1. SURGICEL^® Absorbable Hemostat. Full Prescribing Information, Ethicon, Inc.


SURGICEL Essential Product Information

• INDICATIONS
SURGICEL^® Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL^® ORIGINAL, SURGICEL^® FIBRILLAR™, SURGICEL^® NU-KNIT^®, and SURGICEL^® SNoW™ Absorbable Hemostats can be cut to size for use in endoscopic procedures.

• PRECAUTIONS
Use only as much SURGICEL^® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction.

In urological procedures, minimal amounts of SURGICEL^® Absorbable Hemostat should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

Since absorption of SURGICEL^® Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.

If SURGICEL^® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped.

Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient.  (Examples: controlling hemorrhage after tonsillectomy and controlling epistaxis.)

Care should be taken not to apply SURGICEL^® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse Reactions section of the complete product package insert).

• ADVERSE EVENTS
“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.

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.

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.

For more information, please consult your doctor or for product quality and technical questions, call 1-800-795-0012.  For complete product information including indications, contraindications, warnings, precautions, and adverse reactions, please reference the individual product package inserts.