Ethicon Surgicel Original Absorbable Hemostat

How does Surgicel Absorbable Hemostat Work?

• The mechanism of action whereby Surgicel Absorbable Hemostat accelerates clotting is not completely understood, but it appears to be a physical effect rather than any alteration of the normal physiologic clotting mechanism. 
• After Surgicel Absorbable Hemostat has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a hemostatic adjunct in the control of local hemorrhage. 
• When used properly in minimal amounts, Surgicel Absorbable Hemostat is absorbed from the sites of implantation with practically no tissue reaction. Absorption depends upon several factors including the amount used, degree of saturation with blood, and the tissue bed. 
• In addition to its local hemostatic properties, Surgicel Absorbable Hemostat is bactericidal in vitro against a wide range of gram positive and gram negative organisms including aerobes and anaerobes.

Contraindications

• Although packing or wadding sometimes is medically necessary, SURGICEL Absorbable Hemostat should not be used in this manner, unless it is to be removed after hemostasis is achieved.
• Surgicel Absorbable Hemostat should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical chance of cyst formation.
• When Surgicel Absorbable Hemostat is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure.
• Should not be used to control hemorrhage from large arteries.
• It should not be used on non hemorrhagic serous oozing surfaces, since body fluids other than whole blood, such as serum, do not react with Surgicel Absorbable Hemostat to produce satisfactory hemostatic effect.
• Surgicel Absorbable Hemostat is an absorbable hemostat, and should not be used as an adhesion prevention product.

Adverse Reactions

• Encapsulation of fluid and foreign body reactions have been reported.
• There have been reports of stenotic effect when Surgicel Absorbable Hemostat has been applied as a wrap during vascular surgery.
• Although it has not been established that the stenosis was directly related to the use of Surgicel Absorbable Hemostat, it is important to be cautious and avoid applying the material tightly as a wrapping. 
• Paralysis and nerve damage have been reported when Surgicel Absorbable Hemostat was used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
• While most of these reports have been in connection with laminectomy, reports of paralysis have also been received in connection with other procedures.
• Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when Surgicel Absorbable Hemostat was placed in the anterior cranial fossa.
• Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported.
• There has been one report of a blocked ureter after kidney resection, in which postoperative catheterization was required.

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