BACKGROUND: There has been growing interest in the potential for adverse immunologic reactions to metals in biomedical devices and increasing referrals for the evaluation and management of metal hypersensitivity reactions reported in orthopedic, cardiac, gynecologic, and dental implant devices. However, there are few studies that give evidence-based recommendations on how to evaluate this issue in our practices. METHODS: We reviewed reasonable evidence and expert opinion on biomedical device hypersensitivity and published guidelines on pre- and postimplantation evaluation of delayed hypersensitivity reactions in patients suspected of possible metal hypersensitivity to biomedical devices. RESULTS: There is consensus that routine preimplantation evaluation in individuals with no history of adverse cutaneous reactions to metals or a history of implant-related adverse events is not necessary. However, patients with a history of metal hypersensitivity of a magnitude sufficient to cause concern for the patient or health care provider may benefit from evaluation by patch testing (PT) before device implantation. Patients after implantation and with chronic unexplained implant failure or with dermatitis may benefit from patch test evaluation after other causes, such as infection and biomechanical issues, are ruled out. However, a positive metal patch test result does not prove symptom causality, and the decision regarding implant revision can only be made after a thorough discussion among the patient, the allergist or dermatologist, and the orthopedic surgeon. CONCLUSION: Consensus guidelines for the evaluation of hypersensitivity to biomedical devices can be used by the practicing physician while awaiting for the results of further investigations.
BACKGROUND: There has been growing interest in the potential for adverse immunologic reactions to metals in biomedical devices and increasing referrals for the evaluation and management of metalhypersensitivity reactions reported in orthopedic, cardiac, gynecologic, and dental implant devices. However, there are few studies that give evidence-based recommendations on how to evaluate this issue in our practices. METHODS: We reviewed reasonable evidence and expert opinion on biomedical device hypersensitivity and published guidelines on pre- and postimplantation evaluation of delayed hypersensitivity reactions in patients suspected of possible metalhypersensitivity to biomedical devices. RESULTS: There is consensus that routine preimplantation evaluation in individuals with no history of adverse cutaneous reactions to metals or a history of implant-related adverse events is not necessary. However, patients with a history of metalhypersensitivity of a magnitude sufficient to cause concern for the patient or health care provider may benefit from evaluation by patch testing (PT) before device implantation. Patients after implantation and with chronic unexplained implant failure or with dermatitis may benefit from patch test evaluation after other causes, such as infection and biomechanical issues, are ruled out. However, a positive metal patch test result does not prove symptom causality, and the decision regarding implant revision can only be made after a thorough discussion among the patient, the allergist or dermatologist, and the orthopedic surgeon. CONCLUSION: Consensus guidelines for the evaluation of hypersensitivity to biomedical devices can be used by the practicing physician while awaiting for the results of further investigations.