Lipodissolve Products for Weight Loss

On April 7, 2010, the Food and Drug Administration (FDA) issued warning letters to companies selling lipodissolve products and alerted consumers about the risk of skin reactions with the products.

The lipodissolve procedure involves a series of injections that purport to selectively melt away pockets of fat in the body. The procedure also is known as lipozap, lipotherapy, mesotherapy and injection lipolysis, and is usually administered in medical spas.

There are no drugs approved by the FDA for injection for fat elimination.

Lipodissolve injections often contain the chemicals phosphatidylcholine (PC) and deoxycholate (DC) in various combinations with one another. Vitamins, minerals, herbal extracts and other drugs are sometimes added to the cocktail.

PC is an unproven dietary supplement that has been promoted for liver disorders, peripheral vascular disorders, elevated blood fats (cholesterol), fat particles circulating in the blood and low levels of choline. DC is a bile derivative.

Lipodissolve products are widely sold throughout the U.S. Many medical spas have established websites to promote and offer lipodissolve products for cosmetic procedures. It is impossible to know the volume of drug products used in these procedures. Medical spas and compounding pharmacies, which may mix and sell lipodissolve drugs, are generally not required to register with the FDA or to report the products they make or use.

The safety of lipodissolve products

The overall safety of lipodissolve products is unknown. There have been published reports of adverse effects from their use, which include incidents of injection-site reactions (e.g. prolonged swelling, redness and pain). Inflammation, ulceration, abscess, tissue death, scarring and other skin reactions also have been seen, according to the FDA’s announcements.

In addition, the FDA has received reports through its MedWatch Adverse Event Reporting Program from lipodissolve users that describe permanent scarring, deformation, and deep, painful knots under the skin in areas where lipodissolve had been injected.

Lipodissolve warning letters

This year, the FDA issued warning letters to six U.S.-based medical spas and a company in Brazil for making false or misleading statements about lipodissolve on their websites.

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, Fla.)
• All About You Med Spa (Madison, Ind.)

These companies were cited for a variety of violations, including making unsupported claims that the products have outstanding safety records and are superior to other fat loss procedures, including liposuction. In addition, some of the warning letters indicated that the companies had made claims that lipodissolve products can be used to treat some medical conditions, such as male breast enlargement, benign fatty growths (known as lipomas), excess fat deposits and surgical deformities. The FDA stated that it is not aware of clinical evidence to support any of these claims.

What You Can Do

You should avoid lipodissolve procedures and products because there is no evidence that they are safe or effective. In fact, they may be dangerous.

A change in lifestyle, reduction in calories and an increase in exercise are safe and effective ways to lose weight and keep it off. Changing your lifestyle is not advertised in the media because the only person who would profit is you.

MedWatch

Consumers and health care professionals may report serious side effects to the FDA’s MedWatch Adverse Event Reporting Program either online or by regular mail, fax or phone.

• Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088