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)

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.

[Estimating the coverage of systematic vaccinations among the Balearic Island infant population]. / Estimación de la cobertura de las vacunaciones sistemáticas en la población infantil de las Islas Baleares.

BACKGROUND: In order for vaccination programs to be carried out properly, it is essential for the vaccination coverage to be known. On the Balearic Islands, the reported coverage was much less than for the rest of Spain. The objective of this study is that of estimating the coverage of the vaccinations included on the recommended schedule up to 18 months of age (4 doses of oral polio, tetanus and diphtheria; 3 doses of whooping cough; 1 dose of measles, rubella and mumps). METHODS: A descriptive, cross-sectional study of the population base. The ideal-time frequency distribution estimators and the corresponding confidence intervals were calculated at 95% (CI95%) for a sample of the resident two-year-old (born in 1995) Balearic Island population selected by means of a single-stage conglomerate random sampling based on census sections. The National Public Health System and National Health Institute vaccination records were reviewed, the data from the vaccination document having been requested from the families and the clinical record from the private pediatricians by telephone. RESULTS: The sample included 606 children, it having been possible to obtain full information on 532 children. Full information was obtained on 377 cases (62%) from the public health sector records. The least degree of coverage was found for the diphtheria vaccine, 518 children having been fully vaccinated, 96.8% (CI95% = 94.8-98.1), the highest degree of coverage having been found for the whooping cough vaccine, 537 children, 98.9% (CI95% = 97.5-99.5). CONCLUSIONS: Good vaccination coverage was found to exist on the Balearic Islands, being similar to what has been being estimated for Spain as a whole. The objective included within the Polio Eradication Plan is accomplished, very little information being gathered from the public sector.

Estimación de la cobertura de las vacunaciones sistemáticas en la población infantil de las Islas Baleares / Estimating the coverage of systematic vaccinations among the Balearic Island infant population

Fundamentos: Para un buen desarrollo de los programas de vacunación es primordial conocer la cobertura de vacunación. En las Islas Baleares la cobertura notificada era muy inferior a la del resto de España. El objetivo de este trabajo es la estimación de la cobertura de las vacunas incluidas en el calendario recomendado hasta los 18 meses de edad (4 dosis de polio oral, tétanos y difteria; 3 de tosferina; 1 de sarampión, rubeola y parotiditis).Métodos: Estudio descriptivo, transversal, de base poblacional. Se calcularon los estimadores puntuales de distribución de frecuencias y los intervalos de confianza al 95 per cent (IC95 per cent) correspondientes, sobre una muestra de la población residente en Baleares de dos años de edad (nacida en 1995), seleccionada por muestreo aleatorio por conglomerados en una sola etapa a partir de las secciones censales. Se consultan los registros de vacunas de Sanidad y de los centros de salud del Insalud, se pide telefónicamente a las familias los datos del documento de vacunación y a los pediatras privados los de la historia clínica. Resultados: La muestra incluía 606 niños. Pudo obtenerse la información completa de 532. Se consiguió la información completa de 377 casos (62 per cent) a partir de los registros del sector público. La cobertura más baja fue la de la vacuna antidiftérica, 518 niños complentamente vacunados, el 96,8 per cent (IC95 per cent = 94,8 - 98,1) y la más alta la de la vacuna antipertussis, 537 niños, el 98,9 per cent (IC95 per cent = 97,5 - 99,5).Conclusiones: En las Islas Baleares existe una buena cobertura de la vacunación, similar a lo que se viene estimando en España en su totalidad. Se cumple el objetivo incluido en el Plan de Erradicación de la Polio. La información recogida desde el sector público es escasa (AU)