FDA Warns of Dangers of Unauthorized Fat-Dissolving Injections

27 December 2023

Reports of severe side effects prompt FDA to issue a warning about unapproved fat-dissolving injections.

The Food and Drug Administration (FDA) has issued a warning about the potential dangers of using unauthorized versions of fat-dissolving injections. These injections, also known as lipolysis injections, are nonsurgical procedures that aim to melt away small amounts of fat beneath the skin. While the FDA has approved one such injection, called Kybella, it has recently come to their attention that unapproved versions are being used at clinics and med spas across the United States, including those sold online under various brand names.

1. The proliferation of unapproved fat-dissolving injections:

The FDA has expressed concern over the increasing availability of unapproved fat-dissolving injections in the market. These unauthorized injections, sold under brand names like Aqualyx, Lipodissolve, Lipo Lab, and Kabelline, contain chemicals such as phosphatidylcholine and sodium deoxycholate that have not been approved by the FDA. The agency has received reports of severe side effects associated with the use of these unapproved injections, including scarring, infections, skin deformities, cysts, and painful knots.

2. Lack of proper licensing and self-administration risks:

In some cases, the FDA discovered that these injections were administered at clinics or med spas by individuals who may not have had the necessary licensing or qualifications. Additionally, there have been instances of people purchasing fat-dissolving products online and self-administering them, which poses significant risks. Dr. Dan Maselli, an obesity medicine physician, warns that injecting oneself with these products purchased online is dangerous due to the lack of knowledge about the chemicals used and the potential for injecting into the wrong tissues, such as muscles, blood vessels, or nerves.

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3. Serious side effects and patient experiences:

The FDA highlighted the case of a woman who developed knots on both of her arms one week after receiving unapproved injections. The knots persisted even after two months of antibiotic treatment. This case serves as an example of the serious and potentially long-lasting side effects that can occur as a result of using unauthorized fat-dissolving injections. The FDA’s warning aims to prevent further cases of harm and inform consumers about the risks associated with these unapproved products.

4. The allure of quick fixes and cosmetic concerns:

Specialists in obesity medicine, such as Dr. Shauna Levy, emphasize that people often seek fat-dissolving treatments as a quick fix for weight loss or cosmetic reasons. However, these treatments fail to address the underlying issue of metabolic health, which is crucial for sustainable weight loss. Dr. Levy suggests that medications like Ozempic and Wegovy, as well as bariatric surgery, are more effective in improving metabolic health. Fat-dissolving injections may cause the fat to die, but they can also lead to adverse reactions due to the body’s response to the dead tissue.

5. Seeking professional guidance and FDA recommendations:

To ensure safety and efficacy, individuals seeking fat-dissolving injections for cosmetic reasons are advised to consult licensed plastic surgeons. The FDA also urges consumers to avoid purchasing fat-dissolving products from websites, as they may be ineffective and carry a high risk of severe side effects. If someone experiences side effects from unapproved injections, the agency recommends seeking immediate medical attention.

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The FDA’s warning about the dangers of unauthorized fat-dissolving injections sheds light on the potential risks associated with these treatments. Reports of severe side effects, such as scarring, infections, and skin deformities, highlight the importance of using FDA-approved injections and seeking treatment from licensed professionals. As the demand for quick fixes and cosmetic procedures continues to rise, it is crucial for individuals to prioritize their overall metabolic health and consult experts in the field. The FDA’s recommendations aim to protect consumers and ensure their safety when considering fat-dissolving injections.

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