What are the risks of FDA-approved fillers?
Remember to work with a licensed health care provider to ask what you can expect for FDA-approved fillers. Then contact your health care provider if you are concerned about a particular side effect.
The most common side effects include:
- bruising
- redness
- swelling
- pain
- itching
Additional side effects less commonly reported include:
- infections
- lumps and bumps
- discoloration or change in pigmentation
Rare but serious risks include:
- scarring, blurred vision, partial vision loss, and blindness if the dermal filler is inadvertently injected into a blood vessel. It is recommended that health care providers take care to avoid injection into blood vessels (especially around the forehead, nose and eye area) for these reasons.
- allergic reaction that may lead to a severe reaction (anaphylactic shock) that requires emergency medical help.
Most side effects occur shortly after injection and go away within two weeks. In some cases, side effects may emerge weeks, months, or years later. Talk to your licensed health care provider if you have questions or concerns.
5 Tips for Consumers About Injectable Dermal Fillers
- ALWAYS work with a licensed health care provider who uses properly labeled, sealed vials for treatments. You also can ask to confirm that you are receiving an FDA-approved filler. And never get injectable fillers from unlicensed providers or in non-medical settings like hotels or private homes.
- ALWAYS request and read the patient labeling information on FDA-approved injectable wrinkle fillers from your licensed health care provider.
- ALWAYS know the type of product to be injected and all of its possible side effects. Know where each product used is to be injected. Talk to your licensed health care provider if you have any questions.
- NEVER buy dermal fillers on the Internet. They may be fake, contaminated, and/or harmful.
- NEVER get any type of filler or liquid silicone injected for body contouring. This means you should never get breast fillers, “butt” fillers, or fillers for spaces between your muscles. These products, which include certain types of injectable silicone, can be dangerous and can cause serious injury and even death.
Also, know that the safety of these products is unknown for use in pregnant or breastfeeding women or in patients under 18 years of age. The safety also is unknown if used with Botox or other wrinkle therapies. (The FDA regulates Botox Cosmetic as a drug. See the section below for more information.)
You should discuss the different types of FDA-approved dermal fillers and the results you want to achieve with your licensed health care provider, who can refer you to a licensed dermatologist or plastic surgeon. (You may want to contact the American Academy of Dermatology, the American Society of Plastic Surgeons, or the American Society for Aesthetic Plastic Surgery.)
Ask your licensed health care provider if you have specific questions.
More About Botox
Botox Cosmetic and other botulinum toxin type A products such as Dysport and Xeomin are indicated to treat wrinkles. Remember that they are injectable drugs but not dermal fillers. They work by keeping muscles from tightening so the wrinkles don’t show as much. Adverse events 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.
The FDA has approved these products only for the temporary improvement in the appearance of frown lines, forehead lines, and crow’s feet. If you have questions about these products, talk to your licensed health care provider.
If you'd like to report suspected criminal activity related to FDA-regulated products, you can make a report on the FDA’s website.
And if you ever have a problem with an FDA-regulated product — such as an injury or an issue with the way the product works — please report the problem to the FDA. The agency continues to track approved products for safety even after they’ve been sold. You can file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Subscribe: FDA Consumer Health Information
Updated: November 14, 2017
Pages: 1 · 2
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