FDA
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Food and Drug Administration
U.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-22                         Print Media:         301-827-6242
May 1, 1998                    
                               Consumer Inquiries:  800-532-4440

NEW FIBRIN SEALANT APPROVED TO HELP CONTROL BLEEDING IN SURGERY

FDA today approved the first of a new class of commercially available blood-derived products called fibrin sealants that are applied topically to help control bleeding. Fibrin sealants can be used to stop oozing from small, sometimes inaccessible, blood vessels during surgery when conventional surgical techniques are not feasible. The product is effective for use in cardiopulmonary bypass and colostomy operations and also in situations when a traumatic injury to the spleen has occurred.

The main active ingredient of fibrin sealant is fibrinogen, a protein from human blood that forms a clot when combined with thrombin -- another blood protein that facilitates blood clotting. The product works by forming a flexible material over the oozing blood vessel that can often control bleeding within five minutes.

Although many surgeons have legally prepared their own fibrin sealants, these locally prepared products are not standardized or consistent, and the available sources of fibrinogen are not virally inactivated.

This product is manufactured by Oesterreichisches Institut Fuer Haemoderivate G.M.B.H. in Vienna, Austria and distributed by Baxter Healthcare Corporation, Glendale, Calif. under the brand name TISSEEL.

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