Tattoo-associated granulomatous inflammatory reaction with intensive keloid formation

Objective: The trend of tattooing means an extensive destruction of the epidermis and injection of ink components representing unphysiological substances into the subcutis for a large proportion of the population. Against this background, consumer safety becomes a challenge because currently, neither a “positive list” of safe substances nor an authorization procedure for tattoo agents is available. We describe a case of poisoning reported to the BfR in the context of notifications enforced by the German Chemicals Act § 16e. Case report: A 57-year-old patient who already had several tattoos had a special tattoo applied with magenta colorant in an area of about 20 x 10 cm on his right lower leg. On the next day, he experienced extensive reddening and swelling, hyperthermia, itching and scaling of the skin in this area. After outpatient care for about eight months, the patient was admitted to a university hospital specializing in dermatology. The skin with the coloured tattoo was purulently infiltrated, erythematous and exhibited scaly changes, particularly in the lower part. Histological findings revealed a tattoo-associated granulomatous inflammatory reaction with intensive keloid formation. Large parts of the tattoo were excised, and the wound was covered with split skin graft transplanted from the upper leg. After three weeks of inpatient treatment, the patient was discharged in a stable general condition with the wound being free from irritation. Conclusion: Tattoo application is in a regulatory vacuum; it is not medical treatment and not cosmetic treatment. The Council of Europe Committee of Ministers has taken up the issue in the resolution ResAp(2008)1. They recommend a “positive list” of substances proved safe for this use under certain conditions. Also the resolution applies to composition and labelling, the risk evaluation, the conditions of the application and the obligation to inform the public and consumers. This might be a first step towards regulating these hazardous substances but there is a research need to obtain information on the metabolism of these substances (circulation of the substances in the body), the risks of long-term exposure, epidemiology of tattoo-related skin diseases and the toxicokinetic aspects for intradermal application, target organs, skin and lymph nodes. Finally, a risk assessment requires knowledge of the exact ingredients of tattoo inks such as colorants and other agents, methods for detecting and quantification as well as toxicological data for such ingredients.