A Great Fit For Anal Fistula Repair - Gore Medical

A great fit
for anal fistula repair
PERFORMANCE by design

We’ve met the challenge of
anal fistula repair head-on.
The management of anal fistula presents a challenge to the
general and colorectal surgeon. The balance is finite between
eradicating the anal fistula and maintaining anal continence.
Traditional surgical techniques – such as fistulotomy,
fistulectomy and other invasive procedures – divide and sever
the sphincter, thereby increasing the risk of incontinence.
The GORE ® BIO-A ® Fistula Plug provides a significant step
forward in both technique and treatment. By providing a
synthetic scaffold for soft tissue repair that facilitates tissue
generation and healing, the GORE ® BIO-A ® Fistula Plug offers
surgeons an alternative approach for sphincter-preserving anal
fistula repair.
Its patented design enables robust device placement, thereby
reducing the likelihood of becoming dislodged. A single plug
configuration is tailorable to fit most anal fistula shapes and
sizes. Because it is engineered to conform to the anal fistula
tract, the device reduces the potential for failure due to fall-out.
GORE ® BIO-A ® Fistula Plug non-woven web
creates a 3D porous structure with tunnels
for cellular infiltration.

An Advanced, Easily Customized Design
Robust device placement.
The design of the GORE ® BIO-A ® Fistula Plug features
bundled hollow tubes attached to a circular disk. The
disk helps the plug stay in place, reducing the chance
of the leading cause of anal fistula plug failure — the
extrusion of the plug through the distal opening of
the anal fistula tract. It also facilitates reproducible
anchoring for dependable performance.
Engineered to conform to the tract
and reduce failure due to fall-out.
The 3D structure of the tubes expands to fill the
defect, snugly holding the device in place within the
anal fistula.
Minimizing risk of incontinence.
Fistula repairs using the GORE ® BIO-A ® Fistula
Plug avoid dividing the sphincter muscles, thereby
reducing the risk of incontinence. The fistula
plug provides a scaffold for soft tissue repair and
facilitates closure of the fistula.
One configuration tailorable to fit
most anal fistula shapes and sizes.
The design of the GORE ® BIO-A ® Fistula Plug allows
surgeons to configure the device for individual anal
fistula geometries. Each tube can be trimmed or
removed entirely, so the device conforms to most
anal fistula shapes and sizes.

A Heritage of High Performance:
A proven, synthetic 100% bioabsorbable material
The GORE ® BIO-A ® Fistula Plug is a revolutionary combination of a proven, synthetic 100% bioabsorbable material 1 —
Polyglycolic Acid:Trimethylene Carbonate (PGA:TMC): Without the risk associated with biologics, this synthetic tissue
scaffold provides uniformity and consistency. This remarkably versatile polymer is chemically and mechanically stable
and chemically inert.
This 100% synthetic bioabsorbable scaffold facilitates tissue generation and healing. The PGA:TMC fibers form a 3D matrix
of open, highly interconnected pores. Cells migrate into the scaffold and tissue is generated as the body gradually absorbs
the material, leaving no permanent material in the body.
Porous 3D matrix facilitates
tissue generation and healing
Porcine Submucosa
Plug Surface (50x)
GORE ® BIO-A ® Fistula
Plug Surface (50x)
Material Replaced by Tissue at 1:1 Ratio 2
Percent Volume of Defect
100
80
60
40
20
0
Day of Implant 3 Months* 6 Months*
GORE ® BIO-A ® Web
Collagen
*Cells & Blood Vessels Make Up Remaining Volume

More than 15 years of clinical experience
GORE ® BIO-A ® Material is backed by 15 years of clinical use and Gore research, as well
as clinical use in numerous parts of the body, including the mouth, abdominal wall,
colon, stomach, heart, lung, liver, pancreas and spleen.
GORE ® BIO-A ® Fistula Plug GORE ® SEAMGUARD ®
Bioabsorbable Staple
Line Reinforcement
GORE ® BIO-A ® Tissue
Reinforcement
GORE ® BIO-A ® Hernia Plug

Frequently Asked Questions
Specific questions regarding
plug use:
• Do you recommend debriding / curetting the tract?
The standard of care prescribed by the surgeon should be
used in this case. Gently debriding or curetting the tract creates
a non-epithelialized wound bed which allows for the infiltration
of cells that function in wound healing and regeneration of tissue.
Care should be taken during debriding since it has the potential to
enlarge or damage the anal fistula tract.
• Do you close the internal opening of the anal fistula tract?
Close the external opening(s)?
The disk of the GORE ® BIO-A ® Fistula Plug is securely seated
at the internal opening by being sutured to or covered with the
patient’s rectal mucosa. To allow for natural drainage of the anal
fistula tract in the post-operative period, the external (secondary)
opening of the anal fistula tract should not be closed.
• How can I tailor the device to fill the tract?
Tubes can be trimmed off as needed to accommodate the
diameter of the anal fistula tract. Six tubes can fill an anal fistula
tract of approximately 6 mm in diameter.
• What guidelines do you have on trimming the plug
(disk or tubes)?
It is not recommended to trim the disk. In trimming off tube(s)
for sizing the plug for the anal fistula tract: remove the centermost
tubes first. Take care to ensure that the disk lies flat and
is well apposed to the rectal mucosa at the internal (primary)
opening of the anal fistula tract.
Questions regarding GORE ®
BIO-A ® Material:
What is GORE ® BIO-A ® Material?
GORE ® BIO-A ® Material is a uniquely designed web of
biocompatible polymers that is gradually absorbed by the
body while its 3D matrix is replaced by vascularized soft tissue.
As a synthetic bioabsorbable tissue scaffold, it is not derived
from human or animal tissue but engineered for uniformity,
consistency, and versatility in soft tissue reinforcement.
• What is left once the material is absorbed?
Cells infiltrate the 3D matrix and replace the web with
vascularized soft tissue at an approximate 1:1 ratio as it absorbs
over six months. Histology from animal 2 and human explants 3
indicates the tissue is initially a mix of type I and type III collagen
with maturation into primarily type I collagen, reflecting a normal
wound healing process.
• How is this different from a “biologic”?
GORE ® BIO-A ® Material provides a non-permanent scaffold for
tissue generation like biologics, but is made of bioabsorbable
polymers (67% PGA:33% TMC). Due to its synthetic nature, the
product is consistent and uniform with handling characteristics
that facilitate placement and no risk of human or animal source
contamination. It is easy to use with no operative preparation,
such as soaking or stretching.
• What can be expected post-operatively?
It is common for patients to experience drainage during the
post-operative healing period. Patients should be advised that
they may experience discomfort during this period. Typically
these symptoms will subside during the weeks following the
procedure. The material of the plug is absorbed and tissue
generation occurs over a six month period.
Insist on a Great Fit.
The GORE ® BIO-A ® Fistula Plug combines a proven, synthetic 100% bioabsorbable
material 1 with a patented design engineered to conform to the tract.
Insist on a great fit for anal fistula repair: the GORE ® BIO-A ® Fistula Plug.
Product Name Size Catalogue Number
GORE ® BIO-A ® Fistula Plug Six 9 cm tubes, 16 mm disk FP0616

W. L. Gore & Associates, Inc.
Flagstaff, AZ 86004
+65.67332882 (Asia Pacific)
00800.6334.4673 (Europe)
800.437.8181 (United States)
928.779.2771 (United States)
goremedical.com
1
Katz AR, Mukherjee DP, Kaganov AL, Gordon S. A new synthetic monofilament
absorbable suture made from polytrimethylene carbonate. Surgery, Gynecology &
Obstetrics 1985;161(3):213-222.
2
Morales-Conde S, Flores M, Fernández V, Morales-Méndez S. Bioabsorbable
vs polypropylene plug for the “Mesh and Plug” inguinal hernia repair. Poster
presented at the 9th Annual Meeting of the American Hernia
Society; February 9-12, 2005; San Diego, CA.
3
Carl R. Doerhoff, MD, FACS, SurgiCare of Missouri, P.C., Jefferson City, Missouri,
USA. Experience with the GORE ® BIO-A ® Hernia Plug in Inguinal Herniorrhaphy.
Products listed may not be available in all markets. GORE ® , BIO-A ® ,
PERFORMANCE BY DESIGN are trademarks of W. L. Gore & Associates.
©2012 W. L. Gore & Associates, Inc. AQ2917-EN1 MAY 2012