Dermal Fillers Do’s and Don’t by FDA

Types of Dermal Fillers

Temporary fillers include the following materials:

• Hyaluronic acid, a sugar that is naturally found in the body
• Calcium hydroxylapatite, a mineral and a major component of bone
• Poly-L-lactic acid (PLLA), a biodegradable, synthetic material

There’s only one FDA-approved dermal filler that is not absorbed by the body. It is made with polymethylmethacrylate (PMMA) beads suspended in a solution that contains bovine (cow) collagen. PMMA beads are tiny round, smooth, plastic beads.

FDA-approved uses of Dermal Fillers

Dermal fillers are approved for specific uses in people aged 22 and older.

Those uses include:

• Correcting moderate-to-severe facial wrinkles and skin folds
• Increasing fullness of lips, cheeks, chin, under-eye hollows, jawline, and back of the hand
• Restoring facial fat loss in people with human immunodeficiency virus (HIV)
• Correcting acne scars on the cheek

FDA warnings about unapproved fillers

The FDA has not approved injectable silicone or any injectable fillers for body contouring or enhancement. The FDA has warned against getting filler injected into the breasts, buttocks, or spaces between the muscles. Using injectable filler for large-scale body contouring or body enhancement can lead to serious injury, including long-term pain, infection, permanent scarring or disfigurement, and even death.

The FDA has not approved needle-free devices for the injection of dermal fillers and warns against using them to inject hyaluronic acid or other lip and facial fillers. The injectors use high pressure and do not provide enough control over where filler will be placed. Serious injuries and in some cases, permanent harm to the skin, lips or eyes have occurred.

The FDA also warns against buying or using lip or facial fillers that are sold directly to the public. They are not FDA approved and may be contaminated with chemicals and infectious organisms. The only FDA-approved dermal fillers are supplied by a prescription for injection by a licensed health care professional using a syringe with a needle or a cannula (a small flexible tubing with a blunt tip that is inserted under the skin).

Risks of FDA-approved fillers

As with any medical procedure, there are risks involved with the use of dermal fillers. Most side effects reported in clinical trials and post-market surveillance occur shortly after injection and go away within a few weeks. In some cases, side effects may emerge weeks, months, or years later.

Common risks include:

• Bruising
• Redness
• Swelling
• Pain
• Tenderness
• Itching
• Rash
• Difficulty in performing activities (only observed when injected into the back of the hand)
• People should be tested for allergies before receiving dermal fillers made with certain materials, especially materials derived from animals, such as collagen.

Unintended injection into blood vessels

The most serious risk associated with dermal fillers is accidental injection into a blood vessel.  Filler that enters a blood vessel can cause skin necrosis (death of tissue), stroke, or blindness. While the chances of this happening are low, if it does happen, the resulting complications can be serious and may be permanent.

Removing Dermal Fillers

If a person want to have fillers removed or reduced because of side effects, they may need additional procedures to reduce the filler or surgery to remove it. These procedures carry their own risks. Be aware that it may be difficult or impossible to remove some filler materials.

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.