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What CE-Approved Dermal Filler Means

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Dr. Hardik Soni

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Dermal filler treatments are FDA-approved alternative solutions to plastic surgery, which result in the correction of facial wrinkles and improve skin laxity. FDA approval on dermal filler substances and ingredients (e.g, lidocaine) is often the primary explanation offered as to why these injectable treatments are safe and certified effective. However, some would notice a CE marking on these dermal fillers as well.

So what is a CE mark and why is it important for dermal fillers? The CE marking is a regulatory mark used across the European Union, which certifies that a product is safe for use by the surgeon, the patient, and the physician assistant to the aesthetic procedure. In relation to dermal fillers for wrinkle areas, the CE mark doesn’t just ensure the safety of using the injectable treatment, it also indicates the quality of the product used.

What Dermal Filler CE Means

Dermal fillers stimulate collagen production to add volume to the skin and make it look plumper. This can also be used for lip augmentation and the treatment of deep wrinkles. The goal of the treatment is the correction of fine lines, moderate to severe facial wrinkles, and facial folds (e.g, nasolabial folds) by restoring collagen without having the need to undergo plastic surgery. 

However, there are still safety concerns involving the certification and regulatory use of dermal fillers. Most sources would claim that dermal fillers are safe because they’re FDA-approved, but it’s also best to check whether the dermal filler that will be used in the aesthetic procedure has a CE mark approval. In addition, dermal fillers are not just classified as medical devices, they’re also classified as aesthetic medicine and cosmetics.

The Conformité Européenne (CE) mark is a mandatory conformity mark used by the goods sold across the European Union for regulation. All the products sold in the European Union must have this mark, otherwise, they wouldn’t be allowed to be sold in the market. The CE mark approval indicates that a product is of excellent quality aside from being a safe product in treating facial wrinkles.

How CE-Approved Fillers Differ From FDA Approved Fillers

FDA is usually the only regulatory requirement in the United States, whereas CE is a regulatory requirement in the European Union. Products that don’t indicate either a CE or an FDA mark are considered unregulated fillers, which can put a patient at a greater risk of serious adverse reactions. Whether an injectable filler bears only one safety and regulatory certification mark isn’t very important as both FDA and CE mark assures the safety of using the product.

In general, the CE and FDA mark don’t have much of a difference in certifying the safety and effectiveness of this aesthetic procedure. The testing of CE and FDA are both extensive, although they differ in one crucial detail: the timing of the extensive laboratory testing of possible adverse reactions.

FDA-approved products had already undergone a long period of clinical trial and laboratory testing, while such things are usually shortened for CE-approved dermal filler products. However, this doesn’t entail that FDA products are safer than those bearing the CE mark because CE-marked products go through a more long-term process of regulation.

Companies bearing the CE marking are consistently auditing and reporting the post-testing phase updates on their product, which means that the products having this mark are consistently improved and developed into better versions. FDA approval on the other hand only hints at the safety of the product without any requirement to further innovate.

Kinds of Dermal Fillers That Are CE Approved

There are many kinds of dermal fillers that are CE approved to treat facial wrinkles, aside from being FDA approved. Among the popular CE-approved dermal filler products that are usually used in dermal filler treatment sessions are some of the products under the following brands:

  • Juvederm hyaluronic acid fillers (e.g, Juvederm Ultra)
  • Restylane HA filler
  • Belotero HA filler
  • Sculptra dermal filler
  • Radiesse dermal filler

The ones mentioned above use the dermal filler substances hyaluronic acid, poly-L-lactic acid, and calcium hydroxylapatite. Consequently, Merz Pharma, Allergan, and Galderma Laboratories are one of the manufacturers of CE-approved dermal filler products. Lidocaine, a hyaluronic acid filler ingredient manufactured by Merz Pharma, also has a CE mark.

There are also numerous cross-linked hyaluronic acid filler brands that have CE markings. It’s important to check whether a filler injection is a CE-approved dermal filler before using it for the dermal filler treatment.

In addition, Joonghun Pharmaceutical Co, a company headed by CEO Sukjoon Yoon, that creates dermal fillers has also acquired a CE mark for 6 of its cross-linked hyaluronic acid filler products from its Lorient product line.

Effective Dermal Filler Treatments at Ethos Spa

The effectiveness and safety of dermal fillers as a medical device for wrinkle correction depends on the quality of dermal fillers used for the treatment. This ensures that the side effects (e.g, mild pain, swelling, bruising) and adverse events are controlled and minimized, and any complications are usually reversible. Aside from the quality of dermal fillers, the expertise and training of medical professionals are also essential for a successful dermal filler treatment.  

With Ethos Spa, we make sure that you receive safe and effective cosmetic treatments from our expert aesthetic professionals. Offering the latest advances in skincare and cosmetics, our well-trained staff administer facial filler treatment with utmost skill – precision, and techniques through years of training. Get started on your beauty journey and set an appointment with our experts today.

Dr. Hardik Soni

MD, Founder/Lead Physician

About Dr. Hardik Soni

Dr. Hardik Soni is the founder and Medical Director of Ethos Aesthetics + Wellness. His primary focus is on minimally invasive and non-invasive cosmetic procedures including botulinum injection (Botox and Dysport), dermal fillers (Juvederm, Restylane, Radiesse), laser hair removal, chemical peels, and laser skin rejuvenation. Dr. Soni believes in a more conservative approach and his first goal is education. Clients are able to determine the ideal treatments after discussion with Dr. Soni regarding the expected outcomes, cost, as well as risks.

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