Injection lipolysis

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Injection lipolysis (called by various proprietary and generic names including Lipo-dissolve, Lipodissolve, LipoShape, Lipostabil, Flab Jab and Fat Jab) is a controversial cosmetic procedure in which drug mixtures are injected into patients with the goal of breaking down fat. This practice, using drugs generally based on phosphatidylcholine and deoxycholate (PCDC), evolved from the initial intravenous use of those drug formulations to treat blood disorders.[1][2].

In 1966, investigators noted that the intravenous infusion of PC-containing solutions could remove fat emboli[3]. Later, a drug formulation called Lipostabil containing 5% PC and 4.75% deoxycholate (DC) was approved in Germany and used in the treatment of fat embolism[4][5], dyslipidemia[6], and alcohol-induced liver cirrhosis[7]. The first report of Lipostabil injection for fat removal demonstrated that infra-orbital ("under the eyelid") fat could be removed by Lipostabil injection[8]. While no placebo-controlled studies have demonstrated the safety or efficacy of this therapy, numerous retrospective studies of Lipostabil injections have reported the efficacy of this ‘off-label’ practice[9][10][11][12][13][14][15][16][17]. While the safety of Lipodissolve injections has yet to be proven in a prospective, placebo-controlled, double-blind clinical study, retrospective studies suggest that this practice does not present significant medical risk[18]. The mixture is injected directly into the subcutaneous fat through multiple microinjections administered over multiple treatment sessions. The desired end result is the removal of localized fat deposits[19].

The injection of Lipodissolve for fat removal remains somewhat controversial. In statements to the New York Times [20] and USA Today, [21] the FDA has taken the position that the injection of Lipodissolve mixtures for fat removal is an example of “unapproved drugs for unapproved uses.” Despite that, multiple businesses have initiated commercialization of Lipodissolve by opening clinics that advertise and administer Lipodissolve injection for fat removal [22]. One of these businesses states on its website that "Pharmacies are permitted to compound drugs pursuant to a valid patient/physician/pharmacist relationship - even if the drugs have not been approved by the FDA." [23] The FDA has stated that it is “investigating and evaluating” the situation.[21]

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[edit] Lipodissolve regulation in Kansas

On August 18, 2007, the Kansas State Board of Healing Arts voted unanimously to ban all commercial use of Lipodissolve and to allow the use of the drug only as part of FDA-sanctioned clinical trials under an Investigational New Drug Application. “We have to protect the public from the potentially disastrous effects of unproven drugs,” said Mark Stafford, the board’s general counsel, who noted that Lipodissolve is not approved for treating fat by the Food and Drug Administration [24]. Stafford also stated that the board had received at least half a dozen complaints about the procedure, including side effects such as nodules, infections and nausea.

On August 31, Fig,. a company that manages or operates 15 medical body shaping centers offering the Lipodissolve procedure filed a petition for a temporary restraining order in Shawnee, Kansas to prevent the ban from going into effect [25] Fig states on their public website "Pharmacies are permitted to compound drugs pursuant to a valid patient/physician/pharmacist relationship - even if the drugs have not been approved by the FDA." [26]. FDA spokesperson Karen Riley told USA Today on September 10, 2007 that FDA maintains a different view and considers injection of compounded Lipodissolve mixtures for fat removal as "unapproved drugs for unapproved uses" and noted that FDA is "investigating and evaluating" the situation.[21]

On September 10, 2007 at a special meeting the Kansas State Board moved to "replace its permanent Lipodissolve ban with a temporary ban to allow public comment on the move, which could still begin Friday", according to Mark Stafford, general counsel of the healing arts board. [21]

On September 13, 2007, Shawnee County District Judge David Bruns blocked the State Board's ban stating that the board erred by approving the ban without enough public input [27].

[edit] Health warnings

Three medical associations have issued health warnings cautioning against the use of injection lypolysis, including the American Society of Plastic Surgeons (ASPS), the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society of Dermatologic Surgery (ASDS).

[edit] International regulation

The Medicines and Healthcare Products Regulatory Agency, the governmental body regulating the manufacture and commercialization of drugs in the United Kingdom, issued a similar warning to physicians considering the use of these substances for cosmetic purposes, stating these drugs "are being unlawfully advertised in the UK as a cosmetic product for the reduction of fat." The MHRA also pointed out that considerable safety concerns remain due to the fact that these agents have not been tested in controlled clinical trials. While British physicians can still inject Lipodissolve for fat removal, the drug cannot be promoted as a drug for that purpose. As of July, 2005, The Medical Protection Society, the organization that provides British doctors with legal advice and coverage against litigation costs and damages, ceased offering malpractice insurance for use of Lipodissolve because of safety concerns [28].

[edit] FDA investigations

In June 2007, the FDA told NPR[29] and the Washington Post[30] that it is investigating organizations marketing and/or distributing Lipodissolve. In 2003, the FDA sent a warning letter to a physician engaged in the unlawful marketing and distribution of Lipodissolve. The June 22, 2003 letter orders the physician to "immediately cease marketing and distributing this product." The letter uses the term "Lipostabil" rather than "Lipodissolve", but these terms refer to mixtures with the same compositions. The letter also reiterated FDA's position that the product in question is a "new drug" per section 210(ff)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act, in that the product in an injectable agent that "alters the structure or function of the body." Both the route of administration (i.e., injection) and the claim that the agent alters "structure or function of the body" (i.e., it removes fat) qualifies the product as a "new drug" under the Federal Food, Drug, and Cosmetic Act and thus requires that a New Drug Application (NDA; section 505(a) of the Act) be filed with the FDA prior to marketing.

July 22, 2003 FDA warning letter, p. 1

July 22, 2003 FDA warning letter, p. 2

July 22, 2003 FDA warning letter, p. 3

[edit] FDA OASIS

On June 18, 2007, the FDA OASIS (Operational and Administrative System for Import Support[31] posted to its public access website [32] that the agency had refused to allow the delivery of PCDC mixtures prepared at a U.S.-based compounding pharmacy. On its website, the FDA stated that the two reasons for the “refusal” were as follows:

1. Reason: DRUG GMPS Section: 501(a)(2)(B), 801(a)(3); ADULTERATION Charge: It appears that the methods used in or the facilities or controls used for manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing.

2. Reason: UNAPPROVED. Section: 505(a), 801(a)(3); UNAPPROVED NEW DRUG Charge: The article appears to be a new drug without an approved new drug application.

[edit] References

  1. ^ Matarasso, A. and Pfeifer, T.M. (2005). "Mesotherapy for body contouring". Plast Reconstr Surg 115 (Pt 5): 1420–4. doi:10.1097/01.PRS.0000162227.94032.ED. 
  2. ^ Duncan, D.I. (2005). "Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction.". Aesthetic Surg J 25 (Pt 5): 530–543.. doi:10.1016/j.asj.2005.07.009. 
  3. ^ Kroupa, J. (1966). "Lipostabil in the prevention of fat embolism. (Experimental study).". Rozhl Chir. 45 (Pt 7): 444–452.. 
  4. ^ Schroder, D., Buttenschon, K., Herrmann, F., Brede, S. (1991). "Is there a drug treatment approach for prevention and therapy of fat embolism syndrome?". Klin Wochenschr. 69 (Pt 26): 229–233.. 
  5. ^ Stohlmacher, P., Haferland, W., and Gottschall, S. (1975). "Diffuse foam cell pneumonia following fatty embolism treated with lipostabil. A contribution to the pathology of therapy.". Z Arztl Fortbild (Jena). 69 (5): 237–239.. 
  6. ^ Klimov, A.N., Konstantinov, V.O., Lipovetsky, B.M., Kuznetsov, A.S., Lozovsky, V.T., Trufanov, V.F., Plavinsky, S.L., Gundermann, K.J., and Schumacher. R.. (1995). "“Essential" phospholipids versus nicotinic acid in the treatment of patients with type IIb hyperlipoproteinemia and ischemic heart disease." 9 (6): 779–784... 
  7. ^ Lieber, C.S., Weiss, D.G., Groszmann, R., Paronetto, F., Schenker, S. (2003). "For the Veterans Affairs Cooperative Study 391 Group., II. Veterans Affairs Cooperative Study of polyenylphosphatidylcholine in alcoholic liver disease." 27: 1765–1772.... 
  8. ^ Rittes, P.G. (2001). "The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads." 27 (4): 391–2.. 
  9. ^ Duncan, D.I. (2005). "Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction.". Aesthetic Surg J 25 (Pt 5): 530–543.. doi:10.1016/j.asj.2005.07.009. 
  10. ^ Rotunda, A.M., M.M. Avram, and Avram, A.S. (2005). "Cellulite: Is there a role for injectables?" 7 (3-4): 147–54.. 
  11. ^ Ablon G, Rotunda, AM. (2004). "Treatment of lower eyelid fat pads using phosphatidylcholine: clinical trial and review." 30 (3): 422–7.. 
  12. ^ Hexsel, D., Serra, M., Mazzuco, R. (2003). "Phosphatidylcholine in the treatment of localized fat." 2 (5): 511–8.. 
  13. ^ Rotunda, A.M., G. Ablon, and M.S. Kolodney (2005). "Lipomas treated with subcutaneous deoxycholate injections" 53 (6): p. 973–8. 
  14. ^ Rotunda, A.M. and M.S. Kolodney (2006). "Mesotherapy and Phosphatidylcholine Injections: Historical Clarification and Review" 32: p. 465–480. 
  15. ^ Bechara, F.G., Sand, M., Hoffmann, K., Sand, D., Altmeyer, P., and Stucker, M. (2007). "Fat tissue after lipolysis of lipomas: a histopathological and immunohistochemical study." 34 (7): p. 552–7. 
  16. ^ Bechara, F.G., Sand, M., Altmeyer, P., and Hoffmann, K. (2006). "Intralesional lipolysis with phosphatidylcholine for the treatment of lipomas: pilot study" 142 (8): p. 1069–70. 
  17. ^ Bechara, F.G., Sand, M., Sand, D., Rotterdam, S., Stucker, M., Altmeyer, P., and Hoffmann, K. (2006). "Lipolysis of lipomas in patients with familial multiple lipomatosis: an ultrasonography-controlled trial" 10 (4): p. 155–9. 
  18. ^ Duncan, D. and Hasengschwandtner, F. (2005). "Lipodissolve for subcutaneous fat reduction and skin retraction". Aesthetic Surgery Journal 25 (5): 530–543. doi:10.1016/j.asj.2005.07.009. 
  19. ^ Duncan, D.I. (2005). "Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction.". Aesthetic Surg J 25 (Pt 5): 530–543.. doi:10.1016/j.asj.2005.07.009. 
  20. ^ Feel Pudgy? There’s a Shot for That - New York Times
  21. ^ a b c d Lipodissolve proves popular despite lack of FDA nod - USATODAY.com
  22. ^ fig. Medically Supervised Body Shaping - Advanced LipoDissolve, Smartlipo, Personalized Body Management
  23. ^ Myth vs. Fact | fig. and Advanced LipoDissolve
  24. ^ http://www.kansascity.com/news/breaking_news/story/237263.html
  25. ^ Fig. seeks to reverse Kansas ruling on LipoDissolve - St. Louis Business Journal:
  26. ^ Myth vs. Fact | fig. and Advanced LipoDissolve
  27. ^ http://www.kansascity.com/business/story/274635.html
  28. ^ You're on your own if you give flab jab, insurers warn doctors - Times Online
  29. ^ Fat-Dissolving Injections: Too Good to Be True? : NPR
  30. ^ Can Shots Safely 'Melt Away Fat'? - washingtonpost.com
  31. ^ FDA/ORA OASIS Home Page
  32. ^ OASIS REFUSALS United States

[edit] External links