BSA/glutaral-related adverse effects reported by Health Canada
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BSA/glutaral-related adverse effects reported by Health Canada From 1 January 2000 to 1 June 2006, Health Canada has received 13 reports of adverse incidents suspected to be associated with BioGlue surgical adhesive, which contains bovine serum albumin (BSA) and glutaral, according to the latest issue of the Canadian Adverse Reaction Newsletter. Seven of the reports described events that were consistent with ongoing inflammatory processes at sites where BioGlue had been used previously. In four of these reports, BioGlue was suspected to be associated with persistent infection or sterile discharge, whereas BioGlue-related foreign body reactions were reported in the other three cases. Among the three patients who developed BioGluerelated foreign body reactions, patient 1 received BioGlue for sealing dural tissue during a spinal procedure and, over a period of months, developed recurring clear drainage. Upon reoperation, a cyst-like mass that was alleged to contain BioGlue was removed and the patient subsequently recovered. Patient 2 received BioGlue to help repair dural leaks and, during reoperation 5 months later, a firm green mass was found and removed from the patient’s wound area. Patient 3 received BioGlue to help repair a dural defect and, during reoperation more than 4 months later, a dural leak was discovered and a dark green mass was removed. Gaffen A, et al. BioGlue Surgical Adhesive: reported incidents of chronic inflammation and foreign-body reactions. Canadian Adverse Reaction Newsletter 801050798 16: 1-2, No. 4, Oct 2006
0114-9954/10/1124-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 21 Oct 2006 No. 1124
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