The lived experiences of metal hypersensitivity

Author:

Dordunoo Dzifa1ORCID,Doane Gweneth1,Carey Jett1,Lagura Jell Adrienne1,Mallidou Anastasia1ORCID,van der Merwe Jans2,Schroeder Scott1

Affiliation:

1. School of Nursing, University of Victoria, Victoria, Canada

2. Department of Orthopaedics, University of Saskatchewan, Saskatoon, Canada

Abstract

Background Immunological responses to metal ions can occur in people with metal implantable devices. Nevertheless, patients are not routinely asked about metal hypersensitivity nor tested for it prior to surgical procedures. Moreover, we have not identified any published literature on patients’ experiences with this condition. We undertook this study to better understand the experiences of patients with metal hypersensitivity and to determine what information would help them make an informed decision about implantable medical devices with metal compositions. Methods This is a patient-oriented research using an interpretative phenomenological methodology. We enrolled 16 people from five countries (Canada, New Zealand, Spain, the UK, and the USA) who experienced metal hypersensitivity following implantable medical device. We collected data from in-depth, semi-structured interviews focused on pre-procedural patient education and postoperative experiences to elucidate the barriers and opportunities related to metal hypersensitivity. We analyzed the data using interpretative phenomenological analysis. Results The majority were white biological women between the ages of 34 and 65. None of the participants were informed about immunological responses to metals in implants during the consenting process. They encountered many challenges when symptoms of metal hypersensitivity occurred. The outcomes for the few who had the implants removed were mixed. Conclusion Hypersensitivity reactions to metal need to be discussed as part of the consenting process, and additional strategies are needed to mitigate this issue in the health system.

Funder

University of Victoria

BC Support Unit

Publisher

SAGE Publications

Subject

Health Policy,Health (social science),Leadership and Management

Reference68 articles.

1. U.S. Food & Drug Administration. Medical device. Accessed January 2020 https://www.fda.gov/industry/regulated-products/medical-device-overview#What%20is%20a%20medical%20device

2. Development of Implantable Medical Devices: From an Engineering Perspective

3. U.S. Food & Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions. 2019. https://www.fda.gov/news-events/press-announcements/statement-fdacommissioner-scott-gottlieb-md-and-jeff-shuren-md-directorcenter-devices-and-3

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