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Approved and Unapproved Uses of Soft Tissue Fillers (Cosmetic Injectables)
Approved and unapproved uses of cosmetic fillers

How injectable Fillers help prevent wrinkles and nasolabial folds

Injectable fillers can help correct and prevent the appearance of wrinkles and folds, such as nasolabial folds by filling in areas where soft tissue has depleted due to age, external factors, or even illness. As the skin ages or comes into contact with harmful external factors like constant sun or smoke, the internal structure of the skin becomes compromised. Important proteins like collagen, elastin, and hyaluronic acid are not produced as effectively as in younger, healthier skin, and so the skin becomes dry, loses volume, and even begins to wrinkle and sag.

Dermal fillers are able to fix this issue by implanting the lost substances, like hyaluronic acid, back into the skin, hydrating the skin on a cellular level and adding plumpness. Dermal fillers are also able to help stimulate cell production, leading to an increase in production in those important proteins like collagen and elastin. Some filler treatments even include antioxidant ingredients to help fight off free radicals, preventing further damage and providing long-lasting results. Dermal fillers are the most popular treatment for correcting nasolabial folds, the wrinkles that begin at the sides of the mouth and extend toward the nose.

Approved Uses

The FDA has approved dermal fillers, also known as soft tissue fillers, injectable implants, or wrinkle fillers, for a number of uses to help create a smoother, more radiant appearance. Dermal fillers are medical devices and should only be administered by a licensed and experienced health-care professional. Soft tissue fillers made from absorbable material are approved for:

  1. The correction of moderate to severe wrinkles and skin folds in the face. This includes nasolabial folds.
  2. Increasing volume in the back of the hands, also known as hand augmentation.
  3. The correction of lipoatrophy, a form of facial fat loss, in patients with HIV.
  4. Lip and cheek augmentation.
  5. Correcting contour deficiencies, which may include wrinkles and acne scars.

Unapproved Uses

While dermal fillers are very versatile and can be used in many areas to help restore hydration and volume, there are a number of cosmetic treatments that they have not been approved for, including:

  1. Increasing the size of the breasts (breast augmentation)
  2. Increasing the size of the buttocks
  3. Increasing the fullness of the feet
  4. Implantation into bones, tendons, ligaments, or muscles

The FDA has also not approved more permanent silicone injectables for large-scale body enhancements or contouring. Attempting to use injectables in such a manner can have many adverse effects, including ongoing pain, infection, and even serious permanent injures such as scarring, disfigurement, embolism, stroke, and death.


While fillers have undergone controlled clinical studies to ensure the safety and effectiveness of the treatment, there are still some risks associated with soft tissue filler injections. As with any medical procedure, short-term and long-term side effects are a possibility. Most side effects experienced are mild and will appear shortly after injection and go away in under 2 weeks.

Common side effects:

  • Bruising, redness, swelling, or pain at the injection site
  • Tenderness
  • Itching or rash
  • Difficulty performing tasks if injected into the back of the hands

Less common side effects:

  • Nodules or granulomas in or under the skin
  • Infection
  • Open wounds
  • Allergic reaction
  • Necrosis of the skin

Rare side effects:

  • Anaphylactic shock
  • Movement of implant material from initial injection site
  • Leakage of implant material
  • Permanent nodules
  • Vision issues
  • Stroke

Though these side effects have been reported, the vast majority of dermal injection procedures are safe and free of complication or serious adverse effects when administered by a licensed practitioner.

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