Contraindications - COOK Medical Biodesign Surgisis Mode D'emploi

BIODESIGN® SURGISIS® FISTULA PLUG
INTENDED USE
The Cook® Biodesign® Surgisis® Fistula Plug is for implantation to reinforce
soft tissue for repair of recto-vaginal or anorectal fistulas. The plug is supplied
sterile and is intended for one time use.
Rx ONLY
This symbol means the following:
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Fistula Plug
This product is intended for use by trained medical professionals.

CONTRAINDICATIONS

• This plug is derived from a porcine source and should not be used for
patients sensitive to porcine materials.
• Not for vascular use.
PRECAUTIONS
• Do not resterilize. Discard all open and unused portions.
• Plug is sterile if the package is dry, unopened and undamaged.
• Do not use if the package seal is broken.
• Discard plug if mishandling has caused possible damage or contamination
or if the plug is past its expiration date.
• Do not implant the plug in a grossly infected or abscessed fistula tract.
• In fistula cases involving evidence of acute inflammation, purulence,
or excessive drainage, a seton should be used to allow the tract to
mature and stabilize for six to eight weeks before placing the plug.
• Ensure that the plug is rehydrated prior to placement, cutting, or suturing.
• Placement of the plug in tracts less than 1 cm in length can result in
incomplete incorporation and/or expulsion of the plug.
GENERAL
• Users should be familiar with surgical technique for recto-vaginal or
anorectal fistula repair.
• Users should exercise good surgical practice for the management of clean-
contaminated, contaminated or infected fields.
• The potential for infection of the graft material following implantation
may be reduced by the use of prophylactic antibiotics and cleaning of the
fistula tract. (See Use of Antimicrobials)
• The plug should always be introduced through the rectal (primary) fistula
opening.
• The plug should be drawn into the fistula tract completely, until the button
is set against the rectal wall.
• The external/vaginal (secondary) fistula opening should remain open to
allow drainage to occur.
• IMPORTANT: A rectal exam is recommended at the end of the 4th post-
operative week to confirm separation of the non-resorbing button from
the rectal wall. It is also recommended that users counsel patients on
abstaining from strenuous physical activity for at least 2 weeks following
anorectal fistula repair, or 6 weeks following recto-vaginal fistula repair.
Refer to the section on Post-Operative Care.
POTENTIAL COMPLICATIONS
Complications that can occur with the plug include, but are not
limited to:
• Inflammation
• Induration
• Migration
• Extrusion
• Seroma formation
• Infection
• Abscess
• Fistula recurrence
• Delayed or failed incorporation of the plug
If any of the following conditions occur and cannot be resolved, plug removal
should be considered:
• Infection
• Abscess
• Acute or chronic inflammation (Initial application of surgical graft materials
may be associated with transient, mild, localized inflammation)
• Allergic reaction
STORAGE
This plug should be stored in a clean, dry location at room temperature.
This symbol means the following: Surgisis®
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ENGLISH