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Injectable facial implants, also known as wrinkle fillers, dermal fillers or facial soft tissue fillers, are medical device implants approved for medical use by the Food and Drug Administration (FDA) to fill in facial wrinkles in order to create a smoother appearance.
Most injectable wrinkle fillers have a temporary effect, because over time they are absorbed by the body. FDA has approved only one product made from a material that remains in the body and is not absorbed. Some wrinkle fillers contain lidocaine, which is intended to decrease pain or discomfort related to the injection.
The materials used in injectable wrinkle fillers include:
Absorbable materials (temporary)
- Collagen: Collagen is a type of protein that is a major part of skin and other tissues in the body. Sources of purified collagen used in wrinkle fillers can be from cow (bovine) or human cells. The effects of collagen fillers generally last for 3-4 months. They are the shortest lasting of injectable filler 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 wrinkle smoothing effect. Sources of hyaluronic acid used in wrinkle fillers can be from bacteria or rooster combs (avian). In some cases, hyaluronic acid used in wrinkle 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, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle. The effects of this material last approximately 18 months.
- 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 materials (permanent)
- 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. For wrinkle filling, PMMA beads are suspended in a gel-like solution that contains cow (bovine) collagen and injected into the wrinkle.
The absorbable (temporary) injectable wrinkle fillers are FDA approved for the correction of moderate to severe facial wrinkles and skin folds, such as nasolabial folds. Nasolabial folds are the wrinkles on the sides of your mouth that extend towards the nose. They are commonly referred to as "smile lines" or "marionette lines."
The non-absorbable (permanent) injectable wrinkle filler is FDA approved ONLY for the correction of nasolabial folds.
Some injectable wrinkle fillers are approved for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). The FDA has approved two absorbable injectable wrinkle fillers for lip augmentation in patients over the age of 21.
Patients may need more than one injection to get the desirable wrinkle smoothing effect. Successful results will depend on the health of the skin, the skill of the doctor, and type of filler used. The time that the smoothing effect lasts depends on the filler material used.
As in any medical procedure, there are risks involved with the use of injectable wrinkle fillers. That is why it is important for you to understand their limits and possible risks.
Most side effects associated with wrinkle fillers happen shortly after injection and most go away after several days.
In some cases the side effects may appear weeks, months or years after injection.
Any injectable wrinkle filler could cause long-term side effects, permanent side effects, or both.
Common side effects include:
- Itching, rash
Less common side effects include:
- Raised bumps in or under the skin (nodules or granulomas) that may need to be surgically removed
- Open or draining wounds
- A sore at the injection site
- Allergic reaction
- Necrosis (tissue death)
Allergy testing is required for particular types of filler materials, such as those taken from cows (bovine). In rare cases, severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance can occur.
The following side effects have also been reported to FDA:
- Migration/ movement of filler material from the site of injection
- Leakage or rupture of the filler material at the injection site or through the skin (which may result from tissue reaction or infection)
- Blurred vision and flu-like symptoms
If you choose to have these fillers removed through surgery, you may experience the same risks typically associated with surgery. You should be aware that it may be difficult to remove the filler material.
Wrinkle fillers should not be injected into blood vessels, because they may obstruct blood flow.
FDA has approved injectable wrinkle fillers for treatment of moderate to severe wrinkles and localized fat loss (lipoatrophy) in the face. The FDA has approved two absorbable injectable wrinkle fillers for lip augmentation in patients over the age of 21
FDA has NOT approved injectable wrinkle fillers to:
- Augment (increase volume of) or alter the shape of facial features such as cheeks and nose
- Increase breast size (breast augmentation)
- Increase size of the buttocks
- Rejuvenate the hands or feet
- Implant into bone, tendon, ligament, or muscle
FDA has NOT approved liquid silicone or silicone gel for injection to fill wrinkles or augment tissues anywhere in the body.
Information for Patients
Before deciding to have injectable wrinkle fillers, it is recommended that:
- You seek a specialist in the fields of dermatology or plastic surgery.
- Select a doctor who is trained to perform the wrinkle filler injection procedure. Having wrinkle filler injected should be considered a medical procedure, not a cosmetic treatment.
- You know the type of product that is being used and all possible side effects.
- You ask for the patient labeling for the product that your doctor plans to use. Patient labeling should be available for all FDA approved injectable wrinkle fillers.
- You have realistic expectations about the benefits you want to achieve. Discuss the amount of wrinkle smoothing effect that you expect and the amount of wrinkle smoothing effect that your doctor expects to be able to achieve based on your situation.
Additionally, you should be aware that:
- FDA approval is based on controlled, clinical study of these products when used in the face.
- The safe use of these products with Botox or other wrinkle therapies has not been evaluated in a controlled, clinical study.
- The safe use of these products repeatedly over a long period of time has not been evaluated in a controlled, clinical study.
- Health insurance does not typically cover elective surgical procedures such as wrinkle correction.
- The safety of these products is unknown when used during pregnancy, while breast feeding or in patients under 18 years of age.
You should NOT use some of these products if any of the following applies to you:
- Your skin is inflamed or infected. If you have an active inflammatory condition, (cysts, pimples, rashes, or hives) or infection, wrinkle filler injection should be delayed until this inflammatory condition has been managed.
- You are prone to excessive scarring (keloids) and/or thick scarring (hypertrophic scars)
- You have a bleeding disorder
- You have severe allergies or have a history of anaphylaxis (acute allergic reaction)
- You are allergic to collagen or eggs (when considering wrinkle fillers that contain collagen or egg derived products)
- You are allergic to animal products (when considering wrinkle fillers that contain materials from animals)
- You are allergic to lidocaine (when considering wrinkle fillers that contain lidocaine)