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Dermal Fillers After 50: FDA Safety Checks Before You Book

Fillers for smile lines, cheeks, lips and the backs of the hands are FDA-regulated medical devices, not spa treatments. The FDA warns against needle-free filler pens, at-home injections and fillers bought online, and lists the warning signs that need emergency care.

Woman in her late fifties sitting in a bright clinic consultation room, listening attentively, with a hand mirror resting in her lap.
In this article
  1. What fillers are approved for
  2. Uses the FDA hasn’t approved
  3. The serious risk to know
  4. Checklist before you book

Fillers can soften the lines from nose to mouth, restore some fullness to cheeks and lips, and plump thinning skin on the backs of the hands.1 They’re often booked like a beauty appointment, but the FDA1 regulates them as medical device implants and says getting them should be considered a medical procedure.1

What fillers are approved for

FDA1-approved uses include:1

  • moderate to severe wrinkles and folds, including smile lines and lines around the mouth
  • adding volume to lips, cheeks, chin and the backs of the hands
  • permanent fillers, only for smile lines and cheek acne scars

Some fillers are absorbed over time and need repeat treatments.1

Uses the FDA hasn’t approved

The FDA1 recommends against fillers for body contouring and says use between the eyebrows, in the nose, around the eyes, in the forehead or in the neck is not approved.1 Injectable silicone isn’t approved for any cosmetic use.1 Needle-free “pens” aren’t approved for injecting fillers, and no fillers are approved for over-the-counter use.1

The serious risk to know

The most concerning risk is filler accidentally entering a blood vessel and blocking blood flow. It’s uncommon, but it can cause tissue death, vision problems including blindness, and stroke.1

Common side effects include bruising, redness, swelling, tenderness and itching.1 Lumps can form, and some problems appear weeks, months or even years later.1 Some fillers can be hard or impossible to remove, especially permanent ones.1

Checklist before you book

  1. Choose a licensed clinician with experience in dermatology or plastic surgery, and ask about their training.1
  2. Never inject yourself or buy filler online; products may be counterfeit or unapproved.1
  3. Ask which product, and read its patient labeling together.1
  4. Ask about each injection site and its specific risks.1
  5. Mention bleeding disorders, severe allergies, or allergies to lidocaine or animal products.1
  6. Ask about combining with wrinkle-relaxer injections; that hasn’t been studied in controlled trials, and neither has long-term repeated use.1
  7. Know the emergency signs: unusual pain, vision changes, white, gray or blue skin near the site, or stroke symptoms.1

Swelling near old filler can also flare after an illness, a vaccine or dental work.1 Mention past fillers to your dentist and doctor. Our articles on counterfeit wrinkle-relaxer injections and LED face masks cover related decisions.

Try: “Which filler would you use, where exactly, and what’s your plan if it gets into a blood vessel?”

Skin, Head to Toe includes a short-shelf planner and a 12-week SkinLog. Use them to record the product, sites, date and any reactions after each treatment. See the book.

This article is for general educational purposes only and is not medical advice. It isn't a substitute for diagnosis or treatment from a qualified healthcare professional who knows your health history. Please don't ignore professional advice or delay getting care because of something you read here. Seek emergency care right away for vision changes, severe pain, skin that turns white, gray or blue, or any sign of stroke during or after a filler injection. If you think you may be having a medical emergency, call 911 or your local emergency number right away. This article discusses a category of medical devices and FDA safety information. It does not evaluate any particular brand, product or provider. Girl Playbook does not endorse any specific product, test, or provider.

Read our health disclaimer

Girl Playbook sells this book. It provides education and worksheets, not individualized medical care.

Sources

The research behind this article, in the order it’s cited. How we source our articles.

  1. U.S. Food and Drug AdministrationDermal Fillers (Soft Tissue Fillers) (opens in a new tab)abcdefghijklmnopqrstuv

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