If you are considering allowing unapproved fillers to be used on you: STOP! Unapproved dermal fillers are not always safe.
DermatologyTimes.ModernMedicine.com brought this subject to light in an article published on its website on August 6, 2014 entitled FDA: Stop Using Unapproved Dermal Filler.
The article specifically discusses a product called “Expression” by Enhancement Medical, LLC. The product is deemed as low risk to patients if it’s used as intranasal splint to minimize bleeding and swelling and to prevent the adhesions in the septum and nasal cavity. However, when Expression is used as a treatment for wrinkles, adverse effects have been reported that have posed a safety risk to patients. Some of the adverse effects have been described as swelling, lumps, bruising, discoloration, and the development of hard nodules.
On August 5, 2014, The United States Food and Drug Administration (FDA) released a safety communication entitled, Adverse Events Associated with Use of Enhancement Medical’s “Expression” Intranasal Splint as a Dermal Filler.
The communication from the FDA included the following recommendations for people undergoing procedures that use dermal fillers:
- Only receive dermal filler injections from a licensed health care provider.
- Ask your health care provider if the dermal filler they are using is FDA-approved and appropriate for the procedure you are undergoing.
- Discuss the possibility of adverse reactions to dermal fillers with your health care provider.
- If you received a dermal filler injection and are experiencing adverse events (i.e., swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules), contact your health care provider.
- If you have already received treatment with Expression as a dermal filler, discuss appropriate monitoring with your health care provider.
Walnut Creek Skin & Laser uses only approved fillers in our office. Juviderm is often our filler of choice because it is approved by the FDA as a dermal filler as a wrinkle treatment. The product consists of an injectable gel and the treatment is non-surgical. The potential side effects associated with Juviderm are generally mild, and the recovery time associated with a Juviderm treatment is minimal. There’s also very little downtime after a Juviderm treatment.
There are many dermal fillers available to the public – and some are approved by the FDA and some are not. There is a very thorough article posted on the United States National Library of Medicine – National Institutes of Health entitled Dermal Fillers: Do’s and Don’ts that offers very useful pieces of advice to individuals considering a dermal filler treatment. Make sure to read it for more information about the potential dangers of using non-approved dermal fillers.
If you are thinking about utilizing a discount or low-priced facility that uses unapproved dermal fillers, it’s time to think again. The risk is not worth the money you might save.