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Dermal Fillers, Aesthetic Medical Devices Regulated by FDA

Jun 10 2022


Aesthetic (cosmetic) devices are typically used to improve appearance. They may be regulated by FDA depending upon their intended use and whether they impact the structure or function of the body.


Dermal fillers, also known as injectable implants, soft tissue fillers, lip and facial fillers, or wrinkle fillers are medical device implants approved by the FDA for use in helping to create a smoother and/or fuller appearance in the face, including nasolabial folds (the lines extending from the sides of the nose to the edges of the mouth), cheeks, chin, lips, and back of the hands.



It is Class III and approved through the PMA process. During PMA application review the FDA reviews the following to make a final benefit/risk determination :


  • Quality System Inspection(s) and Bioresearch Monitoring (BIMO) Audit (audit of clinical study data) conducted by FDA personnel

  • Substantive review

- Nonclinical Studies

- Clinical Studies

- Labeling: Clinician and Patient



The FDA's approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue and the hands.



Materials


Most dermal fillers have a temporary effect, because they contain materials that are absorbed by the body over time. The FDA has approved only one product made from a material that remains in the body and is not absorbed. Some dermal fillers also contain lidocaine, which is intended to decrease pain or discomfort related to the injection.



Absorbable (temporary) materials

  • Hyaluronic acid: Hyaluronic acid is a type of sugar (polysaccharide) that is present in body tissues, such as in skin and cartilage. It is able to combine with water and swell when in gel form, causing a smoothing/filling effect. Sources of hyaluronic acid used in dermal fillers can be from bacteria or rooster combs (avian). In some cases, hyaluronic acid used in dermal fillers is chemically modified (crosslinked) to make it last longer in the body. The effects of this material last approximately 6 – 12 months.

  • Calcium hydroxylapatite: Calcium hydroxylapatite is a type of mineral that is commonly found in human teeth and bones. For wrinkle filling in the face or for the hand, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle in the face or under the skin in the back of the hand. The effects of this material last approximately 18 months. While in the body, calcium hydroxylapatite will be visible in x-rays and may obscure underlying features.

  • Poly-L-lactic acid (PLLA): PLLA is a biodegradable, biocompatible man-made polymer. This material has wide uses in absorbable stitches and bone screws. PLLA is a long lasting filler material that is given in a series of injections over a period of several months. The effects of PLLA generally become increasingly apparent over time (over a period of several weeks) and its effects may last up to 2 years.


Non-absorbable (permanent) materials

  • Polymethylmethacrylate beads (PMMA microspheres): PMMA is a non-biodegradable, biocompatible, man-made polymer. This material is used in other medical devices, such as bone cement and intraocular lenses. PMMA beads are tiny, round, smooth particles that are not absorbed by the body. When used as a soft tissue filler, PMMA beads are suspended in a gel-like solution that contains cow (bovine) collagen and injected into the face. Collagen is a type of protein that is a major part of skin and other tissues in the body.



Approved Uses of Dermal Fillers


The FDA has approved dermal fillers for use in adults 22 years of age or older (over the age of 21) for specific uses :


  • Absorbable (temporary) fillers are approved for moderate to severe facial wrinkles and skin folds, such as nasolabial folds (lines extending from the sides of the nose to the edges of the mouth) and perioral lines (small wrinkles in the skin around the mouth and lips).

  • Augmentation (increased volume) of lips, cheeks, chin, and back of the hand.

  • Non-absorbable (permanent) fillers are approved for only nasolabial folds and cheek acne scars.

  • The restoration and correction of signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).

  • Correction of contour deficiencies, such as wrinkles and acne scars.



Unapproved Uses of Dermal Fillers


The FDA recommends against using dermal fillers or any injectable filler for body contouring and enhancement to :


  • Increase breast size (breast augmentation)

  • Increase size of the buttocks

  • Increase fullness of the feet

  • Implant into bone, tendon, ligament, or muscle

  • Inject the glabella (area between eyebrows), nose, periorbital area (around the eyes), forehead, or neck



These uses for dermal fillers are not approved by the FDA.


Injectable silicone is not approved for any aesthetic procedure including facial and body contouring or enhancement. Silicone injections can lead to long term pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death.


Needle-free devices are not approved by the FDA for the injection of dermal fillers. The safety and effectiveness of needle-free devices for injection of dermal fillers is not known. The FDA has also not approved any dermal fillers for over-the-counter (OTC) use.




Dermal Fillers and Botulinum Toxin Products


The FDA also has approved botulinum toxin products such as Botox, Dysport, Xeomin and Jeuveau to treat facial wrinkles. These products are not dermal fillers. They are injectable drugs that work by keeping muscles from tightening, so the wrinkles don’t show as much. The safe use of dermal fillers in combination with Botox and other treatments has not been evaluated in clinical studies.


Although botulinum toxin products are derived from the same bacteria that cause botulism, the amounts used for cosmetic purposes are purified and many orders of magnitude smaller. The FDA has approved these injectable drugs for the temporary improvement in the appearance of one, or perhaps several types of facial lines, including frown lines, forehead lines, and crow’s feet.


Side effects reported in clinical trials include facial weakness, eyelid drooping, and brow drooping. Other adverse events included localized pain, swelling, reddening, and bruising at the injection site. In rare cases, injections have resulted in double vision, dry eyes, or difficulty swallowing or breathing. The injection of botulinum toxin products for cosmetic purposes is not recommended for use while pregnant or lactating.




Provision Consulting Group can help you to be in compliance with any

products that are subject to the FDA assist businesses with U.S. Food and Drug

Administration (FDA) registration and compliance requirements.

We offer streamlined solutions to complex procedural issues affecting U.S.

FDA-regulated industries, including medical devices; dietary supplements;

over-the-counter drugs, and cosmetic products.



If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

please CONTACT US.


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SOURCE :

https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/dermal-fillers