Surgifoam Absorbable Sponges are a sterile, porcine absorbable gelatin sponge intended for hemostatic use. Surgifoam sponges liquefies within 2 to 5 days when applied to bleeding mucosal regions. It absorbs up to 40 times its own weight, completely absorbed within 4 to 6 weeks. It can be used dry or wet, saturated with sterile sodium chloride solution. Surgifoam sponges are easy to handle: malleable and can be shaped as needed or easily cut to size. Sponges can also be utured over.

Features

• Sterile.
• Latex-Free.
• Porous in appearance.
• Sterile, porcine gelatin absorbable powder.

Indication

• SURGIFOAM Sponge, used dry or saturated with sterile sodium chloride solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. Although not necessary, SURGIFOAM Sponge can be used with thrombin to achieve hemostasis.

CONTRAINDICATIONS

• Do not use SURGIFOAM in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
• Do not use SURGIFOAM in intravascular compartments because of the risk of embolization. Do not use SURGIFOAM in patients with known allergies to porcine collagen

WARNINGS

• SURGIFOAM should not be used in the presence of infection and should be used with caution in contaminated areas of the body
• SURGIFOAM should not be used in instances of pumping arterial hemorrhage
• SURGIFOAM will not act as a tampon or plug in a bleeding site.
• SURGIFOAM should be removed if possible once hemostasis has been achieved because of the possibility of dislodgment of the device or compression of other nearby anatomic structures.
• SURGIFOAM should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
• The safety and effectiveness of SURGIFOAM for use in ophthalmic procedures have not been established.
• SURGIFOAM should not be used for controlling post-partum bleeding or menorrhagia.
• The safety and effectiveness of SURGIFOAM have not been established in children and pregnant women.

PRECAUTIONS

• Safe and effective use of this product has been reported in a published neurologic retrospective study involving 1700 cases in Europe. Safe and effective use has not been proven through randomized, controlled clinical studies in the United States.
• SURGIFOAM is supplied as a sterile product and cannot be resterilized. When placed into cavities or closed tissue spaces, care should be exercised to avoid overpacking. SURGIFOAM Sponge may swell to its original size on absorbing fluids, creating the potential for nerve damage.
• SURGIFOAM should not be used for packing a cavity unless excess product not needed to maintain hemostasis is removed.
•  Once hemostasis is achieved, any excess SURGIFOAM should be carefully removed.
•  SURGIFOAM should not be used in conjunction with autologous blood salvage circuits.
•  SURGIFOAM should not be used in conjunction with methyl methacrylate adhesives. The safety and effectiveness for use in urological procedures have not been established through a randomized clinical study.
•  In urological procedures, SURGIFOAM should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.