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 continuesto be a surgical challenge. Reports published in themedical literature indicate 3 to 13%1 of laparotomypatients develop incisional hernias. Moreover,clinical studies indicate that the traditional, oropen, technique to repair large abdominal walldefects is associated with recurrence rates rangingfrom 25-49%.2,3,4

In 1992, a successful series of laparoscopic incisionalhernia repairs was reported in the medical literature.5

Since then, the technique has been refined and hasgrown in acceptance within the surgical community.Advocates of this approach cite a shorter hospitalstay and lower recurrence rates as key outcomes.This year, a multi-center study of 407 patientsreported a 3.4% recurrence rate at 23 months.Complications associated with the procedure havealso been cited to be lower than those reported withtraditional repairs.

The contributing authors of this text have a combinedexperience of several hundred laparoscopic incisionalhernia repairs. W.L. Gore & Associates, Inc., ishonored to provide this compendium of informationon an innovative and apparently effective laparoscopicsurgical technique for abdominal wall defects.

W.L. Gore & AssociatesOctober, 2000

References1. 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, FACSCarolinas Medical Center

Charlotte, NC

Roy Smoot, Jr., MD, FACSNanticoke Surgical Associates

Seaford, DE

Guy Voeller, MD, FACSAssociate Professor of Surgery and Anesthesiology

at the University of Tennessee

Memphis, TN

Karl LeBlanc, MBA, MD, FACSSurgical Specialty Group, Inc.

Baton Rouge, LA

Contents

Abdominal Wall Incisional Hernias – Etiology and Historical Perspective 1

Laparoscopic Hernia Repair 7

Complications of LaparoscopicVentral/Incisional Hernia Repair 19

Prosthetic Biomaterials in LaparoscopicIncisional and Ventral Herniorrhaphy 23

Despite the implication of Moynihan’s statement, the technical

aspects of abdominal wall closure may be excellent, but ventral

hernias may occur. Incisional hernias are quite common (5% to

10% of celiotomy incisions) and occur generally within the first

2-3 years of abdominal exploration. Occasionally abdominal

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

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

Abdominal Wall Incisional Hernias-Etiology and Historical Perspective

Figure 1.1

1

"Never judge the surgeon

until you have seen him

(or her) close the wound."

Lord Moynihan

Frederick Greene, MD, FACS

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 1.2

Figure 1.3

3

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

4

Figure 1.4

Figure 1.5a and 1.5b

Figure 1.6

GORE-TEX®

Soft Tissue Patch

GORE-TEX® DUALMESH®

Biomaterial

GORE-TEX® DUALMESH® PLUSBiomaterial

GORE-TEX®

DUALMESH® Biomaterialwith CORDUROY Surface

GORE-TEX®

DUALMESH® PLUS Biomaterialwith CORDUROY Surface

Textured Surface

100x 100µSmooth Surface

100x 100µ

5

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 3microns 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.

6

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

Laparoscopic Hernia RepairPatient Selection

Roy T. Smoot, Jr., MD, FACS, Stephen D. Carey MD,

Samuel K. Miller MD, Francisco J. Rodriguez MD

8

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

Figure 2.2

9

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.

10

Figure 2.3

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.

11

Figure 2.4

Figure 2.5

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

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

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

Adhesiolysis

12

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.

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.

Repair Issues

Figure 2.6

13

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

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.

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

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

Figure 2.7

Figure 2.9

Figure 2.8

14

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

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 2.12

Figure 2.10

Figure 2.11

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

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

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 2.13a

Figure 2.14

Figure 2.13b

15

16

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.

Lysis of adhesions in the re-operative abdomen may represent

a significant obstacle to the surgeon early in his/her experience

Laparoscopically Assisted VHR

17

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.

Reference1. 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

18

Complication n %

Prolonged ileus 9 2.21

Seroma >6wk 8 1.97

Suture site pain >8wk 8 1.97

Intestinal injury 5 1.23*

Cellulitis of trocar site 5 1.23

Mesh infection 4 0.98

Hematoma orpost-op bleeding 3 0.74

Urinary retention 3 0.74

Fever of unknown origin 3 0.74

Respiratory distress 2 0.49

Intraabdominal abscess 1 0.25

Trocar site herniation 1 0.25

Total 53 13.0

*Six patients in our total experiencehad enterotomies, but only five arelisted here because the other patientrequired conversion to an openrepair and was not included inthe data analysis.

Complications in 407 Patients

Who Underwent Laparoscopic

Ventral Hernia Repair

19

Complications of LaparoscopicVentral/Incisional Hernia Repair

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

as soft tissue problems such as non-healing wound.1 White

reported 34% of 250 open ventral hernia repairs had wound

related complications.2 The complications of the open repair

mainly relate to the type of mesh that is most commonly used

(polypropylene and polyester meshes).1,2 In addition, the wide

dissection of soft tissue that is required for a Stoppa type retro

rectus repair or a Chevrel type anterior repair leads to the

many wound related problems. One of the major reasons for

the evaluation of laparoscopic ventral/incisional hernia repair

is the hope that many of the above complications can be limited.

In a recent study of 407 patients with laparoscopic ventral/

incisional hernia repair3, it was reported that 13% of the patients

had complications. As can be seen in Table 3.1, the vast majority

of these complications were minor. The most obvious thing one

notices when evaluating the complications in Table 3.1 is that

the soft tissue and mesh complications so often seen with open

ventral/incisional hernioplasty are infrequent with the laparo-

scopic approach (especially if one pays attention to technique).

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

Guy Voeller, MD, FACS

Figure 3.1

20

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

21

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.

References1. 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.

22

Reinforcement of

native tissue weakness

Aging (laxity of tissues)

Neurological deficit

(denervation)

Replacement of lost

musculofascial tissue

caused by:

Trauma

• Internal

• External

Infection

Indications for Implantation

of a Prosthetic Biomaterial

23

Prosthetic Biomaterials in LaparoscopicIncisional and Ventral Herniorrhaphy

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

was introduced in 1983 using the GORE-TEX® Soft Tissue Patch

made by W. L. Gore and Associates, Inc. (Flagstaff, AZ).6 Since

that time, other materials have been developed in an effort to

approach the characteristics of the “ideal prosthesis”. This

chapter will identify these goals and the properties of the vari-

ous biomaterials that are currently available to repair incisional

and ventral hernias. The rationale for the choice of a prosthesis

will be developed.

Indications for Use ofProsthetic Biomaterials

The main purpose of the use of these materials is the repair of

a defect in the abdominal wall. The etiology of these defects

Karl LeBlanc, MBA, MD, FACS

Figure 4.1

24

can vary. The specific indications of use of the materials are

listed in Figure 4.1.

Musculofascial tissue can be lost in a variety of ways. The most

common, of course, would be due to the increase of intra-

abdominal pressure that results in a weakening of the

abdominal wall musculature. The overweight patient (that is so

prevalent in the United States) is a significant example of this

basis of herniation. Other problems such as emphysema or the

chronic bronchitis of smokers results in a constant increase in

intra-abdominal pressure. External factors would include gunshot

wounds and motor vehicle accidents. More commonly, however,

is the inherent weakness that develops after an incision in the

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,

the development of a postoperative wound infection will

increase the risk of herniation by as much a five times.7,8,9

The effects of aging and the declining ability of the elderly

patients to repair the native tissues will lead to the loss of

fascial strength. This is commonly seen with the direct inguinal

hernia. It also occurs with the enlargement of the linea alba

that is referred to as a diastasis recti. These defects can

enlarge and become symptomatic requiring repair.

The most common defect that results from a denervation phe-

nomenon follows the flank incision that is utilized in a nephrec-

tomy. A similar defect can eventuate from the incision that is

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

Cuts easily and without fraying

Ideal Clinical Characteristics

of Synthetic Biomaterials

Permanent repair of the

abdominal wall

(i.e. no recurrences)

Ingrowth characteristics that

result in a normal pattern of

tissue repair and healing

Easily assumes the conformity

of the abdominal wall

musculature anatomy

Lack of adhesion predisposition

Atrium Mesh, Atrium Medical

Corporation, Hudson, NH

Polypropylene Biomaterials

and Manufacturer

Trelex Mesh, Meadox Medical

Corporation, Oakland, NJ

Bard® Marlex® Mesh, C.R. Bard,

Murray Hill, NJ

Prolene Mesh, Ethicon,

Somerville, NJ

Parietex Composite Biomaterial,Sofradim International,

Villfranche-sur-Saône, France

Surgipro Mesh, United States

Surgical Corporation, Norwalk, CT

Figure 4.4a

Figure 4.2

Figure 4.3

2.5

2

1.5

1

0.5

07d 15d 90

Adhesion Tenacity* (max=3)

ePTFE Polypropylene

n 7d n 15d n 90d

Polypropylene 6 1.66 7 2.3 39 1.2ePTFE 6 0.3 7 1 39 0.2

60

50

40

30

20

10

01 2 6 753 4

Frequency of Adhesion Formation*

1. ePTFE GORE-TEX® Soft Tissue Patch (12.1%)

2. ePTFE MYCROMESH® Biomaterial (11.3%)

3. ePTFE DUALMESH® Biomaterial (0.0%)

4. Knitted Polypropylene Mesh (58.6%)

5. Knitted Interlocked

Polyester Fiber Mesh (44.8%)

6. Knitted Multifilament Yarns

of Polypropylene Mesh (24.1%)

7. Knitted Interlocked

Polypropylene Mesh (57.1%)

25

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.

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

of some type of prosthetic biomaterial. Outside of the United

States, however, the repair of these hernias is frequently per-

formed without their use; cost being the limiting factor.

The currently available products in use today are polypropy-

lene (PPM), polyester, or expanded polytetrafluoroethylene.

The many PPM biomaterials that are popular in the surgical

repair of the incisional hernia are listed in Figure 4.3.

Laboratory studies involving both rabbit and porcine models

have demonstrated the differences in the adhesive potential in

these different products (Figures 4.4a and 4.4b).10,11,13 In these

experiments the amount of adhesions and the difficulty that

was encountered in the dissection of them off of the biomaterial

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

graphs were analyzed to produce an “adhesion score”. The

scores ranged from 1-7 (7 being the worst possible score).

The extent of the prosthesis covered by adhesions was given a

number from 1-4 based on increasing 25% points of coverage.

The tenacity was graded from 1-3 based upon adhesions that

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

sor dissection. It is apparent that the stiffer the biomaterial

and the larger the pore sizes, there is a corresponding increase

in the amount of adhesions seen as well as an increasing diffi-

culty in the removal of them from the prosthesis. The greatest

extremes are noted between MARLEX® Mesh and GORE-TEX®

Figure 4.4b

Figure 4.5b

Figure 4.5a

* Data on file.

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 LaparoscopicIncisional 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

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

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 7-14days, at which point, it has been resorbed. The package insert

Figure 4.6

Figure 4.7

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-

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 100patients 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 17-22microns, which allows the penetration of fibroblasts and the

deposition of collagen into the structure of the product

Figure 4.10

Figure 4.11

Figure 4.12

27

28

(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.

This is a two-layered biomaterial that is composed entirely of

ePTFE. One surface has 3 micron interstices (the visceral sur-

face) while the opposite side has 22 micron interstices (the

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.

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

Figure 4.13

Figure 4.14

GORE-TEX® Soft Tissue Patch

250x 100µ

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.

The most exciting development in the use of a biomaterial for

laparoscopic incisional herniorrhaphy has been the develop-

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

higher abdominal wall attachment strength than polypropylene.

The results of this animal study were statistically significant.*

The original DUALMESH® Biomaterial did not differ from

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.

Figure 4.15a

Figure 4.15b

* Data on file.

29

Textured Surface

GORE-TEX® DUALMESH® Biomaterial

100x 100µ

GORE-TEX® DUALMESH® Biomaterial

with CORDUROY Surface

100x 100µ

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

References1. 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.

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

Australia: +61 / 2-9453-0300Benelux: +31 / 73-687-24-46

: +86 / 21-6485-4990Deutschland: +49 / 89-46-12-0España: +34 / 93-480-6900France: +33 / 1-60-79-60-79

: +852 / 2622-9622: +91 / 22-8217166

Italia: +39 / 045-6209-333: +81 / 3-3327-0011: +82 / 2-393-3411

New Zealand: +64 / 9-415-8334Österreich: +43 / 662-629-551Singapore: +65 / 275-4673Sverige: +46 / 31-706-78-00

: +886 / 2-87717799United Kingdom: +44 / 1506-460123United States: 800 / 437-8181

520 / 779-2771

W. L. Gore & Associates, Inc.

Flagstaff, AZ 86004

www.goremedical.com