Dermal Fillers; Risks of Cosmetic Injectables

On June 8, 2017, the FDA updated its information on dermal fillers, also known as injectable implants, soft tissue fillers, or wrinkle fillers. Dermal 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, cheeks and lips, and for increasing the volume of the back of the hand.


The FDA has approved different dermal fillers for specific uses. The FDA has approved dermal fillers made from absorbable or temporary material for the correction of moderate to severe facial wrinkles and skin folds, such as nasolabial folds, which are the wrinkles on the sides of the mouth that extend towards the nose often referred to as “smile lines” or “marionette lines.” The FDA approved a dermal filler made from non-absorbable (permanent) material only for the correction of nasolabial folds and cheek acne scars in patients over the age of 21 years. The FDA has approved some dermal fillers 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 several absorbable dermal fillers for uses such as lip and cheek augmentation in patients over the age of 21, and the correction of contour deficiencies, such as wrinkles and acne scars. The FDA has also approved one filler for hand augmentation, which increases the volume of the back of the hands.


Patients may need more than one injection to get the desirable smoothing/filling effect. Successful results will depend on the health of the skin, skill of the doctor, and amount and type of filler used. The time that the effect lasts depends on the filler material used and the area where it is injected.


FDA approval is based on controlled, clinical study of these products when used in the face or hand. The safe use of these products with Botox or other dermal (skin) therapies has not been evaluated in a controlled, clinical study. The safety of these products used repeatedly over a long period of time has not been evaluated in a controlled, clinical study. The safety of these products is unknown when used during pregnancy, while breast feeding, or in patients under 18 years of age. The safety of these products is unknown in patients who are prone to excessive scarring (keloids) and/or thick scarring (hypertrophic scars).


The FDA has not approved dermal fillers for use in other cosmetic procedures. For example, the FDA has not approved dermal fillers to increase breast size (breast augmentation); increase size of the buttocks; increase fullness of the feet; or implant into bone, tendon, ligament, or muscle.


The FDA has not approved liquid silicone or silicone gel for injection to fill wrinkles or augment tissues anywhere in the body.


As in any medical procedure, there are risks involved with the use of dermal fillers. That is why it is important for patients to understand their limits and possible risks. Any dermal filler can cause short- or long-term side effects, permanent side effects, or a combination. However, most side effects associated with dermal fillers occur shortly after injection and most go away in less than two weeks. Swelling and pain after hand treatment may last a month or more. In some cases, side effects may appear weeks, months, or years after injection. Patients should be tested for allergies before using fillers made with certain materials, especially animal materials (e.g., cow or rooster comb).


The following risks accompany FDA-approved uses of dermal fillers. The risks associated with unapproved uses of dermal fillers, or with the use of unapproved products are not known. Common side effects include bruising, redness, swelling, pain, tenderness, itching, rash, and difficulty in performing activities (only observed when injected into the back of the hand). Less common side effects include raised bumps in or under the skin (nodules or granulomas) that may need to be surgically removed, infection, open or draining wounds, a sore at the injection site, allergic reaction, and necrosis (tissue death). The following rare side effects have also been reported to the FDA: severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance; 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; the formation of permanent hard nodules in the face or hand; vision abnormalities, including blindness; stroke; injury to the blood supply; and damage to the skin or the lips.


If a patient has permanent fillers removed or reduced through surgery, the patient may experience the same adverse events typically associated with surgery. It it may be difficult to remove the filler material.


Health care providers should only use FDA-approved dermal fillers. The FDA urged health care providers to carefully inspect all dermal filler packages for authenticity. The FDA was aware of counterfeit products being marketed and used in the U.S. Note that the approved indications for use of dermal fillers vary depending on the product. The FDA may not have reviewed use of dermal fillers in some locations in the body.


In addition to the advice regarding using the correct, authentic dermal filler, the FDA advised health care providers regarding how to use dermal fillers. Health care providers should not inject dermal fillers if they do not have the appropriate training or experience. Regarding informed consent, health care providers should thoroughly inform the patient of all risks of the procedure and the specific product intended to be used. Before injection, health care providers should make sure that they are familiar with the anatomy at and around the site of injection, and do not inject dermal fillers into blood vessels in the face. During injection, health care providers should inject dermal fillers slowly and apply the least amount of pressure necessary.


The FDA advised health care providers regarding injection of dermal fillers into blood vessels. Health care providers should know the signs and symptoms associated with injection into blood vessels, and have an updated plan detailing how the patient will be treated should this occur. This plan may include on-site treatment and/or immediately referring the patient to another health care provider for treatment. Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure. Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel. Educate facility staff and employees on how to quickly assist patients calling with signs and symptoms of filler complications on how to receive appropriate medical care. Health care providers should report to the FDA and the manufacturer if they become aware of any adverse event associated with the use of dermal fillers, including unintentional injection of dermal filler into a blood vessel.


See the FDA Information on Dermal Fillers


See also Medical Law Perspectives Report: Cosmetic Surgery Gone Wrong: High Hopes Meet Unexpected Results


See also Medical Law Perspectives Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory


See also Medical Law Perspectives Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?


See also Medical Law Perspectives Report: Breast Surgery Revisited: Liability Risks of the Resurgery Epidemic