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

CONTRAINDICATIONS:
This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material.

PRECAUTIONS:
   • Do not resterilize. Discard all open and unused portions of the device.
   • SURGISIS GOLD is sterile if the package is dry, unopened and undamaged.
      Do not use if the package seal is broken.
   • Discard device if mishandling has caused possible damage or contamination,
      or if the device is past its expiration date.
   • Ensure that device is rehydrated prior to cutting, suturing, stapling,
      or loading of the device laparoscopically.
   • Ensure that all layers of SURGISIS GOLD are secured when
      suturing or stapling.
   • Place device in maximum possible contact with healthy, well-vascularized
      tissue to encourage cell ingrowth and tissue remodeling.
   • Suturing or stapling more than one device together may decrease
      device performance.
   • No studies have been conducted to evaluate the reproductive impact
      of the clinical use of SURGISIS GOLD.

POTENTIAL COMPLICATIONS:
Possible adverse reactions with the use of any prosthesis may include, but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence of tissue defect.

STORAGE:
This device should be stored in a clean, dry location at room temperature.

STERILIZATION:
This device has been sterilized with ethylene oxide.

SUGGESTED INSTRUCTIONS FOR USING SURGISIS GOLD
These recommendations are designed to serve only as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.

NOTE: Always handle SURGISIS GOLD using aseptic technique, minimizing contact with latex gloves.

Required Materials
   • Sterile forceps
   • Rehydration fluid: room temperature, sterile saline or sterile
      lactated Ringer’s solution.

1. Using aseptic technique, remove the inner tray from its outer bag and place the tray in the sterile field.
2. Open the tray carefully. Use the tray to rehydrate the device by adding room temperature, sterile saline or sterile lactated Ringer’s solution.
3. Allow SURGISIS GOLD to rehydrate for at least ten (10) minutes prior to cutting, suturing, stapling, or loading, the device laparoscopically.
4. Prepare the hernia repair site using standard surgical techniques.
5. Using aseptic technique, trim SURGISIS GOLD to fit the site, providing a small allowance for overlap.
6. Using aseptic technique, transfer SURGISIS GOLD to the surgical site and suture or staple into place, avoiding excess tension.
   NOTE: Surgical experience indicates that suturing or stapling SURGISIS GOLD with close tissue approximation produces better outcomes. Fundamental surgical principles suggest a suture spacing approximately equal to suture bite depth.
7. Complete the standard surgical procedure.
8. Discard any unused portions.
   NOTE: Interrupted sutures can provide additional security against recurrence of tissue defect in the event of suture failure.

If the device is cut too small for the defect, excess tension may be placed on the suture line. This can result in recurrence of the original tissue defect or development of a defect in the adjacent tissues.

MECHANICAL PROPERTIES
Nominal properties for Surgisis Gold are listed below:

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