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Patch Testers’ Opinions Regarding Diagnostic Criteria for Metal Hypersensitivity Reactions to Metallic Implants

Schalock, Peter C. MD*; Thyssen, Jacob P. MD

doi: 10.1097/DER.0b013e31829cb113

Background Metal hypersensitivity reactions to implanted devices remain a challenging and controversial topic. Diagnostic criteria and methods are not well delineated.

Objective Diagnostic criteria for hypersensitivity reactions after metallic device implantation are evaluated in this study by a multinational group of patch testers using Thyssen’s previously published criteria.

Methods A total of 119 dermatologists at the 2012 European Contact Dermatitis Society and 2013 American Contact Dermatitis Society meetings answered a survey regarding their opinions on topics relating to metal hypersensitivity.

Conclusions Four major and 5 minor diagnostic criteria emerged. Approximately 80% of respondents found the following criteria useful (major criteria): chronic dermatitis beginning weeks to months after metallic implantation, eruption overlying the metal implant, positive patch test to a metal component of the implant, and complete clearing after removal of the potentially allergenic implant. Minor criteria (<61% of respondents) were as follows: systemic allergic dermatitis reaction, therapy-resistant dermatitis, morphology consistent with dermatitis, histology consistent with allergic contact dermatitis, and a positive in vitro test to metals (eg, lymphocyte transformation test). In the challenging situation such as a symptomatic or failing orthopedic device, applying these 4 major criteria and the 5 supportive minor criteria may be useful for guiding decision making.

From the *Department of Dermatology, Massachusetts General Hospital, Harvard School of Medicine, Boston; and †National Allergy Research Centre, Department of Dermato-Allergology, Gentofte Hospital, University of Copenhagen, Denmark.

Address reprint requests to Peter C. Schalock, MD, Department of Dermatology, Massachusetts General Hospital, BAR622, 55 Fruit St, Boston, MA 02114. E-mail:

The authors have no funding or conflicts of interest to declare.

© 2013 American Contact Dermatitis Society
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