The U.S. Food and Drug Administration sent letters to six U.S. based medical spas for making false or misleading statement about drugs that they claim will eliminate fat in a procedure called “lipodissolve.”
The U.S. companies claim that the drugs used for lipodissolve procedures are both safe and effective; however, these drugs have not been approved or even evaluated by the FDA.
Lipodissolve is a popular cosmetic treatment which claims to eliminate fat. It involves a series of drug injections that are purported to dissolve and permanently remove small pockets of fat from the body. The process is also known as meso therapy, lipozap, lipotherapy, or injection lipolysis. The drugs most commonly used in lipodissolve procedures include phosphatidycholine and deoxycholate. The drugs are usually combined with each other and may also be combined with herb extracts, minerals and vitamins. None of the components of lipodissolve injections have been approved or studied by the FDA for this purpose.
The companies also claim that lipodissolve can be used to treat certain medical conditions such as male breast enlargement, benign fatty growths called lipomas, excess fat deposits and surgical deformities. The FDA says it is not aware of any credible scientific evidence for these claims. The FDA also said it has received reports of adverse effects from people who have undergone the lipodissolve procedure. These effects include skin infection, swelling, redness, skin necrosis, permanent scarring, skin deformation, and deep, painful knots under the skin in areas where lipodissolve drugs were injected.
The FDA is also concerned about the lack of a standardized for these products and the maintenance of sterility in the injection solutions.
Many dermatologists and physicians use lipodissolve as a treatment in their offices. Right now, the FDA is concentrating on companies that make false claims about lipodissolve on their web sites; however, the FDA warns that lipodissolve is not approved for fat removal and anyone getting the treatment is taking a risk.
Doctors are required to inform patients of all risks when they undergo a medical procedure. When you sign an informed consent form, you acknowledge that the doctor has told you about the normal risks of the procedure and that you agree to those risks. However, you do not agree to mistreatment or medical negligence.
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