cost analysis, non fi xation methods, and long-
term outcomes.
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DOI 10.1007/978-1-4614-4824-2_44,
© Springer Science+Business Media New York 2013
44. Biologic Mesh: When and Why—A
Critical Appraisal
Jaime A. Cavallo , Corey R. Deeken ,
and Brent D. Matthews
Ventral Hernia Repair Reinforcement
The US Markets for Soft Tissue Repair Report prepared by the
Millennium Research Group estimates that 305,900 ventral hernia repair
were performed in the United States in 2006 [ 1 ] , reaf fi rming ventral
hernia repair as one of the most common procedures in general surgery.
The 10-year cumulative rate of recurrence for suture repair of ventral
hernias is as high as 63%, which contributes to the high incidence of
repair [ 2 ] . Signi fi cant risk factors for recurrence include surgical
technique, history of previous failed hernia repairs, large hernia size,
obesity, smoking habits, and patient comorbidities that contribute to
diminished soft tissue integrity. To reduce recurrence to a 10-year
cumulative rate <32%, level A and B evidence supports reinforcement
with synthetic or biologic materials for all incisional ventral hernia
repairs [ 2, 3 ] . Likely attributable to these evidence-based recommendations
for material reinforcement, it is estimated that synthetic or biologic
reinforcement materials were used in nearly 95% of the ventral hernias
performed in the United States in 2006 [ 1 ] . Market analysts predict a 7%
annual growth rate in the $1 billion United States soft tissue repair
device industry, largely impelled by costly biologic scaffold materials for
ventral hernia repair. The aging patient population, the prevalence of
comorbidities contributing to diminished soft tissue integrity, the high
incidence of obesity, and the rising demand for bariatric procedures with
high potential for sequelae of incisional ventral hernias are major factors
driving the anticipated market expansion for ventral hernia reinforcement
materials. In particular, demand for biologic scaffold materials is expected