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CAPA’s 29th Annual Conference

Palm Springs, CA

ADVANCES IN HERNIA SURGERY
Sponsored by

Kenneth Sim, M.D.

Anatomy and Pathophysiology
Agenda of the Groin
z Anatomy and Pathophysiology
z Approach to Herniorrhaphy
z Overview of the PROLENE*
(Polypropylene) Prolene Hernia System (PHS)
z Summary of PHS features and benefits
z Surgical Cases
z Questions and Answers

*Trademark

“The anatomy of the inguinal
region is misunderstood by
surgeons of all levels of seniority.”

Robert E. Condon, M.D.
Inguinal Anatomy Inguinal Anatomy

Hessert’s Triangle Pathogenesis of direct hernia
Normal Abnormal

Cadavers without Patients who had
hernia= 3 cm sq. hernia repair= 9cm sq.

Question A groin hernia is a pathologic hole
Is a groin hernia simply a hole in in the transversalis
the abdominal wall? fascia that comes through the
anatomic hole
Answer
Inguinal and femoral hernias are Myopectineal Orifice
pathologic holes within a larger of the pelvis.
anatomic hole
Henri Fruchaud
1894-1960
z French anatomist
and surgeon
z Described the
Myopectineal Orifice
z Mentor to Stoppa
and Rives

Myopectineal Orifice Myopectineal Orifice: Triple Triangles
of the Groin
z Boundaries z Femoral
z Two Panes z Medial
z Protected by -
z Lateral
z Perforated by -
Myopectineal Orifice: Triple Triangles
of the Groin
Approach to Herniorraphy:
Lateral triangle Goals of repair
boundaries
Minimal operative and post-operative discomfort
• Inguinal ligament z

z Effective repair
• Deep epigastrics z Lowest possible recurrence rate
• Line between 1+2 z Rapid return to normal activities
z Cost effective
z Ideally, one approach to most hernias (“KISS”
principle)

Approach to Herniorraphy:
Current Inguinal Hernia Repair Approach to Herniorraphy:
Techniques
Current Repair Techniques
z 94 % Tension-free Mesh repairs:
– 41 % “Flat” Mesh z Tension Repairs
– 41 % “Device” (13 % overall) – High recurrence rate
– 18 % Laparoscopic – Patient discomfort
z 6 % Tension repairs – Other potential complications
– Bassini and Cooper’s ligament primarily

Source: Ethicon internal sources

Approach to Herniorraphy: Approach to Herniorraphy:

Tension-free Hernia Repair : Mesh Prosthesis Tension-free Hernia Repair : Mesh Prosthesis

Ideal mesh characteristics Mesh characteristics

z Porous – tissue ingrowth z Metallic meshes - fragmentation problems
z Reactive – stimulate fibroblast ingrowth z Polyethylene mesh – sterilization problems
z Inert – minimize foreign body reaction, z PTFE – low porosity, minimal tissue ingrowth
allergic reaction, infection
z Polypropylene – most widely accepted as the
z Strength – to prevent early recurrence “ideal” prosthetic material for extraperitoneal
z Flexibility – avoid fragmentation use. Amid, P.K., Shulman, A.G., Lichtenstein, I.L.,Selecting synthetic mesh for the repair of
groin hernia Postgraduate General Surgery: 1992; Vol. 4, No. 2, pp 150-155
Approach to Herniorraphy: Tension-free Hernia Repair Techniques:

Tension-free Hernia Repair Techniques: z Lichtenstein Repair
– Introduced in 1986
z Lichtenstein – Improved results over
prior methods of repair
z Laparoscopic Approach
– Became the new
z Plug & Patch standard in hernia
z Kugel patch repair
z PROLENE Hernia System

Tension-free Hernia Repair Techniques: Tension-free Hernia Repair Techniques:

z The Laparoscopic
Approach z The Plug & Patch
– Evolved into an – Introduced in 1993
effective – Simple procedure
preperitoneal – Some concerns1 :
repair – potential for patient discomfort
– reported cases of mesh migration
– Mesh shrinkage (up to 75 %)

1 Amid, P.K., Classification of biomaterials and their related complications in abdominal wall surgery. Hernia, Vol. 1,
pps 15-21, 1997

Perfix Plug Tension-free Hernia Repair Techniques:
Shrinkage
Complications z Kugel Patch
– More difficult than
Recurrence and cost
other TF repairs ?
Myopectineal Orifice: Triple Triangles Myopectineal Orifice: Triple Triangles
of the Groin of the Groin
Prior to mesh Following mesh
repairs, failures repairs, failures
were most are more
common just common in the
above the pubic lateral triangle
tubercle
Interstitial hernias

Groin interstitial hernias Observation on causes of interstitial
recurrent hernias
A hernia in which the sac
burrows through or between the • Increased vulnerability of portions of the lateral triangle
transversus abdominus and • Imbalance of pressure distribution over MPO
oblique muscles of the groin. • Damage to internal ring sling mechanism
• Spigelian • Inadequately managed lipomas at the lateral aspect of the
internal ring

• Recurrent lateral inguinal • Insufficient mesh reinforcement of medial AND lateral triangles.

Myopectineal Orifice Myopectineal Orifice

Prosthetics Prosthetics

• Lichtenstein • Plug(s) alone
Myopectineal Orifice Myopectineal Orifice

Prosthetics Prosthetics
• Plug(s) with • Laparoscopic
separate patch

Tension-free Hernia Repair Techniques:
Can we provide complete coverage
z The PHS Repair
of the MPO without the – Introduced in 1998
Laparoscope? – A secured posterior
repair from a simple
anterior approach
Can we provide better protection
– Lowest reported
than that achieved with the recurrence rate1
Laparoscope? – Lower cost
– “3-in-1” repair
Yes, we can… [1] “PHS Repair” A. Gilbert, International Hernia Congress
presentation, London, England 2003 June

PHS description PHS design and function
Bilayer, 3-in-1, PPM device Underlay patch Overlay Mesh
Cylinder Connector

• Underlay patch = Post. repair • Blocks all 3 triangles
of groin (myopectineal
• Onlay patch = Ant. repair orifice)

• Connector = Plug effect • Repairs (or prevents) Mesh Underlay
indirect, direct, and
• Available in 3 sizes femoral hernias
PHS design and function PHS design and function
On-lay patch Overlay Mesh Connector Overlay Mesh
Cylinder Connector Cylinder Connector

• Reinforces medial • Connects both
and lateral triangles patches

• Small slit • Virtually
accommodates Mesh Underlay eliminates Mesh Underlay
spermatic cord migration

• 2 – 4 sutures secure • Acts as a plug in
entire device defect

Myopectineal Orifice Myopectineal Orifice

Prosthetics Prosthetics
•PROLENE •PROLENE
Hernia System Hernia
System

Myopectineal Orifice Myopectineal Orifice

Prosthetics Prosthetics
• PROLENE • PROLENE
Hernia System Hernia System
Myopectineal Orifice Myopectineal Orifice

Prosthetics Prosthetics
• PROLENE • PROLENE
Hernia System Hernia System

Direct Hernia

Myopectineal Orifice Myopectineal Orifice

Prosthetics Prosthetics
• PROLENE • PROLENE
Hernia System Hernia System

PHS Applicability “…why I use it…” PHS Applicability “…where I use it…”
z Posterior repair from a simple anterior
approach. z Indirect, Direct, and Pantaloon
z Covers entire Myopectineal Orifice. inguinal hernias
z Local, regional, or general anesthesia. z Femoral hernias
z Test the repair in OR. z Umbilical hernias
z Concern with issues of mesh shrinkage, z Many Ventral and Incisional
plug migration, patient comfort, cost, and
recurrence rates are minimized. hernias
z Single method for all groin hernias, umbilical z Spigelian hernias
hernias, and other abdominal wall hernias.
“KISS principle”
Myopectineal Orifice with PHS Operative Techniques with
PROLENE Hernia System
z Covers entire MPO
z Flat mesh conforms
to contour of pelvic
wall
z No rigid edges
z Vulnerable areas
covered by 2 layers
of mesh
z Virtually no
migration

Results of 2975 PHS Repairs Advantages of the PROLENE* Hernia
Hernia Institute of Florida1 System
• Ambulatory 99%
z Underlay covers entire Myopectineal orifice
• Resumption of activity 1-2 days
z Cost effective “3 - in - 1” repair
• Infection 13
z Virtually eliminates recurrence
• Hematoma 12
z Virtually eliminates migration
• Seroma 60 total/ 3 asp. z Fast tissue ingrowth
• Persistent neuralgia 1 (2x rec hernia) z Minimal sutures
• Testicular atrophy 1 (2x rec hernia) z Mesh conforms to the preperitoneal space

• Recurrences 2 (both in 1st week) .07% z Single product regardless of size of groin defect
Courtesy A. Gilbert, MD

Umbilical Hernia Repairs Using the PROLENE* (Polypropylene) Hernia System, A
Surgeon Survey Presented at the Prospective Study
2003 International Hernia Congress John W. Murphy, MD., F.A.C.S.
Arthur I. Gilbert, M.D., F.A.C.S.
Table 1: Summary of Patient Enrollment Table 2: Duration of Postoperative Pain
N Patients
Patients Enrolled: 24 Postoperative Pain Duration N Patients
Sample size of survey: 50 respondents out of 187 polled Male Patients: 19 < 24 hours: 4
Female Patients: 5 24 hours: 6
Total number of repairs using PHS: 3,369
Patients lost to followup: 4 1 week: 9
Average months using PHS: 11 (range of 1-48 months) Reported Recurrences: 0 3 weeks: 5

Table 3: Postoperative Pain Rating at 1 Week
Average PHS repairs per surgeon: 67 (range of 6-1000 repairs)
Pain Rating N Patients
Average learning curve for PHS: 4 repairs (range of 1-6 evaluations) 1 - Least Pain: 13
2: 2
Total number of reported recurrences using PHS: 5 failures/3,369 repairs (0.148%) 3: 1
4: 3
Surgeons reporting satisfaction with PHS: 50 responded Yes 5 - Intense Pain: 1

Survey Summary: Conclusions: The PROLENE hernia system can be used to safely repair umbilical hernias that are
greater than 2 cm diameter. In this study to date, there were no recurrences and postoperative pain was
• All responding surgeons were satisfied with their use of PHS minimal in most patients. These results are similar to a very recent study of the PROLENE hernia system that
reported minimal postoperative pain and no recurrences after a median follow-up of 13 months in 48
• For the responding surgeons, the reported hernia recurrence rate umbilical hernia repairs1.
using PHS was 0.148% Presented at the International Hernia Congress, London, England, 2003

1Perrakis,
E, Velimenzia G, Vezakis A, et al. A new tension-free technique for the repair of umbilical hernia, using the Prolene Hernia
“PHS Repair” A. Gilbert, International Hernia Congress presentation London, England June 2003 System – early results from 48 states. Hernia. 2003;April 11.

*Trademark
A Transperitoneal View of the
PROLENE Hernia System Open Mesh Repair
Awad S, Bruckner B, Itani K, Munoz R, Berger D, Fagan S
Department of Surgery, Baylor College of Medicine
Operative Techniques with
Underlay patch
PROLENE Hernia System
of PHS

Femoral
Underlay patch
Vessels Inverted
Of PHS
Hernia Sac

Transperitoneal view of underlay patch of PHS demonstrating how it contours
to the shape of the abdomen secondary to the intraabdominal pressure

Conclusions: This is the first report to demonstrate that the underlay patch of
the PHS successfully deploys in the preperitoneal space thus providing a
preperitoneal and an onlay repair through an open technique. In contrast
to laparoscopic preperitoneal repairs, the underlay of the PHS is not fixed to
the surrounding structures allowing for greater flexibility of the underlay to
contour to the abdominal wall tension free.
Presented at the International Hernia Congress, London, England, 2003

Essential Product Information
NONABSORBABLE SYNTHETIC SURGICAL MESH

DESCRIPTION: The PROLENE polypropylene Hernia System is a sterile, pre-shaped, three-dimensional device constructed of an onlay
patch connected by a mesh cylinder to a circular underlay patch. The material is undyed PROLENE polypropylene mesh constructed of
knitted nonabsorbable polypropylene filaments.

Questions & Answers ACTIONS/PERFORMANCE: The PROLENE Hernia System is a nonabsorbable mesh used to reinforce or bridge inguinal hernia
deficiencies to provide extended support during and following wound healing. Animal studies show that implantation of PROLENE mesh
elicits a minimum to slight inflammatory reaction, which is transient and is followed by the deposition of a thin fibrous layer of tissue which
can grow through the interstices of the mesh, thus incorporating the mesh into adjacent tissue. The mesh remains soft and pliable, and
normal wound healing is not noticeably impaired. The material is neither absorbed nor is it subject to degradation or weakening by the action
of tissue enzymes.

INDICATIONS: This product is is intended to be used for the repair of abdominal wall hernia defects.

WARNINGS: The PROLENE Hernia System is provided by ETHICON, INC. as a sterile product. This device is for single use only. Do not
resterilize. Discard opened packages and unused product. When this device is used in infants or children with future growth potential, the
surgeon should be aware that this product will not stretch significantly as the patient grows. The PROLENE Hernia System should only be
used in contaminated wounds with the understanding that subsequent infection may require removal of the device.

PRECAUTIONS: Sutures or clips, if necessary, should be placed such that a minimum of 6.5mm (1/4") of mesh should extend beyond the
suture line.

ADVERSE REACTIONS: Potential adverse reactions are those typically associated with surgically implantable materials which include
infection potentiation, inflammation, adhesion formation, fistula formation and extrusion.

STERILITY: The PROLENE Hernia System is sterilized by Ethylene Oxide. Do not resterilize. Do not use if package is opened or damaged.
Discard open, unused product.

STORAGE: Recommended storage conditions: below 25?C, 77?F, away from moisture and direct heat. Do not use after expire date.

HOW SUPPLIED: The PROLENE Hernia System is available sterile, undyed in two sizes-medium and large.

CAUTION: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.