Outbreak of Mesotherapy-Associated Skin Reactions --- District of Columbia Area, January--February 2005

Mesotherapy is a treatment involving local subcutaneous injections of minute quantities of various substances (e.g., vitamins or plant extracts) for cosmetic purposes (e.g., fat and wrinkle reduction or body contouring) or relief of musculoskeletal pain. In February 2005, the Virginia Department of Health and CDC were notified of a cluster of skin reactions unresponsive to antimicrobial therapy among patients who had been administered mesotherapy by an unlicensed practitioner in the District of Columbia (DC) area. This report 1) summarizes the subsequent investigation by CDC and state and local health departments in Virginia, Maryland, and DC, which identified prolonged skin reactions in 14 patients, and 2) provides recommendations for practices related to mesotherapy. Patients should accept medical therapy only from licensed practitioners and should not permit injection of substances that have not been approved by the Food and Drug Administration (FDA)*. Licensed practitioners should follow safe-injection practices when practicing mesotherapy and patients should observe that safe-injection practices are followed.

During January--February 2005, an infectious diseases physician reported visits by several patients with skin reactions at the sites on their bodies where they had received mesotherapy injections. The injections had been administered in a private home by a person who told patients he was a physician from Colombia. When no diagnosis could be made and the lesions failed to respond to standard antimicrobial therapy, the physician sought assistance from the Virginia Department of Health and CDC. Because the patients said they knew of others with similar skin reactions after mesotherapy injections from the same practitioner, a joint press release was issued by the health departments of DC, Maryland, and Virginia, asking that any person who had received injections from the practitioner call a designated hotline.

Twenty persons were interviewed by respective state and local health departments in Virginia and DC regarding their experiences with the practitioner. Sixteen (80%) patients reported reactions at one or more sites of injection. Fourteen patients reported prolonged (i.e., lasting >3 days) skin reactions consistent with the case definition. The majority of patients had redness and swelling, and certain patients had drainage or ulceration at the sites of mesotherapy injections received during October--November 2004; a total of 11 had persistent lesions at the time of interview, 10--16 weeks after their injections. All 14 patients with conditions consistent with the case definition were female; median age was 41 years (range: 18--63 years). Reactions occurred primarily on the torso and legs; no reactions occurred in the face, even though six patients had received facial injections. Fourteen patients reported breaches in safe-injection practices by the practitioner, including 1) failure to practice hand hygiene, 2) failure to prepare the skin with an antiseptic, 3) failure to wipe vials with alcohol before injection, and 4) failure to wear gloves. Of 11 patients who could recall, all reported use of a new needle; however, nine patients reported use of a multidose vial. Patients reported being told their injections contained various substances (e.g., plant extracts from artichoke and thuja, liquid "graphites," and procaine). With the exception of procaine, none of the substances reported by patients have been approved for subcutaneous injection by the FDA.

Lesion aspirates from seven patients were cultured for mycobacteria at the Virginia Division of Consolidated Laboratory Services; culture sensitivity was limited by small specimen volume. To maximize mycobacterial recovery and preserve viability of aerobic actinomycetes, specimens were processed without decontamination. In addition, cultures included media to support growth of Mycobacterium haemophilum and were incubated at both 86^ºF (30^ºC) and 98.6^ºF (37^ºC). One specimen grew three colonies of M. chelonae; specimens from the other six patients had no growth at 12 weeks. Aspirates from four patients had sufficient volume for bacterial and fungal cultures, but no growth was detected. Histopathologic examination of four biopsy samples was performed at CDC. Some samples had evidence of fat necrosis and inflammation in subcutaneous tissues, but special stains did not detect bacteria, fungi, or mycobacteria in any sample.

At the time of the investigation, none of the vials of injected substances could be obtained for analysis, and the practitioner could not be reached for questioning. Patients reported that the practitioner told them he had traveled back and forth from Colombia to provide mesotherapy to more than 100 patients in Florida, New York, New Jersey, and the DC area. However, the practitioner was not licensed to practice medicine in DC, Maryland, or Virginia. FDA is conducting an investigation with assistance from Virginia authorities.

Reported by: W Furlong, MD, Arlington, Virginia; BA Cunanan, Arlington County Public Health Div; LA Weymouth, PhD, D(ABMM), JL Pearson, DrPH, Virginia Div of Consolidated Laboratory Svcs; DC Sockwell, MSPH, SR Jenkins, VMD, J Marr, MD, M Tipple, MD, Virginia Dept of Health. DD Shah, MPH, D Blythe, MD, Maryland Dept of Health and Mental Hygiene. GR Lum, MPH, AC Glymph, MPH, JO Davies-Cole, PhD, District of Columbia Dept of Health. A Srinivasan, MD, Div of Healthcare Quality Promotion, National Center for Infectious Diseases, E Meites, RH Sunenshine, MD, EIS Officer, CDC.

Editorial Note:

The findings from this investigation determined that 14 women had prolonged skin reactions after mesotherapy injections of non-FDA--approved products administered by an unlicensed practitioner in the DC area. Cause of the reactions is unknown. Both infectious and noninfectious complications of mesotherapy have been described previously; however, injection-site infections with nontuberculous mycobacteria were the problem reported most commonly (1--5). In this investigation, clinical findings of prolonged skin reactions that were unresponsive to antimicrobial therapy and histopathology were consistent with nontuberculous mycobacterial infection in almost all cases; however, only one sample grew colonies of M. chelonae. Inadequate aseptic measures have been cited as the most likely cause of mesotherapy-related infections (1,2), and multiple breaches in safe-injection practices were reported by the majority of patients in this investigation. These lapses increased the risk for infectious complications.

The histopathology in these cases also is consistent with a chemical or allergic reaction, and certain substances (e.g., cosmetic fillers and a mixture of aminophilline, xantinol nicotinate, and lidocaine) have been reported to cause reactions following mesotherapy injections (5,6). Investigators could not fully assess the potential for chemical or allergic reactions in these cases because injected materials were not available for testing.

Mesotherapy has been practiced extensively in Europe since 1945 and in South America since 1986 (7) and appears to be gaining in popularity in the United States (8). Laws governing who may provide the injections and what may be injected vary by country. In 2003, the Brazilian government banned the use of phosphatidylcholine in mesotherapy injections for cosmetic fat reduction because of safety concerns and the lack of efficacy (8,9). The practice had become so common in Brazil that lay persons in nonmedical locations such as gyms and beauty salons were administering the injections (9). In the United States, laws governing medical procedures vary by state; however, in Virginia, mesotherapy is considered a medical procedure that must be practiced by a licensed provider. To minimize the risk for infectious complications from mesotherapy, providers should adhere to recommended standard precautions, follow safe-injection practices with appropriate aseptic techniques (Box), and inject only FDA-approved products that are prepared following guidelines to ensure sterility, as described in the FDA's good manufacturing practices (10).

References

1. Nagore E, Ramos P, Botella-Estrada R, Ramos-Ñíguez JA, Sanmartín O, Castejón P. Cutaneous infection with Mycobacterium fortuitum after localized microinjections (mesotherapy) treated successfully with a triple drug regimen. Acta Derm Venereol 2001;81:291--3.
2. Paul C, Burguiere AM, Vincent V, Susbielle P, Bonvalet D, Dubertret L. BCG-induced mycobacterium infection induced by alternative medicine [French]. Ann Dermatol Venereol 1997;124:710--2.
3. Marco-Bonnet J, Beylot-Barry M, Texier-Maugein J, et al. Mycobacterium bovis BCG cutaneous infections following mesotherapy: 2 cases [French]. Ann Dermatol Venereol 2002;129:728--31.
4. Friedel J, Piedmont Y, Truchetet F, Cattan E. Mesotherapy and cutaneous mycobacteriosis caused by Mycobacterium fortuitum: alternative medicine at risk [French]. Ann Dermatol Venereol 1987;114:845--9.
5. Lombardi T, Samson J, Plantier F, Husson C, Küffer R. Orofacial granulomas after injection of cosmetic fillers: histopathologic and clinical study of 11 cases. J Oral Pathol Med 2004;33:115--20.
6. Rosina P, Chieregato C, Miccolis D, D'Onghia FS. Psoriasis and side-effects of mesotherapy. Int J Dermatol 2001;40:581--3.
7. Bryant R. Controversial mesotherapy: Could it be the next botox? Dermatology Times; December 1, 2004.
8. Rotunda AM, Suzuki H, Moy RL, Kolodney MS. Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution. Dermatol Surg 2004;30:1001--8.
9. Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D. Phosphatidylcholine in the treatment of localized fat. J Drugs Dermatol 2003;2:511--8.
10. Food and Drug Administration. Current good manufacturing practice for finished pharmaceuticals. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration; 1996. Available at http://www.fda.gov/cder/dmpq/cgmpregs.htm.

* Center for Drug Evaluation and Research, Food and Drug Administration. Index to drug-specific information. Available at http://www.fda.gov/cder/drug/drugsafety/drugindex.htm.

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Date last reviewed: 11/9/2005