FDA Issues Stern Warning
In a recent safety warning issued by the FDA they state "Many of these over-the-counter fillers are meant to be used with at-home injection devices, none of which have been OK’d by the FDA. [these devices] use high pressure rather than needles to force facial or lip fillers into the skin. The hand-held devices are marketed under names like Hyaluron Pen and Hyla-Pen, and using descriptors like microinjectors, noninvasive injection pens, noninvasive nebulizer syringes, high-pressure pens or sprayer pens."
It is extremely dangerous to purchase over-the-counter fillers and even more dangerous to have them injected by a non-licensed individual.
It is extremely dangerous to purchase over-the-counter fillers and even more dangerous to have them injected by a non-licensed individual. There are nerves and blood vessels in the face that, when damaged, can cause paralysis or necrosis. The only fillers cleared by the FDA should be injected and must be injected with a needle or cannula by a licensed healthcare professional.
The FDA states "The unregulated fillers and devices have been linked to serious adverse events, including permanent damage to the skin, lips and eyes."
The American Society for Dermatologic Surgery (ASDSA) has also issued a patient safety alert regarding self-injecting hyaluron pens after videos surfaced online of children/teens buying and injecting themselves and others. The ASDSA stated that “Facial injections require an in-depth knowledge and expertise of anatomy and, when left to untrained consumers, pose the risk of serious injury.”
Unapproved fillers are often manufactured in foreign countries that do not do an effective job of regulating the manufacturers of these medical products.
It’s not just the delivery system that is dangerous. Unapproved fillers are often manufactured in foreign countries that do not do an effective job of regulating the manufacturers of these medical products. Ingredients can be contaminated with dangerous chemicals, made in unclean environments or even cut with other dangerous ingredients to reduce cost. Once injected these inferior products can cause infections, severe reactions, and even necrosis. These conditions can cause permanent damage and some injected products must be removed surgically. When self-injecting the consumer rarely has a way of knowing if the product they are injecting is genuine or safe. Unfortunately, most of these products are often discovered when clients begin reporting adverse effects from the contaminated or poor quality products. Further, there is little recourse with the manufacturer and little may be done to prevent them from continuing to sell their products.
Having your procedure performed by an ethical injector gives you the option to have your hyaluronic acid (HA) lip fillers reversed if you're not happy with the results. An ethical injector will not attempt to reverse an injection if they don’t know exactly what product was injected in the first place because they are unable to predict what the results might be. This unfortunately means that someone who used a hyaluron pen and is unhappy with results are very likely to have surgical removal as their only option.
If you received more HA filler than you expected, aren't happy with the appearance of your lips or the results were uneven or lumpy you don't have to live with the results until the filler naturally dissolves in 3-18 months. HA Fillers can be fully or even partially dissolved by an experienced injector. Injections of hyaluronidase can fully dissolve HA fillers if you aren't happy with your results. Hyaluronidase can also be used to partially dissolve HA fillers to even out asymmetrical or lumpy results or to just reduce size if you feel your injections made your lips too full.
Dr. Doser, DNP, FNP-C, is a nurse practitioner with a clinical doctorate, the highest clinical degree given in her profession.
Dr. Doser echoes the FDA and ASDSA's warnings and highly recommends that any type of medical cosmetic procedure only be administered by a medical professional. When considering an aesthetic medical procedure, first and foremost, you must be able to trust your injector.
Dr. Doser, DNP, FNP-C, is a nurse practitioner with a clinical doctorate, the highest clinical degree given in her profession. Since 2005, she has excelled in the healthcare profession as an educator, nurse practitioner, and lead clinician. Her specialties include aesthetic rejuvenation, high-risk obstetrics, women's health, and urgent care.
Dr. Doser has traveled the United States training physicians and nurses on proper injection techniques and the nature of adverse events for Galderma Laboratories and has served as a subject matter expert in the areas of neuromodulators, fillers, and collagen stimulators. She has been featured on Oregon's KOIN Channel 6 News, offering her expert opinion on skin care and various health topics.
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