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The Importance of Caution in the Use of Unregulated Anticellulite Treatments

The Importance of Caution in the Use of Unregulated Anticellulite Treatments We read with great interest in the Archives “A Complication of Mesotherapy: Noninfectious Granulomatous Panniculitis” by Davis and colleagues,1 which describes the morbid outcome of a woman injected with a deoxycholate-containing solution for the treatment of cellulite. The patient was diagnosed with a “mesotherapy-induced noninfectious granulomatous panniculitis”1(p809) in tissue obtained from numerous violaceous nodules and erosions on her thighs, buttocks, knees, and lower legs. The volume and concentration of the deoxycholate injected and the injection technique used were not known despite the comprehensive investigation and workup of the patient (Mark D. P. Davis, MD, e-mail correspondence, June 30, 2008). Control of these factors is critical to ensure treatment success and minimize adverse events with deoxycholate-containing solutions for the reduction of adipose tissue.2,3 It is apparent from the article's accompanying photographs1 that the practitioner used an unorthodox injection technique, given the haphazard, closely spaced distribution and locations of the lesions. Perhaps the nurse injector was not aware that “mesotherapy ingredients phosphatidylcholine solubilized with deoxycholate . . . [are] meant primarily for localized fat ablation rather than as a treatment of cellulite,”4(p148) which is emphasized in our group's recent review of injectable treatments for cellulite.4 In fact, we did not find any peer-reviewed literature substantiating the use of common mesotherapy ingredients as an effective means of reducing cellulite.4 Although there is evidence that some nondetergent medications (such as β-adrenergic agonists) may be effective for localized fat reduction, clinical trials investigating their use for cellulite are lacking. Investigational uses of sodium deoxycholate injected deeply into subcutaneous fat2 and lipomas3 have been reported to reduce these fatty collections without the untoward events described by Davis et al.1 While this nonionic detergent possesses potent adipolytic activity, it is important to underscore that nonadipose tissue may similarly be affected, particularly if high concentrations (up to 5%) are used.3 According to the US Food and Drug Administration (FDA), injectable fat loss treatments (known colloquially as lipodissolve, lipolysis, or mesotherapy) are “unapproved drugs for unapproved purposes.”5 In light of the fact that standardized injection protocols using approved, pharmaceutical-grade formulations do not exist, it would be unremarkable if reports of adverse events like those reported by Davis et al1 increase in frequency. As with other popular cosmetic procedures such as botulinum toxin injections, improper dose and technique can transform an otherwise very positive outcome into an avoidable adverse event. Until rigorous clinical trials are performed with FDA oversight, physicians and patients should be informed that the FDA considers localized fat ablation using fat-dissolving injections a “buyer beware situation.”5 We therefore urge caution in the use of these treatments. Back to top Article Information Correspondence: Dr Rotunda, 1401 Avocado Ave, Ste 810, Newport Beach, CA 92660 (amr@drrotunda.com). Financial Disclosure: Dr Rotunda has served as consultant to Kythera Biopharmaceuticals Inc, Calabasas, California, and has codeveloped a patent pending process that describes the use of detergents for the treatment of adipose tissue. Dr Avram owns stock options in Zeltiq Aesthetics Inc, Pleasanton, California. References 1. Davis MDWright TIShehan JM A complication of mesotherapy: noninfectious granulomatous panniculitis. Arch Dermatol 2008;144 (6) 808- 809PubMedGoogle ScholarCrossref 2. Salti GGhersetich ITantussi FBovani BLotti T Phosphatidylcholine and sodium deoxycholate in the treatment of localized fat: a double-blind, randomized study. Dermatol Surg 2008;34 (1) 60- 66PubMedGoogle ScholarCrossref 3. Rotunda AMAblon GKolodney MS Lipomas treated with subcutaneous deoxycholate injections. J Am Acad Dermatol 2005;53 (6) 973- 978PubMedGoogle ScholarCrossref 4. Rotunda AMAvram MMAvram AS Cellulite: is there a role for injectables? J Cosmet Laser Ther 2005;7 (3-4) 147- 154PubMedGoogle ScholarCrossref 5. Rubin R Lipodissolve proves popular despite lack of FDA nod. http://www.usatoday.com/news/health/2007-09-10-lipodissolve_N.htm. Accessed November 28, 2008 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Dermatology American Medical Association

The Importance of Caution in the Use of Unregulated Anticellulite Treatments

Archives of Dermatology , Volume 145 (3) – Mar 1, 2009

The Importance of Caution in the Use of Unregulated Anticellulite Treatments

Abstract

We read with great interest in the Archives “A Complication of Mesotherapy: Noninfectious Granulomatous Panniculitis” by Davis and colleagues,1 which describes the morbid outcome of a woman injected with a deoxycholate-containing solution for the treatment of cellulite. The patient was diagnosed with a “mesotherapy-induced noninfectious granulomatous panniculitis”1(p809) in tissue obtained from numerous violaceous nodules and erosions on her thighs, buttocks, knees,...
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Publisher
American Medical Association
Copyright
Copyright © 2009 American Medical Association. All Rights Reserved.
ISSN
0003-987X
eISSN
1538-3652
DOI
10.1001/archdermatol.2008.613
Publisher site
See Article on Publisher Site

Abstract

We read with great interest in the Archives “A Complication of Mesotherapy: Noninfectious Granulomatous Panniculitis” by Davis and colleagues,1 which describes the morbid outcome of a woman injected with a deoxycholate-containing solution for the treatment of cellulite. The patient was diagnosed with a “mesotherapy-induced noninfectious granulomatous panniculitis”1(p809) in tissue obtained from numerous violaceous nodules and erosions on her thighs, buttocks, knees, and lower legs. The volume and concentration of the deoxycholate injected and the injection technique used were not known despite the comprehensive investigation and workup of the patient (Mark D. P. Davis, MD, e-mail correspondence, June 30, 2008). Control of these factors is critical to ensure treatment success and minimize adverse events with deoxycholate-containing solutions for the reduction of adipose tissue.2,3 It is apparent from the article's accompanying photographs1 that the practitioner used an unorthodox injection technique, given the haphazard, closely spaced distribution and locations of the lesions. Perhaps the nurse injector was not aware that “mesotherapy ingredients phosphatidylcholine solubilized with deoxycholate . . . [are] meant primarily for localized fat ablation rather than as a treatment of cellulite,”4(p148) which is emphasized in our group's recent review of injectable treatments for cellulite.4 In fact, we did not find any peer-reviewed literature substantiating the use of common mesotherapy ingredients as an effective means of reducing cellulite.4 Although there is evidence that some nondetergent medications (such as β-adrenergic agonists) may be effective for localized fat reduction, clinical trials investigating their use for cellulite are lacking. Investigational uses of sodium deoxycholate injected deeply into subcutaneous fat2 and lipomas3 have been reported to reduce these fatty collections without the untoward events described by Davis et al.1 While this nonionic detergent possesses potent adipolytic activity, it is important to underscore that nonadipose tissue may similarly be affected, particularly if high concentrations (up to 5%) are used.3 According to the US Food and Drug Administration (FDA), injectable fat loss treatments (known colloquially as lipodissolve, lipolysis, or mesotherapy) are “unapproved drugs for unapproved purposes.”5 In light of the fact that standardized injection protocols using approved, pharmaceutical-grade formulations do not exist, it would be unremarkable if reports of adverse events like those reported by Davis et al1 increase in frequency. As with other popular cosmetic procedures such as botulinum toxin injections, improper dose and technique can transform an otherwise very positive outcome into an avoidable adverse event. Until rigorous clinical trials are performed with FDA oversight, physicians and patients should be informed that the FDA considers localized fat ablation using fat-dissolving injections a “buyer beware situation.”5 We therefore urge caution in the use of these treatments. Back to top Article Information Correspondence: Dr Rotunda, 1401 Avocado Ave, Ste 810, Newport Beach, CA 92660 (amr@drrotunda.com). Financial Disclosure: Dr Rotunda has served as consultant to Kythera Biopharmaceuticals Inc, Calabasas, California, and has codeveloped a patent pending process that describes the use of detergents for the treatment of adipose tissue. Dr Avram owns stock options in Zeltiq Aesthetics Inc, Pleasanton, California. References 1. Davis MDWright TIShehan JM A complication of mesotherapy: noninfectious granulomatous panniculitis. Arch Dermatol 2008;144 (6) 808- 809PubMedGoogle ScholarCrossref 2. Salti GGhersetich ITantussi FBovani BLotti T Phosphatidylcholine and sodium deoxycholate in the treatment of localized fat: a double-blind, randomized study. Dermatol Surg 2008;34 (1) 60- 66PubMedGoogle ScholarCrossref 3. Rotunda AMAblon GKolodney MS Lipomas treated with subcutaneous deoxycholate injections. J Am Acad Dermatol 2005;53 (6) 973- 978PubMedGoogle ScholarCrossref 4. Rotunda AMAvram MMAvram AS Cellulite: is there a role for injectables? J Cosmet Laser Ther 2005;7 (3-4) 147- 154PubMedGoogle ScholarCrossref 5. Rubin R Lipodissolve proves popular despite lack of FDA nod. http://www.usatoday.com/news/health/2007-09-10-lipodissolve_N.htm. Accessed November 28, 2008

Journal

Archives of DermatologyAmerican Medical Association

Published: Mar 1, 2009

Keywords: detergents,deoxycholate,ablation,cellulite,mesotherapy,adipose tissue,adverse event,lecithin,sodium,agonists,erosion,lipoma,biological products,botulinum toxins,panniculitis

References

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