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DERMAL FILLERS - INJECTABLES
Minimally Invasive Cosmetic Facial Rejuvenation

Smooth Wrinkles and Lines - Rejuvenate Skin
FDA approved Dermal Injectable Fillers Listed by Name and Company


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Dermal Fillers & Injectables: Smooth Wrinkles and Reduce Folds

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FDA Spproved Injectable Dermal Fillers for Facial Rejuvenation.

WARNING!
The following is general information on injectable dermal fillers.
This page was not authored by a medical professional and is not medical advice.

You have reached the DERMAL FILLERS page of:
- BoardCertifiedPlasticSurgeon.com

What are dermal fillers?
Dermal filler devices are, in general, approved for injection into the mid to deep dermis for the correction of moderate to severe wrinkles and folds.

Below are the names of some popular FDA approved dermal fillers.

  • Artefill ® -
    Manufactured by: Artes Medical USA, Inc.
    Chemical name: polymethylmethacrylate
    FDA Approved: October 27, 2006.
    Used for: the correction of nasolabial folds
    - hydration is key in maintaining a dewy looking skin.
  • Radiesse ® Injectable Gel Filler
    Manufactured by: Bioform Medical, Inc.
    FDA Approved: December 22, 2006
    Chemical Name: Hydroxylapatite
    Used for: the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
  • Sculptra ®
    Manufactured by: Sanofi Aventis Pharmaceuticals, Inc
    FDA Approved: August 03, 2004
    Chemical Name: Poly (L-lactic acid)
    Used for: the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with or receiving treatment for human immunodeficiency virus.
  • Hydrelletm
    Hyaluronic acid dermal filler with Lidocaine
    Manufactured by: Anika Therapeutics, Inc.
    32 Wiggins Avenue, Bedford MA 01730
    Distributed by: Coapt
    FDA Pre-Market* Approval:
    P050033/S013 - 3/9/12
    180-Day Hydrelle(tm) Anika Therapeutics Inc.
    01730 Approval for updates to the approved product label based on the results of the post-approval clinical study.
    Verify at the www.FDA.gov website for the latest information.
  • Hylaform® - avian (bird) dermal filler.
    Hylaform Plus ®
    Captique®
    Manufactured by: Genzyme Biosurgery
    FDA Approved: April 22, 2004
    Chemical Name: Hyaluronic Acid Used for: injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
  • Restylane ® Injectable Gel
    Perlane ®
    - Injectable Gels
    Manufactured by: Medicis Aesthetics Holdings, Inc.
    FDA Approved: March 25, 2005
    Restylane used for: mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
    Perlane ® - a sterile gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically cross-linked with BDDE, stabilized and suspended in a saline solution.
  • Juvederm ® Injectable Gel
    Manufactured by: Allergan
    FDA Approved: June 2, 2006
    Used for: injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
    Chemical name: hyaluronic acid (HA)
  • Elevess ®
    Manufactured by: Anika Therapeutics, Inc.
    FDA Approved: December 30, 2006
    Used for: injection into the mid to deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
  • Evolence Porcine
    Collagen Dermal Filler
    DISCONTINUED since 2009 - Johnson & Johnson.
    FDA Approved: June 27, 2008
    Used for: an injectable product indicated for the correction of moderate to deep facial wrinkles and folds such as nasolabial folds.
  • Cosmoderm®
    Cosmoplast®
    Manufactured by: Allergan
    FDA Approved: March 11, 2003
    Used for: Human- Based Collagen are injected into the superficial papillary dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars.
  • Zyderm Collagen Implant
    Zyplast
    Manufactured by: Allergan
    Chemical name: bovine dermal collagen
    FDA Approved: July 22, 1981
    Zyderm ® is used for the correction of contour deformities of the dermis in non-weight bearing areas.
    Zyplast is indicated for the correction of contour deficiencies of soft tissue.

The information on this page could be outdated.
Verify at the FDA.gov / Food & Drug Administration website: type in dermal fillers.


General Information About Dermal Fillers
In general, dermal fillers are indicated for injection into mid to deep dermis for the correction of moderate to severe wrinkles and folds. Some devices have limited indications for use such as:
- correction of nasolabial folds (contraindicated for injection in areas other than nasolabial folds
- restoration and/or correction of signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Some dermal fillers are also indicated for use to fill areas of acne scars.
All dermal fillers are contraindicated for patients with
- known sensitivities to the filler material; and
- history of severe allergy or anaphylaxis; and
- bleeding disorders.

Warnings and Precautions
In general, the following warnings and precautions are applicable to all dermal fillers. There are additional warnings that may be device specific, such as those related to device material composition.
Avoid injection into blood vessels as vascular occlusion (and possible subsequent tissue necrosis) may occur:
- Injection should be deferred until infection or inflammation has been controlled or resolved.
- The safety and effectiveness of device injection for lip augmentation had not been established.
- Injection into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
- The safety in patients susceptible to keloid formation, hyperpigmentation and hypertrophic scarring has not been established.
- Long term safety and effectiveness of the device beyond duration of clinical study have not been investigated.

For more information about adverse effects and safety of injectable dermal fillers:
http://www.FDA.gov
Type in "dermal fillers".

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