BD^® Avitene™ Microfibrillar Collagen Hemostat (MCH)

Avitene™ MCH

Indications for Use: Avitene™ (MCH) is used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Contraindications: Avitene™ (MCH) should not be used in the closure of skin incisions as it may interfere with the healing of the skin edges. This is due to simple mechanical interposition of dry collagen and not to any intrinsic interference with wound healing. It has been reported with other collagen hemostatic agents, that by filling porosities of cancellous bone, they may significantly reduce the bond strength of methylmethacrylate adhesives. MCH should not, therefore, be employed on bone surfaces to which prosthetic materials are to be attached with methylmethacrylate adhesives. Warnings: Avitene™ MCH is inactivated by autoclaving. Ethylene oxide reacts with bound hydrochloric acid to form ethylene chlorohydrin. This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user. MCH is not for injection or intraocular use. The safety and effectiveness of Avitene™ MCH when used in conjunction with thrombin has not been established and is not recommended. It should be used dry. Discard any unused portion. MCH is not intended to treat systemic coagulation disorders. Appropriate therapy to correct the underlying coagulopathy should be instituted prior to use of the product. As with any foreign substance, use in contaminated wounds may enhance infection. Precautions: Only the minimum amount of Avitene™ (MCH) necessary to produce hemostasis should be used. After several minutes, excess material should be removed; this is usually possible without the reinitiation of active bleeding. Any excess Avitene™ (MCH) not removed at the time of surgery may either present itself as a (recurring) mass or a (space-occupying) lesion or it may lead to a foreign body reaction that may present with or without clinical signs and it may lead to a foreign mass or lesion or postoperative abscess formation upon imaging. Imaging may initially not be capable of distinguishing the difference. Removal of excess material, ideally performed upon the conclusion of the initial procedure, typically resolves all signs and symptoms. Failure to remove excess MCH may result in bowel adhesion or mechanical pressure sufficient to compromise the ureter. In otolaryngological surgery, precautions against aspiration should include removal of all excess dry material and thorough irrigation of the pharynx. MCH contains a low, but detectable, level of intercalated bovine serum protein which reacts immunologically as does beef serum albumin. Increases in anti-Bovine Serum Albumin (BSA) titer have been observed following treatment with MCH. About two-thirds of individuals exhibit antibody titers because of the ingestion of food products of bovine origin. Intradermal skin tests have occasionally shown a weak positive reaction to BSA or MCH but these have not been correlated with lgG titers to BSA. Tests have failed to demonstrate clinically significant elicitation of antibodies of the lgG class against BSA following MCH therapy. Care should be exercised to avoid spillage on nonbleeding surfaces particularly in abdominal or thoracic viscera. Avitene™ (MCH) should not be used in conjunction with autologous blood salvage circuits, as Avitene™ may pass through the filters of such systems. It has been suggested that fragments of MCH may pass through filters of blood scavenging systems, therefore the reintroduction of blood from operative sites treated with MCH should be avoided. Teratology studies in rats and rabbits have revealed no harm to the animal fetus. The safety of this product has not been established in infants, children, pregnant women, or breastfeeding women. Avitene™ non-woven web should not be used as a surface dressing except for immediate control of bleeding. Avoid packing Avitene™ tightly in cavities, especially within the bony enclosure of the CNS or within other relatively rigid cavities where swelling may interfere with normal function or possibly cause necrosis. Avitene™ is not recommended for use in patients sensitive to bovine-derived collagen. The risk with respect to transmissible Spongiform Encephalopathies (TSE) has been minimized in accordance with regulatory guidelines. Only physicians qualified in the appropriate surgical techniques should use this device. Adverse Reactions: The most serious adverse reactions reported which may be related to the use of Avitene™ (MCH) are potentiation of infection including abscess formation, hematoma, wound dehiscence, and mediastinitis. Other reported adverse reactions possibly related are adhesion formation, allergic reaction, foreign body reaction, and subgaleal seroma (report of a single case). The use of MCH in dental extraction sockets has been reported to increase the incidence of alveolalgia. Transient laryngospasm due to aspiration of dry material has been reported following the use of MCH in tonsillectomy.

Avitene™ Ultrafoam™

Indications for Use: Avitene™ Ultrafoam™ sponge is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Contraindications: Avitene™ Ultrafoam™ sponge should not be used in the closure of skin incisions as it may interfere with the healing of the skin edges. This is due to simple mechanical interposition of dry collagen and not due to any intrinsic interference with wound healing. It has been reported with other collagen hemostatic agents, that by filling porosities of cancellous bone, they may significantly reduce the bond strength of methylmethacrylate adhesives. Avitene™ Ultrafoam™ should not, therefore, be employed on bone surfaces to which prosthetic materials are to be attached with methylmethacrylate adhesives. Warnings: Avitene™ Ultrafoam™ is inactivated by autoclaving. Ethylene oxide reacts with bound hydrochloric acid to form ethylene chlorohydrin. This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user. Opened, unused product should be discarded. As with any foreign substance, use in contaminated wounds may enhance infection. Avitene™ Ultrafoam™ sponge should not be used in instances of pumping arterial hemorrhage. It should not be used where blood or other fluids have pooled, or in cases where the point of hemorrhage is submerged as it may mask an underlying source of bleeding, resulting in a hematoma. Avitene™ Ultrafoam™ sponge will not act as a tampon or plug in a bleeding site, not will it close off an area of blood collecting behind a tampon. Avitene™ Ultrafoam™ sponge is not intended to treat systemic coagulation disorders. Appropriate therapy to correct the underlying coagulopathy should be instituted prior to use of the product. Not for injection, intraocular or intravascular use. Precautions: Avitene™ Ultrafoam™ sponge, like other collagen hemostats, should not be left in infected sites or on infected surfaces. As with other hemostatic agents, it is not recommended for use in persons with known sensitivity to material of bovine origin. The risk with respect to transmissible Spongiform Encephalopathies (TSE) has been minimized in accordance with regulatory guidelines. Any excess Avitene™ Ultrafoam™ not removed at the time of surgery may either present itself as a (recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that may present with or without clinical signs and symptoms as a recurring mass or lesion or postoperative abscess formation upon imaging. Imaging may initially not be capable of distinguishing the difference. Removal of excess material, ideally performed upon the conclusion of the initial procedure, typically resolved all signs and symptoms. Microfibrillar Collagen Hemostat (MCH) contains a low, but detectable, level of intercalated bovine serume protein which reacts immunologically as does beef serum albumin. Increases in anti-Bovine Serum Albumin (BSA) titer have been observed following treatment with MCH. About two-thirds of individuals exhibit antibody titers because of the ingestion of food products of bovine origin. Intradermal skin tests have occasionally shown a weak positive reaction to BSA or MCH but these have not been correlated with IgG titers to BSA. Tests have failed to demonstrate clinically significant elicitation of antibodies of the IgG class against BSA following MCH therapy. When placed in cavities or closed spaces, care should be exercised to avoid overpacking Avitene™ Ultrafoam™ sponge as it may press against neighboring structures. The safety of this product has not been established in infants, children, pregnant women or in breastfeeding women. Only physicians qualified in the appropriate surgical techniques should use this device. Adverse Reactions: The most serious adverse reactions reported which may be related to the use of other collagen products, are potentiation of infection including abscess formation, hematoma, wound dehiscence and mediastinitis. Other reported adverse reactions possibly related are adhesion formation, allergic reaction, foreign body reaction and subgaleal seroma (report of a single case), and increased incidence of alveolalgia when used for the packing of dental extraction sockets.