Dermal fillers—also known as injectable implants, soft tissue fillers, lip and facial fillers, or wrinkle fillers—are considered by the FDA to be medical device implants, and they are approved for use in those 22+ years of age to help create a smoother and/or fuller appearance in the cheek, chin, lips, and back of the hands, but not in the decolletage, breast, buttocks, nose, or areas near the eyes and eyebrows.

These implants are generally considered safe, but the following risks and potential complications should be understood prior to undergoing such procedures:

1. The procedure should not be performed on those that are pregnant or breast-feeding. 

2. An emerging risk of delayed-onset inflammation near treatment sites has been reported following viral or bacterial infections, vaccinations, or dental procedures.

3. Some dermal fillers are absorbed over time, so you may need to repeat the procedure to maintain the desired effect. 

4. Successful results will depend on the underlying tissue structure and the type of filler used. The time that the effect lasts depends on the filler material and the area where it is injected. Review the individual dermal filler’s label for additional information.

5. The safe use of these products in combination with neuromodulators such as Botox has not been evaluated and should be avoided.

6. The safety of these products used repeatedly over a long period of time has not been evaluated in a controlled, clinical study.  

7. The FDA recommends that you seek a licensed health care provider with experience in the fields of dermatology or plastic surgery and one that is trained to perform the procedure. Having filler injected should be considered a medical procedure, not a cosmetic treatment. Ask your health care provider about his/her training and experience injecting dermal fillers.

8. Do not purchase dermal filler products online, because they could be counterfeit or not approved for use in the U.S.

9. Do not inject yourself with dermal fillers.

What if I want to have the dermal filler removed?

There is no approved method of removing dermal fillers. Some dermatologists and plastic surgeons assert that hyaluronic-acid-based fillers could be dissolved with hyaluronidase. Even so, calcium hydroxylapatite (CaHA) and poly-L-lactic acid (PLLA) fillers can’t be dissolved and must break down naturally over time, a time period that has not been studied and is not known. 

Risks specific to the decolletage.

When fillers are used in the decolletage area, they are used off-label (i.e., not approved by the FDA). Social media is fueling more use of fillers in this area, especially among those taking GLP-1 receptor agonists for weight loss that are seeking to improve the skin rippling/folds that often results due to reduced fat.

The FDA is concerned, however, that fillers could: (i) migrate from the injection site or form nodules and/or granulomas and interfere with mammograms, (ii) cause false positive readings on breast imaging or clinical exams,  (iii) impact lymphatic drainage and breastfeeding, or (iv) result in lymph-node enlargement near injection sites.

An FDA panel noted that individuals with darker skin types or known wound-healing issues—both of whom might easily form keloids or nodules—or those with a history of radiotherapy, lymphoma, or other blood cancers are at an even higher risk.

Representatives from dermatology and plastic surgery organizations have crafted guidelines for safe use of fillers in the decolletage; these guidelines, however, are often ignored, as about 75% of these injections are done by non-medical people, and filler use is generally unregulated. Moreover, adverse events are certainly under-reported. 

What to tell your health care provider if you choose to have the procedure done.

If you have any of the following conditions/symptoms, alert your health-care provider:

1. You have an active inflammatory condition (cysts, pimples, rashes, or hives) or an infection.

2. You have a bleeding disorder.

3. You have severe allergies.

4. You are allergic to collagen or eggs (some dermal fillers contain collagen or egg-derived products).

5. You are allergic to animal products (some dermal fillers contain materials from animals).

6. You are allergic to local anesthetic such as lidocaine (some dermal fillers contain lidocaine).

7. You are allergic to bacteria (some dermal fillers contain hyaluronic acid material derived from bacterial fermentation).

Common side effects of the procedure.

The FDA has periodically examined dermal filler safety. Their webpage lists common reactions such as bruising, redness, swelling, and pain.  Less common risks listed by the FDA include: Inflammation (swelling or redness) near the injection site; raised bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgically removed; infection; open or draining wounds; soreness at the injection site; allergic reaction; tissue necrosis (tissue death).