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© 1997 Oxford University Press

other

Immunotoxicity of Medical Devices1

KATHLEEN RODGERS*, PAAL KLYKKEN{dagger}, JOSHUA JACOBS{ddagger}, CARMELITA FRONDOZA§, VESNA TOMAZIC and JUDITH ZELIKOFF||

*Livingston Research Center, University of Southern California School of Medicine 1321 North Mission Road, Los Angeles, California 90033 {dagger}Dow Corning Corporation Midland, Michigan 48686 {ddagger}Department of Orthopedic Surgery, Rush Medical College, Rush Arthritis and Orthopedic Institute Chicago, Illinois 60612 §Johns Hopkins Orthopedics, Good Samaritan Hospital 5601 Loch Raven Boulevard G-1, Baltimore, Maryland 21239 Center for Medical Devices, Food and Drug Administration Rockville, Maryland 20857 ||New York University Medical Center, Nelson Institute of Environmental Medicine Long Meadow Road, Tuxedo, New York 10987

Received December 5, 1966; accepted December 9, 1996

Determination of the ability of a medical device to interact with the immune system currently involves assessment of the immuno-genic potential and biocompatibility of the device or an extract of the device. However, implants are often in the body for extended periods of time and/or are placed by a surgical procedure that in and of itself will generate an acute inflammatory response. This symposium discussed studies that have been performed to evaluate the immunogenicity of various devices consisting of several different compositions (i.e., silicone, metals, and latex) in contact with different anatomical sites, the ability of a device to modulate an inflammatory response generated by a surgical procedure or trauma, and the response of the body to a material left in place for extended periods of time. This symposium brought together scientists from many different disciplines to begin to identify and fill in the gaps in this area.


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