In 1994, the European Union recognized the significant troubles associated with the increasing incidence of hypersensitivity to nickel, and on June 30, 1994, the EU issued a ‘Nickel Directive,’ which regulates the use of nickel in jewelry and other products that come in contact with the skin. The aim of the legislation is to prevent the general population from becoming sensitized to nickel and to reduce nickel allergic contact dermatitis reactions in the majority of nickel-sensitized individuals. China adopted a similar standard in 2012.
Although no such directive exists in the United States, efforts are under way to mandate safe use guidelines for nickel. In 2014, it was estimated that roughly 2.5 million US adults and 250,000 children were suffering from nickel allergy, at an estimated cost of $5.7 billion per year for treatment of symptoms.
In November 2014, Loma Linda University the Nickel Allergy Alliance, and the Dermatitis Academy created the first open access self-reported patient registry to record nickel allergy prevalence data in the US, and in August 2015, the American Academy of Dermatology (AAD) adopted a nickel safety position paper.
In addition, concerns about allergies to implanted medical devices have risen and are now on the forefront. On March 15, 2019, these concerns prompted the acting FDA Commissioner, Scott Gottlieb, MD, to issue a statement expressing concerns about biological responses to materials, including metals, in patients with implanted medical devices. More specifically he stated that, “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.” He went on to say, “To this end, we're undertaking a broad effort to engage the public, scientists and industry stakeholders to gather information and help us determine the current state of the science, critical gaps in the existing science that need to be addressed, what approaches should be considered to further our understanding of medical device materials and improve the safety of devices for patients.”
Earlier in January 2019, in Orthopedics Today, the cover story entitled “Metal allergy: A clinical conundrum” was published. This and other publications are indicative of the attention that is being directed to the topic of allergies to metals found in medical and dental implants.
Very importantly, the medical and scientific communities continue to study and publish their data with respect to metal allergies, which will help to achieve the goals as outlined by Scott Gottlieb, MD.