FDA Approved Injectable Dermal Fillers for Facial Rejuvenation.
Approved
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.
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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.
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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).
-
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:
https://www.FDA.gov
Type in "dermal fillers".
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