An outbreak of cutaneous infection due to Mycobacterium abscessus associated to mesotherapy.

INTRODUCTION: In February 2009 an outbreak of subcutaneous abscesses due to Mycobacterium abscessus was detected in Spain which affected healthy women who had undergone mesotherapy procedures in an aesthetic clinic. METHODS: Epidemiological research, health inspection and microbiological studies were conducted. The patients were given antibiotic treatment (according to susceptibility testing) with clarithromycin, and in some cases, combined with amikacin. RESULTS: Seventeen out of 77 patients treated in the clinic were affected. The products used for the injections were homeopathic drugs in multi-dose vials. The environmental samples were negative. The sterile injection equipment and the clinical procedures were evaluated as correct. The storage conditions for the drugs were also correct, and all the samples tested negative for Mycobacteria. However Paenibacillus provencensis was isolated from samples of unused multi-dose vials and the withdrawal of the product from distribution was ordered. Deficiencies were detected in the sterile products process of at the homeopathic drug factory, so the production line was suspended. CONCLUSIONS: The results of environmental investigation suggest the most likely cause of the outbreak could have been the contamination of the products in the factory, although there was no laboratory confirmation. The widespread use of homeopathic products in invasive procedures requires extreme control during the manufacturing, handling and packaging process. It is important to consider mesotherapy and parenteral use of homeopathic medicines as potential sources of infection and therefore the same precautions in the procedures and quality assurance of products should be applied as with any other drug or medical activity.

An outbreak of cutaneous infection due to Mycobacterium abscessus associated to mesotherapy

Introduction: In February 2009 an outbreak of subcutaneous abscesses due to Mycobacterium abscessus was detected in Spain which affected healthy women who had undergone mesotherapy procedures in an aesthetic clinic. Methods Epidemiological research, health inspection and microbiological studies were conducted. The patients were given antibiotic treatment (according to susceptibility testing) with clarithromycin, and in some cases, combined with amikacin. Results Seventeen out of 77 patients treated in the clinic were affected. The products used for the injections were homeopathic drugs in multi-dose vials. The environmental samples were negative. The sterile injection equipment and the clinical procedures were evaluated as correct. The storage conditions for the drugs were also correct, and all the samples tested negative for Mycobacteria. However Paenibacillus provencensis was isolated from samples of unused multi-dose vials and the withdrawal of the product from distribution was ordered. Deficiencies were detected in the sterile products process of at the homeopathic drug factory, so the production line was suspended. Conclusions The results of environmental investigation suggest the most likely cause of the outbreak could have been the contamination of the products in the factory, although there was no laboratory confirmation. The widespread use of homeopathic products in invasive procedures requires extreme control during the manufacturing, handling and packaging process. It is important to consider mesotherapy and parenteral use of homeopathic medicines as potential sources of infection and therefore the same precautions in the procedures and quality assurance of products should be applied as with any other drug or medical activity (AU)

Introducción: En febrero de 2009 se detectó en Baleares un brote de abscesos subcutáneos causados por Mycobacterium abscessus que afectaba mujeres jóvenes y sanas que se habían sometido a procedimientos de mesoterapia en una clínica de estética. Métodos: Se realizaron investigación epidemiológica, inspección sanitaria y estudios microbiológicos clínicos y ambientales. Los pacientes iniciaron tratamiento antibiótico (según antibiograma) con claritromicinay, en los casos más graves, amikacina. Resultados: Aparecieron lesiones en 17 de las 77 personas sometidas a la mesoterapia en el período de riesgo. Los productos inyectados eran fármacos homeopáticos en multivial. Las muestras ambientales fueron negativas. No se evidenciaron deficiencias en los equipos y procedimientos. Los medicamentos estaban correctamente almacenados y todas las muestras fueron negativas para Mycobacteria, aunque se identificó Paenibacillus provencensis de multiviales precintados y el producto fue retirado de la distribución. Se detectaron deficiencias en la producción de estériles en la fábrica, por lo que la línea de producción fue suspendida y el producto retirado. Conclusiones: Los resultados de la investigación ambiental sugieren que la causa más probable del brote habría sido la contaminación del producto en origen, aunque no fue confirmada por laboratorio. La difusión del uso de productos homeopáticos en procedimientos invasivos requiere un control riguroso durante la fabricación, manipulación y envasado. Es importante considerar la mesoterapia y el uso parenteral de productos homeopáticos como fuentes potenciales de infección y por lo tanto extremar las precauciones y la garantía de calidad de los productos y los procedimientos de la misma manera que con cualquier otro producto farmacológico o actividad médica (AU)