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    Host Reaction to Silicone Implants: A Long-Term Clinical and Histopathological Study

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    Host tolerance to implant materials has been evaluated since the initiation of a research project for use of silicone for joint replacement since 1962. Both the local and systemic tolerance to implants was analyzed in biomechanical and biological studies in laboratory animals and humans. Both soft tissues and bone reactions have been evaluated by pathological and radiological studies. The early studies included implant procedures on 25 dogs. Three dogs were sacrificed after 10 years and complete autopsies were performed to evaluate the local and systemic biocompatibility. End-bearing amputation stump implants were inserted in two of these dogs and the third animal had implant capping of ribs at the costovertebral junction and a silicone active tendon in a hind leg. A smooth-surfaced fibrous capsule surrounded the implants with no evidence of bone absorption or bursa formation; small silicone wear particles were well tolerated by giant cells. A complete organ and reticuloendothelial system review failed to show evidence of metastases of silicone particles. A similar, excellent biocompatibility of silicone implants was demonstrated in the autopsy of a rheumatoid patient who had silicone implants in both hands, radial heads, and feet starting 12 years before death. A few, small, well-tolerated silicone particles were seen in giant cells in the synovium with minimal inflammatory cells and no focal necrosis. A small amount of well-tolerated silicone particles were present in giant cells in an axillary node. A thorough organ study failed to show distant silicone particle metastases. These studies showed the good biocompatibility of silicone implants.


    host tolerance, implant materials, silicone, wear particles, foreign body giant cell, fibrous capsule, biological degradation, fatigue (materials)

    Author Information:

    Swanson, AB
    Director of the Grand Rapids Hospital's Orthopaedic Surgery Training Program, Director of Hand Surgery Fellowship and Orthopaedic Researchprofessor of Surgery, Blodgett Memorial Medical CenterMichigan State University, Grand RapidsLansing, MIMI

    Kent Maupin, B
    Orthopaedic surgeon, Blodgett Memorial Medical Center, Grand Rapids, MI

    Nalbandian, RM

    deGroot Swanson, G
    Plastic surgeon and coordinator of Orthopaedic Researchassistant clinical professor of Surgery, Blodgett Memorial Medical CenterMichigan State University, Grand RapidsLansing, MIMI

    Committee/Subcommittee: F04.48

    DOI: 10.1520/STP33257S