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The American Society of Aesthetic Lipodissolve [ASAL] objects to the inclusion of "Lipodissolve" in the recent warning against injection therapy (MESOTHERAPY) for localized fat reduction issued by the American Society of Aesthetic Plastic Surgery [ASAPS]. The procedure, Lipodissolve was introduced by the founders of ASAL in 2001 as distinct from "Mesotherapy". The ASAL took care to include ingredients which were safe and whose mechanism of action was understood. The ASAL diligently limited training only to physicians and their nurses to perform the procedure. The ASAL and its original cohort, "Network Lypolysis", thus trained more than 300 physician in Europe, and so far, more than 200 physicians in the United States.
ASAPS is incorrect in stating that there are no data relative to the effectiveness and safety of the procedure. As it relates to Lipodissolve, more than 50,000 treatment sessions have been reported in European and American peer reviewed journals demonstrating: a] objective evidence of improvement, based on actual measurements and pictures, in approximately 90% of the patients, and b] a paucity of serious side effects.1-4,6,7 Serious side effects reported with liposuction such as death, fluid overload, epinephrine and lidocaine toxicity, thrombosis, fat embolism and complications of general anesthesia have not been reported with Lipodissolve therapy.5
The main ingredient in the Lipodissolve formula is phosphatidylcholine [PC], a lipid. It is dissolved in a bile salt [deoxycholate], which is how it exists in bile where it helps to breakdown the ingested fat cells and digest fat on a daily basis. When injected in to the unwanted superficial body fat, it similarly breaks down fat cells and "digests fat", as it does naturally in proximal duodenum. In the subcutaneous area the dead fat cells are then gradually removed by the body's physiologic repair mechanisms, the same way as after any trauma or even after liposuction which leaves dead fat cells in the area to be removed by similar physiologic processes. PC along with other phospholipids are significant dietary source of essential fatty acids. Mammalian cell membranes are primarily composed of PC and other phospholipids mixed with cholesterol esters and salts to maintain fluidity. In other words it is not some foreign or toxic substance.
ASAPS's statement that this "procedure is not FDA approved" is misleading. FDA approves drugs and devices, not procedures. ASAL maintains that there is no FDA approval requirement relative to phosphatidylcholine for two reasons. One, it is a "supplement" and as such has been used for years for liver health, cholesterol and other possible benefits. Supplements do not require FDA approval and can be administered by injection,(as are vitamins and minerals as in Meyer's cocktail, intravenous nutrition or hyper-alimentation consisting of amino acids, vitamins, minerals, lipids, and others. Second, in Lipodissolve, the ingredients are mixed by a compounding pharmacist upon a physician's order for specific patients, which does not require FDA approval [FDA Modernization Act Section 503a Compounding Pharmacy].
Lipodissolve is not a surgical procedure. Accordingly, ASAL has compiled an advisory board that includes highly credentialed physicians with diverse but relevant backgrounds in the fields of dermatology, aesthetic surgery and internal medicine. These individuals are experienced clinicians, speakers, writers, researchers and teachers, and provide advice regarding the procedure and its evolution. They conduct training workshops for other physicians in the U.S. So far the North American advisers have performed more than 2,000 Lipodissolve procedures with satisfactory results in more than 90% of the patients - without any serious side effects. The ASAL has an on going monitoring process to record these events.
References:
1. Hasengschwandtner,F. Phosphatidylcholine treatment to induce lypolysis. Journal of Cosmetic Dermatology, 2005; 4:308-313
2. Duncan, ID, Hasengschwandtner,F. Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction. Aesthetic Surgery Journal, 2005-September/October; 25(5):530-43
3. Heinrich, K-G. Efficacy of Injections of Phosphatidylcholine into Fat Deposits, A non-surgical alternative to liposuction in body contouring. Presented as a scientific publication at the convention "Operative Dermatology" at Frankfurt, October 28-31, 2004
4. Palmer, M, Curran, J, Bowler, P. Clinical experience and safety using phosphatidylcholine injections for the localized reduction of subcutaneous fat: a multicentre, retrospective UK study. Journal of Cosmetic Dermatology, 2006; 5:218-25
5. Platt, MS, et.al. Deaths associated with liposuction: case reports and review of the
literature. Journal Forensic Science. 2002, Jan; 47(1):205-7
6. Duncan,DI,Chubaty,R,Clinical Safety Data and Standards of Practice for Injection Lipolysis: A Retrospective Aesthetic Surgery J, 2006;26:000.
7. Hasengschwandtner,F, Furtmueller,F, Spanbaner,M,Silye,R.Detailed Documentation of Lipolysis Treatment: Blood Values,Histology, and Ultrasound Findings.Aesthetic Surgery J 2007, 27:204-211
There is a common misconception that cosmetic surgery is primarily for women. The avoidance of cosmetic surgery by men may be due to deeply ingrained notions of manliness and the stereotypical portrayal of cosmetic surgeries. Studies show, however, that more men are electing cosmetic surgery to correct various appearance related complaints. Many of the false notions men have may stem from a lack of information on what conditions are treatable with cosmetic surgery.
According to the American Society of Plastic Surgeons, there were 1.2 million men who had cosmetic surgery procedures in 2005. That figure indicates a 44% increase in male surgeries since 2000. The most common procedure is , commonly referred to as a nose reshaping; 99,680 men elected to have this procedure in 2005. Due to the high incidence of broken noses in men and the attending medical problems that can come from disrupted nasal passages, this procedure seems to be more socially acceptable.
Liposuction is also gaining popularity among males. The most common areas of liposuction for men are in the abdominal region and the flanks. According to the ASPS study, 35,673 men had liposuction procedures in 2005. Contrary to popular belief, liposuction is not an alternative to weight loss. It is typically performed in areas that may require sculpting to obtain a more desirable appearance. The average amount of fat that is removed is less than ten pounds.
Blepharoplasty, or eyelid surgery, can be a functional or cosmetic procedure that reshapes the upper or lower eyelid. The ASPS study indicates that 32,988 men had blepharoplasty procedures performed in 2005. Asian blepharoplasty is a common procedure performed on Asian men to give the appearance of a double eyelid, which gives the man a western look.
Male breast enhancement treats , which means "woman like breasts." It is a fairly common and often embarrassing condition with which many men struggle. There are several contributing factors to this condition, including:
·Impaired liver function
·Medications that contain estrogen
·Use of anabolic steroids
·And many other ailments and conditions
According to the study, 16,275 men elected this surgery in 2005. When diet and exercise fail to reduce male breast size, it often becomes desirable to correct the problem with cosmetic surgery.
Not all procedures available involve major surgery; men are also opting for minimally invasive procedures. The top five such procedures are:
·Botox
·Microderm abrasion
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·Chemical peel
·Laser skin resurfacing
As technology and medical advances continue, more cosmetic procedures will be safely performed on men and women in increasing numbers. As the social stigmas associated with enhancing looks through surgery abate, more men will likely turn to cosmetic surgeons to improve their appearance.