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Injection lipolysis is a controversial cosmetic procedure in which drug mixtures are injected into patients with the goal of destroying fat cells. 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]
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 practice. [2] [3] [4] [5] [6] [7] [8] [9] [10] 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. [2]
In 1966, investigators noted that the intravenous infusion of PC-containing solutions could remove fat emboli. [11] Later, a drug formulation called Lipostabil containing 5% PC and 2.5% deoxycholate (DC) was approved in Germany and used in the treatment of fat embolism, [12] [13] dyslipidemia, [14] and alcohol-induced liver cirrhosis. [15] The first report of Lipostabil injection for fat removal demonstrated that infra-orbital ("under the eyelid") fat could be removed by Lipostabil injection. [16]
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).The Aesthetic Surgery Education and Research Foundation has funded on behalf of the American Society for Aesthetic Plastic Surgery a half side comparison study with interesting results [17]
On April 7, 2010, the US Food and Drug Administration issued Warning Letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called "lipodissolve", or for otherwise misbranding lipodissolve products. "We are concerned that these companies are misleading consumers", said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by the FDA for fat removal".
For the complete FDA statement, see here .
To see the warning letter, see .
The FDA has received reports of adverse effects in persons who have had the procedure using these drugs, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where the lipodissolve products have been injected. The warning letters were issued to the following U.S. companies: Monarch Medspa, King of Prussia, Pa; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn PURE Med Spa, Boca Raton, Fl.; and All About You Med Spa, Madison, Ind. The Brazilian company receiving a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com.
The FDA is requesting a written response from the U.S. companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future. Each U.S. company has been informed in its warning letter that failure to promptly correct the violations may result in legal action. Each of the companies involved has been cited for a variety of regulatory violations, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction. Additionally some of the letters indicate that the companies have made claim that lipodissolve products can be used to treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities. The FDA is not aware of clinical evidence to support any of these claims.[ citation needed ]
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 because 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. [18]
On the other hand the therapy is very often administered especially in German speaking countries because the drug Lipostabil N has been approved in Germany for more than 40 years. A physicians' network, the NETWORK-Lipolysis with 3,000 members worldwide amongst them 1,000 alone in German speaking countries has collected safety data. The latest published so-called Lipolysis Report 2015 has been published in 2016. [19] 4% of the members have answered the survey. 29,889 patient results have been collected with in total ca. 76,000 treatment sessions. Nowadays the composition is compounded by pharmacies in Germany and Switzerland.[ citation needed ]
Botulinum toxin (BoNT) is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction, thus causing flaccid paralysis. The toxin causes the disease botulism. The toxin is also used commercially for medical and cosmetic purposes.
Penis enlargement, or male enhancement, is any technique aimed to increase the size of a human penis. Some methods aim to increase total length, others the shaft's girth, and yet others the glans size. Techniques include surgery, supplements, ointments, patches, and physical methods like pumping, jelqing, and traction.
Lipolysis is the metabolic pathway through which lipid triglycerides are hydrolyzed into a glycerol and three fatty acids. It is used to mobilize stored energy during fasting or exercise, and usually occurs in fat adipocytes. The most important regulatory hormone in lipolysis is insulin; lipolysis can only occur when insulin action falls to low levels, as occurs during fasting. Other hormones that affect lipolysis include glucagon, epinephrine, norepinephrine, growth hormone, atrial natriuretic peptide, brain natriuretic peptide, and cortisol.
A lipoma is a benign tumor made of fat tissue. They are generally soft to the touch, movable, and painless. They usually occur just under the skin, but occasionally may be deeper. Most are less than 5 cm (2.0 in) in size. Common locations include upper back, shoulders, and abdomen. It is possible to have a number of lipomas.
A cannula is a tube that can be inserted into the body, often for the delivery or removal of fluid or for the gathering of samples. In simple terms, a cannula can surround the inner or outer surfaces of a trocar needle thus extending the effective needle length by at least half the length of the original needle. Its size mainly ranges from 14 to 24 gauge. Different-sized cannula have different colours as coded.
Phosphatidylcholines (PC) are a class of phospholipids that incorporate choline as a headgroup. They are a major component of biological membranes and can be easily obtained from a variety of readily available sources, such as egg yolk or soybeans, from which they are mechanically or chemically extracted using hexane. They are also a member of the lecithin group of yellow-brownish fatty substances occurring in animal and plant tissues. Dipalmitoyl phosphatidylcholine is a major component of pulmonary surfactant and is often used in the L/S ratio to calculate fetal lung maturity. While phosphatidylcholines are found in all plant and animal cells, they are absent in the membranes of most bacteria, including Escherichia coli. Purified phosphatidylcholine is produced commercially.
Mesotherapy is a non-invasive non-surgical technique that uses micro-injections of pharmaceutical and homeopathic preparations, plant extracts, vitamins, and other ingredients into subcutaneous fat. Mesotherapy injections allegedly target adipose fat cells, apparently by inducing lipolysis, rupture and cell death among adipocytes.
An infantile hemangioma (IH), sometimes called a strawberry mark due to appearance, is a type of benign vascular tumor or anomaly that affects babies. Other names include capillary hemangioma, strawberry hemangioma, and strawberry nevus. They appear as a red or blue raised lesion on the skin. Typically, they begin during the first four weeks of life, growing until about five months of life, and then shrinking in size and disappearing over the next few years. Often skin changes remain after they shrink. Complications may include pain, bleeding, ulcer formation, heart failure, or disfigurement. It is the most common tumor of orbit and periorbital areas in childhood. It may occur in the skin, subcutaneous tissues and mucous membranes of oral cavities and lips as well as in the liver, spleen and kidneys.
Deoxycholic acid, also known as cholanoic acid, and sold under the brand name Kybella among others, is a bile acid. Deoxycholic acid is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria. The two primary bile acids secreted by the liver are cholic acid and chenodeoxycholic acid. Bacteria metabolize chenodeoxycholic acid into the secondary bile acid lithocholic acid, and they metabolize cholic acid into deoxycholic acid. There are additional secondary bile acids, such as ursodeoxycholic acid. Deoxycholic acid is soluble in alcohol and acetic acid. When pure, it comes in a white to off-white crystalline powder form.
Lipoatrophy is the term describing the localized loss of fat tissue. This may occur as a result of subcutaneous injections of insulin in the treatment of diabetes, from the use of human growth hormone or from subcutaneous injections of copaxone used for the treatment of multiple sclerosis. In the latter case, an injection may produce a small dent at the injection site. Lipoatrophy occurs in HIV-associated lipodystrophy, one cause of which is an adverse drug reaction that is associated with some antiretroviral medications.
Carboxytherapy is a non-surgical cosmetic medicine treatment. Carboxytherapy employs injections or transdermal application to infuse gaseous carbon dioxide below the skin into the subcutaneous tissue through a needle or skin. It has a necrotizing effect on fat tissue fat cells, stimulate blood flow, improve the skin's elasticity and reduce the appearance of cellulite As of 2009, Carboxytherapy wasn't approved by the FDA. It has also become a popular treatment for stretch marks.
Liposuction, or simply lipo, is a type of fat-removal procedure used in plastic surgery. Evidence does not support an effect on weight beyond a couple of months and does not appear to affect obesity-related problems. In the United States, liposuction is the most common cosmetic surgery.
Benign symmetric lipomatosis is a skin condition characterized by extensive symmetric fat deposits in the head, neck, and shoulder girdle area. The German surgeon Otto Wilhelm Madelung was the first to give a detailed description of the disorder. This condition is very rare, with an estimated incidence of 1 in 25,000, and affects males up to 30 times more frequently than females.
Pulsed electromagnetic field therapy, also known as low field magnetic stimulation (LFMS) uses electromagnetic fields in an attempt to heal non-union fractures and depression. By 2007 the FDA had cleared several such stimulation devices.
Aesthetic medicine is a broad term for specialties that focus on altering cosmetic appearance through the treatment of conditions including scars, skin laxity, wrinkles, moles, liver spots, excess fat, cellulite, unwanted hair, skin discoloration and spider veins. Traditionally, it includes dermatology, oral and maxillofacial surgery, reconstructive surgery and plastic surgery, surgical procedures, non-surgical procedures, and a combination of both. Aesthetic medicine procedures are usually elective.
Cellulite is the herniation of subcutaneous fat within fibrous connective tissue that manifests as skin dimpling and nodularity, often on the pelvic region, lower limbs, and abdomen. Cellulite occurs in most postpubescent females. A review gives a prevalence of 85–98% of women, indicating that it is physiological rather than pathological. It can result from a complex combination of factors ranging from hormones to heredity.
Tofacitinib, sold under the brand Xeljanz among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Tesamorelin (INN) is a synthetic form of growth-hormone-releasing hormone (GHRH) which is used in the treatment of HIV-associated lipodystrophy, approved initially in 2010. It is produced and developed by Theratechnologies, Inc. of Canada. The drug is a synthetic peptide consisting of all 44 amino acids of human GHRH with the addition of a trans-3-hexenoic acid group.
Semaglutide, sold under the brand name Ozempic among others, is an antidiabetic medication used for the treatment of type 2 diabetes and long-term weight management.
Fat removal procedures are used mostly in cosmetic surgery with the intention of removing unwanted adipose tissue. The procedure may be invasive, as with liposuction, or noninvasive using laser therapy, radiofrequency, ultrasound or cold (cryoablation) to reduce fat, sometimes in combination with injections.
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