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Techniques

In Laparoscopic

Ventral Hernia Repair

Frederick Greene, MD, FACS


Roy Smoot, Jr., MD, FACS
Guy Voeller, MD, FACS
Karl LeBlanc, MBA, MD, FACS
Introduction
The repair of incisional and ventral hernias continues
to be a surgical challenge. Reports published in the
medical literature indicate 3 to 13%1 of laparotomy
patients develop incisional hernias. Moreover,
clinical studies indicate that the traditional, or
open, technique to repair large abdominal wall
defects is associated with recurrence rates ranging
from 25-49%.2,3,4

In 1992, a successful series of laparoscopic incisional


hernia repairs was reported in the medical literature.5
Since then, the technique has been refined and has
grown in acceptance within the surgical community.
Advocates of this approach cite a shorter hospital
stay and lower recurrence rates as key outcomes.
This year, a multi-center study of 407 patients
reported a 3.4% recurrence rate at 23 months.
Complications associated with the procedure have
also been cited to be lower than those reported with
traditional repairs.

The contributing authors of this text have a combined


experience of several hundred laparoscopic incisional
hernia repairs. W.L. Gore & Associates, Inc., is
honored to provide this compendium of information
on an innovative and apparently effective laparoscopic
surgical technique for abdominal wall defects.

W.L. Gore & Associates


October, 2000
References
1. Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic ventral and incisional hernia repair in 407
patients. Journal of the American College of Surgeons 2000;190(6):645-650.
2. Hesselink VJ, Luijendijk RW, de Wilt JHW, Heide R, Jeekel J. An evaluation of risk factors in incisional
hernia recurrence. Surgery, Gynecology & Obstetrics 1993;176:228-234.
3. van der Linden FT, van Vroonhoven TJ. Long-term results after surgical correction of incisional hernia.
Netherlands Journal of Surgery 1988;40(5):127-129.
4. Stoppa RE. The treatment of complicated groin and incisional hernias. World Journal of Surgery 1989;
13(5):545-554.
5. LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded
polytetrafluoroethylene: preliminary findings. Surgical Laparoscopy & Endoscopy 1993;3(1): 39-41.
Authors
Frederick Greene, MD, FACS
Carolinas Medical Center
Charlotte, NC

Roy Smoot, Jr., MD, FACS


Nanticoke Surgical Associates
Seaford, DE

Guy Voeller, MD, FACS


Associate Professor of Surgery and Anesthesiology
at the University of Tennessee
Memphis, TN

Karl LeBlanc, MBA, MD, FACS


Surgical Specialty Group, Inc.
Baton Rouge, LA
Contents
Abdominal Wall Incisional Hernias –
Etiology and Historical Perspective 1

Laparoscopic Hernia Repair 7

Complications of Laparoscopic
Ventral/Incisional Hernia Repair 19

Prosthetic Biomaterials in Laparoscopic


Incisional and Ventral Herniorrhaphy 23
Abdominal Wall Incisional Hernias-
Etiology and Historical Perspective
Frederick Greene, MD, FACS

"Never judge the surgeon Despite the implication of Moynihan’s statement, the technical
until you have seen him aspects of abdominal wall closure may be excellent, but ventral
hernias may occur. Incisional hernias are quite common (5% to
(or her) close the wound."
10% of celiotomy incisions) and occur generally within the first
2-3 years of abdominal exploration. Occasionally abdominal
Lord Moynihan wall incisional hernias will occur many years after creation.
Obviously the initial closure is the most important, since faulty
technique will universally lead to development of herniation.
There are other associated co-morbid conditions, which may
encourage the creation of incisional herniation (Figure 1.1).
These include intra-abdominal or wound infection, morbid obesity,
steroid use, previous use of the incision, hematoma formation
and respiratory compromise with increased cough. Other factors
include duration of the operation, crossing incisions, ineffective
wound drainage, and excessive wound tension. Two other
important variables include nutritional aspects as well as the
presence of cancer which overall reduce the ability for wound
healing and collagen deposition in the wound. In addition, the
prior use of chemotherapy or external beam radiation directed
to the abdominal wall may enhance the opportunity for incisional
hernia formation. Modern approaches to the repair of abdom-
inal wall ventral and incisional hernias depend on thorough
Figure 1.1 knowledge of the abdominal wall anatomy as well as an under-
standing of successful and unsuccessful approaches to repair
used in the past. Clearly, the most efficacious approach is the
initial attention to excellent technical detail when the first
abdominal wall entry and closure is made, thus avoiding the
development of postoperative hernia whenever possible.

Most incisional hernias occur in the midline. This results from


the fact that it is the most common area of incision for exploration
of the abdomen and that the lack of muscle coverage over the
linea alba contributes to wound breakdown. It has been noted
that transverse incisions tend to herniate where these incisions

1
Figure 1.2

cross the linea alba. With the increasing use of mid-line sternotomy
incisions, a subxyphoid incisional hernia is common because of
breakdown of the mid-line fascial closure below the sternum
(Figure 1.2). These incisional hernias are generally small
(3-4 cm in diameter) but have a higher (10%) incarceration rate.

Historically, incisional hernias have been repaired with either


primary suture techniques or placement of a variety of (and
sometimes novel!) prosthetic materials (Figure 1.3). Surgeons
recognized early that inert products would be the best materials
to use when placed in contact with living tissue. For many years
surgeons reported intricate maneuvers in order to use the
patient’s own tissue for abdominal wall closure. William J. Mayo
reported using overlapping tissue techniques in a large series
of umbilical hernia repairs at the meeting of the American
Surgical Association in 1901. The report by Mayo generated
the term “pants-over-vest”, although Mayo described that most
of his operations were closed in side-to-side fashion. The con-
cept of creating a relaxing incision dates from the early 1900’s
and still may be utilized in a certain condition where a pros-
thetic mesh may be contraindicated. Charles Gibson, Professor
of Surgery at Cornell, reported “an operation for cure of large
ventral hernia” at the American Surgical Association meeting in
the early 1900’s and advocated the creation of relaxing inci-
sions to permit the closure of large mid-line ventral hernias.
Although Gibson reported his concern regarding the opportuni-
ty for herniation through the relaxation areas, no such hernias
actually occurred in his series.

Figure 1.3

2
At that same meeting where Dr. Mayo described the “pants-
over-vest” method, A.J. McCosh, a surgeon from the College of
Physicians and Surgeons in New York, reported an operation
on a woman who most likely had a desmoid removed from the
abdominal wall. She was left with a large defect so he reported
that “I filled up the gap with a celluoid plate inserting it
between the peritoneum and the external oblique muscle, tucking
it under the edges of the latter. The plate was perforated by
twenty five or thirty perforations made with a ticket punch . . .
although this was nearly three years ago, the woman is still
perfectly comfortable.” Until the late 1950’s when a more
suitable synthetic material was developed, surgeons tended to
use silver or stainless steel wire or tantalum mesh because of
the inert qualities of these products. In more recent times,
close observational studies have supported the concept that
even in small defects (3 to 4 centimeters in diameter) a prosthetic
material should be used in order to avoid the tension created by
primary fascial closure.

Theodore Bilroth wrote in 1857, “if we could artificially pro-


duce tissue of the density and toughness of fascia and tendon,
the secret of the radical cure of the hernia would be discovered”.
Prior attempts to use autogenous tissue (musculofascial) had
been complicated by unacceptably high recurrence rates. Hence,
the development of synthetic prosthetic materials to repair
abdominal wall incisional hernias began at the end of the 19th
century. Unfortunately, the synthetic prostheses developed and
used in the first half of the 20th century were prone to compli-
cations and failure.

The first prostheses were metallic. Silver wire mesh, intro-


duced in Germany (1900) and adopted in the United States
(1903) was limited by its weak tensile strength and susceptibility
to oxidize, corrode and fragment. Tantalum mesh, first reported
in the United States in 1948, but introduced in Canada in 1940,
was resistant to corrosion, but tended to fragment (metal fatigue)
from repeated flexion of the abdominal wall. If the silver wire
mesh or tantalum mesh fragmented, the metal fragments could
erode into the abdominal cavity causing abscesses, chronic
sinus tracts, or intestinal fistulae. Stainless steel wire mesh,
also introduced in 1940’s, did not oxidize and infrequently frag-
mented. However, the metal’s rigidity limited a patient’s ability
to flex the abdominal wall and re-operation required the

3
GORE-TEX®
Soft Tissue Patch
GORE-TEX® DUALMESH®
Biomaterial
GORE-TEX® DUALMESH® PLUS
Figure 1.4 Biomaterial
GORE-TEX®
DUALMESH® Biomaterial
with CORDUROY Surface

GORE-TEX®
DUALMESH® PLUS Biomaterial
with CORDUROY Surface

Figure 1.5a and 1.5b

Smooth Surface Textured Surface


100x 100µ 100x 100µ

Figure 1.6

4
removal of the stainless steel mesh secondary to tremendous
tissue ingrowth.

A variety of synthetic polymeric meshes were developed in the


second half of the 20th century and revolutionized abdominal
wall incisional hernia repair. With these meshes, abdominal wall
defects could be repaired without undue tension on the sutured
tissue, decreasing the high recurrence rates of abdominal wall
incisional hernia repair reported 100 years earlier. Sir Francis
Usher introduced woven monofilament polypropylene mesh in
1958. It was modified to a knitted mesh in 1962 so that the
mesh would not unravel when it was cut. Polypropylene mesh
gained widespread popularity over the next 30 years and several
types of polypropylene mesh are commercially available today.
Polyester mesh was also introduced in the 1950’s in Europe.
Rives and Stoppa employed polyester mesh in their landmark
article describing a preperitoneal technique for abdominal wall
incisional hernia repair in 1989. The technique described by
Rives and Stoppa has become the standard by which all
abdominal wall incisional hernia repairs are measured.
Polypropylene mesh and polyester mesh revolutionized
abdominal wall incisional hernia repair because the meshes
did not deteriorate with age, were pliable, and would stretch,
allowing for more even load distribution. Nevertheless, the
large interstices in polypropylene and polyester mesh promoted
adhesion formation when the mesh came into contact with the
visceral abdominal cavity. Reported complications included
small bowel obstruction, erosion, and fistulization. Expanded
polytetrafluoroethylene (ePTFE), initially used as a vascular
prosthesis, was adapted for abdominal wall incisional hernia
repair in 1983 by W.L. Gore & Associates and modified several
times in the 1990’s (Figure 1.4). Unlike the polypropylene and
polyester meshes that preceded it, ePTFE is microporous and
select products are uniquely designed with pores measuring 3
microns on the visceral side (facing the abdominal cavity) and
22 microns on the other side (facing the abdominal wall)
(Figure 1.5a and 1.5b). This design promotes fibroblastic and
vascular ingrowth from the abdominal wall (22 micron side),
but inhibits tissue attachment to the material (3 micron side)
when exposed to the intra-abdominal cavity (Figure 1.6). There
are no reports of fistulization or small bowel obstructions due
to adhesions from ePTFE material. Using sound scientific
principles and improving surgical techniques, the approaches
to abdominal wall hernia will continue to advance during the
21st Century.

5
6
Laparoscopic Hernia Repair
Patient Selection
Roy T. Smoot, Jr., MD, FACS, Stephen D. Carey MD,
Samuel K. Miller MD, Francisco J. Rodriguez MD

It is vital to begin any discussion of an evolving surgical


procedure with patient selection issues. This is certainly true
of Laparoscopic Ventral Hernia Repair (LVHR). With increasing
experience, this approach can be applied to essentially all
patients who are acceptable risks for general anesthesia.
Primary central defects, such as an umbilical hernia that is
larger than would be appropriate for primary suture repair, are
excellent cases to embark on (Figure 2.1). Multiple prior
abdominal procedures may significantly increase the challenge
of laparoscopic adhesiolysis. In the author’s experience, the
presence of polypropylene mesh from previous open repairs
commonly results in dense adhesions, increasing the risk of
enterotomy. As one’s comfort and confidence with LVHR
matures, these issues can be safely managed. This is also true
for larger and more complex hernias as well as those in more
atypical locations. Incarceration alone is not a contraindication
to proceeding laparoscopically. In many cases, reduction can
be accomplished after the onset of general anesthesia, muscle
relaxation, and abdominal wall distention via pneumoperi-
toneum. Should reduction still not be possible, conversion to a
laparoscopically assisted approach will allow reduction under
direct vision, closure of the limited laparotomy and completion
of the repair laparoscopically, with safety and confidence. The
details of this approach and its other potential applications will
be discussed later.

The presence of ascites in patients with correctable coagulopathy


is not an absolute contraindication to LVHR. The inexperienced
surgeon early in his experience with LVHR should not attempt

Figure 2.1
Figure 2.2

this. The tracts chosen for trocar placement should be of sufficient


obliquity to minimize the risk of post-operative ascitic leak.
Subcutaneous ascites collection, in the area of the hernia sac,
has not been a problem.

Loss of domain has long been recognized as a significant prob-


lem for all surgeons, not to mention the problem of the massive
defect to be repaired. There are many problems to overcome,
but these too have been successfully repaired after attempts
via other techniques have failed or been abandoned.

Finally, parastomal hernias have been problematic for both


patients and their surgeons. Most patients are hesitant to have
their stoma moved (Figure 2.2). The risk of recurrence after
suture repair is high and surgeons are appropriately concerned
about prosthetic contamination in open approaches to repair.
Laparoscopic repair allows distant prosthetic material introduc-
tion and another alternative to the historical options described.

The ultimate limitations of this procedure will be dictated by


the innovation and creativity of those surgeons who move forward
in its applications. Conversely, this procedure will be discarded
if it is not approached with sound judgement, appropriate
patient selection, and recognition of one’s own skill and profi-
ciency in performing LVHR. We must remind ourselves of the
adage “first do no harm” and move forward recognizing our
own individual and unique limitations.

Patient Preparation
After the induction of general endotracheal anesthesia, the
patient is placed in the supine position. If at all possible the

8
arms should be tucked at the patient’s side. Position can be
adjusted as necessary based on the location of the hernia
defect. The abdomen is widely prepped to allow placement of
lateral trocars, typically to the table bilaterally, above the
xyphoid cephalad, and below the pubis onto the upper thighs.
All hair should be clipped to avoid pulling it down when fixa-
tion sutures are tied. Adhesive drapes may be used according
to surgeon’s preference. Even the largest patches can be passed
through a 10 mm trocar, therefore avoiding contact with the skin.

Prophylactic antibiotics are administered within 30 minutes of


the skin incision.

The bladder is decompressed with a foley catheter and the


stomach is decompressed with an orogastric tube. With
increasing experience and depending upon hernia location, the
use of these tubes can be individualized.

Laparoscopic Access
The first challenge in performing LVHR is gaining access to the
free peritoneal cavity. A site distant from any prior incision and
the hernia defect is chosen. Typically this is in the right upper
quadrant (RUQ) or left upper quadrant (LUQ). The absence of
incisions in these locations does not necessarily guarantee the
absence of adhesions to viscera. While many approaches for
access to the peritoneal cavity have been described, including
blind insufflation and specialty trocars, we feel strongly that
open access in the fashion of Hasson is by far the safest alter-
native. Proficiency in this technique must be in the armamen-
tarium of the advanced laparoscopic surgeon. The issue of gas
leak at the Hassson site can be successfully managed with the
use of balloon tipped trocars. If initial attempts to gain access
are unsuccessful, an alternative site can be selected. If access
remains a problem, consideration could be given to a
Laparoscopically Assisted Ventral Hernia Repair, whereby all
adhesions are lysed via a limited laparotomy that is then
closed airtight and the procedure can be completed laparo-
scopically. Trocars can actually be placed with the abdomen
open after the completion of adhesiolysis, and prior to closure.
This will be discussed further, later in this chapter.

9
Trocar placement is critical to the satisfactory progress and
completion of LVHR (Figure 2.3). Use of the 5 mm spiral tacker
for fixation allows the remaining trocars to be 5 mm in size,
with the exception of the initial Hasson trocar. A quality 5 mm
scope is necessary if 5 mm trocars are to be used. There is
disagreement among surgeons as to the benefits of angled
scopes. This is an issue of individual preference and should be
based on the operating surgeon’s experience. We have used a
5 mm, zero degree scope, exclusively. The benefits of angled
scopes may be offset by the potential orientation difficulties
that angled scopes present. There is also a significant decrease
in light transmission with angled scopes. It is necessary to
move between each of the ports depending on which portion of
the procedure is underway. All secondary ports are to be
placed under direct vision, without exception. To do anything
other places the abdominal contents at significant risk of
injury. Perhaps with the exception of very laterally placed
defects, a total of four trocars gives one the maximum flexibility.
This may change with experience, but as one gains this
experience an approach utilizing RUQ/RLQ/LUQ/LLQ ports
should be viewed as standard. This includes the initial Hasson
entry port. Never compromise exposure in order to avoid
placing a trocar. Trocars should be placed as far lateral as
possible to allow one to work easily on the under surface of
the anterior abdominal wall. Further consideration should be
given to the impact the thighs and chest wall may have on the
ability to work superiorly and inferiorly. The four trocar approach
avoids the problems associated with “mirror image” visualization.
With four ports, dissection can always proceed in the direction
of scope visualization.

Figure 2.3

10
Adhesiolysis
After free access to the peritoneal cavity is obtained, the most
challenging part of LVHR begins. This also represents the
greatest risk to the patient. The difficulty of adhesiolysis is
unpredictable, although the presence of polypropylene mesh
should be a red flag indicating the potential for the presence of
dense and difficult to dissect adhesions, often involving the
bowel (Figure 2.4).1

All maneuvers performed as part of the lysis of adhesions must


be done under direct vision. This is best carried out by sharp
dissection (Figure 2.5) utilizing bimanual palpation of the
anterior abdominal wall, placing the adhesions under variable
degrees of tension. There is significant risk in extensive blunt Figure 2.4
dissection, as the bowel may be fixed at several points placing
it at risk for unrecognized perforation with the tip of dissecting
instruments. In spite of the enthusiasm for different energy
sources, these are best avoided. As in open cases, dissection
should be carried out at the avascular junction of the adhesions
and the anterior abdominal wall. Ligating clips or the limited
application of an energy source can be used when significant
bleeding or vessels are encountered. In the majority of cases,
even this is unnecessary. The risk of monopolar cautery is well
known, but there is also risk of thermal injury by direct contact
with ultrasonic or radio frequency dissection instruments. This
is particularly true in the poorly visualized area behind adhesions.

Our approach to adhesiolysis does not need to differ from that


done in open laparotomy with emphasis on traction and counter-
traction, sharp dissection and precise visualization. It is critical
that all adhesions to the anterior abdominal wall be released
to allow adequate patch placement and fixation. All hernia
contents must also be completely reduced. This is aided by Figure 2.5
bimanual palpation. If at any point during this procedure,
including trocar entry and adhesiolysis, there is even a suspicion
of visceral injury, laparoscopy should be immediately aborted
and open laparotomy carried out to directly evaluate all areas
of suspicion. This is also true even in the absence of concern
for injury if it becomes clear that continued attempts at adhesi-
olysis may be non-productive or dangerous. This is not failure
but demonstrates sound surgical judgement. In the absence of

11
visceral injury, lysis of adhesions can be completed via this
limited laparotomy, the abdomen closed and LVHR completed.
Should bowel injury be identified, it should be appropriately
repaired. The placement of a prosthetic would be contraindicated.
Other management options for the treatment of this hernia
should be considered or a planned return to the OR for a
laparoscopic repair could be done in a staged fashion. The
laparoscopic repair of visceral injury is to be discouraged in
these patients who have already sustained a major complication.
Secondary failure of a laparoscopic repair of an enterotomy
may prove to be catastrophic to the patient. This is particularly
true early in one’s experience with this procedure. There have
been reports of mortality related to unrecognized visceral
injury. Failure to prevent this ominous complication may result
in the demise of LVHR, in spite of its clear superiority over
historical alternatives.

Repair Issues
Once adhesiolysis has been completed, the exact extent of the
hernia can be directly evaluated (Figure 2.6). The defects are
carefully drawn onto the skin of the anterior abdominal. In the
case of multiple defects, the area drawn should include all of
the defects. We have progressed to repairing the entire area of
a previous incision as opposed to simply repairing a single
defect. There have been a number of patients who have pre-
sented later in follow-up of LVHR and are discovered to have a
new hernia, outside the area of previous repair. In open sur-
gery these may have simply been considered recurrences. If
there is any difficulty in delineating the margins of the defect,
a spinal needle can be passed perpendicular to the anterior
abdominal wall and through the margins of the defect.

Figure 2.6

12
The size of the defect is measured. The patch size is a mini-
mum of 3 cm larger than the defect in all directions. This is also
drawn onto the skin to facilitate suture placement (Figure 2.7).
Our material of choice is GORE-TEX® DUALMESH® PLUS
Biomaterial (Figure 2.8). It has two distinct surfaces designed
to meet the requirements of intra-peritoneal placement. The
macromesh portion is designed to go against the abdominal
wall to promote early and strong soft tissue ingrowth. The
other surface is designed to prevent tissue attachment to the
material, and is positioned adjacent to the viscera. It is critical Figure 2.7
to orient the patch appropriately. This is facilitated by the col-
oration pattern present secondary to the “antimicrobial
impregnation”. Brown side down-against the viscera. The
rough surface is placed against the abdominal wall.

Figure 2.8

Once the patch size has been determined it is cut to size. Four
sutures (Figure 2.9) are attached to the margins of the patch
and appropriately labeled. Those who use oval shapes generally
use a numbering system to maintain patch orientation. Our
practice, using rectangular patches, uses contrasting color
sutures (Ethibond® Suture & GORE-TEX® Suture) on each end
to allow easy orientation after introduction of the patch into
the peritoneal cavity. GORE-TEX® Suture is hydrophobic and is
easily separated in the moist intra-abdominal environment.

Once the patch has been cut to size and the sutures are
placed, the patch is rolled like a scroll, in its long axis, with the Figure 2.9
sutures inside. There are alternative methods for rolling the
patch, but using this technique we have been able to introduce
the largest patch available through a 10 mm trocar without

13
removing the trocar. Under direct vision, a long 5 mm grasping
forceps is passed from a 5 mm port on the contralateral side
from the 10 mm port, through the 10 mm port in a retrograde
fashion and out of the abdomen. The rolled patch is tightly
compressed and grasped by the forceps and delivered into the
abdominal cavity. Using two graspers the patch is unrolled and
appropriately oriented. Using contrasting colored sutures
makes patch orientation relatively easy. One color is cephalad
and the other is caudad.

With the patch completely unrolled and appropriately oriented,


the next step is to place the initial fixation sutures. A stab
wound with an 11 blade is made at the appropriate position as
dictated by previously drawn repair margins. These are passed
through the abdominal wall using the GORE Suture Passer
Instrument (Figure 2.10) and tied down onto the anterior fas-
cia. This is accomplished by passing the closed GORE Suture
Passer Instrument into the abdominal cavity under direct vision
(Figure 2.11). One suture of a pair is grasped and brought to
the GORE Suture Passer Instrument, which is then opened. The
suture is delivered into the slot, which is closed by pulling up
on the center ring of the GORE Suture Passer Instrument. At a
different angle, the closed needle is reintroduced creating a
fascial bridge over which the suture will be tied. The sutures
are tied securely but care needs to taken that the suture does
Figure 2.10 not strangulate the encircled tissue and bridge. Post-operative
pain may be related to how tight these sutures are tied. In real-
ity, the sutures are better placed approximately 1.5 cm outside
of the margins of the patch drawn on the skin (Figure 2.12).
This is done to offset measuring errors related to the fact that
the peritoneal cavity is a smaller sphere inside a larger sphere
that is the skin of the anterior abdominal wall. This adjustment
will result in better patch tension while the abdomen is insuf-
flated as well as better contours upon completion. If there is

Figure 2.11

Figure 2.12

14
inadequate tension on the patch at completion, the patch may
eventrate into the hernia, resulting in a less than ideal result.

With the initial sutures in place and tied to support the patch,
spiral tacks can then be placed around the margin of the patch
at 1 cm intervals (Figure 2.13a and 2.13b). Bimanual deformity
of the abdominal wall will allow the tacker to fire at a 90-degree
angle as well as obtaining a secure purchase in the abdominal
wall. It is important to continue to spread the patch out at the
margins to obtain proper tension. While the concept of tension Figure 2.13a
in a prosthetic hernia repair goes against all conventional
wisdom, remember that the tension is released once
pneumoperitoneum is released.

Sutures are now placed at 5 cm intervals around the margin of


the repair. Inadequate tack or suture placement has been
associated with relatively early recurrence. This suture placement
is different from the suturing described above. A suture is
loaded in the GORE Suture Passer Instrument. A stab wound is
again made with an 11 blade. The closed GORE Suture Passer
Instrument is passed through the abdominal with its suture
(Figure 2.14). Under direct vision it is passed through the
margin of the patch about 1 cm from the margin. If it is necessary
to change the angle of the GORE Suture Passer Instrument for Figure 2.13b
any reason it must be completely removed and redirected.
Once the suture is delivered, it is grasped and the GORE Suture
Passer Instrument is opened, releasing the suture. This is
facilitated by pulling back slightly on the open GORE Suture
Passer Instrument, which tends to blouse the suture making it
easier to grasp. The GORE Suture Passer Instrument is
removed, left empty, redirected to create a fascial bridge, and
under direct vision is passed just outside the margin of the
patch. The GORE Suture Passer Instrument is then opened
under direct vision and the suture is delivered into the open

Figure 2.14

15
slot. The needle is closed and removed. This suture is then
tied. This is repeated until sutures have been placed at 5 cm
intervals. The skin of the suture stab wounds may be dimpled
after the suture is tied. This is easily remedied by pulling the
skin up with a skin hook or towel clip. These wounds are
closed with steri-strips. The patient should be informed about
the number of wounds that are created. Many times they only
remember mention of the four operative trocar sites and they
wake up with the ultimate “band-aid” operation.

The fascia of the 10 mm trocar is closed under direct vision


with a suture delivered by the GORE Suture Passer Instrument.
Pneumoperitoneum is reduced and the tension of the repair
can be inspected if desired.

Trocars are removed. The fascial suture is tied. The skin of the
trocar sites is repaired according to surgeon preference.

Diet is resumed as clinically indicated and tolerated. There is


significant pain after an operation of this magnitude and needs
to be treated satisfactorily. Discharge is possible when the
patient is able to tolerate a reasonable diet, pain well controlled
on oral analgesics, ambulate independently and able to carry
out their activities of daily living. This group of patients represents
a wide cross section of disease ranging from the simple
umbilical hernia to the multiply recurrent, incarcerated
hernia with prior mesh present.

Post-op management must be individualized. While post-op


pain and hospital length of stay are important parameters in
laparoscopic surgery, with LVHR I feel we have made a significant
improvement over earlier techniques even if they still have
significant post-op pain and their LOS is unchanged compared
to open surgery. The decrease in morbidity and recurrence
rates will offset any of these acute issues.

Laparoscopically Assisted VHR


Lysis of adhesions in the re-operative abdomen may represent
a significant obstacle to the surgeon early in his/her experience

16
with LVHR. This is often the most challenging part of this procedure
and is the source of the major morbidity and mortality.

Conversion to Laparoscopically Assisted VHR can occur at


several points during LVHR. If free access to the peritoneal
cavity cannot be achieved at the onset of the procedure, then a
limited laparotomy can be made to evaluate the status of the
peritoneal cavity. If the hernia can be completely reduced and
the adhesions lysed to allow laparoscopic placement of a patch,
then ports can be placed, a patch introduced through the
laparotomy and the incision closed in an airtight fashion.
Pneumoperitoneum is then established and the repair is com-
pleted laparoscopically, as described earlier. The patient still
receives many of the benefits of LVHR, including a broad based
repair and the lack of significant flaps and dead space. There is
increasing evidence that the long-term risk of recurrence is
substantially reduced by this superior technique. The
laparotomy incision is widely supported and reinforced by
the prosthetic repair.

Laparoscopically Assisted VHR is also a viable alternative to


conversion to open repair when safe adhesiolysis is not possible.
As described above, a limited laparotomy is made. The extent
of this incision can be accurately defined and limited by the
laparoscopic identification of the problem area. Once all adhe-
sions have been safely divided, a careful inspection of the viscera
should be carried out to eliminate any concern about visceral
injury. With this complete, the procedure can be resumed as
described above.

This is an excellent intermediate option to totally abandoning


LVHR in those circumstances where access or adhesiolysis are
problematic. We continue to use it when safe lysis of dense
adhesions cannot be achieved endoscopically, especially in the
presence of polypropylene mesh. With experience, the frequency
of conversion to a Laparoscopically Assisted VHR will decrease.
We feel it is a valuable adjunct to even the most experienced
endoscopic surgeon and his more challenging patients.

Reference
1. Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncan TD, et al. Comparison of laparoscopic
and open ventral herniorrhaphy. American Surgeon 1999;65:827-832

17
18
Complications of Laparoscopic
Ventral/Incisional Hernia Repair
Guy Voeller, MD, FACS

Multiple studies have documented that open ventral hernioplasty


has significant morbidity. Leber reported a 27% long-term
complication rate with open ventral/incisional hernia repair;
among them being infection, hematoma and seroma, chronic
sinus tract formation, mesh extrusion, fistula formation as well
Complications in 407 Patients as soft tissue problems such as non-healing wound.1 White
Who Underwent Laparoscopic
Ventral Hernia Repair reported 34% of 250 open ventral hernia repairs had wound
Complication n %
related complications.2 The complications of the open repair
Prolonged ileus 9 2.21 mainly relate to the type of mesh that is most commonly used
Seroma >6wk 8 1.97 (polypropylene and polyester meshes).1,2 In addition, the wide
Suture site pain >8wk 8 1.97 dissection of soft tissue that is required for a Stoppa type retro
Intestinal injury 5 1.23* rectus repair or a Chevrel type anterior repair leads to the
Cellulitis of trocar site 5 1.23
many wound related problems. One of the major reasons for
Mesh infection 4 0.98
Hematoma or
the evaluation of laparoscopic ventral/incisional hernia repair
post-op bleeding 3 0.74 is the hope that many of the above complications can be limited.
Urinary retention 3 0.74
Fever of unknown origin 3 0.74
Respiratory distress 2 0.49 In a recent study of 407 patients with laparoscopic ventral/
Intraabdominal abscess 1 0.25 incisional hernia repair3, it was reported that 13% of the patients
Trocar site herniation 1 0.25 had complications. As can be seen in Table 3.1, the vast majority
Total 53 13.0
of these complications were minor. The most obvious thing one
*Six patients in our total experience
had enterotomies, but only five are notices when evaluating the complications in Table 3.1 is that
listed here because the other patient
required conversion to an open
the soft tissue and mesh complications so often seen with open
repair and was not included in ventral/incisional hernioplasty are infrequent with the laparo-
the data analysis.
scopic approach (especially if one pays attention to technique).
Figure 3.1

In the study cited there were only four cases of mesh infection.
One of these cases showed no bacterial growth when the mesh
was later removed. The author in his own personal series of
over 200 laparoscopic ventral/incisional hernia repairs has yet
to have a single case of mesh infection. It is important that the
prosthetic be treated just like a vascular prosthetic graft so
that the skin of the abdomen is always covered with an Ioban®
drape which thus prevents the mesh and surgeon’s hands from

19
ever coming in contact with the skin and transferring any bacteria
to the prosthetic. Each patient will develop a fluid collection,
what is commonly called a seroma, between the mesh and the
abdominal wall. Many of these are not apparent to the patient
or the surgeon but some are evident and can be bothersome to
the patient. In Table 3.1, it can be seen that 8 patients (approxi-
mately 2%) had seromas that persisted for 6-10 weeks. No
complications from these seromas were reported in the study.
Most surgeons do not aspirate these fluid collections for fear of
infecting the prosthetic. However, the author has freely aspirated
the seromas if they are large or if they are bothersome to the
patient. The author has never seen an infection of the prosthetic
from aspiration of these fluid collections.

There were 8 patients (approximately 2%) in the study that had


pain localized to one area (presumed a suture site or tack site).
This was described as a very focal burning or sharp pain. All of
these resolved; 6 with required pain medication and 2 with local
anesthetic injection. Since we first started evaluating laparo-
scopic ventral/incisional hernia repairs, we have believed that
suture fixation of the mesh is critical to long-term success and
lower recurrence rates. We were concerned that all of the
sutures used and the tacks used (to prevent internal herniation)
could be problematic with respect to long term postoperative
discomfort. Fortunately, this has not been the case as is
substantiated by Table 3.1.

Probably the most dreaded complication that has been seen


with laparoscopic ventral/incisional hernia repair is bowel
injury. Enterotomy is a well-documented complication during
open ventral/incisional hernioplasty. It commonly occurs and
can be readily visualized and handled through an incision.
Laparoscopy presents a whole new situation with respect to
enterotomy. Prevention is the first line of defense. Lysis of
adhesions is well visualized due to the magnification and high
intensity light source inherent in the laparoscopic technique. It
is very important that energy sources be used very sparingly if
at all during laparoscopic lysis of adhesions. If a surgeon
enters the proper planes, there is very little bleeding and thus

20
low need for energy sources. Inappropriate use of energy
sources is a common cause of unrecognized enterotomy.
Monopolar cautery has the problem of current spread, and it is
very easy to coagulate one area and see the current spread to
the adjacent area instantaneously. For this reason monopolar
cautery should not be used adjacent to the bowel. The ultrasonic
or radio frequency dissection instruments are “sold” with the
supposed advantage that there is minimal thermal spread
unlike monopolar cautery. Although this may be true, the tip
remains very hot and any touching of viscera can cause a burn
that may not be apparent during the operation. It is only after
several hours, either that night or the next day, when the tissue
sloughs, that the enterotomy presents itself. We do not recom-
mend the use of ultrasonic or radio frequency dissection
instruments for laparoscopic ventral/incisional hernia repairs
for this reason. The most important thing to remember is that if
lysis of adhesions involving the intestine is not safe, i.e. the
surgeon can not see well or the surgeon can not determine if
an enterotomy has occurred, the patient should be opened!
Multiple deaths have been reported from laparoscopic ventral/
incisional hernioplasty due to bowel injuries that have not
been perceived during surgery and only become apparent post-
operatively. By the time the diagnosis is made, the patients are
septic and succumb to this complication. Using atraumatic
bowel graspers, minimal use of energy sources and converting
to an open procedure, if any questions of bowel injury exist,
can readily prevent this dreaded complication.

References
1. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair
of incisional hernias. Archives of Surgery 1998;133:378-382.

2. White TJ, Santos MC, Thompson JS. Factors affecting wound complications in repair of ventral hernias.
American Surgeon 1998;64(3):276-280.

3. Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic ventral and incisional hernia repair in 407
patients. Journal of the American College of Surgeons 2000;190(6):645-650.

21
22
Prosthetic Biomaterials in Laparoscopic
Incisional and Ventral Herniorrhaphy
Karl LeBlanc, MBA, MD, FACS

Introduction
The use of prosthetic biomaterials in the repair of defects of
the abdominal wall has gained significant popularity over the
last two decades. The prime indication for these products was
in the repair of inguinal hernias by the “tension free” technique
championed by Lichtenstein.1 The success of this method of
repair led others to employ the tension free concept with the
original polypropylene and other prosthetic biomaterials that
have been developed for the same purpose.

The use of a biomaterial in the repair of incisional and ventral


hernias has gained in popularity because of the unacceptably
high rate of recurrence after primary repair of up to 50% or
more.2,3 The use of these materials has resulted in a decrease
in the rate of recurrence but the open technique has continued
to have a failure rate of 11-21% despite the use of the prosthe-
ses.2,4,5 The laparoscopic repair of incisional and ventral hernias
Indications for Implantation was introduced in 1983 using the GORE-TEX® Soft Tissue Patch
of a Prosthetic Biomaterial made by W. L. Gore and Associates, Inc. (Flagstaff, AZ).6 Since
Replacement of lost that time, other materials have been developed in an effort to
musculofascial tissue approach the characteristics of the “ideal prosthesis”. This
caused by: chapter will identify these goals and the properties of the vari-
Trauma
ous biomaterials that are currently available to repair incisional
• Internal
• External
and ventral hernias. The rationale for the choice of a prosthesis
Infection will be developed.

Reinforcement of
native tissue weakness Indications for Use of
Aging (laxity of tissues) Prosthetic Biomaterials
Neurological deficit
(denervation)
The main purpose of the use of these materials is the repair of
Figure 4.1 a defect in the abdominal wall. The etiology of these defects

23
Ideal Clinical Characteristics
can vary. The specific indications of use of the materials are
of Synthetic Biomaterials listed in Figure 4.1.
Permanent repair of the
abdominal wall
Musculofascial tissue can be lost in a variety of ways. The most
(i.e. no recurrences)
common, of course, would be due to the increase of intra-
Ingrowth characteristics that
abdominal pressure that results in a weakening of the
result in a normal pattern of
abdominal wall musculature. The overweight patient (that is so
tissue repair and healing
prevalent in the United States) is a significant example of this
Easily assumes the conformity
basis of herniation. Other problems such as emphysema or the
of the abdominal wall
musculature anatomy
chronic bronchitis of smokers results in a constant increase in
intra-abdominal pressure. External factors would include gunshot
Lack of adhesion predisposition
wounds and motor vehicle accidents. More commonly, however,
Cuts easily and without fraying is the inherent weakness that develops after an incision in the
Figure 4.2 abdominal wall such as in laparoscopy or laparotomy.

Life threatening infections and gangrene will produce large


areas of tissue necrosis and resultant tissue loss. More frequently,
Polypropylene Biomaterials
and Manufacturer the development of a postoperative wound infection will
increase the risk of herniation by as much a five times.7,8,9
Atrium Mesh, Atrium Medical
Corporation, Hudson, NH

Bard® Marlex® Mesh, C.R. Bard, The effects of aging and the declining ability of the elderly
Murray Hill, NJ patients to repair the native tissues will lead to the loss of
Prolene Mesh, Ethicon, fascial strength. This is commonly seen with the direct inguinal
Somerville, NJ
hernia. It also occurs with the enlargement of the linea alba
Parietex Composite Biomaterial, that is referred to as a diastasis recti. These defects can
Sofradim International,
enlarge and become symptomatic requiring repair.
Villfranche-sur-Saône, France

Surgipro Mesh, United States


Surgical Corporation, Norwalk, CT The most common defect that results from a denervation phe-
Trelex Mesh, Meadox Medical nomenon follows the flank incision that is utilized in a nephrec-
Corporation, Oakland, NJ tomy. A similar defect can eventuate from the incision that is
Figure 4.3 used for a lumbar sympathectomy or an anterior approach to the
lumbar interbody fusion for degenerative disk disease. In these
entities, there is usually not a defined fascial edge that is seen
with the more common anterior abdominal wall defects. This is
due to the broad surface of the denervated musculature that
has intact fascia but lacks the reinforcement of the muscle tissue.

Prosthetic Biomaterials in Herniorrhaphy


The prosthetic biomaterials that are used in the repair of
inguinal hernias can be used in the repair of other types of
hernias, as well. The significant considerations with the use
Figure 4.4a

24
within the abdominal cavity involve the very real possibility of
the development of adhesions, bowel attachment and fistulization.
Additionally, other concerns are apparent when the hernia
repair moves from the groin to the anterior abdominal wall. In
that instance, the “ideal” surgical biomaterial would represent
the characteristics listed in Figure 4.2.

The synthetic biomaterials are of many types, sizes and shapes.


The use of these is widespread in the repair of inguinal hernias. Figure 4.4b
The current use of the prosthesis as a tension-free repair of
incisional hernias has gained widespread acceptance within
the last several years. Approximately 90% of incisional and
ventral hernias in the United States are repaired with the use
Frequency of Adhesion Formation*
of some type of prosthetic biomaterial. Outside of the United
60
States, however, the repair of these hernias is frequently per-
50
formed without their use; cost being the limiting factor.
40
30

The currently available products in use today are polypropy- 20

lene (PPM), polyester, or expanded polytetrafluoroethylene. 10


0
The many PPM biomaterials that are popular in the surgical 1 2 3 4 5 6 7
1. ePTFE GORE-TEX® Soft Tissue Patch (12.1%)
repair of the incisional hernia are listed in Figure 4.3. 2. ePTFE MYCROMESH® Biomaterial (11.3%)
3. ePTFE DUALMESH® Biomaterial (0.0%)
4. Knitted Polypropylene Mesh (58.6%)
5. Knitted Interlocked
Laboratory studies involving both rabbit and porcine models Polyester Fiber Mesh (44.8%)
6. Knitted Multifilament Yarns
have demonstrated the differences in the adhesive potential in of Polypropylene Mesh (24.1%)
these different products (Figures 4.4a and 4.4b).10,11,13 In these 7. Knitted Interlocked
Polypropylene Mesh (57.1%)
experiments the amount of adhesions and the difficulty that
was encountered in the dissection of them off of the biomaterial Figure 4.5a
at 30 and 90 days after implantation were evaluated. The
percentage of the prosthetic material that was covered by
adhesions was noted and is shown in Figure 4.5a. The tenacity
of the adhesions is shown in Figure 4.5b. The data from these Adhesion Tenacity* (max=3)
graphs were analyzed to produce an “adhesion score”. The ePTFE Polypropylene

scores ranged from 1-7 (7 being the worst possible score). 2.5
The extent of the prosthesis covered by adhesions was given a 2
number from 1-4 based on increasing 25% points of coverage. 1.5
The tenacity was graded from 1-3 based upon adhesions that 1

were easily pulled off, bluntly dissected off or cut off with scis- 0.5

sor dissection. It is apparent that the stiffer the biomaterial 0


7d 15d 90
and the larger the pore sizes, there is a corresponding increase n 7d n 15d n 90d
Polypropylene 6
in the amount of adhesions seen as well as an increasing diffi- ePTFE 6
1.66
0.3
7
7
2.3
1
39
39
1.2
0.2
culty in the removal of them from the prosthesis. The greatest
Figure 4.5b
extremes are noted between MARLEX® Mesh and GORE-TEX®
* Data on file.

25
DUALMESH® Biomaterial. To overcome the problems with adhe-
sions to the omentum and bowel as well as the risk of fistuliza-
tion, the use of PPM within the abdominal cavity is to be avoided.

Biomaterials for Laparoscopic


Incisional and Ventral Herniorrhaphy
The products currently available for laparoscopic incisional and
ventral herniorrhaphy are modifications of older materials, a
composite of these materials, or new modifications. In general,
all of these prosthetic devices can and have been used in both
open and laparoscopic incisional herniorrhaphies. Only a few
Figure 4.6
of these products have any long-term follow-up data to support
the goal of a diminution of adhesion risk while providing for
effective tissue incorporation.

Two composite materials incorporate polypropylene with an


anti-adhesive material. The first of these to be introduced was
BARD® COMPOSIX® Mesh (Figure 4.6). This material uses
polypropylene with a very thin layer of ePTFE. In the author’s
experience, this biomaterial is as stiff as two layers of
polypropylene rather than one flat mesh (Figure 4.7). The
ePTFE layer is easily punctured and can separate from the PPM
during the surgical manipulation for its implantation.
Additionally, it is nearly impossible to roll this product into a
sufficiently small size to permit its easy introduction into the
Figure 4.7 abdominal cavity via a 10 mm trocar site which eliminates the
possibility of introduction through a 5 mm (Figure 4.8). There is
very limited reported clinical data regarding the long-term use
and benefits of this biomaterial.

SEPRAMESH Composite is the newest of these composite pros-


thetic synthetic materials (Figure 4.9). A single layer of polypropy-
lene is covered by the previously released SEPRAFILM® which is
marketed as an anti-adhesive biomaterial. The “barrier” is a
combination of sodium hyaluronate and carboxymethylcellu-
lose foam. This portion of the product is stated to last 7-14
days, at which point, it has been resorbed. The package insert

Figure 4.8

Figure 4.9

26
supplied with the product states that “it is still recommended
to pull down omentum whenever possible…to mitigate the risk
of visceral adhesion”. There are only reports regarding the
SEPRAFILM® product in use in the experimental animal. Clinical
trials and long-term studies are ongoing. In my experience with
this product in the laboratory, I have found it impossible to
maintain complete coverage of the PPM by the barrier foam
because it is easily dislodged during manipulation outside and
inside the abdominal cavity (Figure 4.10).

PARIETEX® Composite biomaterial is manufactured in France


and is not currently available in the United States. This pros-
Figure 4.10
thesis is a three-dimensionally woven polyester that has
resorbable hydrophilic collagen within the interstices of the
product. As with the SEPRAFILM® product, the absorbable por-
tion of the product is designed to prevent the development of
intra-abdominal adhesions when placed over the bowel. There
is only limited clinical data available on this product.

The only prosthetic biomaterial that has any long-term usage


within the abdominal cavity is that of ePTFE. In our early
report,3 we used the GORE-TEX® Soft Tissue Patch (Figure
4.11), as it was the only ePTFE material available. We contin-
ued to use this biomaterial until the GORE-TEX® DUALMESH®
Biomaterial (Figure 4.12) became available in 1994. Our
experience with both of these products has been accepted for
publication.12 This paper reports the results of our initial 100 Figure 4.11
patients in which we attempted the laparoscopic method of
incisional and ventral hernia repair. The average follow-up
interval was 51 months. In no case, was there any sequelae
related to the use of either prosthetic biomaterial (i.e. GORE-TEX®
Soft Tissue Patch or DUALMESH® Biomaterial). Subsequent to
that review, these patients continue to do well.

The GORE-TEX® Soft Tissue Patch is a one-millimeter thick


sheet of ePTFE. The interstices of the product are 17-22
microns, which allows the penetration of fibroblasts and the
deposition of collagen into the structure of the product

Figure 4.12

27
(Figure 4.13). This provides for a favorable degree of ingrowth.
However, many surgeons have felt that this amount of ingrowth
is inadequate to provide for a reliable repair of a hernia. In our
experience, however, this has not resulted in any adverse clini-
cal event. In fact, the characteristics of ingrowth present favor-
able attributes.

In an effort to design a prosthesis that more nearly approaches


the ideal, the original DUALMESH® Biomaterial was developed.
GORE-TEX® Soft Tissue Patch This is a two-layered biomaterial that is composed entirely of
250x 100µ ePTFE. One surface has 3 micron interstices (the visceral sur-
face) while the opposite side has 22 micron interstices (the
Figure 4.13
parietal surface). The decrease in the size of the interstices
duplicates the inhibition of tissue penetration that is character-
istic of the Gore PRECLUDE® Membranes. The experience that I
have had with laparoscopic operations that followed the
implant of this biomaterial has shown good results. One can
appreciate the ingrowth of vascularity over the implant surface.
In other procedures, it has been noted that few adhesions can
be seen that involve the periphery of the biomaterial (Figure
4.14). This represents the points of fixation to the abdominal
wall and is predictable. Occasionally, one will see a moderate
amount of adhesions to the patch itself. In the majority of
cases in which this is seen, they have been easily separable from
the biomaterial.

Figure 4.14 The DUALMESH® Biomaterial is also available with the addition
of antimicrobial agents (DUALMESH® PLUS Biomaterial). The
incorporation of silver and chlorhexidine adds a unique dimension
to the use of any prosthetic biomaterial. While the verification
of the effectiveness of the addition of these agents in the
diminution of infectious complications in hernia repair may be
difficult, the use of these agents in the clinical setting has been
shown to be safe in a multicenter trial.14

The addition of the silver has added a very beneficial side


effect to the product because the silver imparts a brown coloration
to the visceral surface of the biomaterial. When the biomaterial
is placed into the abdominal cavity, this color significantly
reduces the laparoscopic glare that is apparent on the surface
of all other ePTFE prostheses. This is a great aid in the use of
this biomaterial.14

28
The DUALMESH® PLUS Biomaterial has been further modified
to add perforations to the material. This represents an effort to
satisfy those surgeons who prefer a prosthetic material that
has larger interstices which will allow fibroblastic penetration
through these pores. The addition of these perforations, how-
ever, results in a material that is thicker than the nonperforated
product (1.5 mm vs. 1.0 mm). This size difference is not partic-
ularly significant except that in the laparoscopic technique, the
additional bulk makes its use more cumbersome.
Textured Surface
GORE-TEX® DUALMESH® Biomaterial
The most exciting development in the use of a biomaterial for 100x 100µ
laparoscopic incisional herniorrhaphy has been the develop-
Figure 4.15a
ment of the newest DUALMESH® product, with CORDUROY
Surface. This material has the same visceral surface texture as
the original prosthesis (3 microns). The parietal surface, however,
is considerably different from the original. With the scanning
electron microscopic view, the differences are quite striking
(Figures 4.15a and 4.15b). This reconfiguration enhances the
levels of tissue penetration into the parietal interface.
Additionally, the handling characteristics within the patient
seem to be improved as well. I have implanted this product,
along with polypropylene within the rabbit model to verify the
increased level of tissue penetration. At 3 days post-implant
the DUALMESH® Biomaterial with CORDUROY Surface has a
GORE-TEX® DUALMESH® Biomaterial
higher abdominal wall attachment strength than polypropylene.
with CORDUROY Surface
The results of this animal study were statistically significant.* 100x 100µ
The original DUALMESH® Biomaterial did not differ from
Figure 4.15b
polypropylene on a statistically significant level. These are
both quite important findings. This result instills confidence
in the use of these biomaterials in the repair of incisional
(and other) hernias.

The new DUALMESH® Biomaterial can be obtained with and


without the impregnation of silver and chlorhexidine
(DUALMESH® PLUS Biomaterial). As with the older prostheses,
the brown color of the visceral surface is very beneficial. I have
used this product in both the standard and antimicrobial prod-
ucts since it was released for clinical use. These prosthetic
biomaterials represent a truly significant advance for the
laparoscopic surgeon.

* Data on file.

29
The safety of all of the ePTFE biomaterials is well known.
There has never been a reported instance of fistulization, etc.
as has been seen with the polypropylene biomaterials. There is
no risk of immunologic rejection. It is also well known that
these materials do not perform well in the face of an infection.
In most instances, the development of an infection will require
the removal of the prosthesis in 80% of patients. Also, the
ePTFE biomaterials will not allow the development of granula-
tion tissue on their surface (although there is anecdotal evidence
to the contrary). If the skin overlying the biomaterial becomes
necrotic and results in exposure of the patch, special efforts
are necessary to thwart the need for excision of the implant.
Fortunately, the occurrence of these problems is very rare.

Summary
The use of a prosthetic biomaterial for the repair of an incisional
or ventral hernia by the laparoscopic method is mandatory.
There are relatively few prosthetic materials that are suitable
for this application. While the “ideal” product may not be yet
available, the new GORE-TEX® DUALMESH® PLUS product
comes as close to that goal as currently feasible.

30
References
1. Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The tension-free hernioplasty. American Journal
of Surgery 1989;157(2):188-193.

2. Hesselink VJ, Luijendijk RW, de Wilt JHW, Heide R, Jeekel J. An evaluation of risk factors in incisional
hernia recurrence. Surgery, Gynecology & Obstetrics 1993;176:228-234.

3. van der Linden FT, van Vroonhoven TJ. Long-term results after surgical correction of incisional hernia.
Netherlands Journal of Surgery 1988;40(5):127-129.

4. Stoppa RE. The treatment of complicated groin and incisional hernias. World Journal of Surgery
1989;13(5):545-554.

5. Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncan TD, et al. Comparison of laparoscop-
ic and open ventral herniorrhaphy. American Surgeon 1999;65:827-832.

6. LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded polyte-
trafluoroethylene: preliminary findings. Surgery, Laparoscopy & Endoscopy 1993;3(1):39-41.

7. Santora TA, Roslyn JJ. Incisional hernia. Surgical Clinics of North America 1993;73(3):557-570.

8. Bucknall TE, Cox PJ, Ellis H. Burst abdomen and incisional hernia: a prospective study of 1129 major
laparotomies. British Medical Journal – Clinical Research Edition 1982;284(6320):931-933.

9. Fischer JD, Turner FW. Abdominal incisional hernias: a ten-year review. Canadian Journal of Surgery
1974; 17(4):202-204

10. Hooker GD, Taylor BM, Driman DK. Prevention of adhesion formation with use of sodium hyaluronate-
based bioresorbable membrane in a rat model of ventral hernia repair with polypropylene mesh--a
randomized, controlled study. Surgery 1999;125(2):211-216.

11. Dinsmore RC, Calton Jr. WC. Prevention of adhesions to polypropylene mesh in a rabbit model.
American Journal of Surgery 1999;65(4):383-387.

12. LeBlanc, KA, Booth WV, Whitaker JM, Bellanger DE. Laparoscopic incisional and ventral herniorrhaphy
in 100 patients. American Journal of Surgery: in press.

13. LeBlanc KA, Booth WV, Whitaker JM, Baker D. In vivo study of meshes implanted over the inguinal
ring and external iliac vessels in uncastrated pigs. Surgical Endoscopy 1998;12(3):247-251.

14. DeBord JR, Bauer JJ, Grischkan DM, LeBlanc KA, Smoot Jr. RT, Voeller GR, Weiland LH. Short-term
study on the safety of antimicrobial-agent-impregnated ePTFE patches for hernia repair. Hernia
1999;3:389-393.

31
CONTRAINDICATIONS: Patients with hypersensitivity to chlorhexidine or silver; reconstruction of cardio-
vascular defects; reconstruction of central nervous system or peripheral nervous system defects; pre-term
and neonatal populations. WARNINGS: Use with caution in patients with methemoglobinopathy or related dis-
orders. When used as a temporary external bridging device, use measures to avoid contamination; the
entire device should be removed as early as clinically feasible, not to exceed 45 days after placement.
When unintentional exposure occurs, treat to avoid contamination or device removal may be necessary.
Improper positioning of the smooth non-textured surface adjacent to fascial or subcutaneous tissue will
result in minimal tissue attachment. POSSIBLE ADVERSE REACTIONS: Contamination, infection, inflamma-
tion, adhesion, fistula formation, seroma formation, hematoma and recurrence.
W. L. Gore & Associates, Inc.
Flagstaff, AZ 86004
www.goremedical.com

Australia: +61 / 2-9453-0300


Benelux: +31 / 73-687-24-46
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GORE, GORE-TEX®, CORDUROY, DUALMESH®, DUALMESH® PLUS, PRECLUDE®


and designs are trademarks of W. L. Gore & Associates.
All other trademarks are the property of their respective owners.
© 2000, 2001 W. L. Gore & Associates, Inc.
AD0683-EN2 JUNE 2001

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