In Laparoscopic
Complications of Laparoscopic
Ventral/Incisional Hernia Repair 19
"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.
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.
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.
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 1.6
4
removal of the stainless steel mesh secondary to tremendous
tissue ingrowth.
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
Figure 2.1
Figure 2.2
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.
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
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.
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.
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.
Trocars are removed. The fascial suture is tied. The skin of the
trocar sites is repaired according to surgeon preference.
16
with LVHR. This is often the most challenging part of this procedure
and is the source of the major morbidity and mortality.
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
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.
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.
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.
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
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.
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
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.
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).
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.
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
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.
* 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