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The bioceramic orbital implant: a new generation of porous implants
D R Jordan1, L A Mawn, S Brownstein
1Department of Ophthalmology, University of Ottawa Eye Institute, Ontario, Canada.
Purpose:
The authors describe a new generation of porous orbital implant made of aluminum oxide (Al2O3) and compare it with the hydroxyapatite orbital implants (Bio-Eye and FCI hydroxyapatite).
Methods:
The authors examined the new implant macroscopically, with chemical analysis and microscopically with scanning electron microscopy. Animal implantation studies were performed using six adult male New Zealand albino rabbits. Implant vascularization was evaluated by means of magnetic resonance imaging and histopathologic sectioning.
Results:
The Bioceramic orbital implant was found to have very uniform pore structure with an average pore size of 500 microm. The implant was 99.9% aluminum oxide on x-ray diffraction. Magnetic resonance imaging in vivo vascularization studies demonstrated enhancement of the implant to its center by 4 weeks after implantation in the rabbit. Histopathologically, fibrovascularization occurred uniformly throughout the implant and was noted by 4 weeks.
Conclusions:
The Bioceramic orbital implant represents a new porous orbital implant that has a very regular and extensive interconnected pore system, is as biocompatible as hydroxyapatite, is easy to manufacture, structurally strong, and free of contaminants. It is manufactured with no disruption to marine life ecosystems as may occur in the harvesting of coral for other orbital implants. It is less expensive than currently available hydroxyapatite implants and was approved by the U.S. Food and Drug Administration in April 2000.