question: How do companies test invasive treatments like freezing fat off or liposuction? Wouldn't many people die/be seriously injured in the process of making it "safe" for the customers?
comment: Devices go through strict testing on animal models before a human can even come near it. They know the treatment is atleast safe on mammals, which are very similar to us in terms of physiology. This is not always the case, sometimes clinical trials on humans do run badly.
passages: The company developed a medical device to remove fat using a process called cryolipolysis, which it branded as "CoolSculpting". The device works by pulling a piece of flesh between two paddles, which cool it to below freezing and hold the temperature there for a half hour or so. Afterwards the flesh is frozen and numb; the numbness persists for two to three months. For the clinics that use it, there is a high capital investment, and a room is tied up for a relatively long time. It is intended for body contouring and not general weight loss. As of 2013, clinical trials have found that Cryolipolysis is moderately effective and has mostly mild and temporary side-effects.
   In 2010, Zerona, another low-level laser treatment, was cleared for marketing by the FDA as an infrared lamp. Zeltiq obtained FDA marketing clearance for cryolipolysis of the flanks, and in 2012 received marketing clearance for cryolipolysis of the abdomen.
   Typical cost per treatment area varies depending on location. Price in the US ranges from $750 to $1,500, with UK prices about £750 per area to be treated. Treatment time for general use/application is 35–60 minutes per site, depending on the applicator used. In the U.S., the CoolSculpting procedure is FDA-cleared for the treatment of visible fat bulges in the submental area, thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks, and upper arm. It is also FDA-cleared for use on submental area treatments.
  
  Section::::Regulatory status.
   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.
  
  Section::::Health warnings.
   Cryolipolysis is a method to remove fat by freezing. The method involves controlled application of cooling within the temperature range of -11 to +5 °C for the non-invasive, localized reduction of fat deposits, intending to reshape the contours of the body. The degree of exposure to cooling causes cell death of subcutaneous fat tissue, without apparent damage to the overlying skin. It appears primarily applicable to limited discrete fat bulges. Adverse effects include transient local redness, bruising and numbness of the skin are common side effects of the treatment and are expected to subside. Typically sensory deficits will subside within a month. The effect on peripheral nerves was investigated and failed to show permanent detrimental results.
   Based on the premise that fat cells are more easily damaged by cooling than skin cells (such as popsicle panniculitis), cryolipolysis was developed to apply low temperatures to tissue via thermal conduction. In order to avoid frostbite, a specific temperature level and exposure are determined, such as 45 minutes at . While the process is not fully understood, it appears that fatty tissue that is cooled below body temperature, but above freezing, undergoes localized cell death ("apoptosis") followed by a local inflammatory response that gradually over the course of several months results in a reduction of the fatty tissue layer.
   Anderson and colleagues invented a crude device to noninvasively remove fat by freezing it, in a process called cryolipolysis; and a startup company called Juniper Medical exclusively licensed patent filings on the invention from Massachusetts General Hospital when Juniper was founded; Juniper became Zeltiq Aesthetics. 
   Since 2003, Loders Croklaan, a wholly owned subsidiary of Malaysia's IOI Group has been providing trans fat free bakery and confectionery fats, made from palm oil, for giant food companies in the United States to make margarine.
  
  Section::::Food industry response.:Major users' response.
  
  Some major food chains have chosen to remove or reduce trans fats in their products. In some cases these changes have been voluntary. In other cases, however, food vendors have been targeted by legal action that has generated a lot of media attention.
   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".
   The device received FDA clearance to be marketed for removing love handle fat from people's sides in September 2010 and from the stomach in 2012. It has also been approved by Health Canada and the European Union. By late 2010 CoolSculpting had been introduced as a body-sculpting procedure in Europe, Asia and Canada. By 2011, Zeltiq was approved to market the procedure in 46 countries.
   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 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.br
   Various lipolysis techniques including injection lipolysis, RF, laser, ultrasound, and cryolipolysis were forbidden in France by a decree of the French Public Health Authority in 2011. The decree was revised in 2012, distinguishing invasive techniques, which remain forbidden, from permitted non-invasive techniques; laser, RF, ultrasound and cryolipolysis that did not penetrate the skin became legal, and injection lipolysis and mesotherapy remained illegal. Laser devices that involve inserting the probe through the skin transcutaneously but do not suck out the liquefied material are also prohibited. Surgeons are permitted to perform surgical liposuction techniques using laser-assisted lipolysis so long as suction is performed.
   One plastic surgeon in Australia describes Lipotuck as a procedure that "tends to be safer" because it uses tumescent liposuction, a procedures that "numbs and softens the fat," which "avoid[s] bleeding." Lipotuck is also more routine, and can be done as an outpatient procedure. Lipotucks can have the risk of seroma, which happens when some fluid collects in the surgical area that requires a small incision to drain afterwards.
   Fat is sometimes removed from one location to another on a person in an autograft, such as in some breast reconstruction and breast augmentation procedures. These techniques are distinct from bariatric surgery, which aims to treat obesity by minimizing food consumption or by interfering with the absorption of food during digestion. They are distinct from injection lipolysis, which depends on device-based procedures, while injection lipolysis relies solely on injections marketed as causing lipolysis.
  
  Section::::Invasive.
  
  Section::::Invasive.:Liposuction.
   It is very difficult to measure or estimate the actual human consumption of these substances. Highly unsaturated omega-3 rich oils such as fish oil are being sold in pill form so that the taste of oxidized or rancid fat is not apparent. The health food industry's dietary supplements are self-regulated and outside of FDA regulations. To properly protect unsaturated fats from oxidation, it is best to keep them cool and in oxygen-free environments.
  
  Section::::Mechanism.
   Ultrasound-assisted liposuction techniques used in the 1980s and 1990s were associated with cases of tissue damage, usually from excessive exposure to ultrasound energy. Third-generation UAL devices address this problem by using pulsed energy delivery and a specialized probe that allows physicians to safely remove excess fat. UAL is beneficial in people with a particular skin tone, in liposuction of areas that are more difficult to remove fat, that include treatment of gynecomastia, or areas where secondary liposuction is being performed.
  
  Section::::Techniques.:Sutures.
   The police claimed that the suspects told them that they sold the fat at a price of $15,000 per liter, but medical experts cast doubt on that, saying that so much body fat is extracted in routine medical procedures such as liposuction, that there should not be such a high demand for it.
  
  The story was that the gang members severed victims' heads, arms and legs, removed organs and suspend torsos from hooks above candles, which warmed the flesh as the fat dripped into tubs below.
   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.
   Zeltiq brought the device to market first for use in numbing the skin prior to dermatology procedures being done; Zeltiq received FDA clearance to market it for this purpose under the de novo pathway in 2010. While the company did not market its device for removing fat at that time, doctors on its scientific board were talking about that use at scientific meetings and on TV news, and doctors started using it off-label for "body-sculpting".
   Section::::Restrictive action taken by FDA against Lipodissolve.
   Physical lipolysis involves destruction of fat cells containing the fat droplets and can be used as part of cosmetic body contouring procedures. Currently there are four main non-invasive body contouring techniques in aesthetic medicine for reducing localized subcutaneous adipose tissue in addition to the standard minimally invasive liposuction: low-level laser therapy (LLLT), cryolipolysis, radio frequency (RF) and high-intensity focused ultrasound (HIFU).. However, they are less effective with shorter lasting benefits and can remove significantly smaller amounts of fat compared to traditional surgical liposuction or lipectomy. However, future drug developments can be potentially combined with smaller procedures to augment the final result.
   Liposuction is a type of cosmetic surgery that removes fat from the human body in an attempt to change its shape. Evidence does not support an effect on weight beyond a couple of months and it does not appear to affect obesity related problems. In the United States it is the most commonly done cosmetic surgery.
  
  Serious complications include deep vein thrombosis, organ perforation, bleeding, and infection. Death occurs in about one per ten thousand cases.
   The Agri-Food and Veterinary Authority of Singapore labels artificially marbled beef as "beef tallow-injected further processed beef". Hokubee Australia markets its fat-injected beef product under the brand name Meltique, though its halal products use canola oil instead of fat, due to concerns about cross-contamination with pork tallow.
   Injection lipolysis
  
  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.
  
raw_presuppositions: Invasive treatments are first tested on people. Invasive treatments must be tested on humans.
raw_corrections: Invasive treatments are first tested on animals. Testing is done on animals until it is deemed safe enough on mammals.