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FDA Issues Warnings About Lipodissolve

 

Injection lipolysis has been a hotly debated issue, and the FDA is now stepping in.

Lipodissolve appears to be on the way out as the U.S. Food and Drug Administration (FDA) recently sent warning letters to six medical spas and a Brazilian company for claiming the lipo injection treatments can eliminate fat. The medicines used in the injections have not been evaluated or approved by the FDA for this use.

lipodissolve fda warning


Lipodissolve, also known as mesotherapy, lipozap, lipotherapy, or injection lipolysis, involves a series of drug injections which are supposed to dissolve and permanently remove fatty deposits. The medicines most commonly used are phosphatidylcholine and deoxycholate, usually in various combinations with one another, and occasionally other vitamins, minerals or herbal extracts.

The FDA is not aware of any credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown. The US medical spas have 15 days to reply in writing to the FDA with a plan to correct their claims and prevent future violations. The Brazilian company uses the web to market lipodissolve products and the FDA has issued an import alert against the lipodissolve drugs.

The FDA has received reports of side effects from lipodissolve such as permanent scarring, skin deformation, and deep painful knots under the skin at the injection site.